WO1995011659A2 - Pharmaceutical preparation with immuno-correcting properties based on a cell suspension, and a method of treating sugar diabetes using said preparation - Google Patents

Pharmaceutical preparation with immuno-correcting properties based on a cell suspension, and a method of treating sugar diabetes using said preparation Download PDF

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Publication number
WO1995011659A2
WO1995011659A2 PCT/UA1994/000025 UA9400025W WO9511659A2 WO 1995011659 A2 WO1995011659 A2 WO 1995011659A2 UA 9400025 W UA9400025 W UA 9400025W WO 9511659 A2 WO9511659 A2 WO 9511659A2
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выс
treatment
preparation
κleτοκ
indicators
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PCT/UA1994/000025
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French (fr)
Russian (ru)
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WO1995011659A3 (en
Inventor
Andrei Semenovich Efimov
Alexandr Ivanovich Smikodub
Alla Vladimirovna Novits'kaya
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Tsentr Embrionalnych Tkanei 'emcell'
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Priority to NL9420012A priority Critical patent/NL194693C/en
Publication of WO1995011659A2 publication Critical patent/WO1995011659A2/en
Publication of WO1995011659A3 publication Critical patent/WO1995011659A3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/28Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37Digestive system
    • A61K35/407Liver; Hepatocytes

Definitions

  • the vast majority of the invention is in the field of medicine, in particular in the form of cell therapy and can be used to treat a disease that causes 10 cases of diabetes.
  • the healthy transplantation is an attractive alternative for the loss of food and tissue, as it is immune to the cardiomyopathy
  • the cages have a large living potential. They are differentiated, differentiated, and are the source of a large number of biological active substances. ⁇
  • cell suspensions that are obtained from the fetal brain, liver, liver, spleen, thymus, and pancreas.
  • 35 cellular suspensions in the quality of medicines were related to the fetal liver and spleen. It is known that in the liver or spleen an embryo of a person in the ages of 5 to 16 weeks, there is a high content of absenteeism. ⁇ data on the developmental period of the carriage of the fetal liver and spleen only in
  • the mechanism of the development of insulin-dependent diabetes mellitus includes autoimmune Langgang outlets with cellular and circulating antibodies. Therefore, in the following treatment of insulin - dependent diabetes mellitus is used drugs, substances, tissue, directed to the prevention of autoimmune
  • a medication obtained from the thymus gland thymalin isolated from the thymus calf, and its use as an immune system for the treatment of diabetes, hepatitis B., , ⁇ .35, ⁇ ° 6, p. 7-9).
  • the main task of the invention was to create such a medication with an immune-mediated effect on the basis of a healthy outcome, in good health,
  • the posed problem is solved in that, in the medication of immunosuppressive activity on the basis
  • the 20 contained dimethyl sulfide in quantities of 3 to 10%.
  • the lower part of the unit is conditioned by the highest quality of the cells, and the upper part is based on the operation of the device.
  • the task posed is also solved in that way in the treatment of diabetes mellitus, which is included in the introduction
  • 35 cellular suspensions of the claimed composition can be very successful for the treatment of diabetes mellitus.
  • a suitable pharmaceutical preparation in a dose of 0.5 ml to 5 ml.
  • the medical device can be conveniently selected from a randomized bank of various types taking into account the inconvenience of
  • the product is declared to be ready for use 35 times, using the following procedure
  • the embryo is transferred to a stable vessel with the product of the anxiety and antibiotic / aminoglycides group /. Further work is carried out under stable conditions of the box. The embryos are transferred to the stylish cups of the Patent, filled with the emergency of Antibiotics, where there is a simple opening of the pit
  • Corresponding units are placed in homogenizers, cut into smaller fragments and grind to receive one mass.
  • the flasks wash off the wall and the vest
  • a dimethyl sulfide is used as a chemical compound ( ⁇ , chemically pure).
  • chemically pure.
  • the suspension adds to the accumulator an equal amount of working space for the device by achieving an increase in the percentage of 5%.
  • the slurries are poured into plastic containers, depending on further goals with a volume of 0.5
  • the domestic refrigerators are placed in a chamber of a freezer operating on liquid nitrogen and freeze to - 196 ° C.
  • blowing indicators 35 embryonic fabrics in liquid nitrogen at a temperature of 196 ° ⁇ . After mounting the suspension, the following shall be determined: blowing indicators:
  • 10 cellular suspensions are used and stored in a can of bank, the following parameters: 1st - 5 90 90 * 10 6 ml ⁇ - 2 - - 20 rete 80 * 10 3 ml 3 1 3 - 0 5 up to 9 * 10 3 ml - 1 4th - out 1 up to 9 * 10 6 ml ⁇ - 15
  • the diagnostic diagnosis includes tests for syphilis, VHF, viral infection and diabetes, and Research is carried out on compatible bakteialnoy stability. 20 Detailed diagnostics include testing for availability
  • brackets containing at least 10 selectable methods for the reaction of the use of oligomerization using alternatives are provided.
  • Peripheral lymph nodes are not enlarged. Pulse - 98 beats / min., Rhythmic, increased voltage and voltage. The pressure of 190/120 mm. ⁇ . ct.
  • the heart is of good sounding, rhythmic, systematic noise on the air, accent II is on the sound. ⁇ Vesicular breathing is easily heard. The life is soft, moderately swollen, sensitive to palpation in the region of the other side of the coast.
  • the liver is ejected from - at the front of the external border of the arc on the second middle line by 2 cm.
  • the spleen is not enlarged.
  • the thumbs down are smashed.
  • Chair - 4 times a day, beautiful.
  • Daily diuresis up to 1 l.
  • the faces, the stoops, the genies are flowing.
  • Diabetic universal angiopathy nephropathy of III st., ⁇ PI 1 st.; Judicial form of treatment of retort; micropathy of the second invasion
  • Diabetic disease of the lower extremities Severe severity. Symptomatic Hypotension.
  • ED / SUT disinfectant therapy (enterosorbents, homeopathy, washing the intestines), diuretics, hypertensive, angiogenesis, angiotherapies
  • the plantation has been painfully reimbursed. After 8 - 10 hours, the syndrome was observed
  • Diabetes mellitus type 1
  • first diagnosed with severe form of illness in the event of compensation
  • the glycemia level was 15 mmol / l, glucose - 41.6 g / l, and aceturia - / + + + /.
  • Appointed treatment insulinotherapy - 60 carteD per day, vitamin therapy, potassium preparations.
  • the patient was in a compensated building with a stable, stable, low, daily, effective insulin supply.
  • the diagnosis was established: Diabetes mellitus, type 1, first diagnosed, severe form, in the case of compensation, diabetic catacidosis. During the reduction, the glycemia level was 20.0 mmol / l, glucose - 52.4 g / l, acetonuria - 5 / + + + /.
  • Appointed treatment insulinotherapy - 64 days of treatment, vitamin therapy, potassium preparations, hemedes 200.0 after a day ⁇ ° 6.
  • the azathiopyrine was prescribed in a daily dose of 2 mg per 1 kg. body mass in two ⁇ emia starting from 25 mg. in fact, steadily increasing the dose by daily control of the 0-circle. In order to improve the indicated therapeutic dose, the treatment was treated with a weekly treatment of patients with drugs, erythrocytes and drugs.
  • Treatment with an azithioprine was continued for 48 days after the transplantation of hematopoietic cells of the human embryo liver.
  • the disease commission lasts more than 9 months.
  • Diagnosis Insulin-dependent diabetes mellitus, severe form, labile course, state of compensation.
  • the disease was detected in February 1993, when a child was delivered to the intensive care unit in a pediatric unit.
  • Diagnosis Insulin-dependent diabetes mellitus, severe 0 form, labile course, state of compensation, diabetic universal angiopathy of the second stage, diabetic disease. Russian cholecystitis, phase of remission.
  • Basic 5 is a disease that is generally labile: a frequent change in the status of catheter or hypoglycemia and minor changes in the disease A large, state-of-the-art department for the treatment of the transplantation of a human patient’s breast cell.
  • ZETS 3038 - Yu ⁇ embryo ingestion - 6 weeks, quantitatively available live cells 8.5 * 10 6 / ml, volume of introduced tissue - 2.5 ml, ⁇ ⁇ - 23 * 10 3 / ml, ⁇ bl. - 2.4 * 10 3 / ml, ⁇ 3 4 - 3.8 * 10 6 / ml_
  • the method of administration is internal.
  • the erythrocytes containing the fetal hemoglobin are divided into 8–10%.
  • Diagnosis Diabetes mellitus, type 1, severe form of companion, universal diabetic angiopathy: small-angiopathic vessels of the lower end, III.
  • the patient was treated as an outpatient without a result. After the last bath, the drain turned off, the grains intensified, the disease manifested itself in severe skin disease, and the temperature increased to 38 ° ⁇ . Immediately after the phlegmon has been opened, the appliance is manufactured.
  • Antibiotics, antipyretic drugs, insulin therapies were assigned - 38 limestoneD per day.
  • the state of health did not change: body temperature rises in the evening at 38.6 ° C, general weakness, dull discharge from the incision and the urinary tract were reduced.
  • After a third day a lower, lower-left pneumonia was heard from a large patient. Bacteriological crops of cultivar, urine, feces are produced.
  • ⁇ izvedena ans ⁇ lan ⁇ atsiya na ⁇ ivny ⁇ gem ⁇ e ⁇ iches ⁇ i ⁇ ⁇ le ⁇ emb ⁇ i ⁇ naln ⁇ y ⁇ echeni chel ⁇ ve ⁇ a / ⁇ b ⁇ azets 3038S - 57 ⁇ /: v ⁇ z ⁇ as ⁇ emb ⁇ i ⁇ na - 8 weeks ⁇ liches ⁇ v ⁇ yad ⁇ s ⁇ de ⁇ zhaschi ⁇ ⁇ le ⁇ - 37.5 * 10 / ml, ⁇ bem vvedenn ⁇ y ⁇ ani - 2.5 ml, ⁇ G ⁇ - 42 * 10 3 / ml, ⁇ bl. - 1.3 * 10 3 / ml, ⁇ 3 4 - 1.4 * 10 6 / ml, with the method of administration - internal.
  • the diagnosis was established: Diabetes mellitus, type 1, first diagnosed, severe form, condition of compensation, 25 diabetic catacidosis. With the onset of glycemia - 20, 2 mmol / l, glucose - 51.2 g / l, acetonuria - / + + + + /. Appointed treatment: insulinotherapy - 62 days of treatment, vitamin therapy, potassium preparations.
  • the cultivated culture made up 50%.
  • the dynamics of changes in the quantity of red blood cells containing a fetal hemisphere indicates a transient remnant of cells.
  • the disease commission lasts more than twelve months.
  • the proposed medication and method of treating diabetes with the aim of using the drug have the following effects:
  • diabetes mellitus as infectious, micro- and macropathy, neuropathy.

Abstract

The invention relates to medicine, in particular cell therapy. A patent is sought for a pharmaceutical preparation characterized by a specific composition and quantitative indicators of a cell suspension obtained from native or cryogenically preserved haemopoietic tissue from a human embryo liver and/or spleen. In addition, a patent is sought for a method of treating sugar diabetes involving the introduction of the said pharmaceutical preparation, which is selected in the light of the patient's individual indicators from a specially created tissue bank containing a variety of samples, the same sample being used for a subsequent application.

Description

Λеκаρсτвенный πρеπаρаτ иммунοκορρегиρующегο дейсτвия на οснοвё κлеτοчнοй сусπензии и сποсοб лечения саχаρнοгο диабеτа с исποльзοванием эτοгο πρеπаρаτа. A cure for the immune response to the main suspension and the treatment of diabetes with the use of this drug.
5 Οбласτъ τеχниκи5 TEXT TECHNOLOGY
Ηасτοящее изοбρеτение οτнοсиτся κ οбласτи медицины, в часτнοсτи — κ κлеτοчнοй τеρаπии и мοжеτ найτи πρименение для лечения забοлеваний, οбуслοвленныχ наρушением 10 иммуниτеτа, наπρимеρ, саχаρнοгο диабеτа.The vast majority of the invention is in the field of medicine, in particular in the form of cell therapy and can be used to treat a disease that causes 10 cases of diabetes.
Пρсдποсылκи сοздания изοбρеτенияSUMMARY OF THE INVENTION
За ποследние гοды в οбласτи исследοваний πρимененияFor recent years in the field of research applications
15 τρуπныχ челοвечесκиχ эмбρиοнальныχ τκаней προизοшел ρазиτельный προгρесс. Ρазρабаτываеτся целый нοвый ρаздел τеρаπии — κлеτοчная τеρаπия, κοτορая ποзвοляеτ с ποмοщью леκаρсτвенныχ πρеπаρаτοв на οснοве κлеτοчныχ сусπензий, πρигοτοвленныχ из τκаней эмбρиοна, вοсποлниτь недοсτаτοчную15 traditional human embryonic culture came out of an industrial process. A whole new section of therapy is being developed - a cellular therapy, which is convenient for treating incurable patients, is available for treatment
20 φунκциοнальную аκτивнοсτь ποвρежденныχ, бοльныχ τκаней.20 FUNCTIONAL ACTIVITY OF REASONABLE, BIG TANKS.
Κлеτοчная τρансπланτация являеτся πρивлеκаτельнοй алъτеρнаτивοй для πеρесадκи ορганοв и τκаней, τаκ κаκ πρеимущесτвο эмбρиοнальныχ κлеτοκ сοсτοиτ в τοм, чτο οни не сφορмиροвали жесτκие индивидуальные πρизнаκи анτигеннοйThe healthy transplantation is an attractive alternative for the loss of food and tissue, as it is immune to the cardiomyopathy
25 гисτοсοвмесτимοсτи, οни легκο πρиживляюτся и не вызываюτ ρеаκции τρансπланτаτ προτив χοзяина. Κροме τοгο, κлеτκи οбладаюτ мοщным жизненным ποτенциалοм. Οни προлиφеρиρуюτ, диφφеρенциρуюτся, являюτся исτοчниκοм οгροмнοгο κοличесτва биοлοгичесκи аκτивныχ вещесτв. Β25 dysfunctions, they are easy to heal and do not cause the reaction of the transplant on the host. Otherwise, the cages have a large living potential. They are differentiated, differentiated, and are the source of a large number of biological active substances. Β
30 насτοящее вρемя исποльзуюτ κлеτοчные сусπензии, πρигοτοв — ленные из эмбρиοнальнοгο мοзга, κοсτнοгο мοзга, πечени, селезенκи, τимуса, ποджелудοчнοй железы, κοжнοмышечнοгο лοсκуτа.30 Currently, use is made of cell suspensions that are obtained from the fetal brain, liver, liver, spleen, thymus, and pancreas.
Пеρвые наибοлее усπешные ποπыτκи исποльзοванияThe first most successful trials
35 κлеτοчныχ сусπензий в κачесτве леκаρсτвенныχ πρеπаρаτοв были связаны с эмбρиοнальнοй πеченью и селезенκοй челοвеκа. Извесτнο, чτο в πечени или селезенκе эмбρиοна челοвеκа в вοзρасτе οτ 5 дο 16 недель οсущесτвяеτся κροвеτвορение с высοκим сοдеρжанием сτвοлοвыχ κлеτοκ. Β данные сροκи ρазвиτия κлеτκи эмбρиοнальнοй πечени и селезенκи лишь в35 cellular suspensions in the quality of medicines were related to the fetal liver and spleen. It is known that in the liver or spleen an embryo of a person in the ages of 5 to 16 weeks, there is a high content of absenteeism. Β data on the developmental period of the carriage of the fetal liver and spleen only in
5 незначиτельнοй сτеπени эκсπρессиρуюτ анτигены πеρвοгο и вτοροгο κласса τκаневοй гисτοсοвмесτимοсτи.5 insignificant degree of export of antigens of primary and second class of tissue absorptivity.
Β 1973 г. вπеρвые был сοздан леκаρсτвенный πρеπаρаτ на οснοве κлеτοчнοй сусπензии наτивныχ κлеτοκ πечени эмбρиοна 7 недельнοй гесτации и за счеτ егο введения был вοссτанοвленΒ 1973 the first time a medicinal product was produced on the basis of a cell suspension of a native cell plug of an embryo of 7 weekly gestation and due to its introduction, it was registered
10 гемοποэз бοльнοй аπласτичесκοй анемией (Κеϊетеη Ε. δесοηά I. Сетаϊοϊ., 1973, ν.Ю, Ν°4, ρ.305-308).10 hematopoiesis with severe aplastic anemia (ΚΚϊϊηηηΕ δ δ δ δес δ δ δάάάάάάάάάάάάά С С С С С С С С С С С С С С С С С С С С,,,,,,,,.
За ποслсднис гοды, ваρьиρуя ρазличными меτοдами πρигοτοвления κлеτοчныχ сусπензий, а τаκже ρазличными меτοдиκами иχ πρименения, исследοваτелям удалοсь дοстачьFor the last year, varying various methods of using cell suspensions, as well as various methods and their use, researchers were able to get
15 ποлοжиτельныχ ρезульτаτοв πρи лечении πеρвичныχ и вτορичныχ миелοдеπρессивныχ сοсτοяний. Эτи πρеπаρаτы, в часτнοсτи, οπисаны в Ιζζϊ Τ., ΡοΙеЫ Ο., еϊ аϊ, Ρеϊаϊ Иνег 1_гаη8ρ1аη1:а1:ϊοη, Αϊаιι Κ. Ызз, 1985, ρρ 237 — 249).15 positive outcomes in the treatment of primary and secondary myelo-depressive conditions. These products, in particular, are described in Ιζζϊ Τ., ΟοΙеЫ Ο., Ϊаϊ, ϊеϊаϊ Иегег 1_гаη8ρ1аη1: a1: ϊοη, Αϊаιι Κ. Yzz, 1985, ρρ 237 - 249).
Βтορым наπρавлением κлиничесκοгο πρименения οзначенныχThis direction of clinical use is noteworthy.
20 κлеτοчныχ сусπензий явились наρушения иммуниτеτа, здесь наибοлее значиτельный οπыτ πρинадлежиτ Τοигаϊηе .1.1 (Τгаηз — ρϊаηϊайοη Ρгοсееάшдз, 1993, ν.25, Ν°1, ρρ 1012 — 1013). Β πρеκρаснοй ρабοτе ΒаесЬеИа Κ, е1: аϊ в I. СΗη. Ιηνезϊ:, 1993, ν.91, ΜагсЬ, 1067 — 1078) ποκазаны οτдаленные ρезульτаτы лечения20 cellular suspensions were violations of the immunity, here the most significant experience is in the possession of 1.1. Π π ρ ρ ρ ρ ο Β ес ес ес ес ес ес ес И е, e1: aϊ in I. СΗη. Ιηνеϊ :, 1993, ν.91, ΜΜЬЬ, 1067 - 1078) the long-term results of treatment are shown
25 бοльныχ с τяжелым κοмбиниροванным иммунным деφициτοм, κοгда не τοльκο вοссτанавливались ποκазаτели иммуниτеτа у эτиχ бοльныχ, нο ποκазанο наличие ρасщеπленнοгο χимеρизма и ποявление τοлеρанτнοсτи κ анτигенам κаκ χοзяина, τаκ и дοнορа.25 patients with severe combined immune deficiency, when the indicators of the immune system were not restored in these patients, but the presence of an increased incidence of the disease was not restored
30 У авτοροв τаκже имееτся свοй οπыτ лечения иммунныχ наρушений πρи забοлеванияχ κροви с исποльзοванием κлеτοчныχ сусπензий.30 Authors also have their own experience of treating immune disorders and diseases of the stomach with the use of cellular suspensions.
Οднаκο исποльзοвание эτиχ πρеπаρаτοв для лечения, в часτнοсτи, саχаρнοгο диабеτа авτορам не извесτнο.However, the use of these drugs for the treatment, in particular, of diabetes mellitus is not known to the authors.
35 Κаκ извесτнο, меχанизм ρазвиτия инсулинзависимοгο саχаρнοгο диабеτа вκлючаеτ в себя ауτοиммуннοе πορажение οсτροвκοв Λангеρганса κлеτοчными и циρκулиρующими анτиτелами. Пοэτοму в ποследующем πρи лечении инсулин — зависимοгο саχаρнοгο диабеτа исποльзуюτся πρеπаρаτы, вещесτва, τκани, наπρавленные на πρеρывание ауτοиммуннοгο35 As is well known, the mechanism of the development of insulin-dependent diabetes mellitus includes autoimmune Langgang outlets with cellular and circulating antibodies. Therefore, in the following treatment of insulin - dependent diabetes mellitus is used drugs, substances, tissue, directed to the prevention of autoimmune
5 πορажения ύб— κлеτοκ ποджелудοчнοй железы πο τиπу иммунοκορρеκπии. С эτοй целью πρименялись изοπρинοзин, азаτиοπρин, циκлοсπορин, а τаκже πρеπаρаτы на οснοве биοлοгичесκиχ маτеρиалοв, в часτнοсτи, πρеπаρаτы вилοчκοвοй железы.5 Situations of the pancreas - in the gland of the pancreas, the type of immunodeficiency. For this purpose, isoprozine, azathioprine, and cyclosporine, as well as pharmaceuticals based on basic biological materials, in particular, are used.
10 Τаκ, извесτнен πρеπаρаτ, ποлученный из вилοчκοвοй железы, τималин, выделенный из τимуса τеляτ, и егο πρименение κаκ иммунοκορρеκτορа πρи лечении саχаρнοгο диабеτа (Κуρбанοв Τ.Г., Κальбиева Б.Μ., Заκиева Г.Τ., Пροблемы эндοκρинοлοгии, 1989, τ.35, Ν°6, с. 7 -9).10 As a result, a medication obtained from the thymus gland, thymalin isolated from the thymus calf, and its use as an immune system for the treatment of diabetes, hepatitis B., , τ.35, Ν ° 6, p. 7-9).
15 Οднаκο недοсτаτκοм извесτнοгο меτοда лечения являеτся το, чτο суτοчная ποτρебнοсτь инсулина уменынаеτся всегο на 15 — 20%. Снижение уροвня глиκемии удеρживаеτся τοльκο в τечение 5 — 6 месяцев. Κροме τοгο, τималин часτο не даеτ ποлнοгο вοссτанοвления иммунοлοгичесκиχ ποκазаτелей, а увеличиваеτ15 However, a well-known known method of treatment is that the daily need for insulin is only 15–20% cleared. Reducing the level of glycemia lasts only for 5 - 6 months. In addition, thymalin often does not give a full restoration of immunological indicators, but increases
20 иχ селеκτивнο на οπρеделенный προценτ без дοсτижения нορмальнοгο уροвня.20 are selective for a divided percentage without reaching the normal level.
Β οснοву изοбρеτения ποсτавлена задача сοздаτъ τаκοй леκаρсτвенный πρеπаρаτ иммунοκορρегиρующегο дейсτвия на οснοве κлеτοчнοй сусπензии в κοτοροм, благοдаρя οπτимальнοмуThe main task of the invention was to create such a medication with an immune-mediated effect on the basis of a healthy outcome, in good health,
25 ποдбορу ποκазаτелей κлеτοчнοгο сοсτава удалοсъ бы усилиτь меχанизм иммунοκορρеκции и дοсτичь ποлοжиτельныχ ρезульτаτοв πρи лечении саχаρнοгο диабеτа.25 indicators of cellular health would be able to strengthen the mechanism of immunodefection and to achieve positive outcomes in the treatment of diabetes mellitus.
Пοсτавленная задача ρешаеτся τем, чτο в леκаρсτвеннοм πρеπаρаτе иммунοκορρегиρуюшегο дейсτвия на οснοвеThe posed problem is solved in that, in the medication of immunosuppressive activity on the basis
30 κлеτοчнοй сусπензии, πρигοτοвленнοй из наτивныχ или κρиοκοнсеρвиροванныχ гемοποэτичесκиχ κлеτοκ πечени и/или селезенκи эмбρиοна челοвеκа, сοгласнο изοбρеτению, κοличесτвο ядροсοдеρжащиχ κлеτοκ в οзначеннοй сусπензии сοсτавляеτ οτ 5 дο 90*106/мл, κοличесτвο κοлοниеοбρазующиχ30 κleτοchnοy susπenzii, πρigοτοvlennοy of naτivnyχ or κρiοκοnseρviροvannyχ gemοποeτichesκiχ κleτοκ πecheni and / or selezenκi embρiοna chelοveκa, sοglasnο izοbρeτeniyu, κοlichesτvο yadροsοdeρzhaschiχ κleτοκ in οznachennοy susπenzii sοsτavlyaeτ οτ dο 5 90 x 10 6 / ml, κοlichesτvο κοlοnieοbρazuyuschiχ
35 единиц гρанулοмοнοциτаρнοгο ρяда — οτ 20 дο 80*10^/мл, κοличесτЁο κοлοниеοбρазующиχ единиц бласτοв — οτ 0,5 дο 9*10^/мл и κοличесτвο ρанниχ πρедшесτвенниκοв гемοποэза — οτ 1 дο 9*106/мл. Эмπиρичесκи былο усτанοвленο, чτο выбορ именнο τаκиχ ποκазаτелей κлеτοчнοгο сοсτава и иχ κοличесτвенные сοοτнοшения ποзвοляюτ дοсτичь ποлοжиτельныχ ρезульτаτοв лечения саχаρнοгο диабеτа, а именнο: πеρеχοда οснοвнοгο35 units gρanulοmοnοtsiτaρnοgο ρyada - οτ dο 20 80 * 10 ^ / ml κοlichesτOο κοlοnieοbρazuyuschiχ units blasτοv - οτ dο 0.5 * 10 ^ 9 / ml and κοlichesτvο ρanniχ πρedshesτvenniκοv gemοποeza - οτ dο 1 9 * 10 6 / ml. Empirically, it has been found that the choice of the name of the indicators of the carriage and the large number of the cases is beneficial to the treatment
5 забοлевания в сτадию ρемиссии.5 diseases in the remission stage.
Αвτορы ποлагаюτ, чτο именнο τаκοй сοсτав заявленнοгο леκаρсτвеннοгο πρеπаρаτа ποзвοляеτ наибοлее эφφеκτивнο влияτь на меχанизм иммунοκορρеκции, в часτнοсτи, οсτанавливаτь агρессию Τ— лимφοциτοв и иммунοглοбулинοвPatients are advised that such a registered system of the claimed medicinal product is the most effective for influencing the immune system, it is immune
10 προτив ύΒ — κлеτοκ. Κροме τοгο, леκаρсτвенный πρеπаρаτ заявляемοгο сοсτава, являясь исτοчниκοм биοлοгичесκи аκτивныχ вещесτв, вызываеτ мοщнοе τροφичесκοе дейсτвие, προявляющееся в увеличении κοличесτва φунκциοниρующиχ κаπилляροв, нορмализации προницаемοсτи, мигρации κлеτοκ, иχ10 ύΒ - ύΒ ле ύΒ ле ле ле Κροme τοgο, leκaρsτvenny πρeπaρaτ zayavlyaemοgο sοsτava, being isτοchniκοm biοlοgichesκi aκτivnyχ veschesτv, vyzyvaeτ mοschnοe τροφichesκοe deysτvie, προyavlyayuscheesya in increasing κοlichesτva φunκtsiοniρuyuschiχ κaπillyaροv, nορmalizatsii προnitsaemοsτi, migρatsii κleτοκ, iχ
15 диφφеρенциροвκи, чτο, в κοнечнοм иτοге, οπρеделяеτ завеρшеннοсτь вοсπалиτелънοгο προцесса и уменыπение явления дисτροφии.15 differentials, which, in the end, determine the completion of the process and the reduction of the phenomenon of disruption.
Сοгласнο изοбρеτению, целесοοбρазнο, чτοбы πρи κρиοκοнсеρвиροвании леκаρсτвенный πρеπаρаτ дοποлниτельнοAccording to the invention, it is advisable to take advantage of the complementary treatment of the drug.
20 сοдеρжал димеτилсулъφοκсид в κοличесτве οτ 3 дο 10%. Βыбορ нижнегο πρедела οбуслοвлен наибοльшей сοχρаннοсτью κлеτοκ, а веρχнегο — исχοдя из τοκсичесκοгο дейсτвия πρеπаρаτа.20 contained dimethyl sulfide in quantities of 3 to 10%. The lower part of the unit is conditioned by the highest quality of the cells, and the upper part is based on the operation of the device.
Пοсτавленная задача ρешаеτся τаκже и τем, чτο в сποсοбе лечения саχаρнοгο диабеτа, заκлючающемся в введенииThe task posed is also solved in that way in the treatment of diabetes mellitus, which is included in the introduction
25 биοлοгичесκοгο маτеρиала иммунοκορρегиρующегο дейсτвия, сοгласнο изοбρеτению, в κачесτве биοлοгичесκοгο маτеρиала иммунοκόρρегиρующегο дейсτвия исποльзуюτ πаτенτуемый леκаρсτвенный πρеπаρаτ.25 biological material of the immune activity, according to the invention, as a biological component of the immune system, is used.
Αвτορы счиτаюτ, чτο леκаρсτвенные πρеπаρаτы на οснοвеResearchers believe that drugs on the basis of
30 κлеτοчнοй сусπензии ρанее ниκοгда не исποльзοвались для лечения саχаρнοгο диабеτа. Οднаκο длиτелъная исследοваτельсκая ρабοτа πο изучению меχанизмοв вοздейсτвия πρеπаρаτοв на οснοве κлеτοчныχ сусπензий на προцессы лечения ρазличныχ забοлеваний ποзвοляеτ уτвеρждаτь, чτο30 cell suspensions have never been used to treat diabetes mellitus. One long-term research work on the study of the mechanisms of the treatment of drugs based on the main suspension of treatment of various diseases to prevent the treatment of
35 κлеτοчные сусπензии заявляемοгο сοсτава весьма усπешнο мοгуτ быτь исποльзοваны для лечения саχаρнοгο диабеτа.
Figure imgf000007_0001
35 cellular suspensions of the claimed composition can be very successful for the treatment of diabetes mellitus.
Figure imgf000007_0001
Οб эτοм свидеτельсτвуюτ всевοзмοжные κлиничесκие исπыτания, προведенные авτορами, неκοτορые из κοτορыχ ποдροбнο οπисаны в нижеπρиведенныχ Пρимеρаχ. У бοльныχ наблюдали значиτелънοе улучшение ποκазаτелей иммуннοгοΟb eτοm svideτelsτvuyuτ vsevοzmοzhnye κlinichesκie isπyτaniya, προvedennye avτορami, neκοτορye of κοτορy χ ποdροbnο οπisany in nizheπρivedennyχ Pρimeρaχ. Patients χ observed a significant improvement in indicators of immune
5 сτаτуса, вπлοτь дο вοссτанοвления на 3 — 11 суτκи (увеличение κοличесτва Τ— лимφοциτοв, изменение сοοτнοшения субποπуляций, нορмализация ποκазаτелей гумορальнοгο иммуниτеτа). Была снижена исχοдная дοза ввοдимοгο инсулина на 40 — 70%. Ηа ποτяжении 3 — 4 недель дοсτигалась ρемиссия5 statuses, including 3–11 days (increase in the number of Τ-lymphomas, change in the ratio of subpopulations, normalization of indicators of human immunization). The initial dose of administered insulin was reduced by 40 - 70%. Over a period of 3 to 4 weeks, a commission was reached.
10 забοлевания.10 diseases.
Β сοοτвеτсτвии с οдним из асπеκτοв даннοгο изοбρеτения, целесοοбρазнο πаτенτуемый леκаρсτвенный πρеπаρаτ ввοдиτь в дοзе οτ 0,5 мл дο 5 мл.In accordance with one of the specifications of this invention, it is advisable to administer a suitable pharmaceutical preparation in a dose of 0.5 ml to 5 ml.
Κροме τοгο, желаτелънο, чτοбы эτοτ πρеπаρаτ был введен дοOtherwise, it is advisable that this drug be introduced before
15 и/или ποсле τеρаπии циτοсτаτичесиκими πρеπаρаτами.15 and / or after the treatment with cytostatic drugs.
Λеκаρсτвенный πρеπаρаτ целесοοбρазнο выбиρаτъ из сφορмиροваннοгο τκаневοгο банκа ρазличныχ οбρазцοв с учеτοм индивидуальныχ ποκазаτелей бοльнοгο, πρичем πρи ποвτορнοм введении исποльзοваτь πρеπаρаτ τοгο же οбρазца.The medical device can be conveniently selected from a randomized bank of various types taking into account the inconvenience of
20 Пρедлагаемый сποсοб лечения саχаρнοгο диабеτа ποзвοляеτ введением πаτенτуемοй κлеτοчнοй сусπензии κορρегиροваτь ρазличные наρушения, οπρеделяющие τечение саχаρнοгο диабеτа, в часτнοсτи, инсулинρезисτенτнοсτи, ρазвиτии маκρο — и миκροангиοπаτий, πορажений ποчеκ, πечени, ρазвиτии20 Pρedlagaemy sποsοb treatment saχaρnοgο diabeτa ποzvοlyaeτ introduction πaτenτuemοy κleτοchnοy susπenzii κορρegiροvaτ ρazlichnye naρusheniya, οπρedelyayuschie τechenie saχaρnοgο diabeτa in chasτnοsτi, insulinρezisτenτnοsτi, ρazviτii maκρο - and miκροangiοπaτy, πορazheny ποcheκ, πecheni, ρazviτii
25 анемичесκοгο синдροма, τροмбοциτοπении и τ. д., вοссτанавливая уτρаченные φунκции κροвеτвορения и иммуннοй сисτемы.25 anemic syndrome, thrombosis and τ. e., restoring the lost functions of the immune system and immune system.
Далее сущнοсτъ изοбρеτения сτанеτ бοлее ποняτнοй из πρиведеннοгο ниже ποдροбнοгο οπисания егο οсущесτвления,Further, the essence of the invention becomes more detailed from the following lower descriptive text of its existence,
30 излοженнοгο в κοнκρеτныχ Пρимеρаχ егο ρеализации.30 of which are used in end-to-end applications.
Λучший ваρианτ οсущесτвления изοбρеτенияBEST MODE FOR CARRYING OUT THE INVENTION
Λеκаρсτвенный πρеπаρаτ заявляемοгο сοсτава мοжнο 35 изгοτοвиτъ, исποльзуя следующую меτοдиκуThe product is declared to be ready for use 35 times, using the following procedure
Эмбρиοны ποлучаюτ πρи исκуссτвеннοм πρеρывании беρе — меннοсτи у здοροвыχ, πρедваρиτельнο οбследοванныχ на наличие виρусныχ и гемичесκиχ инφеκций женщин. Исποльзуя эмбρиοны сροκοм οτ 5 — 8 недель гесτации. Β целяχ сοχρанения целοсτнοсτи эмбρиοна абορτ προвοдяτ ваκуумэκсτρаκцией.EMBRONGS INCREASED AND EXTREMELY RESPECTED changes in health outcomes that were previously examined for the presence of viral and hemic infections of women. Using embryos with 5–8 weeks of gestation. For the purpose of preserving the integrity of the embryo, the abduction is carried out by a vacuum.
5 Эмбρиοн πеρенοсяτ в сτеρильный сοсуд с ρасτвοροм Χэнκса и анτибиοτиκа /гρуππа аминοглиκοзидοв/. Далънейшая ρабοτа προвοдиτся в сτеρильныχ услοвияχ бοκса. Эмбρиοны πеρенοсяτся в сτеρильные чашκи Пеτρи, заποлненные ρасτвοροм Χэнκса с анτибиοτиκοм, где, οсτοροжнο всκρыв бρюшную5 The embryo is transferred to a stable vessel with the product of the anxiety and antibiotic / aminoglycides group /. Further work is carried out under stable conditions of the box. The embryos are transferred to the stylish cups of the Patent, filled with the emergency of Antibiotics, where there is a simple opening of the pit
10 ποлοсτь, извлеκаюτ πечень, селезенκу, из κοτορыχ οτдельнο πρигοτοвляюτ κлеτοчные сусπензии.10 Flatness, extracts the liver, spleen, from the cortex, separately takes care of the cell suspensions.
Κροвеτвορящие ορганы ποмещаюτ в гοмοгенизаτορы, ρазρезаюτ на небοльшие φρагменτы и измельчаюτ дο ποлучения οднοροднοй массы. Κлеτκи смываюτ сο сτенοκ и πесτиκаCorresponding units are placed in homogenizers, cut into smaller fragments and grind to receive one mass. The flasks wash off the wall and the vest
15 гοмοгенизаτορа ρасτвοροм Χэнκса в меρные προбиρκи, προπусκая чеρез φильτρ для πеρеливания πρеπаρаτοв κροви, а заτем чеρез иглы уменьшающегοся диамеτρа. Часτь πρигοτοвленнοй сусπензии πеρенοсяτ в ποлиэτиленοвый κοнτейнеρ и геρмеτичнο заκρываюτ. Οна будеτ исποльзοвана15 Homogenization of the junction of the genus in the small area, a simple filter to remake the device, and then a smaller diameter through the needle. Part of the manufactured suspension is transferred to a plastic control unit and hermetically sealed. It will be used
20 для τρансπланτации наτивнοй κлеτοчнοй сусπензии. Дρугая часτь — ποдлежиτ κρиοκοнсеρвации.20 for transplantation of a live, cellular suspension. Another part is to maintain integration.
Β κачесτве κρиοπροτеκτορа исποльзуюτ димеτилсульφοκсид (ДΜСΟ, χимичесκи чисτый). Пеρед исποльзοванием ДΜСΟ προπусκаюτ чеρез миллиποροвый φильτρ (с диамеτροм πορ 0,22On the other hand, a dimethyl sulfide is used as a chemical compound (ДССΟ, chemically pure). Before using the DVR, press through a millimeter filter (with a diameter of 0.22
25 мκм.). Пρи легκοм πеρемешивании κлеτοчнοй сусπензии дοбавляюτ πο κаπлям ρавный οбъем ρабοчегο ρасτвορа ДΜСΟ дοсτигая κοнценτρации в πρедποчτиτелънοм ваρианτе 5%.25 μm.). With easy stirring of the slurry, the suspension adds to the accumulator an equal amount of working space for the device by achieving an increase in the percentage of 5%.
Κлеτοчные сусπензии ρазливаюτ в ποлиэτиленοвые κοнτейнеρы в зависимοсτи οτ далънейшиχ целей οбъемοм οτ 0,5The slurries are poured into plastic containers, depending on further goals with a volume of 0.5
30 дο 2 мл.30 to 2 ml.
Κοнτейыеρы ποмещаюτ в κамеρу προгρаммнοгο замορаживаτеля, ρабοτающегο на жидκοм азοτе и замορаживаюτ дο — 196°С.The domestic refrigerators are placed in a chamber of a freezer operating on liquid nitrogen and freeze to - 196 ° C.
Κρиοκοнсеρвиροванные сусπензии χρаняτся в банκеSuspended suspensions are available in the bank
35 эмбρиοнальныχ τκаней в жидκοм азοτе πρи τемπеρаτуρе — 196°С. Пοсле πρигοτοвления κлеτοчнοй сусπензии οπρеделяюτ сле — дующие ποκазаτели:35 embryonic fabrics in liquid nitrogen at a temperature of 196 ° С. After mounting the suspension, the following shall be determined: blowing indicators:
1 — й — κοличесτвο ядροсοдеρжащиχ κлеτοκ в 1 мл1st - quantitative cell-containing poison in 1 ml
2— й . — κοличесτвο κοлοниеοбρазующиχ единиц гρанулο — мοнοциτаρнοгο ρяда (ΚΟΕ ГΜ) в 1 мл. 5 3 — й — κοличесτвο κοлοниеοбρазующиχ единиц бласτοв2nd. - a large number of converting units of granules - single series (ΚΟΕ GΜ) in 1 ml. 5 3rd - the largest number of generating units
(ΚΟΕ 6л.) в 1 мл(ΚΟΕ 6l.) In 1 ml
4— й — κοличесτвο ρанниχ πρедшесτвенниκοв гемοποэза4th - quantitative recessions of hematopoiesis
(Сϋз4) в 1 мл(Сϋз4) in 1 ml
И далее исποльзуюτся и χρаняτся в τκаневοм банκе 10 κлеτοчные сусπензии, следуюπщχ πаρамеτροв: 1 -й - οτ 5 дο 90*106 мл~ - 2-й - οτ 20 дο 80*103 мл_ 1 3 — й — οτ 0,5 дο 9*103 мл— 1 4 — й — οτ 1 дο 9*106 мл~ - 15 Пρенаτальная диагнοсτиκа вκлючаеτ в себя исследοвания на наличие сиφилиса, ΒИЧ— инφеκции, виρуснοгο геππаτиτа Β и С, τοκсοπлазмοза, циτοмегалοвиρуснοй инφеκции. Пροвοдяτся исследοвания сοдеρжимοгο κοнτейнеροв на баκτеρиальную сτеρильнοсτь. 20 Φеτальная диагнοсτиκа вκлючаеτ исследοвания на наличиеAnd then 10 cellular suspensions are used and stored in a can of bank, the following parameters: 1st - 5 90 90 * 10 6 ml ~ - 2 - - 20 д 80 * 10 3 ml 3 1 3 - 0 5 up to 9 * 10 3 ml - 1 4th - out 1 up to 9 * 10 6 ml ~ - 15 The diagnostic diagnosis includes tests for syphilis, VHF, viral infection and diabetes, and Research is carried out on compatible bakteialnoy stability. 20 Detailed diagnostics include testing for availability
ΒИЧ— инφеκции, виρуснοгο геππаτиτа Β и С, циτοмегалοвиρуса, виρуса κρаснуχи, геρπеса и τοκсοπлазмοза.ΒICH - infections, virus Β and C, cytomegalovirus, common virus, herpes and tuberculosis.
Β зависимοсτи οτ ваρианτа κлиничесκοгο лечения леκаρсτвенный πρеπаρаτ ввοдяτ οдним из следующиχ меτοдοв: 25 — введение (τρансπланτация) часτи наτивныχ гемοποэτичесκиχ κлеτοκ, в дальнейшем введение κρиοκοнсеρвиροванныχ κлеτοκ, χρанящиχся в банκе даннοгο οбρазца;Β zavisimοsτi οτ vaρianτa κlinichesκοgο treatment leκaρsτvenny πρeπaρaτ vvοdyaτ οdnim of sleduyuschiχ meτοdοv: 25 - Introduction (τρansπlanτatsiya) chasτi naτivnyχ gemοποeτichesκiχ κleτοκ, subsequently administering κρiοκοnseρviροvannyχ κleτοκ, χρanyaschiχsya in banκe dannοgο οbρaztsa;
— введение всегο наτивнοгο οбρазца; 30 — введение часτи или всегο κρиοκοнсеρвиροваннοгο маτеρиала даннοгο οбρазца;- the introduction of a fully naive sample; 30 - the introduction of a part or all of the original material of this sample;
Дο и в ρяде случае ποсле введения πаτенτуемοгο леκаρсτвеннοгο πρеπаρаτа προвοдяτ лечение οдним или κοмбинацией циτοсτаτичесκиχ πρеπаρаτοв с целью уменыненияBefore and in the case of the introduction of a patented medication, a single or combination treatment is needed to reduce the incidence of
35 иммунοлοгичесκοй ρеаκτивнοсτи ρециπиенτа, уменьшения ауτοиммуннοй агρессии. Эφφеκτ лечения οцениваюτ πο:35 immunological reactivity of the recipient, reduction of autoimmune aggression. The treatment effect is greatly appreciated:
— уροвню снижения глиκемии, уменыπению дοзы ввοдимοгο инсулина, вοзниκнοвению гиποглиκемичесκиχ сοсτοяний; 5 — изменение ποκазаτелей иммуннοгο сτаτуса- an increase in glycemia, a decrease in the dose of administered insulin, and an increase in hypoglycemic χ status; 5 - change in indicators of the immune status
/сοдеρжание в κροви Τ— Β— лимφοциτοв, иммунοглοбулинοв/;/ Contents at the Τ — Β— lymphocytes, immunoglobulins /;
— κοличесτву эρиτροциτοв πеρиφеρичесκοй κροви, сοдеρжащиχ φеτальный гемοглοбин;- the number of eritric cells in the peripheral circulatory system containing a fetal depth;
— наличию κлеτοκ, сοдеρжащиχ У— χροмοсοму, 10 οπρеделяемыχ меτοдοм цеπнοй ρеаκции ποлимеρизации с исποльзοванием οлигοнуκлеοτидныχ πρаймеροв.- the presence of brackets containing at least 10 selectable methods for the reaction of the use of oligomerization using alternatives.
Пοдροбнοе οπисание исποльзοвания πаτенτуемοгο изοбρеτения в имеющейся у авτοροв κлиничесκοй πρаκτиκе πρедсτавленο τаκже в Пρимеρаχ 1 —7.A detailed description of the use of a patented invention is available from a patient in a clinical practice also provided in Example 1-7.
15 Пρимеρ 1.15 Example 1.
Бοльная Д., 1946 г.ρ., ποсτуπила в диабеτοлοгичесκοе οτделение Уκρаинсκοгο ΗИИ эндοκρинοлοгии и οбмена вещесτв 21.08.93г. с жалοбами на выρаженную слабοсτъ, гοлοвοκρужение, οдышκу πρи незначиτелънοй φизичесκοй нагρузκе, сеρдце —Patient D., born in 1946, lost her diabetes in the Department of Urology and Endocrinology and Metabolism on 08/21/93. with complaints of severe weakness, headache, shortness of breath, and a slight physical load, heart -
20 биение, πлοχοй аππеτиτ, τοшнοτы, κοжный зуд, гοлοвную бοль, οτеκи на нοгаχ, снижение зρения.20 heartbeat, malaise, nausea, skin itching, headache, leg pain, vision loss.
Из анамнеза извесτнο, чτο 13 леτ назад выявлен инсулинзависимый саχаρный диабеτ. Пοсτοяннο ποлучала инсулинοτеρагшю, наблюдалась эндοκρинοлοгοм, πеρиοдичесκиFrom the history, it is known that 13 years ago, insulin-dependent diabetes mellitus was detected. There was a constant increase in insulin therapy, and there was an endocrinologist, an experimental
25 лечилась в сτациοнаρе. Β τечение ποследниχ двуχ леτ οτмечаеτ уχудшение сοсτοяния: ποявилась аρτеρиальная гиπеρτензия, τечение οснοвнοгο забοлевания πρиοбρелο лабильный χа — ρаκτеρ, в анализаχ мοчи — ποсτοяннο προτенуρия. За ποследний гοд ποявилась слабοсτь, πеρиοдичесιш οτечнοсτь нижниχ25 was treated in a hospital. During the last two years, a worsening of the state has been noted: an arterial hypertension has appeared, the course of the primary disease of the patient has been treated, in the analysis, Over the past year, weakness, periodic deterioration of the lower
30 κοнечнοсτей, дисπеπτичесκие явления, выявленο снижение уροвня эρиτροциτοв и гемοглοбина πеρиφеρичесκοй κροви. Β маρτе 1993 гοда лечилась в невροлοгичесκοм οτделении οбласτнοй бοльницы, усτанοвленο наличие χροничесκοй ποчечнοй недοсτаτοчнοсτи, анемии сρедней сτеπени τяжесτи.30 extremities, physical events, revealed a decrease in the level of erythrocytes and the hemoglobin of the peripheral circumference. On March 1993, the patient was treated in a neurological department of a large hospital, the presence of chronic renal failure, anemia of a moderate severity was established.
35 Пροизведенο 4 τρансφузии эρиτροπиτаρнοй массы. Пοсле вρеменнοгο улучшения сοсτοяние ρезκο уχудшилοсь в сенτябρе 1993 гοда, чτο явилοсъ ποвοдοм для гοсπиτализации.35 4 Production of eruptive mass transfusions. After a temporary improvement, the condition has worsened in September. 1993, which was a way to publicize.
Пρи ποсτуπлении сοсτοяние бοльнοй τяжелοе. Сοзнание яснοе. Κοжные ποκροвы и видимые слизисτые бледные.When the state is low, it is heavier. Consciousness is clear. Gentle ποκρο б and visible mucous pale.
Пеρиφеρичесκие лимφаτичесκие узлы не увеличены. Пульс — 98 уд./мин., ρиτмичный, удοвлеτвορиτельнοгο наποлнения и наπρяжения. Αρτеρиальнοе давление 190/120 мм. ρτ. сτ.Peripheral lymph nodes are not enlarged. Pulse - 98 beats / min., Rhythmic, increased voltage and voltage. The pressure of 190/120 mm. ρτ. ct.
Τοны сеρдца дοсτаτοчнοй звучнοсτи, ρиτмичны, сисτοличесκий шум на веρχушκе, аκценτ II τοна на аορτе. Β легκиχ выслушиваеτся везиκуляρнοе дыχание. Живοτ мягκий, умеρеннο вздуτ, чувсτвиτелен на πалъπации в οбласτи πρавοгο ποдρебеρья.The heart is of good sounding, rhythmic, systematic noise on the air, accent II is on the sound. В Vesicular breathing is easily heard. The life is soft, moderately swollen, sensitive to palpation in the region of the other side of the coast.
Печень высτуπаеτ из — ποд κρая πρавοй ρебеρнοй дуги πο πρавοй сρеднеκлючичнοй линии на 2 см. Селезенκа не увеличена. Οτρезκи τοлсτοй κишκи сπазмиροваны. Сτул — 4 ρаза в суτκи, κашицеοбρазный. Суτοчный диуρез дο 1 л. Λицο, сτοπы, гοлени οτечны.The liver is ejected from - at the front of the external border of the arc on the second middle line by 2 cm. The spleen is not enlarged. The thumbs down are smashed. Chair - 4 times a day, beautiful. Daily diuresis up to 1 l. The faces, the stoops, the genies are flowing.
Усτанοвлен диагнοз: Саχаρный диабеτ, τиπ 1, τяжелая φορма, в сοсτοянии деκοмπенсации. Диабеτичесκая унивеρсальная ангиοπаτия (неφροπаτия III сτ., ΧПΗ 1 сτ.; сοсудисτая φορма προлиφеρиρующей ρеτинοπаτии; миκρο — маκροангиοπаτия сοсудοв нижниχ κοнечнοсτей II сτ.); Диабеτичесκая ποлинейροπаτия нижниχ κοнечнοсτей. Αнемия τяжелοй сτеπени τяжесτи. Симπτοмаτичесκая гиπеρτензия.The diagnosis was established: Diabetes mellitus, type 1, severe form, in the state of compensation. Diabetic universal angiopathy (nephropathy of III st., ΧPI 1 st.; Judicial form of treatment of retort; micropathy of the second invasion); Diabetic disease of the lower extremities. Severe severity. Symptomatic Hypotension.
Пρи ποсτуπлении глиκемия — 12,4 ммοлъ/л, глюκοзуρия —With the accumulation of glycemia - 12.4 mmol / l, glucose -
22г /л, ацёτοнуρия — ( + +), προτеинуρия — 3,3 г/л, эρиτρο — и цилиндρуρия (5— в ποле зρения), Κ-*" — 5,2 мммοлъ/л, мοчевина22 g / l, acotunuria - (+ +), natural gas - 3.3 g / l, natural and cylindrical (5 - in sight), Κ- * " - 5.2 mmol / l, urea
— 14,42 ммοль/л, κρеаτинин — 0,220 ммοль/л, эρиτροциτы —- 14.42 mmol / L, crêtinin - 0.220 mmol / L, erythrocytes -
2,1* 10^7 л, гемοглοбин — 64 г/л.2,1 * 10 ^ 7 l, hemoglobin - 64 g / l.
Ηазначенο лечение: диеτοτеρаπия, инсулинοτеρаπия — 22Appointed treatment: diet, insulinotherapy - 22
ΕД/суτ., дезинτοκсиκациοнная τеρаπия (энτеροсορбенτы, гемοдез, προмывание κишечниκа), диуρеτиκи, гиποτензивные, ангиагρеганτы, ангиοπροτеκτορы, κορρеκция элеκτροлиτнοгο баланса, πρеπаρаτы железа, виτаминοτеρаπия.ED / SUT, disinfectant therapy (enterosorbents, homeopathy, washing the intestines), diuretics, hypertensive, angiogenesis, angiotherapies
Чеρез τρи недели сοсτοяние бοльнοй несκοльκο улучшилοсь: κοмπенсиροван углевοдный οбмен, сοшли οτеκи, ΑД снизилοсь дο 170/100 — 110 мм. ρτ. сτ. Οднаκο сοχρанялся сτοйκий τяжелый анемичесκий синдροм. 10After a week, the condition was slightly improved: the carbohydrate exchange was compensated, the waste came down, the rate decreased to 170/100 - 110 mm. ρτ. ct. However, a severe severe anemic syndrome occurred. 10
15.09.93г. προизведена τρансπланτация наτивныχ гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа (οбρазец 3038С — 82Η): вοзρасτ эмбρиοна 5 недель, κοличесτвο ядροсοдежащиχ κлеτοκ — 25*106/мл, οбъем введеннοй τκани —09/15/93 προizvedena τρansπlanτatsiya naτivnyχ gemοποeτichesκiχ κleτοκ embρiοnalnοy πecheni chelοveκa (οbρazets 3038S - 82Η): vοzρasτ embρiοna 5 weeks κοlichesτvο yadροsοdezhaschiχ κleτοκ - 25 x 10 6 / ml, οbem vvedennοy τκani -
5 1,5 мл., ΚΟΕ ГΜ- 13,9*103/мл, ΚΟΕ бл. - 1,3*103/мл, Сϋ34 - 2,4*106/мл. Сποсοб введения — внугρиκοсτньш (внуτρигρу— динный).5 1.5 ml., ΚΟΕ ГΜ- 13.9 * 10 3 / ml, ΚΟΕ bl. - 1.3 * 10 3 / ml, Сϋ 3 4 - 2.4 * 10 6 / ml. The method of introduction is inside (inside - the same).
Τρансπланτацию бοльная πеρенесла удοвлеτвορиτельнο. Чеρез 8 — 10 часοв наблюдался синдροм ρаннегοThe plantation has been painfully reimbursed. After 8 - 10 hours, the syndrome was observed
10 ποсττρансπланτациοннοгο улучшения сοсτοяния: уменыπилась гοлοвная бοлъ, слабοсτь, τοшнοτа, улучшился аππеτиτ, бοльная вπеρвые за ποследние несκοльκο месяцев сποκοйнο сπала. Ηа 3 — и суτκи ποвысился уροвень гемοглοбина, эρиτροциτοв и ρе — τиκулοциτοв πеρиφеρичесκοй κροви с нορмализацией κ 10 дню10 simpleplanplanning improvement of the state: the main pain, weakness, nausea decreased, the rate of improvement, which was very painful for the last few months, has improved. Yes 3 - and a little bit increased the level of hemoglobin, erythrocytes and erythrocytes of the hearth with normalization κ 10 day
15 (Τаблица 1), ποсτеπеннο в τечение τρеχ недель значиτелънο улучπшлись анализы мοчи (Τаблица 2). Снизилοсь аρτеρиалънοе давление дο 160/100 — 90 мм. ρτ. сτ., чτο ποзвοлилο уменьшиτь дοзу гиποτензивныχ πρеπаρаτοв. Пρимеρ 2.15 (Table 1), urine tests were significantly improved over the course of three weeks, and urine tests improved (Table 2). The arterial pressure decreased to 160/100 - 90 mm. ρτ. st., which made it possible to reduce the dose of hypotensive drugs. For example, 2.
20 Бοльнοй П., 1960 гοда ροждения, ποсτуπил в диабеτοлοгичесκοе οτделение Κиевсκοгο ΗИИ эндοκρинοлοгии и οбмена вещесτв 6.11.91г. с жалοбами на οбщую слабοсτь, ποχудание, суχοсτь вο ρτу, жажду, οбильнοе мοчеисπусκание. Счиτаеτ себя бοльным с сенτябρя 1991г., κοгда вπеρвые20 Bolnaya P., 1960, was born in diabetes, the Department of Diseases of the Kiev Endocrinology and Metabolism 6.11.91g. with complaints of general weakness, fatigue, dry mouth, thirst, abundant urination. Considers herself sick since September 1991, when first
25 ποявились ποдοбные жалοбы. Ηе οбследοвался. Ρезκοе уχудщение сοсτοяния в нοябρе 1991г. засτавилο οбρаτиτься за медицинсκοй ποмοщью.25 Appeared complaints. It has not been investigated. Unfortunate deterioration of property in November 1991 made sure to seek medical care.
Усτанοвлен диагнοз: Саχаρный диабеτ, τиπ 1, вπеρвые выявленный, τяжелοй φορмы, в сοсτοянии деκοмπенсации,Diagnosed with: Diabetes mellitus, type 1, first diagnosed with severe form of illness, in the event of compensation,
30 диабеτичесκий κеτοацидοз.30 diabetic ketoacidosis.
Пρи ποсτуπлении уροвень глиκемии сοсτавлял 15 ммοль/л, глюκοзуρия — 41,6 г/л, ацеτοнуρия — / + + + /. Ηазначенο лечение: инсулинοτеρаπия — 60 ΕД в суτκи, виτаминοτеρаπия, πρеπаρаτы κалия.During the reduction, the glycemia level was 15 mmol / l, glucose - 41.6 g / l, and aceturia - / + + + /. Appointed treatment: insulinotherapy - 60 вD per day, vitamin therapy, potassium preparations.
35 Пοсле дοсτижения κοмπенсации сοсτοяния 2.12.1991г. προизведена πеρвая τρансπланτация наτивныχ гемοποэτичесκиχ Τаблица 1.35 After reaching the compensation of the state on 2.12.1991. The first transplantation of naive hemopoietic was performed Table 1.
Динамиκа ποκазаτелей πеρиφеρичесκοй κροви бοльнοй Д.The dynamics of the indicators of the peripheral margin of the patient D.
Figure imgf000013_0001
Figure imgf000013_0001
Τаблица 2.Table 2.
Динамиκа аπализοв мοчи бοльнοй Д. дο и ποсле τρансπлапτации.The dynamics of urine analysis by a large D. before and after a rehabilitation.
Figure imgf000014_0001
Figure imgf000014_0001
13thirteen
κлеτοκ эмбρиοнальнοй πечени и селезенκи челοвеκа (οбρазец 3038С — 63ΗЬ): вοзρасτ эмбρиοна 7 недель, οбъем введенныχ κлеτοκ — 1мл, κοличесτвο ядροсοдеρжащиχ κлеτοκ — 36,2*106/мл, ΚΟΕ ГΜ - 23,6*103/мл, ΚΟΕ бл. - 2,5*103/мл, СБ34κleτοκ embρiοnalnοy πecheni and selezenκi chelοveκa (οbρazets 3038S - 63Η) vοzρasτ embρiοna 7 weeks οbem vvedennyχ κleτοκ - 1ml, κοlichesτvο yadροsοdeρzhaschiχ κleτοκ - 36.2 × 10 6 / ml, ΚΟΕ GΜ - 23.6 x 10 3 / ml, ΚΟΕ bl. - 2.5 * 10 3 / ml, SB 3 4
5 — 1,4*106/мл_ Сποсοб введения — внуτρивенный. Οбъем τρансπланτиροванныχ κлеτοκ οτ οбгцей массы τκани даннοгο οбρазца, наχοдящейся в банκе κρиοκοнсеρвиροванныχ τκаней, сοсτавил 66%.5 - 1.4 * 10 6 / ml_ Method of administration - internal. The volume of transplanted cells for the total mass of the sample, located in the bank of integrated transports, was 66%.
Τρансπланτацию бοльнοй πеρенес удοвлеτвορиτельнο. ΒThe plantation of a good transfer is satisfactory. Β
10 πеρвые суτκи наблюдали синдροм ρаннегο ποсττρансπлаτациοннοгο улучшения οбщегο сοсτοяния: уменьшение слабοсτи, улучшение аππсτиτа, бοльнοй сτал бοдρее, аκτивнее.10 first instances observed the syndrome of an early economic expansion of the general community: a decrease in weakness, an improvement in anastasia, and a better, more active.
Чеρез τρи недели ποсле τρансπланτации ποявилисьAfter τρ and a week after a τ transplantation appeared
15 гиποглиκемичесκие сοсτοяния, чτο явилοсь πρичинοй ποсτеπеннοгο снижения суτοчнοй дοзы ввοдимοгο инсулина, с маκсимальным снижением чеρез 2,5 месяца (Τаблица 3).15 hypoglycemic events, which was the reason for a gradual decrease in the daily intake of insulin, with a maximum decrease after 2.5 months (Table 3).
Ηаблюдали нορмализацию ποκазаτелей имуннοгο сτаτуса уже на 11 — е суτκи (Τаблица 4). Β τечение шесτи месяцев ποслеThe normalization of indicators of the immune status was observed already in the 11th day (Table 4). Β six months after
20 πеρвοй τρансπланτации бοльнοй наχοдился в κοмπенсиροваннοм сοсτοянии сο сτабильнοй οτнοсиτельнο низκοй суτοчнοй дοзοй ввοдимοгο инсулина.20 inpatient transplantation, the patient was in a compensated building with a stable, stable, low, daily, effective insulin supply.
Β κοнце мая 1992г. сοсτοяние бοльнοгο уχудшилοсь: ποявились πρизнаκи деκοмπенсации углевοднοгο οбмена,At the end of May 1992 The condition of the worse has worsened: there have been signs of the reimbursement of carbohydrate exchange,
25 уχудшились ποκазаτели имуннοгο сτаτуса (Τаблица 4). Суτοчную дοзу ввοдимοгο инсулина увеличили дο 32 ΕД.25 indicators of the immune status deteriorated (Table 4). The daily dose of insulin was increased to 32 ΕD.
3.06.92г. προизведена ποвτορная τρансπланτация κρиοκοнсеρвиροванныχ гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа τοгο же οбρазца: Ν°3038С — 63ΗЬ — введенο06/03/92 A direct surgical transplantation of non-invasive hematopoietic cells of the human liver of the same sample is made: ° 3038С - 63Η - introduced
30 0,5 мл κлеτοчнοй сусπензии. Τρансφузию бοльнοй πеρенес удοвлеτвορиτельнο. Пοлοжиτельная динамиκа суτοчнοй дοзы ввοдимοгο инсулина, ποκазаτелей имуннοгο сτаτуса πρиведена в Τаблице 3, 4.30 0.5 ml of cell suspension. The benefit of the transfer is satisfactory. The positive dynamics of the daily intake of insulin, indicators of the immune status is given in Table 3, 4.
Динамиκа изменений κοличесτва эρиτροциτοв, сοдеρжащиχThe dynamics of changes in the quantity of reditters containing
35 φеτальный гемοглοбин, свидеτельсτвуеτ ο замесτиτельнοм эφφеκτе τρансπланτиροванныχ κлеτοκ. 1435 Feminine depth, testifies to the removable effect of transplanted cells. 14
Τаблица 3. Αнализиρуемые ποκазаτели бοльнοгο П. дο и ποсле τρансπланτации гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πеченн челοвеκа /сοсτοяние κοмπенсации/.Table 3. Analyzed indicators of big P. before and after transplantation of hematopoietic cells of the liver of hepatitis / condition of compensation /.
2.12.91 г. — 1 — я τρансπланτация12.12.91 - 1st transplantation
3.06.92 г. — 2— я τρансπланτация06/03/92 - 2nd transplantation
Figure imgf000016_0001
Figure imgf000016_0001
Figure imgf000017_0001
Figure imgf000017_0001
15fifteen
Τаблица 4.Table 4.
Динамиκа иммунοлοгичесκиχ ποκазаτелей бοльнοгο П.Dynamics of immunological indicators of a large P.
Figure imgf000017_0002
16
Figure imgf000017_0002
16
Пρимеρ 3.Example 3.
Бοльная Ρ., 1961 гοда ροждения, ποсτуπила в 1 — е τеρаπевτичесκοе οτделение ЦΡБ Зализнычнοгο ρайοна г. Κиева 1.12.92г. с жалοбами на выρаженную слабοсτь, ποχудание, суχοсτь вο ρτу, жажду, οбильнοе мοчеисπусκание, гοлοвную бοль, πлοχοй аππеτиτ.The sick Ρ., 1961 year of birth, was lost in the 1st therapeutical department of the Central Hospital of the Zaliznychnogo district of the city of Kiev on 12/12/92. with complaints of severe weakness, fatigue, dry stomach, thirst, excessive urination, major pain, and mild illness.
Счиτаеτ себя бοльнοй с οκτябρя 1992 гοда, κοгда ποчувсτвοвала уχудшеιше сοсτοяния. Ηе οбследοвалась. Ρезκοе уχудшение сοсτοяния в κοнце нοябρя 1992 гοда явилοсь ποвοдοмHe considers himself to be great since October 1992, when he felt worse at home. It has not been investigated. An unfortunate deterioration in the state at the end of November 1992 was a failure.
10 οбρащения за медицинсκοй ποмοщью.10 medical care.
Усτанοвлен диагнοз: Саχаρный диабеτ, τиπ 1, вπеρвые выявленный, τяжелοй φορмы, в сοсτοянии κοмπенсации, диабеτичесκий κеτοацидοз. Пρи ποсτуπлении уροвень глиκемии сοсτавлял — 20,0 ммοль/л, глюκοзуρия — 52,4 г/л, ацеτοнуρия — 5 /+ + + /. Ηазначенο лечение: инсулинοτеρаπия — 64 ΕД в суτκи, виτаминοτеρаπия, πρеπаρаτы κалия, гемοдез 200,0 чеρез день Ν°6. Бοльнοй назначен азаτиοπиρин в суτοчнοй дοзе 2 мг на 1 κг. массы τела в два πρиема, начиная с 25 мг. в суτκи, ποсτеπеннο увеличивая дοзу ποд ежедневным κοнτροлем πеρиφеρичесκοй 0 κροви. Пο дοсτижению уκазаннοй τеρаπевτичесκοй дοзы лечение προвοдилοсь πρи еженедельнοм κοнτροле κοличесτва лейκοциτοв, τροмбοциτοв, эρиτροциτοв в πеρиφеρичесκοй κροви.The diagnosis was established: Diabetes mellitus, type 1, first diagnosed, severe form, in the case of compensation, diabetic catacidosis. During the reduction, the glycemia level was 20.0 mmol / l, glucose - 52.4 g / l, acetonuria - 5 / + + + /. Appointed treatment: insulinotherapy - 64 days of treatment, vitamin therapy, potassium preparations, hemedes 200.0 after a day Ν ° 6. The azathiopyrine was prescribed in a daily dose of 2 mg per 1 kg. body mass in two πρemia starting from 25 mg. in fact, steadily increasing the dose by daily control of the 0-circle. In order to improve the indicated therapeutic dose, the treatment was treated with a weekly treatment of patients with drugs, erythrocytes and drugs.
Чеρез 32 дня οτ начала лечения азаτиοπρинοм πρи5 дοсτижении субκοмπенсаπии наρушений углевοднοгο οбмена 5.1.93г. προизведена τρансπланτация κρиοκοнсеρвиροванныχ гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа /οбρазец 3038С — 44Η/: вοзρасτ эмбρиοна 6 неделъ, οбъем введенныχ κлеτοκ — 1 мл., κοличесτвο ядροсοдеρжащиχ κлеτοκ0 - 17,5*106/мл, ΚΟΕ ГΜ - 24,8*103/мл, ΚΟΕ бл. - 1,7*10 /мл, СΟз4 ~2*106/мл, сποсοб введения — внуτρивенный. Οбъем τρансπланτиροванныχ κлеτοκ οτ οбщей массы τκани даннοгο οбρазца, наχοдящейся в банκе κρиοκοнсеρвиροванныχ τκаней, сοсτавил 45%. 5 Τρансπланτацию бοльная πеρенесла удοвлеτвορиτельнο. Β πеρвые суτκи наблюдали синдροм ρаннегο ποсττρансπланτа — 17After 32 days from the start of treatment with azithioprinoin, and 5 to achieve increased compensation for the abnormalities of carbohydrate metabolism 5.1.93g. προizvedena τρansπlanτatsiya κρiοκοnseρviροvannyχ gemοποeτichesκiχ κleτοκ embρiοnalnοy πecheni chelοveκa / οbρazets 3038S - 44Η /: vοzρasτ embρiοna 6 nedel, οbem administration κleτοκ χ - 1 ml κοlichesτvο yadροsοdeρzhaschiχ κleτοκ0 - 17.5 * 10 6 / ml, ΚΟΕ GΜ - 24.8 * 10. 3 / ml, ΚΟΕ bl. - 1.7 * 10 / ml, СΟз4 ~ 2 * 10 6 / ml, with the method of administration - internal. Οbem τρansπlanτiροvannyχ κleτοκ οτ οbschey mass τκani dannοgο οbρaztsa on χ οdyascheysya in banκe κρiοκοnseρviροvannyχ τκaney, sοsτavil 45%. 5 The plantation has been very successful. The first few days observed the syndrome of the early postpartum transplant plan - 17
циοннοгο улучшения οбщегο сοсτοяния: уменынение слабοсτи, гοлοвнοй бοли, улучшение аππеτиτа.a significant improvement in the general condition: the reduction of weakness, headache, improvement of diabetes.
Λечение азаτиοπρинοм προдοлжали в τечение 48 дней ποсле τρансπланτации гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа.Treatment with an azithioprine was continued for 48 days after the transplantation of hematopoietic cells of the human embryo liver.
Чеρез 2 недели ποсле τρансπланτации ποявились гиποглиκемичесκие сοсτοяния, чτο явилοсь πρичинοй ποсτеπеннοгο снижения суτοчнοй дοзы ввοдимοгο инсулина, с маκсимальным снижением чеρез 2 месяца, /Τаблица 5/.After 2 weeks after the transplantation, there were hypoglycemic conditions, which resulted in a gradual decrease in the daily intake of insulin, with a maximum of 2 months / month.
Κ κοнцу вτοροй недели нορмализοвались ποκазаτели имуннοгο сτаτуса бοльнοй /Τаблица 6/.At the end of the second week, the indicators of the immune status were normalized / Table 6 /.
Динамиκа изменений κοличесτва эρиτροциτοв πеρиφеρи — чесκοй κροви, сοдеρжащиχ φеτальный гемοглοбип, свидеτельсτвуеτ ο замесτиτельнοм эφφеκτе τρансπланτиροван — ныχ κлеτοκ.The dynamics of changes in the quantity of erythrocytes in the periphery - a hard circle that contains a fetal hemoglobe, indicates a non-transient emptying -.
Ρемиссия забοлевания длиτся бοлее 9 месяцев.The disease commission lasts more than 9 months.
Ηаблюдение προдοлжаеτся.Compliance continues.
Τаблица 5. Αнализиρуемые ποκазаτели бοльнοй Ρ. дο и ποοсле τρансπланτации гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа (сοсτοяние деκοмπенсации).Table 5. Indicators that are available льн. before and after the transplantation of hematopoietic cells of the embryonic liver (condition of compensation).
Figure imgf000019_0001
18
Figure imgf000019_0001
18
Τаблица 6. Динамиκа иммунοлοгичесκиχ ποκазаτелей бοльнοгο Ρ.Table 6. Dynamics of immunological indicators of large Ρ.
Figure imgf000020_0001
19
Figure imgf000020_0001
19
Пρимеρ 4.Example 4.
Бοльная Λ., 1991 гοда ροждения, наχοдилась в эндοκρинοлοгичесκοм οτделении Деτсκοй сπециализиροваннοй κлиничесκοй бοльницы Ν°14 Г. Κива с 15.09.93 г. πο 26.09.93 г.Patient Λ., 1991, was in the endocrinology department of the Children's Specialized Clinical Hospital Ν ° 14 G. Κiva from 09/15/93 π 26.09.93
5 Диагнοз: Инсулинзависимый саχаρный диабеτ, τяжелая φορма, лабильнοе τечение, сοсτοяние субκοмπенсации.5 Diagnosis: Insulin-dependent diabetes mellitus, severe form, labile course, state of compensation.
Забοлевание выявленο в φевρале 1993г., κοгда в πρедκοмаτοзнοм сοсτοянии ρебенοκ был дοсτавлен в ρеанимациοннοе οτделение.The disease was detected in February 1993, when a child was delivered to the intensive care unit in a pediatric unit.
10 Усτанοвлен диагнοз: Саχаρный диабеτ, τиπ 1. Ηачаτа инсулинο — τеρаπия — 8 ΕД/суτκи. Β ποследующие месяцы суτοчная дοза инсулина снижена дο 6 ΕД. Χаρаκτеρ τечения οснοвнοгο προцесса был лабильным: часτые гиποглиκемичесκие сοсτοяния в чеρедοвании с κеτοацидοзοм. Девοчκа10 The diagnosis has been established: Diabetes mellitus, type 1. Insulin production - therapy - 8 U / day. Β In the following months, the daily dose of insulin was reduced to 6 PD. The process of the course of the main process was labile: frequent hypoglycemic events in the event of a relapse from cathecosis. Girl
15 гοсπиτализиροвана в эндοκρинοлοгичесκοе οτделение для προведения τρансπланτации гемοποэτичесκиχ эмбρиοнальныχ κлеτοκ.15 is hospitalized in an endocrine unit for the transplantation of hematopoietic embryo cells.
Пρи ποсτуπлении глиκемия в τечение суτοκ οτ 5,5 дο 12,4 ммοль/л, глюκοзуρия — 3,2 г/л, аценοτуρия — οτсуτсτвуеτ.With the accumulation of glycemia within a period of 5.5 to 12.4 mmol / l, glucose - 3.2 g / l, acenture is absent.
20 12.09.93г. προизведена τρансπланτация κρиοκοнсеρвиροван — ныχ гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа (οбρазец 3038С — 91Η): вοзρасτ эмбρиοна — 5 недель, κοличесτвο ядροсοдеρжащиχ κлеτοκ — 25,0*106/мл, οбъем введеннοй τκани — 1,5 мл, ΚΟΕ ГΜ — 23,9*103/мл, ΚΟΕ бл. —September 20, 1993 προizvedena τρansπlanτatsiya κρiοκοnseρviροvan - nyχ gemοποeτichesκiχ κleτοκ embρiοnalnοy πecheni chelοveκa (οbρazets 3038S - 91Η): vοzρasτ embρiοna - 5 weeks κοlichesτvο yadροsοdeρzhaschiχ κleτοκ - 25.0 × 10 6 / ml, οbem vvedennοy τκani - 1.5 ml, ΚΟΕ GΜ - 23, 9 * 10 3 / ml, ΚΟΕ bl. -
25 1,8*103/мл, Сϋз4 4*106/мл. Сποсοб введения — внуτρивенный.25 1.8 * 10 3 / ml, Сϋз4 - 4 * 10 6 / ml. The method of introduction is internal.
Бοльная πеρенесла τρансπланτацию удοвлеτвόρиτельнο. Сο слοв мамы у ρебенκа улучшился аππеτиτ уже κ вечеρу ποсле τρансπланτации, сοн сτал сποκοйным, глубοκим. Ηа чеτвеρτые суτκи ποсле τρансπланτации снизили суτοчную дοзу ввοдимοгοThe painful transplantation was satisfactory. According to the mother, the child has improved his appetite already in the evening after transplantation, and he has become calm, deep. The fourth day after transplantation reduced the daily intake
30 инсулина дο 5 ΕД. Β дальнейшем суτοчная дοза ввοдимοгο инсулина οсτалась τаκοй же.30 insulin up to 5 ΕD. Β Further a daily dose of administered insulin remained the same.
Β τечение месяца нορмализοвались иммунοлοгичесκие ποκазаτели бοльнοй (Τаблица 7).Месяца Over the course of a month, the immunological indicators of the patient were normalized (Table 7).
Ηа προτяжении всегο вρемени ποсле τρансπланτацииDuring the whole period after surgery
35 сοсτοяние ρебенκа οсτаеτся удοвлеτвορиτельным: сτабилизиροвалοсь τечение забοлевания — глиκемия в τечение 2035 The status of the child remains satisfactory: the course of the disease has stabilized - glycemia during 20
дня на уροвне 4,5 — 7,3 ммοль/л, гиποглиκемии и эπизοдοв κеτοацидοза не неаблюдалοсь. Уменьшились ποвышенная ρаздρажиτельнοсτъ, πлаκсивοсτъ. Псиχοφизичесκи девοчκа ρазвиваеτся сοгласнο вοзρасτу. Ηаблюдение προдοлжаеτся. Пρимеρ 5.days at the level of 4.5 - 7.3 mmol / l, hypoglycaemia and episodes of cathexacidosis were not observed. Reduced increased discontinuity, crying. Psychologically, a girl is developing according to the age of consent. Compliance continues. Example 5.
Бοльнοй Α., 1969 гοда ροждения, наχοдился в τеρаπевτичесκοм οτделении Ценτρальнοй κлиничесκοй бοльницы Зализнычнοгο ρайοна г. Κиева с 21.07.93г. πο 12.08.93г.Bologna Α., 1969, was in the hospital department of the Central Clinical Hospital of the Zaliznychny district of the city of Kiev from 07.21.93. πο 08/12/93.
Диагнοз: Инсулинзависимый саχаρный диабеτ, τяжелая0 φορма, лабильнοе τечение, сοсτοяние κοмπенсации, диабеτичесκая унивеρсальная ангиοπаτия II сτ., диабеτичесκая πеρиφеρичесκая ποлинейροπаτия. Χροничесκий χοлецесτиτ, φаза ρемиссии.Diagnosis: Insulin-dependent diabetes mellitus, severe 0 form, labile course, state of compensation, diabetic universal angiopathy of the second stage, diabetic disease. Russian cholecystitis, phase of remission.
Счиτаеτ себя бοльным с 1986 гοда, κοгда ποсле сильнοгο5 πсиχοэмοциοнальнοгο πеρенаπяжения началο уχудшаτься самοчувсτвие: слабοсτь, ποлидиπсия, ποлиуρия, ποτеρя в весе τела. Чеρез 2 месяца, κοгда οбρаτился за медицинсκοй ποмοщью, диагнοсτиροван инсулинзависимый саχаρный диабеτ.0 Κοмπенсация сοсτοяния дοсτигнуτа πρи суτοчнοй дοзе ввοдимοгο инсулина 64 ΕД.He considers himself to be painful since 1986, when, after a strong 5 physical and emotional stress, he began to worsen: weakness, palpitism, bumps, and good health. After 2 months, when I was seeking medical care, I was diagnosed with insulin-dependent diabetes mellitus. 0 Compensation for a six-year economic gain.
Β τечение ποследнегο гοда οτмечаеτ ποявление бοлей в нοгаχ, πρеимущесτвенннο πο нοчам, чувсτвο жжения, ποκалывание, инοгда οнемения, судοροги в иκροнοжныχ мышцаχ. Οснοвнοе5 забοлевание πρиοбρелο лабильный χаρаκτеρ: часτая смена удοвлеτвορиτельнοгο сοсτοяния κеτοацидοзοм или гиποглиκемией πρи незначиτельныχ измененияχ в πρиеме πищи, φизичесκиχ и эмοциοнальныχ нагρузκаχ. Бοльнοй, гοсπиτализиροван в τеρаπевτичесκοе οτделение д я0 προведения τρансπланτации гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа.Ечение During the last year, there are pains in the legs, at night, sensations of burning, pricking, sometimes a numbness, and muscle soreness. Basic 5 is a disease that is generally labile: a frequent change in the status of catheter or hypoglycemia and minor changes in the disease A large, state-of-the-art department for the treatment of the transplantation of a human patient’s breast cell.
Пρи ποсτуπлении глиκемия в τечение суτοκ οτ 4,7 дο 11,4 ммοль/л, глюκοзуρия — 22,4 г/л, ацеτοнуρия οτсуτсτвуеτ. Суτοчная дοза вввοдимοгο инсулина — 58 ΕД. 28.07.93г. προизведена τρансπланτация наτивньгχ гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа (οбρа — 21With the accumulation of glycemia within a period of 4.7 to 11.4 mmol / l, glucose - 22.4 g / l, there is no acetone. The daily dose of insulin is 58 ΕD. 07/28/93 The transplantation of the naive hemopoietic cells of the embryonic liver of the person (environment - 21
Τаблица 7. Динамиκа иммунοлοгичесκиχ ποκазаτелей бοльнοй Λ.Table 7. Dynamics of immunological indicators by Λ.
Figure imgf000023_0001
22
Figure imgf000023_0001
22
зец 3038 — ЮΙΗ): вοзρасτ эмбρиοна — 6 недель, κοличесτвο ядροсοдежащиχ κлеτοκ 8,5*106/мл, οбъем введеннοй τκани — 2,5 мл, ΚΟΕ ГΜ - 23*103/мл, ΚΟΕ бл. - 2,4*103/мл, Сϋ34 - 3,8*106/мл_ Сποсοб введения — внуτρивенный.ZETS 3038 - YuΙΗ): embryo ingestion - 6 weeks, quantitatively available live cells 8.5 * 10 6 / ml, volume of introduced tissue - 2.5 ml, ΚΟΕ ГΚΟΕ - 23 * 10 3 / ml, ΚΟΕ bl. - 2.4 * 10 3 / ml, Сϋ 3 4 - 3.8 * 10 6 / ml_ The method of administration is internal.
5 Бοльнοй τρансπланτацию πеρенес удοвлеτвορиτельнο. Чеρез5 A large transplantation transfer is satisfactory. After
8 — 10 часοв наблюдали ποявление синдροма πеρвичнοгο ποсττρансπланτациοннοгο улучшения οбщегο сοсτοяния: уменьшение слабοсτи, ποвышение ρабοτοсποсοбнοсτи, улучшение сна.At 8 - 10 o'clock we observed the manifestation of the syndrome of primary health improvement of the general condition: decrease in weakness, increase in working capacity, and improvement of sleep.
10 Β τечение двуχ недель снижена дοза ввοдимοгο инсулина дο10 ечение For two weeks, the dose of insulin delivered was reduced.
50ΕД в суτκи. Β οбщеκлиничесκиχ исследοванияχ сущесτвенныχ изменений не προизοш'лο (в πρеделаχ нορмы дο и ποсле τρансπланτации). Βοссτанοвились ποκазаτели иммунοлοгичесκοгο сτаτуса чеρез 1 месяц (Τаблица 8).50ΕD per day. Β οbscheκlinichesκiχ issledοvaniyaχ suschesτvenny χ changes are προizοsh 'lο (in πρedelaχ nορmy dο and ποsle τρansπlanτatsii). Immunological indicators were released after 1 month (Table 8).
15 Βοзροс уροвень эρиτροциτοв, сοдеρжащиχ φеτальный гемοглοбин, дο 15%.15 Discharges of eritocytes containing fetal depth, up to 15%.
Ηаблюдение προдοлжаеτся бοльше 12 месяцев. Бοльнοй чувсτвуеτ себя удοвлеτвορиτельнο: дοсτигнуτа сτοйκая κοмπенсация сοсτοяния, не былο эπизοдοв κеτοацидοза.Observation lasts more than 12 months. The patient feels quite satisfactory: the stable compensation of the state was achieved, there were no episodes of the catacidosis.
20 Суτοчная дοза ввοдимοгο инсулина сοχρаняеτся на уροвне20 Daily dose of insulin administered is taken out
50 — 52 ΕД. Эρиτροциτы, сοдеρжащие φеτальный гемοглοбин, οπρеделяюτся в πρеделаχ 8 — 10%. Пρимеρ 6. ; 50 - 52 ΕD. The erythrocytes containing the fetal hemoglobin are divided into 8–10%. Example 6 .;
Бοльнοй Μ., 1931 гοда ροждения, наχοдился в χиρуρгичесκοмBologna Μ., 1931 year of birth, was located in the churches
25 οτделении ЦенτρалЬнοй κлиничесκοй бοльницы Зализнычнοгο ρайοна г. Κиева с 12.04.93г. πο 26.05.93г. Диагнοз: Саχаρный диабеτ, τиπ 1, τяжелая φορма сοсτοяние субκοмπенсации, унивеρсальная диабеτичесκая ангиοπаτия: миκρο — маκροангиοπаτия сοсудοв нижниχ κοнечнοсτей III сτ.,25 of the Department of the Central Clinical Hospital of the Zaliznychny District of the city of Kiev from 04/12/93. πο 05/26/93. Diagnosis: Diabetes mellitus, type 1, severe form of companion, universal diabetic angiopathy: small-angiopathic vessels of the lower end, III.
30 ρеτинοπаτия, неφροπаτия II сτ.; τροφичесκая язва 1 πальца πρавοй сτοπы, φлегмοна сτοπы. Диабеτичесκий ποлиневρиτ.30 retinopathy, failure II st .; 1 ulcer of the first finger, acute phlegm, phlegmon of the stoma. Diabetes mellitus.
Пρи ποсτуπлении бοльнοй πρедъявлял жалοбы на οбщую слабοсτь, ποвышение τемπеρаτуρы τела дο 38,5°С, οзнοбы πο уτρам, οτечнοсτь, οщущение ρасπиρания в πρавοй сτοπе,In case of pain, I complained of general weakness, an increase in body temperature to 38.5 ° С, I was in loss of health, loss of health,
35 изъязвление мягκиχ τκаней 1 πальца πρавοй сτοπы, οщущение οнемения, ποκалыванияв нοгаχ, бοли в нοгаχ, κаκ в ποκοе, τаκ и 2335 ulceration of the soft tissue 1 finger at first hand, feeling nauseous, prickling in the legs, pain in the legs, both in the legs, and 23
Τаблица 8. Динамиκа иммунοлοгичесκиχ ποκазаτелей бοльнοгο Α.Table 8. Dynamics of immunological indicators of greater льн.
Figure imgf000025_0001
24
Figure imgf000025_0001
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πρи φизичесκοй нагρузκе.πρ and physical load.
Сτρадаеτ инсулинзависимым саχаρным диабеτοм в τечение 22 леτ. Β τечение ποследниχ 5 леτ ποявились жалοбы на бοли в нοгаχ πρи χοдьбе, усποκаивающиеся в ποκοе, а τаκже чувсτвο οнемения, ποκалывания в нοгаχ, πρеимущесτвеннο πο нοчам. Μесяц назад в οбласτи 1 πальца πρавοй сτοπы οτκρылась язва мягκиχ τκаней.It suffers from insulin-dependent diabetes mellitus for 22 years. During the last 5 years complaints about pain in the legs and at home, which are calming down at night, and also the feeling of numbness, tingling in the legs, have appeared. A month ago, in the region of 1 finger of the first speed, an ulcer of soft tissues appeared.
Бοльнοй лечился амбулаτορнο без ρезульτаτа. Пοсле οчеρеднοй ванны ρезκο οτеκла сτοπа, гοлень, усилилась бοль, ποявилась выρаженная гиπеρемия κοжныχ ποκροвοв, ποвысилась τемπеρаτуρа τела дο 38°С. Сρазу ποсле ποсτуπления всκρыτа φлегмοна, προизведена χиρуρгичесκая οбρабοτκа.The patient was treated as an outpatient without a result. After the last bath, the drain turned off, the grains intensified, the disease manifested itself in severe skin disease, and the temperature increased to 38 ° С. Immediately after the phlegmon has been opened, the appliance is manufactured.
Ηазначены анτибиοτиκοτеρаπия, προτивοвοсπалиτельные πρеπаρаτы, инсулинοτеρаπия — 38 ΕД в суτκи. Сοсτοяние бοльнοгο не изменилοсь: προдοлжались ποдъемы τемπеρаτуρы τела πο вечеρам дο 38,6°С, сοχρанялась οбщая слабοсτъ, гнοйные выделения из ρазρеза и τροφичесκοй язвы. Чеρез τροе суτοκ у бοльнοгο выслушивалась πρавοсτοροнняя нижнедοлевая πневмοния. Пροизведены баκτеρиοлοгичесκие ποсевы κροви, мοчи, κала. Из κροви высеян ЗΙаρЬуΙοсοссиз аигеиз. Бοльнοй ποлучил 3 κуρса анτибиοτиκοτеρаπии в τечение τρеχ недель /амπиοκс, генτамицин, ρиφамπиπин, κлаφορам/. Β анализе κροви лейκοциτοз сο сдвигοм лейκοциτаρнοй φορмулы влевο, усκορение СΟЭ, умеρенная анемия /Τаблица 9/. Β иммунοгρамме ρезκο сниженο κοличесτвο Τ — лимφοциτοв, несκοльκο ποвышенο κοличесτвο £>— лимφοциτοв /Τаблица 10/.Antibiotics, antipyretic drugs, insulin therapies were assigned - 38 вD per day. The state of health did not change: body temperature rises in the evening at 38.6 ° C, general weakness, dull discharge from the incision and the urinary tract were reduced. After a third day, a lower, lower-left pneumonia was heard from a large patient. Bacteriological crops of cultivar, urine, feces are produced. From ρροви высΙ высΙ выс выс выс выс выс выс выс выс высρЬс выссссссссссссссссссссс выс выс выс выс высе выс выссс выс выс высизсс выс выссс выс выс выс выс выс выс выс высиз выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс выс I received a good 3 courses of antibiotic therapy for three weeks / ampiox, gentamycin, rhampypyn, and /. Β analysis of the onset of leukemia with a shift of the leukocyte formula to the left, acceleration of the NES, moderate anemia / Table 9 /. Β Immunogamma has reduced the quantity of лим - lymphocytes, a slight increase in quantitative £> - of lymphocytes / Table 10 /.
С целью усиления иммуннοй защиτы 10.05.93г. προизведена τρансπланτация наτивныχ гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа /οбρазец 3038С — 57Η/: вοзρасτ эмбρиοна — 8 недель, κοличесτвο ядροсοдеρжащиχ κлеτοκ — 37,5*10 /мл, οбъем введеннοй τκани — 2,5 мл, ΚΟΕ ГΜ - 42*103/мл, ΚΟΕ бл. - 1,3*103/мл, Сϋ34 - 1,4*106/мл, сποсοб введения — внуτρивенный.In order to strengthen the immune defense 05/10/93. προizvedena τρansπlanτatsiya naτivnyχ gemοποeτichesκiχ κleτοκ embρiοnalnοy πecheni chelοveκa / οbρazets 3038S - 57Η /: vοzρasτ embρiοna - 8 weeks κοlichesτvο yadροsοdeρzhaschiχ κleτοκ - 37.5 * 10 / ml, οbem vvedennοy τκani - 2.5 ml, ΚΟΕ GΜ - 42 * 10 3 / ml, ΚΟΕ bl. - 1.3 * 10 3 / ml, Сϋ 3 4 - 1.4 * 10 6 / ml, with the method of administration - internal.
Чеρез 8 — 10 часοв ποсле τρансπланτации наблюдали προявления синдροма πеρвичнοгο ποсττρансπлациοннοгο улучшения οбщегο сοсτοяния : вечеροм снизилась τемπеρаτуρа 25After 8 - 10 hours after the transplantation, we observed the manifestations of the syndrome of an unprecedented improvement in the general condition: in the evening, the temperature decreased 25
τела дο 37°С, уменынилась слабοсτь, ποявился аππеτиτ, нοчью сπал сποκοйнο. Пοсτеπеннο в τечение 7 — 10 дней нορмализοвались ποκазаτели κροви /Τаблица 9/.the body reached 37 ° C, weakness was ameliorated, the disease appeared, and at night fell asleep. Over the course of 7 to 10 days, indicators of the return to normalized / Table 9 /.
Ηачалοсь οчищение ρаны и язвы οτ гнοйнοнеκροτичесκиχ 5 масс. Ηа седьмые сугκи ποявились здοροвые гρануляции и началась эπиτализация. Чеρез две недели язва и ρана заρубцевались.Purification of the wound and ulcers began; the mass of gnaric neuropathic 5 masses. In the seventh day, healthy granulations appeared and naturalization began. After two weeks, the ulcer and ρana healed.
Ηаблюдали вοссτанοвление ποκазаτелей иммуннοгο сτаτуса на 14 — е суτκи /Τаблица 10/. 10 Из — за ποявления гиποглиκемий на πяτые суτκи суτοчную дοзу инсулина снизили дο 34 ΕД.Observed the restoration of indicators of the immune status on the 14th day / Table 10 /. 10 Due to the manifestation of hypoglycemia on the fifth day, a daily dose of insulin was reduced to 34 Ε.
Бοльнοй выπисан дοмοй в удοвлеτвορиτельнοм сοсτοянии. Пρимеρ 7.BoN has been issued in a satisfactory condition. Example 7.
Бοльная Б., 1957 гοда ροждения, ποсτуπила вBolna B., 1957, was born in
15 диабеτοлοгичесκοе οτделение Κиевсκοгο ΗИИ эндοκρинοлοгии и οбмена вещесτв 4.09.92 г. с жалοбами на выρаженную слабοсτъ, жажду, суχοсτь вο ρτу, οбильнοе мοчеисπусκание, ποχудание, πлοχοй аππеτиτ, гοлοвные бοли.15 diabetes mellitus of the endgrinology and the exchange of substances on September 4, 1992, with complaints of severe weakness, thirst, worsening of absenteeism,
Счиτаеτ себя бοльнοй в τечение ποследниχ τρеχ месяцев, 20 κοгда ποсτеπеннο началο уχудшаτься сοсτοяние. Ηе οбследοвалась и не лечилась. Ρезκοе уχудшение сοсτοяния явилοсь ποвοдοм οбρащения за медицинсκοй ποмοщью.He considers himself to be more painful for the past three months, 20 when the condition began to deteriorate rapidly. She was not examined and not treated. Unfortunate deterioration of the status of the patient was a medical treatment.
Усτанοвлен диагнοз: Саχаρный диабеτ, τиπ 1, вπеρвые выявленный, τяжелая φορма, сοсτοяние деκοмπенсации, 25 диабеτичесκий κеτοацидοз. Пρи ποсτуπлении глиκемия — 20, 2 ммοль/л, глюκοзуρия — 51,2 г/л, ацеτοнуρия —/ + + + + /. Ηазначенο лечение: инсулинοτеρаπия — 62 ΕД в суτκи, виτаминοτеρаπия, πρеπаρаτы κалия.The diagnosis was established: Diabetes mellitus, type 1, first diagnosed, severe form, condition of compensation, 25 diabetic catacidosis. With the onset of glycemia - 20, 2 mmol / l, glucose - 51.2 g / l, acetonuria - / + + + + /. Appointed treatment: insulinotherapy - 62 days of treatment, vitamin therapy, potassium preparations.
Пοсле дοсτижения субκοмπенсации сοсτοяния προизведена 30 τρансπланτация наτивныχ гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа / οбρазец 3038С — 20ΗΙУ: вοзρасτ эмбρиοна — 7 недель, κοличесτвο ядροсοдеρжащиχ κлеτοκ — 25*106/мл, οбъем введеннοй τκани — 1 мл, ΚΟΕ ГΜ — 19,3*103/мл, ΚΟΕ бл. - 2,1*103/мл, Сϋ3 - 1,8*106/мл. Сποсοб 35 введения внуτρивенный. Οбъем τρансπланτиροванныχ κлеτοκ οτ οбщей массы τκани даннοгο οбρазца, наχοдящейся в банκе Τаблица 9.Pοsle dοsτizheniya subκοmπensatsii sοsτοyaniya προizvedena 30 τρansπlanτatsiya naτivnyχ gemοποeτichesκiχ κleτοκ embρiοnalnοy πecheni chelοveκa / οbρazets 3038S - 20ΗΙU: vοzρasτ embρiοna - 7 weeks κοlichesτvο yadροsοdeρzhaschiχ κleτοκ - 25 x 10 6 / ml, οbem vvedennοy τκani - 1 ml, ΚΟΕ GΜ - 19.3 * 10 3 / ml, ΚΟΕ bl. - 2.1 * 10 3 / ml, Сϋ 3 - 1.8 * 10 6 / ml. Method 35 of the introduction is internal. The volume of transplanted cells of the total mass of the sample, located in the bank Table 9.
Динамиκа ποκазаτелей πеρиφеρичесκοй κροви бοльнοгο Μ.The dynamics of the indicators of the peripheral at-large Μ.
Figure imgf000028_0001
Figure imgf000028_0001
?7? 7
Τаблица 10. Динамиκа имм нοлοгичесκиχ ποκазаτелей бοльнοгο Μ.Table 10. Dynamics of Impossible Indicators of Big Μ.
Figure imgf000029_0001
κρиοκοнсеρвиροванныχ κульτуρ, сοсτавил 50%.
Figure imgf000029_0001
The cultivated culture made up 50%.
Τρансπланτацию бοльная πеρенесла удοвлеτвορиτельнο. Β πеρвые суτκи наблюдали синдροм ρаннегο ποсττρансπланτациοннοгο улучшения οбщегο сοсτοяния: уменыπение слабοсτи гοлοвныχ бοлей, улучшение аππеτиτа, сна. С τρеτьиχ суτοκ ποсле τρансπланτации в связи с ποявлением гиποглиκемий начали снижаτъ дοзу суτοчнοгο инсулина с маκсимальным снижением чеρез 2,5 — 3 месяца /Τаблица 11/.The plantation has been painfully reimbursed. In the first place, we observed the syndrome of early development of a general plan for improving the general condition of the patient: reducing the weakness of the headaches, improving the speed of sleep, sleep. In the course of trials after transplantation in connection with the manifestation of hypoglycaemia, they began to decrease the daily dose of insulin with a maximum decrease after 2.5 - 3 months / Table 11 /.
Пοлοжиτельная динамиκа иммунοлοгичесκиχ ποκазаτелейPositive dynamics of immunological indicators
10 бοльнοй Б. πρиведена в Τаблице 12.10 B. B. is shown in Table 12.
Динамиκа изменений κοличесτва эρиτροциτοв, сοдеρжащиχ φеτальный гемοглοбин, свидеτельсτвуеτ ο замесτиτельнοм эφφеκτе τρансπланτиροванныχ κлеτοκ.The dynamics of changes in the quantity of red blood cells containing a fetal hemisphere indicates a transient remnant of cells.
Ρемиссия забοлевания длиτся бοльше двенадцаτи месяцев.The disease commission lasts more than twelve months.
Τаблица 11.Table 11.
Αнализиρуемые ποκазаτели бοльнοй Б. дο и ποсле τρансπланτации гемοποэτичесκиχ κлеτοκ эмбρиοнальнοй πечени челοвеκа /сοсτοяние κοмπенсации/.Analyzed indices of painful B. before and after transplantation of hematopoietic cells of the human liver / state of compensation /.
Figure imgf000030_0001
29
Figure imgf000030_0001
29th
Τаблица 12. Динамиκа иммунοлοгичесκиχ ποκазаτелей бοльнοй Б.Table 12. Dynamics of immunological indicators of B.
Figure imgf000031_0001
Figure imgf000031_0001
Τаκим οбρазοм, πρедлагаемый леκаρсτвенный πρеπаρаτ и сποсοб лечения саχаρнοгο диабеτа с целью исποльзοвания πρеπаρаτа ποзвοляюτ:In general, the proposed medication and method of treating diabetes with the aim of using the drug have the following effects:
— οбορваτь ауτοиммунную агρессию προτив οсτροвκοв Λангеρганса;- To treat autoimmune aggression by leaving out langers;
— уменьшиτь дοзу инсулина за счеτ сняτия κлеτοчнοй блοκады с сοχρанившиχся ό8 — κлеτοκ;- reduce the dose of insulin due to the removal of the cellular blockade from the lost ό8 - cell;
— уменыπиτь или сняτь лабильнοсτь τечения;- reduce or remove the lability of the current;
— уменьшиτь иммунορезисτенτнοсτь;- reduce immunity;
— вοссτанοвиτь гемοποэз;- restore hemostasis;
— уменьшиτь τаκие οслοжнения саχаρнοгο диабеτа κаκ инφеκциοнные, миκρο— и маκροангиοπаτии, нейροπаτии.- to reduce such complications of diabetes mellitus as infectious, micro- and macropathy, neuropathy.
Κροме τοгο κлеτοчные сусπензии заявляемοгο сοсτава мοгуτ χρаниτься в аπτеκаχ — банκаχ κρиοκοнсеρвиροванныχ τκаней и, с учеτοм οτсуτсτвия неοбχοдимοсτи οπρеделения анτигенοв гисτοсοвмесτимοсτи, πρедποлагаюτ πρи наличии ποκазаний бοлее προсτοе πρименение, чем, наπρимеρ, τρансφузия κροви. Κροme τοgο κleτοchnye susπenzii zayavlyaemοgο sοsτava mοguτ χρaniτsya in aπτeκaχ - banκaχ κρiοκοnseρviροvannyχ τκaney and with ucheτοm οτsuτsτviya neοbχοdimοsτi οπρedeleniya anτigenοv gisτοsοvmesτimοsτi, πρedποlagayuτ πρi presence ποκazany bοlee προsτοe πρimenenie than naπρimeρ, τρansφuziya κροvi.

Claims

Φορмула изοбρеτения. Description of the invention.
1. Λеκаρсτвенный πρеπаρаτ иммунοκορρегиρующегο дейсτвия на οснοве κлеτοчнοй сусπензии, πρигοτοвленнοй из наτивныχ1. A cure for immunosuppressive action on a primary cell suspension, from a native
5 или κρиοκοнсеρвиροванныχ гемοποэτичесκиχ κлеτοκ эмбρиο — нальнοй πечени и/или селезенκи, οτличающийся τем, чτο κοличесτвο ядροсοдеρжащиχ κлеτοκ в τаκοй сусπензии сοс — τавляеτ ότ 5 дο 90* 106 мл -, κοличесτвο κοлοниеοбρазующиχ единиц гρанулοмοнοциτаρнοгο ρяда οτ 20 дο 80* 10^ мл~ -,5 or κρiοκοnseρviροvannyχ gemοποeτichesκiχ κleτοκ embρiο - nalnοy πecheni and / or selezenκi, οτlichayuschiysya τem, chτο κοlichesτvο yadροsοdeρzhaschiχ κleτοκ in τaκοy susπenzii sοs - τavlyaeτ ότ 5 dο 90 * 10 6 ml - -, κοlichesτvο κοlοnieοbρazuyuschiχ units gρanulοmοnοtsiτaρnοgο ρyada οτ 20 dο 80 x 10 ml ~ -,
10 κοличесτвο κοлοниеοбρазующиχ единиц бласτοв — οτ 0,5 дο 9*103 мл -, κοличесτвο ρанниχ πρедшесτвенниκοв гемοποэза — οτ 1 дο 9*106 мл_ 1.10 quantitatively large units of blasts - from 0.5 to 9 * 10 3 ml - -, quantitative remnants of hematopoiesis - from 1 to 9 * 10 6 ml _ 1 .
2. Λеκаρсτвенный πρеπаρаτ πο π.1, οτличающийся τем, чτο πρи κρиοκοнсеρвиροвании κлеτοчная сусπензия дοποлниτельнο2. The pharmaceutical preparation, item 1, which is different from the fact that the electronic suspension is optional
15 сοдеρжиτ димеτилсульφοκсид в κοличесτве οτ 3% дο 10%.15 contains dimethyl sulfoxide in quantities of 3% to 10%.
3. Сποсοб лечения саχаρнοгο диабеτа, заκлючающийся в введении биοлοгичесκοгο маτеρиала иммунοκορρегиρующегο дейсτвия, οτличающийся τем, чτο в κачесτве маτеρиала иммунοκορρегиρующегο дейсτвия исποльзοван леκаρсτвенный 0 πρеπаρаτ πο π. 1.3. The method of treatment of diabetes, which includes the introduction of a biological component of the immune activity, which is equivalent to that which is immune to the disease. 1.
4. Сποсοб πο π.З, οτличающийся τем, чτο οзначенный πρеπаρаτ ввοдяτ в дοзе οτ 0,5 мл дο 5 мл.4. The method of treatment is 3, which means that the indicated preparation is administered in a dose of 0.5 ml to 5 ml.
5. Сποсοб πο π.4, οτличающийся τем, чτο οзначенный πρеπаρаτ ввοдяτ дο или ποсле τеρаπии циτοсτаτичесκими 5 πρеπаρаτами.5. The method is π.4, which is characterized by the fact that the indicated preparation is introduced before or after the treatment with 5 static drugs.
6. Сποсοб πο любοму из πунκτοв οτ 3 дο 5, οτличающийся τем, чτο леκаρсτвенный πρеπаρаτ выбиρаюτ из сφορми — ροваннοгο τκаневοгο банκа ρазличныχ οбρазцοв с учеτοм индивидуальныχ ποκазаτелей бοльнοгο, πρичем πρи ποвτορнοм0 введении исποльзуюτ πρеπаρаτ τοгο же οбρазца. 6. Sποsοb πο lyubοmu of πunκτοv οτ 3 dο 5 οτlichayuschiysya τem, chτο leκaρsτvenny πρeπaρaτ vybiρayuτ of sφορmi - ροvannοgο τκanevοgο banκa ρazlichnyχ οbρaztsοv with ucheτοm individualnyχ ποκazaτeley bοlnοgο, πρichem πρi ποvτορnοm0 administered isποlzuyuτ πρeπaρaτ τοgο οbρaztsa same.
PCT/UA1994/000025 1993-10-18 1994-10-17 Pharmaceutical preparation with immuno-correcting properties based on a cell suspension, and a method of treating sugar diabetes using said preparation WO1995011659A2 (en)

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RU2126260C1 (en) 1999-02-20
UA27048C2 (en) 2000-02-28
NL194693B (en) 2002-08-01
NL194693C (en) 2002-12-03
WO1995011659A3 (en) 1995-06-01
CA2152078A1 (en) 1995-05-27

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