nidНефрология и диализNephrology and Dialysis1680-44222618-9801Российское диализное обществоnid-991Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESОпыт применения микофенолата натрия при трансплантации почки (промежуточные результаты 12 месячной мультицентровой открытой наблюдательной программы изучения безопасности, переносимости и эффективности препарата у реципиентов почечного трансплантата)Experience of the use of enteric coated sodium mycophenolate in renal transplant patientsКимИ. Г.KimI. G.kig21@rambler.ruСтоляревичЕ. С.StolyarevichE. S.noemail@neicon.ruВедерниковаР. Н.VedernikovaR. N.noemail@neicon.ruТомилинаН. А.TomilinaN. A.noemail@neicon.ruФНЦ Трансплантологии и искусственных органов им. В.И. Шумакова, г. МоскваRussian Federation201017062025122106110Copyright © Ким И.Г., Столяревич Е.С., Ведерникова Р.Н., Томилина Н.А., 20252025Ким И.Г., Столяревич Е.С., Ведерникова Р.Н., Томилина Н.А.Kim I.G., Stolyarevich E.S., Vedernikova R.N., Tomilina N.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.nephro.ru/jour/article/view/991

Цель исследования : изучить эффективность, безопасность и переносимость микофенолата натрия после трансплантации почки. Материалы и методы: Наблюдение 183 реципиентов ПТ, 16 центров. 1 гр. составили 83 реципиента, получавшие микофенолат натрия с момента операции в сочетании с преднизолоном и неоралом. Во 2 гр. включено 100 пациентов, которым была выполнена конверсия с мофетила микофенолата либо азатиоприна на микофенолат натрия через 57,3 ± 48,6 мес. после ТП. Длительность наблюдения на фоне терапии микофенолатом натрия составила 6 мес. Эффективность иммуносупрессии оценивали по частоте кризов отторжения, выживаемости реципиентов и ПТ. О безопасности препарата судили по функции ПТ, которую оценивали по уровню креатинина (Pcr). При анализе переносимости учитывали частоту выявления нежелательных явлений и частоту снижения дозы/отмены препарата. В гр. 1 кризы отторжения были констатированы в 8,4%. 6-месячная выживаемость больных и ПТ составила 98,7 и 98,7% соответственно. Pcr через 3 и 6 мес. наблюдения составил 120 ± 32 и 124 ± 38 мкмоль/л. Инфекции развивались у 44,5% больных, нарушение функции печени в 13%, лейкопения – в 12%, гастроинтестинальные нарушения – в 7,2%. Из-за развития нежелательных явлений доза микофенолата натрия снижалась у 7 (8,4%) больных. В гр. 2 кризы отторжения не выявлены. 6-мес. выживаемость реципиентов составила 100%, выживаемость ПТ – 98%. 2 ПТ были потеряны вследствие хронического отторжения. Pcr через 3 и 6 мес. наблюдения составил 137 ± 43 и 134 ± 47 мкмоль/л соответственно. Инфекции в этой группе имели место у 27% больных, дисфункция печени – в 6%, желудочно-кишечные нарушения – в 10% и лейкопения – в 11% случаев. У 13 (13%) больных доза микофенолата натрия снижалась, у 3 из них позднее препарат был отменен. Выводы : предварительные результаты исследования подтвердили данные других авторов об эффективности и безопасности применения микофенолата натрия в качестве базисного иммуносупрессанта после ТП, нежелательные побочные явления могут ограничивать применение препарата лишь у небольшого числа пациентов.

Aim of the study was to investigate the efficacy, safety and tolerability of sodium mycophenolate after renal transplantation. Material: 183 renal transplant recipients from 16 centers were analysed. The 1st (de novo) group of 83 recipients who received sodium mycophenolate since renal transplantation (RT) in combination with prednisolone and cyclosporine. The 2nd (maintenance) group of 100 patients was switched from mophetyl mycophenolate or azathioprine to myfortic after 57,3 ± 48,6 months after RT. The duration of follow-up was 6 months. The efficacy of immunosuppression was evaluated by the rates of acute rejection, graft survival, serum creatinine level (Pcr) and creatinine clearance. For the analysis of safety and tolerability of sodium mycophenolate sodium, the frequency of adverse effects and dose reduction/drug withdrawal were taken into account. Results: In de novo group acute rejection was detected in 6% of patients. The 6-month patients and grafts survival were 98,7% and 98,7%, respectively. Pcr at 3 and 6 months of observation was 120 ± 32 mM and 124 ± 38 mM, respectively. Infections haved developed in 44,5%, hepatic disorders in 13%, leucopenia in 12% and gastrointestinal complications in 7,2% of patients. The sodium mycophenolate dose was reduced in 7 (8,4%) patients due to development of adverse effects. No acute rejection was observed in maintenance group. Patient and graft survival at 6 months were 100% and 98%, respectively. Two grafts were lost due to chronic rejection. Pcr at 3 and 6 months of observation was 137 ± 43 mM and 134 ± 47 mM, respectively. Infections in this group occurred in 27%, liver dysfunction in 6%, gastrointestinal disorders in 10% and leucopenia in 11% of patients. In 13 (13%) of patients mycophenolate sodium dose was reduced, and in 3 of those the drug was cancelled completely thereafter. Conclusions : Preliminary results of the study confirmed data of other authors about high efficacy and safety of in basic immunosuppressive therapy after renal transplantation. The adverse effects of sodium mycophenolate can restrict its application to a limited number of patients.

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The authors declare that there are no conflicts of interest present.