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两种吗替麦考酚酯制剂用于肾移植患者的长期有效性和安全性比较
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| 篇名： | 两种吗替麦考酚酯制剂用于肾移植患者的长期有效性和安全性比较 |
| TITLE： | Comparison of long-term efficacy and safety of two mycophenolate mofetil preparations in kidney transplant recipients |
| 摘要： | 目的 比较国产吗替麦考酚酯分散片（dt-MMF）与原研吗替麦考酚酯胶囊（c-MMF）用于肾移植患者的长期有效性和安全性。方法采用回顾性队列研究设计，筛选并纳入2012－2014年在四川大学华西医院接受同种异体肾移植手术患者的病例资料。根据肾移植患者的用药情况，分为dt-MMF组和c-MMF组。两组患者dt-MMF、c-MMF的初始口服剂量均为每次1000mg，每天2次；同时，均联用他克莫司胶囊每次1.5mg，每天2次+醋酸泼尼松片每次5～10mg，每天早餐后口服。收集两组患者在肾移植术前和术后随访5年的临床数据，比较两种药物的有效性与安全性指标，并通过1∶1倾向评分匹配进行结果稳健性分析。结果共纳入符合标准的肾移植患者666例，其中dt-MMF组316例、c-MMF组350例。dt-MMF组和c-MMF组患者的5年生存率分别为99.68％和99.43％，5年移植物存活率分别为96.20％和94.29％，急性排斥反应发生率分别为3.80％和6.57％，5年慢性排斥反应发生率分别为2.22％和2.86％，移植肾功能恢复延迟发生率分别为0.63％和0.29％，差异均无统计学意义（P＞0.05）。两组患者的感染和发生在血液和消化系统等主要不良事件的发生率比较，差异均无统计学意义（P＞0.05）。倾向评分匹配分析显示以上结果稳健（急性排斥反应除外）。结论国产dt-MMF用于肾移植术后免疫抑制治疗的临床有效性和安全性与原研c-MMF无明显差异。 |
| ABSTRACT： | OBJECTIVE To com pare the long-term efficacy and safety betwe en domestic Mycophenolate mofetil dispersible tablets（dt-MMF）and imported Mycophenolate mofetil capsules （c-MMF）in kidney transplant recipients. METHODS In retrospective cohort study ，the data of patients who had undergone the living donor kidney transplantat during the period of 2012 to 2014 in West China Hospital of Sichuan University were screened and included ，and then divided into dt-MMF group and c-MMF group according to the drug use of kidney transplant recipients. Initial oral dose of dt-MMF and c-MMF were both 1 000 mg each time ， twice a day ；at the same time ，both groups were additionally given Tacrolimus capsules 1.5 mg，twice a day+Prednisone acetate tablets 5-10 mg，orally after breakfast every day. The clinical data of the two groups were collected before and after kidney transplant for 5 years；the efficacy and safety indexes of two drugs were compared ，and the robustness of results were analyzed by 1∶1 propensity score matching （PSM）. RESULTS A total of 666 kidney transplant recipients were included ，involving 316 patients in dt-MMF group and 350 patients in c-MMF group. The 5-year patient survival rates of dt-MMF group and c-MMF group were 99.68％ and 99.43％，the 5-year graft survival rates were 96.20％ and 94.29％，the acute rejection rates were 3.80％ and 6.57％，the 5-year chronic rejection rates were 2.22％ and 2.86％，and the incidences of delayed recovery of transplanted renal function were 0.63％ and 0.29％，respectively；there was no statistical significance （P＞0.05）. There were no significant differences in the incidence of major adverse events between 2 groups，including infection ，adverse events of the blood system and diges tive system （P＞0.05）. PSM analysis indicated the efficacy and safety results were robust （except for acute rejection ）. CONCLUSIONS There is no significant difference in clinical efficacy and safety between dt-MMF and c-MMF for immunosuppression after kidney transplant. |
| 期刊： | 2022年第33卷第10期 |
| 作者： | 杨甜，占美，李丹，宋涂润，吴斌，徐珽 |
| AUTHORS： | YANG Tian，ZHAN Mei，LI Dan，SONG Turun，WU Bin，XU Ting |
| 关键字： | 吗替麦考酚酯；肾移植；国产制剂；原研制剂；有效性；安全性；长期随访 |
| KEYWORDS： | mycophenolate mofetil ；kidney transplantat ； |
| 阅读数： | 495 次 |
| 本月下载数： | 8 次 |
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