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肾移植后 3 至 6 个月内类固醇撤药的系统评价。

A systematic review on steroid withdrawal between 3 and 6 months after kidney transplantation.

机构信息

Servicio de Nefrología, Hospital del Mar, Institut Municipal d'Asistencia Sanitaria, Universitat Autonoma de Barcelona, Barcelona, Spain.

出版信息

Transplantation. 2010 Aug 27;90(4):343-9. doi: 10.1097/TP.0b013e3181e58912.

Abstract

BACKGROUND

Steroid withdrawal (SW) after the first posttransplant months in patients receiving a kidney transplant has been recently discouraged in clinical guidelines.

METHODS

A systematic review and meta-analysis of randomized controlled trials assessing SW (beyond the second week after kidney transplantation) was performed. Only trials using a calcineurin inhibitor plus mycophenolic acid were included.

RESULTS

The nine trials (1820 participants) randomly withdrew steroids between 3 and 6 months after transplantation. Death and graft loss were similar in SW and control patients. Including all trials, acute rejection was not more frequent after SW, but stratifying by the drug used, cyclosporine A (CsA) was associated with an increased incidence of overall acute rejection (risk ratio 1.42, 95% confidence interval 1.08-1.87) or biopsy-proven acute rejection (risk ratio 1.61 95% confidence interval 1.20-2.17). Contrarily, tacrolimus allowed SW without increased biopsy-proven acute rejection (P interaction=0.005). Serum cholesterol level was lower after SW than in controls using CsA or tacrolimus. Serum creatinine, blood pressure, serum triglycerides, new-onset diabetes mellitus, infections, or malignancies were similar in SW and control patients.

CONCLUSIONS

SW after 3 to 6 months of kidney transplantation is associated with increased rates of acute rejection only if CsA is used but not with tacrolimus. Graft function and survival remain stable up to 3 years after transplantation, the longest follow-up reported. The interest for late SW has decreased during the past years in the literature. More trials with carefully designed outcome measures are needed in patients treated with low-exposure tacrolimus and mycophenolic acid derivatives.

摘要

背景

在接受肾移植的患者中,在移植后最初几个月后停止使用类固醇(SW)最近在临床指南中受到劝阻。

方法

对评估 SW(在肾移植后第二周之后)的随机对照试验进行了系统评价和荟萃分析。仅纳入使用钙调神经磷酸酶抑制剂加霉酚酸酯的试验。

结果

这九项试验(1820 名参与者)在移植后 3 至 6 个月之间随机停用了类固醇。SW 组和对照组的死亡和移植物丢失率相似。包括所有试验,SW 后急性排斥反应并不更频繁,但按药物分层,环孢素 A(CsA)与总急性排斥反应(风险比 1.42,95%置信区间 1.08-1.87)或活检证实的急性排斥反应(风险比 1.61,95%置信区间 1.20-2.17)发生率增加相关。相反,他克莫司允许 SW 而不增加活检证实的急性排斥反应(P 交互=0.005)。与使用 CsA 或他克莫司的对照组相比,SW 后血清胆固醇水平较低。SW 组和对照组患者的血清肌酐、血压、血清甘油三酯、新发糖尿病、感染或恶性肿瘤发生率相似。

结论

在肾移植后 3 至 6 个月停用 SW 仅与 CsA 相关,而与他克莫司无关,会增加急性排斥反应的发生率。在报道的最长随访 3 年内,移植后移植物功能和存活率保持稳定。近年来,文献中对晚期 SW 的兴趣有所下降。需要在接受低剂量他克莫司和霉酚酸衍生物治疗的患者中进行更多具有精心设计的结局指标的试验。

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