他克莫司用于中国肾移植患者远期疗效的Meta分析

Long-term curative effect of tacrolimus in kidney transplantation patients in China:Meta-analysis

目的:他克莫司在器官移植方面已得到较为广泛的应用,但该药用于亚洲人特别是中国人肾移植远期疗效的报道较少,而且相关研究均为小样本、临床随机对照研究,缺乏有效的说服力。因此文章评估国内肾移植患者长期应用他克莫司进行免疫抑制治疗的有效性和安全性。资料来源:采用电子检索和手工检索进行文献初检,电子检索数据库有Medline database(1980/2008)、中国期刊全文数据库(CNKI:1980/2008)、中国循证医学ΠCochrane中心数据库(CEBM/CCD)、Cochrane图书馆,检索无语种限制。手工检索主要专业期刊以免出现检索遗漏。资料选择:纳入国内外关于他克莫司用于国内肾移植后患者免疫抑制治疗的随机对照研究文献,要求对照组应用环孢素A,其余干预措施相同。排除非随机对照试验及多器官联合移植文章。对结果进行统计荟萃分析(Meta分析),统计学分析采用Stata软件,评价比较疗效及差异的指标采用优势比(OR)及95%可信区间(95%CI)。结局评价指标:①肾移植后1年人/肾存活率。②肾移植后3年人/肾存活率。③肾移植后3年排斥反应发生率。④肾移植后3年感染发生率。⑤肾移植后3年肝功能异常发生率。⑥肾移植后3年血糖异常发生率。结果:共收集国内外3个随机对照研究,其中国内3篇,国外0篇。Meta分析结果显示,他克莫司用于国内肾移植患者移植后3年内排斥反应的发生率优于环孢素A对照组(OR值为0.40,95%CI为0.27～0.61,P<0.0001),他克莫司组患者肾移植后3年内肝功能异常的发生率低于环孢素A对照组(OR值为0.28,95%CI为0.15～0.52,P<0.0001);他克莫司组患者肾移植后1,3年人/肾存活率与环孢素A对照组比较差异无显著性意义;与环孢素A对照组相比,他克莫司组肾移植后3年的血糖异常发生率升高(OR值为2.39,95%CI为1.41～4.05,P=0.001)。结论:选择近20年国内外重要期刊发表的他克莫司用于肾移植后排斥反应的随机对照文章,分析结果显示,国内肾移植患者应用他克莫司与环孢素A相比,移植后3年内排斥反应及肝功能异常的发生率明显降低,对患者移植后1,3年人/肾脏存活率无不良影响,但其不良反应主要表现为血糖升高。

OBJECTIVE：Tacrolimus is widely used in organ transplant.However,the long-term effects of tacrolimus on Asian,in particular in Chinese people,are few.The aim of this study is to evaluate the efficacy and safety of long-term curative effect of tacrolimus used in kidney transplantation patients in China.DATA SOURCES：Electronic and manual retrieve of Medline database,Chinese journal full-text database,Cochrane library,and CEBM/CCD,and relevant medical journals in China were applied.DATA SELECTION：Published randomized controlled trials on tacrolimus in kidney allograft recipient were retrieved,and the data were underwent Meta analysis.Odds ratio （OR） and its 95% confidence interval （CI） were used as the measurement parameter of efficacy comparison.The statistical analyses were performed using Stata software.MAIN OUTCOME MEASURES：① The survival ratio of patient/kidney after 1 year.②The survival ratio of patient/kidney after 3 years.③ Rejection ratio after 3 years.④ Infection rate after 3 years.⑤ Incidence of liver dysfunction after 3 years.⑥Blood glucose disorder after 3 years.RESULTS：A total of 3 trials were eligible for the inclusion efficacy,including 3 Chinese trials and 0 foreign trials.Results of meta-analysis indicated that tacrolimus prevented the recipients of kidney transplantation from rejection effectively in three years [OR=0.40,95%CI （0.27-0.61）,P〈0.000 1].Tacrolimus prevented the recipients of kidney transplantation from impaired liver function in three years [OR=0.28,95%CI （0.15-0.52）,P〈0.000 1].No statistical difference of the 1-year and 3-year survival rate of patients/kidney was found in the patients between group tacrolimus and group cyclosporine.Statistical difference of blood glucose disorder were found in the patients between group tacrolimus and group cyclosporine [OR=2.39,95%CI （1.41-4.05）,P=0.001].CONCLUSIONS：Tacrolimus prevented the recipients of kidney transplantation from rejection and impaired liver function effectively in three years in China.No statistical difference of the 1-year and 3-year survival rate of patients/kidney was found in the patients between two groups.In addition,the main side effect of tacrolimus is blood glucose elevation.