他克莫司和环磷酰胺治疗狼疮肾炎的Meta分析  

Meta-analysis of tacrolimus and cyclophosphamide in the treatment of lupus nephritis

作　　者：王彬[1] 杨敏[1] 李曼[1] 刘华[1] 邹芸[1] 潘家荣[1] 

机构地区：[1]江苏省常州市第一人民医院(苏州大学附属第三医院)肾内科,213003

出　　处：《中华肾脏病杂志》2013年第4期248-252,共5页Chinese Journal of Nephrology

摘　　要：目的系统评价他克莫司和环磷酰胺（CTX）治疗狼疮肾炎的临床疗效。方法采用Cochrane系统综述方法，检索年限从建库至2012年10月；检索范围包括Cochrane图书馆、PubMed、OVID、万方数据库、中国期刊全文数据库、重庆维普中文科技期刊数据库等，同时手工检索相关文献、专业资料和网络信息，对同质资料进行研究。采用Statall软件进行Meta分析。结果共检索出4783篇文献，其中符合纳入标准的文献9篇『8篇随机对照试验（RCT）、1篇队列研究1。Meta分析结果提示，他克莫司治疗组完全缓解率优于环磷酰胺（CTX）治疗组（P〈0．01）；部分缓解率两组差异无统计学意义；他克莫司治疗组总有效率优于CTX治疗组（P〈0．01）；他克莫司组肝功能损伤、胃肠不适、月经紊乱、骨髓抑制等不良反应发生率低于CTX治疗组（分别P〈0．05、〈0．05、〈0．01、〈0．01）；感染、肾功能损伤、糖代谢异常等不良反应发生率两组间差异无统计学意义。结论他克莫司的疗效和安全性优于CTX，但由于受文献资料质量限制，仍需要大样本、多中心、设计良好的RCT进一步验证。Objective To evaluate the clinical efficacy of tacrolimus and cyclophosphamide （CTX） on lupus nephritis. Methods The clinical trials on treatment of lupus nephritis with tacrolimus and CTX published before October 2012 were searched at Cochrane library, PubMed, OVID, Wanfang database, Chinese Journal full- text Database, Chongqing Weipu Database by using the methods of Cochrane systematic review. At the same time the information from related journals, professional data and network were hand- searched. The homogeneous evaluation was performed by Meta- analysis. Statistical analysis of clinical data was performed by using Statal 1 software. Results A total of 4783 reports were found, while only 9 papers （8 randomized controlled trials and 1 cohort study） met the inclusion criteria. Tacrolimus group got better complete remission ratio （Z = 4.05, P 〈 0.01）, similar partial remission ratio （Z = 0.44, P = 0.661）, and better overall remission ratio （Z = 4.29, P 〈 0：01） as compared with CTX group. There were no significant differences between tacrolimus group and CTX group in the incidence of infection （Z = 1.75, P = 0.081）, renal damage （Z= 0.88, P= 0.38） and abnormal glucose metabolism （Z -- 1.91, P = 0.070）. Side effects such as liver function impairment （Z = 2.65, P〈 0.01）, gastrointestinal discomfort （Z= 2.31, P〈 0.05）, menstrual disorders （Z= 3.88, P〈 0.01）, bone marrow suppression （Z = 3.29, P 〈 0.01） in tacrolimus group were lower than those in CTX group. Conclusions Compared with CTX, tacrolimus has better complete remission ratio and overall remission ratio, with less side-effects in the treatment of lupus nephritis. However, large scale, multicenter, well-designed clinical trials should be adopted to further confirm the conclusions.

关 键 词：他罗利姆 狼疮肾炎 环磷酰胺 随机对照试验 队列研究 荟萃分析 

分 类 号：R593[医药卫生—内科学]