雷公藤多苷治疗糖尿病肾脏病临床疗效及安全性的Meta分析

Clinical Efficacy and Safety of Tripterygium Glycosides in Diabetic Kidney Disease: A Meta-Analysis

目的评价雷公藤多苷(TG)治疗糖尿病肾脏病(DKD)的临床疗效及安全性。方法检索中国知网、万方、维普、Cochrane Libarary、Pub Med、Embase、Web of Science数据库,检索时间为建库至2018年12月7日,收集TG治疗DKD的随机对照试验(RCT),两名研究员独立筛选文献、提取数据并交叉核对。采用Rev Man 5. 3软件进行分析。结果共纳入16项RCT,973例患者,试验组523例,对照组450例。试验组24 h尿蛋白定量明显低于对照组(SMD=-0. 78,95%CI-1. 03^-0. 54,P <0. 000 01),血肌酐低于对照组(SMD=-0. 44,95%CI-0. 85^-0. 03,P=0. 04),血尿素氮值低于对照组(WMD=-0. 30,95%CI-0. 59^-0. 01,P=0. 04);试验组和对照组丙氨酸转氨酶、血白细胞计数比较差异无统计学意义(P> 0. 05);试验组不良反应发生率高于对照组(RR=1. 97,95%CI1. 22~3. 19,P=0. 006)。结论 TG治疗DKD的临床疗效肯定,虽存在不良反应,但相对安全。受纳入文献质量等因素限制,此结论有待更多高质量、大样本、多中心的随机双盲对照试验加以验证。

Objective To systematically evaluate the efficacy and safety of tripterygium glycosides( TG) in the treatment of diabetic kidney disease( DKD). Methods The CNKI,Wan Fang,VIP,Cochrane Libarary,Pub Med,Embase,Web of Science databases were retrieved from establishment up to Dec. 7 th,2018 to collect randomized controlled trials( RCT)about TG in the treatment of DKD. Two reviewers screened the literature,extracted and crosschecked the data independently.Rev Man 5. 3 software was used for Meta-analysis. Results A total of 16 RCTs involving 973 patients were included,523 in the test group and 450 in the control group. Compared with the control group,the test group showed better effects in reducing the 24-hour urine protein quantitation( SMD =-0. 78,95% CI-1. 03--0. 54,P < 0. 000 01). The serum creatinine( SMD =-0. 44,95% CI-0. 85--0. 03,P = 0. 04) and blood urea nitrogen( WMD =-0. 30,95% CI-0. 59--0. 01,P = 0. 04)in the test group were lower than the control group. There was no significant difference between the two groups in the alanine aminotransferase and white blood cell count( P > 0. 05). The incidence of adverse reactions in the test group was higher than the control group( RR = 1. 97,95% CI 1. 22-3. 19,P = 0. 006). Conclusion The TG has affirmative effect in the treatment of DKD with acceptable safety,although it has adverse reactions. Due to multiple factors such as quality of the included literatures,this conclusion needs to be verified by more high-quality,large-sample,multi-center randomized double-blind controlled trials.