雷公藤多甙治疗糖尿病肾病的系统评价

目的系统评价雷公藤多甙治疗糖尿病肾病的疗效及安全性。方法电子检索Cochrane图书馆临床对照试验资料库（2010年第1期）、MEDLINE（1996～2010年3月）、EMbase（1980～2010年3月）、中国期刊全文数据库（1994～2010年3月）、中国生物医学文献数据库（1978～2010年3月）,手工检索《中华肾脏病杂志》等相关杂志及重要会议论文集、学位论文汇编,并追溯已获文献的参考文献,收集雷公藤多甙治疗糖尿病肾病（DN）的随机对照试验和半随机对照试验。由两名研究者独立选择试验、评价质量、提取数据,并交叉核对。使用RevMan5.0.7软件进行Meta分析。结果共纳入12个随机对照试验,862例DN患者,＂漏斗图＂呈不对称分布,提示可能存在发表偏倚或纳入文献方法学质量较低。Meta分析结果显示：①雷公藤多甙在降低DN患者24小时尿蛋白临床期WMD=-0.49,95%CI（-0.63,-0.34）;未分期：WMD=-0.60,95%CI（-0.96,-0.24）]、24小时尿白蛋白排泄率WMD=-148.75,95%CI（-238.01,-59.48）]上优于常规治疗;②雷公藤多甙对糖尿病肾病血肌酐水平临床期WMD=-8.43,95%CI（-18.15,1.29）;未分期：WMD=-0.66,95%CI（-2.12,0.79）]、内生肌酐清除率的影响WMD=1.74,95%CI（-6.34,9.83）]与常规治疗没有差异;③雷公藤多甙对DN患者血脂、血压的影响因纳入研究较少,论证强度较低,不能确定;④治疗期间尚未发现严重不良反应。结论雷公藤多甙可能是一种相对安全和有效治疗糖尿病肾病的药物。由于纳入研究的方法质量低下和可能存在发表偏倚,使本系统评价的证据强度不高,上述结论有待进一步开展大样本、高质量、多中心的随机双盲对照试验来证实。

Effects of Tripterygium on Diabetic Nephropathy: A Systematic Review

Objective To evaluate the efficacy and safety of tripterygium for diabetic nephropathy.Methods All randomized or quasi-randomized controlled trials（RCTs or quasi-RCTs） of tripterygium for biabetic nephropathy were collected from The Cochrane Library（Issue 1,2010）,MEDLINE（1996 to March 2010）,CNKI（1994 to March 2010）,and CBM（1978 to March 2010）.Two reviewers evaluated the quality of the trials and extracted the data independently.RevMan 5.0 software was used for meta-analyses.Results A total of 12 RCTs involving 862 patients were identif ied.The methodology of the included trials was poor and potential publication bias existed.The meta-analyses results showed：（1） Compared with the conventional treatment,the tripterygium showed more effects in reducing the 24-hour urinary protein（Clinical phase：WMD=-0.49,95%CI-0.63 to-0.34,No phase：WMD=-0.60,95%CI-0.96 to-0.24）,and the urinary albumin excretion rate（UAER）（WMD=-148.75,95%CI-238.01 to-59.48） was higher than that of the conventional treatment.（2） There were no significant differences between the two groups in the effect on the serum creatinine（Clinical phase：WMD=-8.43,95%CI-18.15 to 1.29,No phase：WMD=-0.66,95%CI-2.12 to 0.79） and creatinine clearance rate（WMD= 1.74,95%CI-6.34 to 9.83）.（3） Without enough data,it was uncertain to define the effect of tripterygium on lipids,blood pressure of the DN patients.（4） No severe adverse events or allergic reactions were reported.Conclusion Tripterygium may be a kind of medicine relatively safe and effective for diabetic nephropathy.However,the evidence is not strong enough because of some low-quality trials and publication bias.Rigorously-designed,randomized,double-blind,and placebo-controlled trials of tripterygium for diabetic nephropathy are needed to further assess the effect.