丹红注射液治疗糖尿病肾病的系统评价

Dan Hong Injection for Diabetic Nephropathy:A Systematic Review

目的评价丹红注射液治疗糖尿病肾病的有效性及安全性。方法采用Cochrane系统评价方法,计算机检索Cochrane图书馆临床对照试验数据库(2009年第2期)、MEDLIN(E1980～2009.6)、EMbas(e1980～2009.6)、CBM(1990～2009.6)、CNKI(1994～2009.6)、VIP(1989～2009.6)及万方数据库(1984～2009.6);同时手工检索相关期刊和会议论文,纳入丹红注射液治疗糖尿病肾病的随机对照试验,按Cochrane协作网肾脏病组的质量评价标准评价纳入研究的方法学质量,提取有效数据并采用Revman5.0软件进行分析。结果共纳入10个RCT,包括736例糖尿病肾病患者。但方法学质量评价显示纳入研究质量不高,均为C级。Meta分析显示:与常规治疗相比,丹红注射液+常规治疗在降低糖尿病肾病患者尿蛋白排泄率[MD=-27.08,95%CI(-30.40,-24,02)]、糖化血红蛋白[MD=-1.12,95%CI(-1.67,-0.56)]及纤维蛋白原[MD=-2.28,95%CI(-2.70,-1.86)]等方面具有优势,但在改善24小时尿蛋白定量[MD=-0.03,95%CI(-0.10,0.04)]、血清肌酐(MD=-1.00,95%CI(-7.86,5.86)]、血清肌酐清除率[MD=-2.30,95%CI(-15.51,10.91)]、胆固醇[MD=-0.10,95%CI(-0.68,0.48)]、甘油三酯[MD=-0.15,95%CI(-0.36,0.05)]、空腹血糖[MD=-0.10,95%CI(-0.68,0.48)]等方面没有差异;与丹参相比,丹红注射液在减少糖尿病肾病患者尿蛋白排泄率[MD=-13.14,95%CI(-18.00,-8.27)]、24小时尿白蛋白(P<0.05)、胆固醇(P<0.05)、甘油三酯(P<0.05)等方面较优;与脉络宁相比,丹红注射液在降低24小时尿白蛋白(P<0.05)及纤维蛋白原(P<0.05)方面具有优势。所有文献均未报道试验组及对照组的不良反应。结论现有研究表明丹红注射液对减少糖尿病肾病患者的尿蛋白排泄率及尿量又一定疗效,也未见明显不良反应。但由于纳入研究质量普遍偏低,上述结论尚需开展更大样本的高质量随机对照试验证实。

Objective To evaluate the effectiveness and safety of Dan hong injection for treating diabetic nephropathy （DN）. Methods We electronically searched CENTRAL （the second issue 2009）, MEDLINE （1980-2009.6）, EMBASE （1980-2009.6）, CNKI （1994-2009.6）, CBM （1990-2009.6）, WANG FANG （1984-2009.6） and VIP （1989-2009.6） to June 2009, and reference lists of all papers identified also were checked. Randomized controlled trials （RCTs）, quasi- RCTs and cross-over studies were identified and assessed according to the Cochrane Handbook for Systematic Reviews of Interventions, and then Revman 5.0 was used to undertake meta analysis. Results Ten RCTs of 736 patients of diabetic nephropathy were included. Meta analyses showed that Dan hong injection was superior to routine treatment in decreasing UAER [MD=-27.08, 95%CI （-30.40, -24.02）], HblAC [MD=-1.12, 95%CI （-1.67, -0.56）] and FDP [MD= -2.28, 95%CI （-2.70, -1.86）]; and Dan hong had similar effects in reducing the 24 hours proteinuria [MD= -0.03, 95%CI （-0.10, 0.04）], serum creatinine [MD=-1.00, 95%CI （-7.86, 5.86）], endogenous creatinine clearance rate [MD=-2.30, 95%CI （-15.51, 10.91）], blood cholesterol [MD=-0.10, 95%CI （-0.68, 0.48）], blood triglyceride [MD= -0.15, 95%CI （-0.36, 0.05）] and fasting blood sugar [MD= -0.10, 95%CI （-0.68, 0.48）]; However, Dan hong had more effective action on decreasing the UAER [MD=-13.14, 95%CI （-18.00, -8.27）], blood cholesterol （P〈0.05） and triglyceride （P〈0.05） comparing with Dan shen, and on reducing 24 hour albuminuria （P〈0.05） and FDP （P〈0.05） with Mai luoning; no significant adverse effects or allergic reactions were reported. Conclusion Dan hong can improve UAER of DN; conclusive results cannot be made about the effectiveness and safety of dan hong for diabetic nephropathy according to limited existing trials. Larger and higher quality randomized controlled trials are needed to assess the available evidence.