目的:系统评价复方血栓通胶囊治疗糖尿病肾病Ⅲ期的疗效与安全性。方法:计算机检索Cochrane Library、Pub Med、Medline、EMbase、Ovid、CNKI、VIP、CBM和Wan Fang Data,查找中文或外文公开发表关于复方血栓通胶囊治疗糖尿病肾病Ⅲ期的随机对照试验。然后根据事先制定的纳入排除标准,筛选出符合条件的文献,再根据Jadad评分标准对纳入文献进行方法学质量评价,最后提取文献相关数据,并使用Rev Man 5.2软件对数据进行Meta分析。结果:纳入9个研究,共805例受试者。主要结局指标示:与单纯常规治疗相比,复方血栓通胶囊联合常规治疗能够降低尿白蛋白排泄率[P〈0.05,MD=-17.79,95%CI(-29.95,-5.64),I2=88%],提高有效率[P〈0.05,OR=3.83,95%CI(2.07,7.09),I2=0]。对于血肌酐[P=0.05,MD=-7.38,95%CI(-14.92,0.15),I2=89%],差异无统计学意义。结论:基于现有研究证据,复方血栓通胶囊联合常规治疗对糖尿病肾病Ⅲ期具有一定的疗效及安全性,但受限于研究质量和样本量,仍有待进一步高质量、多中心、大样本的随机双盲试验加以证实。
Objective : To systematically review the effectiveness and safety of Fufang Xueshuantong Capsule on treating diabetic nephropathy. Methods : We searched journals through database such as Cochrane Library, PubMed, Medline, EMbase, Ovid, CNKI, VIP, CBM and WanFang about randomized controlled trials of Fufang Xueshuantong Capsule on treating Ⅲ stage of diabetic nephropathy. And then we collected studies which matched our inclusion and exclusion standard and extracted the data from these journals after a quality analysis was finished, which was based on Jadad standard. Finally, a Meta - analysis was performed to make a full systematic review by using RevMan 5.2 software. Results : A total of 9 studies involving 805 participants were includ- ed. The main outcomes of the Meta - analysis showed : compared to the conventional treatment group, the Fufang Xueshuantong capsule combined conventional treatment group had a lower level of UAER [ P 〈 0.05, MD = - 17.79,95% CI ( - 29.95, - 5.64 ), 12 = 88% ] and a higher effective rate [ P 〈 0. 05,95 % CI (2.07,7.09), OR = 3.83,12 = 0 ]. But as to SCR [ P = 0.05, MD = -7.38, 95% CI(-14.92,0.15) ,I^2 = 89% ] ,we found no significant difference. Conclusion: According to the existing evidence, Fufang Xueshuantong Capsule had a safe and curative effect on treating Ⅲ stage of diabetic nephropathy. However, as most of the included studies were regarded as low qualities, more well - designed researches should be done.