目的 系统评价补肾活血法联合常规化学药治疗糖尿病肾病(diabetic kidney disease,DKD)的有效性及安全性。方法 计算机检索CNKI、万方、PubMed、Cochrane Library等数据库,检索时间从2011年1月-2021年9月,筛选近10年关于补肾活血法治疗DKD的临床随机对照试验(randomized controlled trial,RCT),其中对照组施以常规西医基础治疗,试验组在对照组基础上配合使用主要功效为补肾活血的中药口服剂。采用Cochrane风险偏倚评估工具进行文献质量评价,使用RevMan 5.3软件进行统计学分析。结果 最终纳入28篇RCTs,共计2365例患者。Meta分析结果显示,试验组相对于对照组能有效提高临床疗效[OR=3.59,95% CI(2.85,4.52),P<0.01],显著降低肌酐水平[SMD=−0.61,95% CI(−0.71,−0.51),P<0.01]、24 h尿蛋白水平[SMD=−0.57,95% CI(−0.69,−0.45),P<0.01]、尿素氮水平[SMD=−0.51,95% CI(−0.62,−0.40),P<0.01]、尿白蛋白排泄率[SMD=−1.45,95% CI(−1.57,−1.32),P<0.01]、尿β₂微球蛋白[SMD=−0.41,95% CI(−0.62,−0.20),P<0.01],有效调节血糖,包括降低空腹血糖[MD=−0.23,95% CI(−0.31,−0.14),P<0.01]、餐后2 h血糖[MD=−0.34,95% CI(−0.50,−0.17),P<0.01] 以及糖化血红蛋白[MD=−0.27,95% CI(−0.35,−0.19),P<0.01],并且具有一定的用药安全性[OR=1.00,95% CI(0.51,1.94),Z=0.00(P=1.00)]。结论 基于补肾活血法的中西医结合治疗糖尿病肾病具有良好临床疗效,有一定的安全性,但受纳入文献质量和数量的限制,上述结论仍需更多大样本、多中心RCT进一步验证。

Objective To systematically evaluate the effectiveness and safety of the tonifying kidney and promoting blood circulation method combined with conventional western medicine in the treatment of diabetic kidney disease (DKD). Methods CNKI, Wanfang, PubMed, Cochrane Library and other databases were searched by computer from January 2011 to September 2021. Randomized controlled trials (RCT) of tonifying kidney and promoting blood circulation in the treatment of DKD in recent 10 years were screened. The control group was treated with conventional western medicine basic treatment, and the experimental group was treated with oral traditional Chinese medicine with the main effect of tonifying kidney and promoting blood circulation. The Cochrane risk bias assessment tool was used for literature quality evaluation, and RevMan 5.3 software was used for statistical analysis. Results A total of 28 RCTs were finally included, with a total of 2365 patients. Meta-analysis results showed that the experimental group can effectively improve the clinical efficacy[OR=3.59, 95% CI (2.85, 4.52), P < 0.01] compared with the control group, and significantly reduce creatinine level[SMD=−0.61, 95% CI (−0.71, −0.51), P < 0.01], 24 h urine total protein level[SMD=−0.57, 95% CI (−0.69, −0.45), P < 0.01], blood urea nitrogen level[SMD=−0.51, 95% CI (−0.62, −0.40), P < 0.01], urinary albumin excretion rate[SMD=−1.45, 95% CI (−1.57, −1.32), P < 0.01], urinary β₂ microglobulin level[SMD=−0.41, 95% CI (−0.62, −0.20), P < 0.01], effectively regulate blood sugar, including lowering fasting blood-glucose[MD=−0.23, 95% CI (−0.31, −0.14), P < 0.01], blood glucose 2 h after meal[MD=−0.34, 95% CI (−0.50, −0.17), P < 0.01] and glycosylated hemoglobin A1c[MD=−0.27, 95% CI (−0.35, −0.19), P < 0.01], and have certain medication safety[OR=1.00, 95% CI (0.51, 1.94), Z=0.00 (P=1.00)]. Conclusion Integrated Chinese and western medicine based on the tonifying kidney and promoting blood circulation method has a good clinical effect in the treatment of diabetic kidney disease and has certain safety. However, due to the limitations of the quality and quantity of the included literature, the above conclusions still need to be further verified by more large-sample and multi-center RCT.

R285.4

国家自然科学基金面上项目（82074242）；天津市中医药重点领域科研项目（2018005）；天津市卫健委中医/中西医结合科研课题（2017019）