张婧 李靖 张海力 曲海顺 张献之 程亚清 张正媚 黄佳钦

摘要 目的：系統评价尿毒清颗粒联合RAAS系统阻滞剂治疗糖尿病肾病的疗效。方法：运用计算机检索CNKI、万方、VIP、Pubmed、Embase及Cochrane Library中关于尿毒清颗粒联合RAAS系统阻滞剂治疗糖尿病肾病随机对照试验（RCT）的研究文献。采用RevMan5.3软件对符合本次研究的文献中所需要的数据进行Meta分析。结果：最终收入15篇随机对照试验，共1 063例患者纳入分析，其中联合治疗538例，对照组525例。Meta分析结果显示尿毒清颗粒联合RAAS系统阻滞剂组在临床缓解率[OR=2.92，95%CI（1.76-4.86）]、24 h尿蛋白定量[MD 0.71，95%CI（0.28-1.14）]、UAER[MD 41.13，95%CI（26.66-55.59）]。但尿毒清颗粒联合RAAS系统阻滞剂观察组在降低血清尿素氮[MD-0.86，95% CI（0.05-1.68，P=0.02）]、降低空腹血糖[MD-0.03，95%CI（-0.15-0.09），P=0.61]方面无治疗优势。2组不良事件发生率差异无统计学意义[RR=2.34，95%CI（0.69-7.95），P=0.17]。结论：尿毒清颗粒联合RAAS系统阻滞剂可能与单独使用RAAS系统阻滞剂一样安全，在提高总有效率、降低24 h尿蛋白定量及UAER方面具有优势。但由于此次纳入分析的文献质量偏低，未来更需要多中心，大样本，研究设计更严谨的随机双盲实验做进一步验证。

关键词 ACEI/ARB;联合用药;Meta分析;尿毒清颗粒;RAAS系统阻滞剂;糖尿病肾病;中医药

Meta-analysis of Niaoduqing Granules Combined with ACEI/ARB in the Treatment of Diabetic Nephropathy

ZHANG Jing，LI Jing，ZHANG Haili，QU Haishun，ZHANG Xianzhi，CHENG Yaqing，ZHANG Zhengmei，HUANG Jiaqin

（Dongzhimen Hospital，Beijing University of Chinese Medicine，Beijing 100700，China）

Abstract Objective：To systematically evaluate the efficacy of Niaoduqing Granules combined with ACEI/ARB in the treatment of diabetic nephropathy.Methods：Computer-researched literature on diabetic nephropathy randomized controlled trials （ RCT ） in the treatment of Niaoduqing Granules combined with ACEI/ARB was screened in CNKI，Wanfang，VIP，Pubmed，Embase，and Cochrane Library.A Meta-analysis of the data required in the literature in accordance with this study was performed using revman 5.3 software.Results：A total of 15 randomized controlled trials were finally analyzed and 1 063 patients were adopted for analysis，including 538 patients receiving the combination treatment and 525 patients in the control group.The results of Meta-analysis showed that the clinical remission rate of Niaoduqing Granule combined with ACEI/ARB was significantly better than of the control group [OR=2.92，95% CI （ 1.76-4.86 ）].The treatment combined with Niaoduqing granule decreased the 24-hour urinary protein quantitation [MD 0.71，95% CI （ 0.28-1.14 ）] and UAER [MD 41.13，95% CI （ 26.66-55.59 ）] levels.However，the combination group had no treatment advantage on reducing serum urea nitrogen [MD 0.86，95% CI （ 0.05-1.68 ），P=0.02] and fasting blood glucose （ MD-0.03，95% CI （-0.15-0.09 ），P=0.61].And there was no significance in adverse events between 2 groups [RR=2.34，95% CI （ 0.69-7.95 ），P=0.17].Conclusion：Niaoduqing Granules-ACEI/ARB combination group maybe as safe as using ACEI/ARB alone，and the combination had an advantage in improvement in total effective rate，reducing of 24-hour urinary protein quantitation and UAER.However，due to the low quality of the literature included in this analysis，more centers and large samples are needed in the future.A more rigorous randomized double-blind trial was designed for further validation.

Keywords ACEI/ARB; Combination of drugs; Meta-analysis; Niaoduqing Granules; RAAS system blocker; Diabetic nephropathy; Traditional Chinese medicine

中图分类号：R256.5;R259文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.02.016

糖尿病肾病（Diabetic Nephropathy，DN）是糖尿病（Diabetes Mellitus，DM）最常见的微血管并发症之一。2017年全球糖尿病患病总人数为4.51亿，预计2045年将达到6.93亿[1]。近年来，中医药对于糖尿病肾病的独特优势不断凸显，其中尿毒清颗粒作为一种典型的中药复方制剂受到广大研究者的关注。尿毒清颗粒由黄芪、白术、茯苓、制何首乌、丹参、菊花、姜半夏、甘草等16味中药组成。含有多种有效的生物活性成分，如异黄酮、大黄素、黄芪甲苷、芍药苷、丹酚酸a等。……