【目的】 运用网状Meta分析评价不同中药注射液联合血管紧张素转化酶抑制剂/血管紧张素Ⅱ受体拮抗剂（ACEI/ARB） 治疗糖尿病肾病蛋白尿的疗效与安全性。【方法】 检索中国知网（CNKI）、维普中文科技期刊数据库（VIP）、万方数据库 （Wanfang Data）、中国生物医学文献数据库（CBM），以及国外数据库如 PubMed、EMbase、Web of Science、Cochrane Library 等各数据库自建库至2023年10月间收载的关于中药注射液联合ACEI/ARB治疗早期糖尿病肾病蛋白尿的临床随机对照试验， 使用 Cochrane偏倚风险工具ROB 2.0对纳入文献进行质量评价，运用R4.3.2和Stata 18.0进行传统Meta分析及网状Meta分析。 【结果】 共纳入72项研究，涉及黄芪注射液、血塞通注射液、葛根素注射液、灯盏细辛注射液、灯盏花素注射液、丹红注射 液、血栓通注射液、银杏叶注射液、疏血通注射液、银杏达莫注射液、丹参注射液、肾康注射液、丹参川芎嗪注射液共 13 种中药注射液。主要结局指标为尿白蛋白排泄率（UAER）、24h 尿蛋白定量（24hUTP）、血肌酐（SCr）、尿白蛋白肌酐比 （UACR）。传统 Meta 分析结果显示：中药注射液联合 ACEI/ARB 在降低 UAER [MD=-26.14，95%CI（-29.39，-22.89）]、 24hUTP [（MD=-0.22， 95%CI（-0.27， -0.18）]、 SCr [MD=-0.34， 95%CI（-0.50， -0.19）]、 UACR [MD=-9.40， 95%CI （-15.64，-3.16）]方面优于单独使用ACEI/ARB，差异均有统计学意义（P < 0.05）。网状Meta分析结果显示：在降低UAER方 面，灯盏细辛注射液联合ACEI/ARB的疗效最佳；在减少24hUTP方面，丹参川芎嗪注射液联合ACEI/ARB的疗效最佳；在降 低SCr方面，肾康注射液联合ACEI/ARB的疗效最佳；在改善UACR方面，丹红注射液联合ACEI/ARB的疗效最佳。【结论】 中 药注射液联合 ACEI/ARB 治疗早期糖尿病肾病蛋白尿在降低 UAER、24hUTP、SCr、UACR 方面，其效果与安全性较单用 ACEI/ARB更佳。但鉴于纳入研究的质量及数量等因素的限制，结论仍需更多高质量的随机对照试验加以证实。

Objective To evaluate the efficacy and safety of different Chinese medicine injections combined with angiotensin converting enzyme inhibitor / angiotensin Ⅱ receptor blocker （ACEI / ARB） in the treatment of proteinuria in diabetic nephropathy by using network Meta-analysis. Methods Clinical randomized controlled trials of Chinese medicine injection combined with ACEI / ARB for the treatment of proteinuria in early diabetic nephropathy were retrieved from the domestic databases such as China National Knowledge Infrastructure（CNKI）， China Science and Technology Journal Database（VIP）， Wanfang Data Knowledge Service Platform（Wanfang Data）， and China Biology Medicine Disc（CBM）， as well as from the oversea databases such as PubMed， EMbase，Web of Science，and Cochrane Library from database inception to October 2023. The Cochrane risk of bias tool ROB2.0 was used to evaluate the quality of the included literature，and traditional Meta-analysis and network Meta-analysis were performed by using R4.3.2 and Stata18.0. Results A total of 72 trials were included， involving 13 Chinese medicine injections，namely Huangqi Injection，Xuesaitong Injection，Puerarin Injection， Denzhan Xixin Injection， Breviscapin Injection， Danhong Injection， Xueshuantong Injection， Yinxingye Injection， Shuxuetong Injection， Yinxing Damo Injection， Danshen Injection， Shenkang Injection， and Danshen Ligustrazine Injection. The primary outcomes were urinary albumin excretion rate（UAER）， 24-hour urinary total protein（24hUTP）， serum creatinine（SCr）， and urine albumin-to-creatinine ratio（UACR）. The results of traditional Meta-analysis showed that Chinese medicine injection combined with ACEI/ARB was more effective on reducing the levels of UAER [MD=-26.14，95% CI（-29.39，-22.89）]，24hUTP （[ MD=-0.22，95% CI （-0.27，-0.18）]，SCr [MD=-0.34，95% CI （-0.50，- 0.19）]，and UACR [MD=-9.40，95%CI （-15.64，-3.16）］ than ACEI / ARB alone， and the differences were all statistically significant（P < 0.05）. The results of network meta-analysis showed that the efficacy of Dengzhan Xixin Injection combined with ACEI/ARB was the optimum in terms of reducing UAER，Danshen Ligustrazine Injection combined with ACEI/ARB was the optimum in terms of decreasing 24hUTP，Shenkang Injection combined with ACEI/ARB was the optimum in terms of decreasing SCr， and Danhong Injection combined with ACEI / ARB had the best efficacy on improving UACR. Conclusion The efficacy and safety of Chinese medicine injection combined with ACEI/ARB in the treatment of proteinuria in early diabetic nephropathy are superior to those of ACEI/ARB alone in terms of lowering UAER，24hUTP，SCr，and UACR. However，due to the limitations of the quality and number of included literatures，the conclusions still need to be confirmed by more high-quality randomized controlled trials.

R259.872

广东省自然科学基金项目（编号：2020A1515011151）；深圳市科技创新委员会项目（编号：JCYJ20220531092201003）；深圳市科 技创新委员会项目（编号：JCYJ20180507183842516）