Abstract: Background　For early-and middle-stage diabetic nephropathy（DN），the efficacies of angiotensin-converting enzyme inhibitor（ACEI）and angiotensin Ⅱ receptor antagonist（ARB）are limited although they are used as first-line drugs. As inflammatory response play a key role in the development of DN，immunosuppressive agents derived from Chinese medicine may be used as adjuvant therapies for DN. Objective　To perform a meta-analysis of the effectiveness and safety of immunosuppressive agents derived from Chinese medicine with ACEI/ARB in the treatment of early-and middle-stage DN. Methods　Randomized controlled trials（RCTs）about effectiveness and safety in early-and middle-stage DN patients treated with immunosuppressive agents derived from Chinese medicine with ACEI/ARB（experimental group）compared with those treated with ACEI/ARB（control group）published in Chinese were screened from databases of CNKI，Wanfang Data，VIP and CBM，and those published in English from databases of Medline，EMBase，the Cochrane Library，Web of Science，from inception to May 5，2020. RevMan 5.3 software was used to complete the meta-analysis. Outcome indicators were the decrease in serum creatinine，24-hour urinary protein quantification and leukocyte count，improvement in serum albumin，and change in glutamic pyruvic transaminase after treatment，incidence of adverse reactions and overall response rate. Results　A total of 23 studies were included，involving 1 878 patients. The analysis revealed that compared to the control group，the experimental obtained greater decreases in serum creatinine level〔MD=-6.06，95%CI（-10.89，-1.22）〕，24-hour urinary protein quantification〔MD=-0.70，95%CI（-0.87，-0.53）〕，and white blood cell count〔MD=-0.42，95%CI（-0.76，-0.08）〕as well as improvement of serum albumin level〔MD=2.83，95%CI（1.66，4.01）〕. The experimental group had higher incidence of adverse reactions〔OR=1.87，95%CI（1.26，2.77）〕and overall response rate〔OR=3.05，95%CI（1.87，4.97）〕（P<0.05）. But there was no significant difference in the change of glutamic pyruvic transaminase level between the two groups〔MD=0.51，95%CI（-0.65，1.66），P=0.39〕. Conclusion　In patients with early-and middle-stage DN，the combination use of immunosuppressive agents derived from Chinese medicine and ACEI/ARB may effectively improve the renal function，serum albumin level and overall response rate，but it may result in higher risk of adverse reactions such as decreased white blood cell count，so it should be used cautiously in clinic practice.

Key words: Diabetic nephropathies, Chinese medicine immunosuppressive agents, Tripterygium wilfordii, Angiotensin-converting enzyme inhibitors, Angiotensin receptor antagonists, Meta-analysis

摘要： 背景　血管紧张素转化酶抑制剂（ACEI）和血管紧张素Ⅱ受体拮抗剂（ARB）是目前临床治疗早中期糖尿病肾病（DN）的一线药物，但作用有限；炎性反应在DN的发生和发展过程中具有重要作用，因此中药免疫抑制剂可能会成为DN的辅助治疗药物。目的　通过Meta分析方法全面评估中药免疫抑制剂联合ACEI/ARB治疗早中期DN的有效性和安全性。方法　计算机检索中文数据库中国知网、万方数据知识服务平台、维普网、中国生物医学文献数据库和英文数据库Medline、EMBase、the Cochrane Library、Web of Science，筛选关于中药免疫抑制剂联合ACEI/ARB（试验组）与ACEI/ARB（对照组）治疗早中期DN有效性和安全性的随机对照试验，检索时间均为建库至2020-05-05。采用RevMan 5.3软件进行Meta分析，结局指标包括治疗前后血肌酐下降水平、治疗前后24 h尿蛋白定量下降水平、治疗前后血白蛋白改善水平、治疗前后丙氨酸氨基转移酶变化水平、治疗前后白细胞计数下降水平、不良反应发生率及总有效率。结果　最终纳入文献23篇，包含1 878例患者。Meta分析结果显示：试验组患者治疗前后血肌酐下降水平〔均数差（MD）=-6.06，95%CI（-10.89，-1.22）〕、治疗前后24 h尿蛋白定量下降水平〔MD=-0.70，95%CI（-0.87，-0.53）〕、治疗前后血白蛋白改善水平〔MD=2.83，95%CI（1.66，4.01）〕、治疗前后白细胞计数下降水平〔MD=-0.42，95%CI（-0.76，-0.08）〕、不良反应发生率〔比值比（OR）=1.87，95%CI（1.26，2.77）〕、总有效率〔OR=3.05，95%CI（1.87，4.97）〕高于对照组（P<0.05），而两组患者治疗前后丙氨酸氨基转移酶变化水平比较，差异无统计学意义〔MD=0.51，95%CI（-0.65，1.66），P=0.39〕。结论　中药免疫抑制剂联合ACEI/ARB可有效改善早中期DN患者肾功能及血白蛋白水平，提高总有效率，但会在一定程度上增加白细胞计数下降等不良反应发生风险，临床需谨慎使用。

关键词: 糖尿病肾病, 中药免疫抑制剂, 雷公藤, 血管紧张素转化酶抑制剂, 血管紧张素受体拮抗剂, Meta分析