目的 系统评估不同中药复方制剂联合高效抗反转录病毒疗法（highly active anti-retroviral therapy，HAART）治疗艾滋病的疗效与安全性。方法 计算机检索知网（CNKI）、维普（VIP）、万方、中国生物医学文献数据库（CBM）、Embase、PubMed、Cochrane Library、Web of Science数据库中口服中药复方制剂联合HAART治疗艾滋病的随机对照试验，检索时限为自建库至2022年1月28日。筛选文献及提取数据后，通过Cochrane推荐的风险偏倚评价工具评估纳入文献的质量，运用Stata14.0分析数据。结果 最终纳入28篇文献，共2566例患者，治疗组1442例，对照组1124例，中药复方制剂9种。在提升CD4⁺T细胞水平方面，抗艾扶正胶囊[SMD＝1.33，95%CI（0.38，2.28）]＞艾复康胶囊 [SMD＝0.91，95%CI（−0.03，1.85）]＞艾灵颗粒 [SMD＝0.54，95%CI（−0.22，1.30）]；在改善CD8⁺T细胞水平方面，清毒胶囊 [SMD＝−0.67，95%CI（−1.39，0.05）]＞艾可清胶囊（颗粒）[SMD＝−0.32，95%CI（−0.79，0.14）]＞芪灵汤 [SMD＝−0.33，95%CI（−0.87，0.21）]；在提升CD4/CD8值方面，艾复康胶囊[MD＝0.15，95%CI（0.03，0.27）]＞康爱保生胶囊（胶囊）[MD＝0.11，95%CI（−0.03，0.25）]＞艾灵颗粒 [MD＝0.02，95%CI（−0.12，0.15）]；在控制病毒载量方面，艾复康胶囊/艾可清胶囊（颗粒）[SMD＝−0.34，95%CI（−0.59，−0.08）]＞康生爱保胶囊（胶囊）[SMD＝−0.27，95%CI（−0.47，−0.07）]＞艾复康胶囊 [SMD＝−0.21，95%CI（−0.54，0.12）]。在不良反应方面，中西医结合疗法发生不良反应的情况较少，安全性较高。结论 在抗病毒的基础上联合中药复方制剂治疗能提高艾滋病临床的综合疗效，其中艾复康胶囊和艾灵颗粒总体疗效较突出，但因纳入文献质量偏低，故需更多高质量的临床研究加以验证。

Objective To evaluate the efficacy and safety of different traditional Chinese medicine compound preparations (TCMCP) combined with highly active antiretroviral therapy (HAART) in the treatment of acquired immune deficiency syndrome (AIDS). Methods The clinical randomized controlled trials of oral TCMCP combined with HAART in the treatment of AIDS were retrieved from CNKI, VIP, Wanfang, China Biomedical Literature Database (CBM), Embase, PubMed, Cochrane Library, Web of Science, the search time was from the establishment of the database to January 28, 2022. After screening the literature and extracting data, the quality of the included literatures was assessed by the risk bias assessment tool recommended by Cochrane, and the data was analyzed by Stata 14.0. Results A total of 28 research papers were included, with 2566 patients, 1442 in the treatment group, 1124 in the control group, involving nine kinds of TCMCP. In terms of improving CD4⁺T cell level, Kang’ai Fuzheng Capsules (抗艾扶正胶囊) [SMD = 1.33, 95%CI = (0.38, 2.28)] > Aifukang Capsules (艾复康胶囊) [SMD = 0.91, 95%CI = (−0.03, 1.85)] > Ailing Granules (艾灵颗粒) [SMD = 0.54, 95%CI = (−0.22, 1.30)]; In terms of improving CD8⁺T cell levels, Qingdu Capsules (清毒胶囊) [SMD = −0.67, 95%CI = (−1.39, 0.05)] > Aikeqing Capsules (Granules) [艾可清胶囊 (颗粒)] [SMD = −0.32, 95%CI = (−0.79, 0.14)] > Qiling Decoction (芪灵汤) [SMD = −0.33, 95%CI = (−0.87, 0.21)]; In terms of increasing the CD4/CD8 ratio, Aifukang Capsules [MD = 0.15, 95%CI = (0.03, 0.27)] > Kang’ai Baosheng Pills (Capsules) [康爱保生丸 (胶囊)] [MD = 0.11, 95%CI = (−0.03, 0.25)] > Ailing Granules [MD = 0.02, 95%CI = (−0.12, 0.15)]; In terms of controlling viral load, Aifukang Capsules/Aikeqing Capsules [SMD = −0.34, 95%CI = (−0.59, −0.08)] > Kang’ai Baosheng Pills (Capsules) [SMD = −0.27, 95%CI = (−0.47, −0.07)] > Aifukang Capsules [SMD = −0.21, 95%CI = (−0.54, 0.12)]. In terms of adverse reactions, the combination of traditional Chinese and western medicine had fewer adverse reactions and higher safety. Conclusion On the basis of antiviral treatment, combined with traditional Chinese medicine compound preparations can better improve the comprehensive clinical efficacy. Aifukang Capsules and Ailing Granules had outstanding overall curative effects. However, due to the low quality of the included literature, the conclusions of the study still need more high-quality studies to verify.

国家中医药管理局项目(201507005);湖南省教育厅科学研究项目(20C1424);湖南省研究生科研创新项目(CX20210697)