中草药治疗艾滋病随机对照临床试验的系统综述

Chinese Herbal Medicine for HIV/AIDS: a Systematic Review and Meta-analysis of Randomized Clinical Trials

目的评价中医药治疗艾滋病的疗效和安全性。方法纳入文献为中草药治疗艾滋病的随机对照临床试验。全面检索Pub Med、Cochrane对照试验注册中心及CNKI、维普、万方和CBM数据库(截至2013年4月)。自行设计资料提取表提取资料,采用Cochrane手册推荐的质量评价工具评价文献质量,应用RevMan5.1软件进行数据分析。结果 3个试验评价为低风险偏倚,其他均为高风险偏倚。艾灵颗粒与安慰剂比较(2个试验,120名受试者)结果显示:CD4细胞计数增加:MD95.47,95%CI:(41.52,149.41);健康相关生活质量评分:MD4.80,95%CI(2.63,6.96)。湘A2联合传统治疗与传统治疗联合安慰剂比较(2个试验,120名受试者):CD4细胞计数增加:MD42.92,95%CI:(4.92,80.86)。艾灵颗粒联合传统治疗与传统治疗联合安慰剂比较(5个试验,334名受试者),CD4细胞计数增加:MD60.82,95%CI:(27.00,94.65)。纳入试验无严重不良反应报告。结论部分中草药如艾灵颗粒等在艾滋病的治疗中表现出潜在优势疗效且无严重不良反应,但由于纳入试验的质量较低和中草药治疗的异质性较大,需要慎重解释结果并在将来的研究中加以验证。

Objective To assess the effectiveness and safety of Chinese herbal medicines （CHMs） for treating HIV/AIDS. Methods Randomized clinical trials （RCTs） of CHMs for HIV/AIDSwere included. PubMed, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure （CNKI）, Chinese Science Journal Database, Chinese Biomedical Database, Wanfang Database were comprehensively retrieved （ended in April 2013）. A self-developed data extraction form was used to extract data. The methodological quality evaluated tool recommended by Cochrane Handbook was used to evaluate the quality of trials. Revman5.1 Software was used to perform data analysis. Results Three trials were assessed as low risk of bias and the other trials as high. Compared with placebo, Ailing Granule （120 participants, 2 trials） increased CD4 cell counts, MD. 95.47 （95%CI. 41.52 -149.41 ） and health-related quality of life scores： MD： 4.80 （95%C1：2.63 -6.96）. Xiang A2 plus traditional treatment （120 participants, 2 trials） increased CD4 cell counts E MD. 42.92 （95%CI. 4.92 -80.86） ], as compared with traditional treatment plus placebos. Ailing Granule plus traditional treatment （344 participants, 5 trials） increased CD4 cell counts [MD： 60.82 （95% CI- 27.00 -94.65） ], as compared with traditional treatment plus placebos. No serious adverse events were reported. Conclusions Some CHMs including Ailing Granule showed potential effects for treatment of HIV/AIDS and were not related with serious adverse reactions. However, the findings should be interpreted with caution and be verified in future studies due to poorer methodological quality of included trials and substantial heterogeneities of CHMs.