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目的通过临床随机和半随机对照试验,对中成药联合高效抗反转录病毒疗法(HAART)治疗艾滋病病毒(HIV)感染者/艾滋病(AIDS)病人(简称HIV/AIDS病人)的疗效和安全性进行系统评价。方法利用相关检索式计算机检索中国知网、万方数据系统、维普生物医药数据库、Medline、EMbase、CBM数据库,收集有关中成药联合HAART的HIV/AIDS病人的随机对照试验,利用Cochrane协作网的系统评价方法进行评估,并利用Cochrane协作网风险偏倚评价标准制作漏斗图评价出版偏倚。分别由两名评价员独立对符合纳入标准的试验进行质量评价和资料提取,然后交叉核对。结果中成药联合HAART药物能够改善HIV/AIDS病人CD4+T淋巴细胞计数[均数差(MD)=0.70,95%可信区间(CI):0.21~1.19,P<0.005];同时对于卡洛夫斯基积分的提升(MD=8.93,95%CI:3.83~14.03,P=0.0006)以及提高治疗的有效率方面(MD=2.35,95%CI:1.46~3.78,P<0.0004)均具有一定的优势。此外,还能改善HIV患者的一些临床并发症,诸如皮疹、腹泻、乏力等,且没有出现明显的不良反应。但是对于CD8+T淋巴细胞计数改善间的差异没有统计学意义(MD=-13.97,95%CI:-163.11~135.17,P=0.85)。结论由于文献质量均较低,方法学较为简单,故仍需多中心、大样本含量、随机对照的临床试验,以期做出更为严谨的系统评价。
Objective To evaluate the efficacy and safety of proprietary Chinese medicines and HAART in the treatment of HIV / AIDS patients Conduct a systematic review. Methods A computer-based search of CNKI, Wanfang Data System, VIP Biomedicine Database, Medline, EMbase and CBM databases was conducted to collect randomized controlled trials of Chinese medicine / HAART patients with HIV / AIDS. The Cochrane Collaboration System Evaluation method, and use the Cochrane Collaboration network risk bias evaluation criteria to make funnel charts to evaluate publication bias. Two reviewers independently assessed the quality of the trials that met the inclusion criteria and extracted the data and then cross-checked them. Results The combination of proprietary Chinese medicines and HAART could improve CD4 + T lymphocyte count in HIV / AIDS patients (mean difference (MD) = 0.70, 95% CI: 0.21-1.19, P <0.005] (P = 0.0003, P <0.0004) in the improvement of treatment effect (MD = 8.93, 95% CI: 3.83-14.03, P = 0.0006) The advantages. In addition, it can also improve some of the clinical complications of HIV patients, such as rash, diarrhea, fatigue, etc., and no significant adverse reactions. However, there was no statistical difference between the improvement in CD8 + T lymphocyte count (MD = -13.97, 95% CI: -163.11 to 135.17, P = 0.85). Conclusion Due to the low quality of the literature and the relatively simple methodology, multi-center, large sample size and randomized controlled clinical trials are still needed in order to make a more rigorous systematic review.