目的 系统分析中医药治疗艾滋病免疫重建不良的临床研究证据特征及分布,总结改善艾滋病免疫重建不良有效干预的研究现状与不足.方法 检索中国知识资源总库、中国学术期刊数据库、中文科技期刊数据库、中国生物医学文献数据库、PubMed、Web of Science、EMbase、Cochrane Library数据库,纳入建库起至2022年12月31日期间中医药治疗艾滋病免疫重建不良的临床研究,以证据图和图表形式呈现临床研究证据特征及分布.结果 共纳入文献71篇,包括干预性研究文献52篇,观察性研究文献14篇,系统评价/Meta分析4篇,专家共识1篇.年度发文量总体呈上升趋势;47.17％的干预性研究样本量＜50例;最常用的艾滋病免疫重建不良诊断标准是cART时间＞24个月(37.14％),CD4细胞计数＜350个/μL(23.81％);干预性研究均为中西医协同治疗,90.38％的干预疗程≥6个月,结局指标对淋巴细胞分类计数关注最多(55频次);随机对照试验文献质量较低;系统评价/Meta分析文献质量极低.结论 中医药治疗艾滋病免疫重建不良的临床研究质量较低,未来需加强临床诊疗及研究的规范性,开展更多大样本、高质量的临床研究,为该领域提供更全面、科学的循证证据.
Analysis of clinical research evidence for traditional Chinese medicine in the treatment of AIDS immunological non-responders
Objective To systematically analyze the characteristics and distribution of clinical research evidence for traditional Chinese medicine(TCM)treatment of AIDS immunological non-responders,and to summarize the current status and deficiencies of effective interventions for improving poor immune reconstitution in AIDS patients.Methods A comprehensive search was conducted in databases including China National Knowledge Infrastructure(CNKI),China Academic Journals,Chinese Science and Technology Journals,China Biology Medicine disc,PubMed,Web of Science,EMbase,and Cochrane Library.Clinical studies of TCM treatment for AIDS immunological non-responders from the inception of the databases to 31 December 2022,were included.Evidence characteristics and distribution were presented in the form of evidence tables and graphs.Results A total of 71 articles were included,involving 52 interventional studies,14 observational studies,4 systematic reviews/meta-analyses,and 1 expert consensus.The annual publication volume showed an overall upward trend;47.17％of the interventional studies had a sample size of＜50 cases;the most commonly used diagnostic criteria for AIDS immunological non-responders were antiretroviral therapy(ART)duration＞24 months(37.14％)and CD4+T lymphocyte count＜350 cells/μL(23.81％).All interventional studies used integrative treatment,combining TCM and Western medicine.With 90.38％of the interventions lasted ≥6 months.Outcome indicators focused most on lymphocyte subtype counts(55 occurrences).The quality of randomized controlled trial literature was low;the quality of systematic reviews/meta-analyses was extremely low.Conclusions The quality of clinical research on the TCM treatment for immunological non-responders is generally low.In the future,it is necessary to strengthen the standardization of clinical diagnosis,treatment,and research,and to carry out more large-sample,high-quality clinical studies to provide more comprehensive and scientific evidence-based evidence in this field.
traditional Chinese medicine(TCM)AIDSimmunological non-respondersclinical researchevidence map
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