中医药治疗艾滋病随机对照试验评价指标的现状分析
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国家自然科学基金项目(U1604287);国家“十三五”科技重大专项(2017ZX10205502),河南省中医管理局中医临床研究基地专项(2017JDZX001);河南省中医药科学研究专项(2021JDZY001)


Evaluation Index of Randomized Controlled Trials of AIDS Treated by Traditional Chinese Medicine
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    目的:通过对中医药治疗艾滋病的随机对照研究文献分析,得到中医药治疗艾滋病的随机对照试验结局指标情况,为未来选择合适的中医药治疗艾滋病的结局指标提供参考。方法:通过检索国家知识基础设施数据库(CNKI)、中国医学生物文献数据库(CBM)、中国学术期刊数据库(CSPD)及中文科技期刊数据库(CCD)、PubMed、EMbase、Cochrane Library等数据库纳入符合中医药诊治艾滋病临床随机对照试验的文献。结果:总纳入32篇文献,患者7 642例,涉及到42种结局指标155次,包括中医证候/证候评分、理化指标、安全事件、西医体征指标、生命质量、远期预后。理化指标72(46.45%)、安全事件43(27.74%)、中医证候/证候评分12(7.74%)、远期预后及安全指标不足。结论:目前中医药治疗艾滋病结局指标数量差异大、种类单一,测量时间点差异性大、中医特色疗法、远期预后及生命质量关注度欠佳、复合指标缺乏标准。本研究通过现有中文核心文献研究,为今后中医药治疗艾滋病的临床随机对照试验结局指标的选择提供借鉴。

    Abstract:

    To obtain the outcome indexes of randomized controlled trials of AIDS treated by traditional Chinese medicine(TCM) through the analysis of related literature,and to provide reference for selecting appropriate outcome indexes for TCM treatment of AIDS in future.Methods:Literature including randomized controlled trials of TCM diagnosis and treatment of AIDS was included by searching China National Knowledge Infrastructure(CNKI),Wanfang Data,VIP,China Biology Medicine disc(CBM),Chinese Science Citation Database(CSPD),Chinese Citation Database(CCD),PubMed,EMbase and Cochrane Library.Results:A total of 32 articles were selected,involving 7 642 patients and 42 outcome indexes for 155 times,which included TCM syndrome score,physical and chemical indexes,safety events,western medicine signs,quality of life,and long-term prognosis.And it was insufficient in terms of physical and chemical indexes(72,46.45%),safety incidents(43,27.74%),TCM syndrome score(12,7.74%),long-term prognosis and safety indexes.Conclusion:At present,there is large difference in the number of outcome indexes and limited types in the TCM treatment of AIDS,as well as large differences in measurement time points and TCM characteristic therapies,with low attention to long-term prognosis and quality of life,and lack of standards for composite indexes.This paper provides reference for selecting outcome indexes of clinical randomized controlled trials of TCM treatment of AIDS in future through the analysis of existing Chinese core literature.

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钟鹏展,徐立然,郭家乐,黄铭燕,宋夕元.中医药治疗艾滋病随机对照试验评价指标的现状分析[J].世界中医药,2023,(19).

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  • 收稿日期:2022-01-22
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  • 在线发布日期: 2023-12-14
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