摘要
通过分析中医药治疗非重症社区获得性肺炎(NSCAP)随机对照试验(RCT)的结局指标现状,为NSCAP临床试验设计和核心指标集的构建提供基础。系统检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、PubMed、EMbase、Cochrane Library、Web of Science,检索时限均为建库至2023年8月31日。由2位评价者独立筛选、提取资料并评价纳入文献的偏倚风险,采用定性分析描述纳入文献的结局指标。初检获得42903篇文献,最终纳入47篇(英文4篇、中文核心43篇)。提取到79种结局指标,出现频次434次,主要分为9大类:理化检测指标(23种,96次)[包含炎症指标(16种,78次)、动脉血气分析(4种,8次)、免疫指标(3种,10次)]、症状体征(7种,86次)、临床疗效时间(15种,83次)、临床疗效率(12种,69次)、安全性事件(3种,50次)、中医证候疗效(4种,26次)、量表评分类(13种,22次)、经济学指标(1种,1次)、其他指标(1种,1次)。结果表明,中医药治疗NSCAP的RCT在结局指标选择方面存在较多问题,主要表现为主要结局指标与次要结局指标区分不明确、终点指标选择不规范、中医证候疗效指标评价标准不规范、生活质量量表及卫生经济学指标使用较少等。建议参考国际核心指标集建立方法,完善医患共建模式下标准化的NSCAP中医临床疗效评价体系,提高临床试验质量。
To analyze the outcome indicators of randomized controlled trial(RCT)of traditional Chinese medicine(TCM)in the treatment of non-severe community-acquired pneumonia(NSCAP),and to provide a basis for the design of NSCAP clinical trials and the construction of core outcome set.CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase,Cochrane Library,and Web of Science were systematically searched from establishment to August 31,2023.Two reviewers independently screened the literature,extracted data,and evaluated the risk of bias in the included studies.Qualitative analysis was used to describe the outcome indicators of the in-cluded studies.A total of 42903 articles were preliminarily obtained,and 47 articles were finally included(4 articles in English and 43 articles in Chinese core).Seventy-nine outcome indicators were extracted,with 434 times.They were mainly divided into 9 catego-ries:physical and chemical indicators(23 kinds,96 times)[including inflammatory indicators(16 kinds,78 times),arterial blood gas analysis(4 kinds,8 times),and immune indicators(3 kinds,10 times)],symptoms and signs(7 kinds,86 times),clinical ef-ficacy time(15 kinds,83 times),clinical efficacy rate(12 kinds,69 times),safety events(3 kinds,50 times),TCM syndrome effi-cacy(4 kinds,26 times),rating scales(13 kinds,22 times),economic indicators(1 kind,1 time),and other indicators(1 kind,1 time).Numerous issues with the selection of outcome indicators of RCT in TCM treatment of NSCAP existed.These issues primarily showed up as unclear distinctions between primary and secondary outcome indicators,non-standard end point selection and TCM syn-drome efficacy indicator evaluation criteria,and insufficiently used quality of life scales and health economics indicators.It is suggested to refer to the establishment method of the international core outcome set,improve the standardized TCM clinical efficacy evaluation system for NSCAP under the doctor-patient co-construction mode,and improve the quality of clinical trial.
作者
孔欣欣
谢凯
黄夏瑾
李贞
殷文静
王海峰
KONG Xin-xin;XIE Kai;HUANG Xia-jin;LI Zhen;YIN Wen-jing;WANG Hai-feng(Department of Respiratory and Critical Care Medicine,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,China;the First School of Clinical Medicine,Henan University of Chinese Medicine,Zhengzhou 450000,China;Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province&Education Ministry of China,Henan University of Chinese Medicine,Zhengzhou 450000,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第19期5343-5353,共11页
China Journal of Chinese Materia Medica
基金
国家自然科学基金面上项目(82074411)
河南省科技研发计划联合基金(优势学科培育类)项目(232301420084)
河南省中医学“双一流”创建呼吸疾病中医药防治科技创新团队项目(HSRP-DFCTCM-T-1)
河南省特色骨干学科中医学学科建设项目(STG-ZYX02-202204)
河南省中医药科学研究专项(2023ZY1005)
河南省中医学“双一流”创建科学研究专项(HSRP-DFCTCM-2023-3-21,HSRP-DFCTCM-2023-8-06)。
关键词
非重症社区获得性肺炎
中医药
随机对照试验
结局指标
核心指标集
non-severe community-acquired pneumonia
traditional Chinese medicine
randomized controlled trial
outcome indica-tor
core outcome set
