摘要
目的:系统分析目前中医药辅助治疗卒中相关性肺炎(SAP)的随机对照试验(RCT)中结局指标的应用现状,为临床研究提供依据.方法:检索中国知网数据库、万方数据库、维普数据库、中国生物医学文献服务系统、PubMed、Web of Science、Cochrane Library、EMbase 以及中国临床试验注册中心、ClinicalTrials.gov,筛选出中医药辅助治疗SAP的RCTs,进行偏移风险评价,并描述性统计分析结局指标使用情况.结果:初步筛选文献9 804篇,最终纳入31篇(其中1篇为试验方案),共提取到92种结局指标,主要概括为8类,根据频次由高到低依次为理化检测(110次)、临床疗效时间(48次)、临床疗效率(34次)、生活质量评价(24次)、症状体征(17次)、安全性评价(16次)、中医证候疗效(3次)、其他指标(3次).结论:中医药辅助治疗SAP的RCTs结局指标遴选存在主次不分,重视替代指标、轻视终点结局指标,复合结局指标评定标准不规范,对中医证候疗效评价、经济学评估和安全性结局指标关注不足等问题.
Abstract
Objective:To analyze the application status of outcome indicators in randomized controlled trial(RCT)of traditional Chinese medicine(TCM)in the treatment of stroke-associated pneumonia(SAP),so as to provide evidence for clinical research.Methods:Cnki database,Wanfang database,VIP database,Sinomed,PubMed,Web of Science,Cochrane Library,EMbase,Chinese Clinical Trial Registry and ClinicalTrials.gov were searched.RCTs on the adjuvant treatment of SAP with TCM were screened,the bias risk was evaluated,and the use of outcome indicators was analyzed by descriptive statistics.Results:A total of 9 804 studies were preliminarily screened,and 31 studies were finally included(one of which was a trial protocol).A total of 92 outcome indicators were extracted,which were mainly summarized into 8 categories,from high to low according to frequency:There were 110 physical and chemical tests,48 clinical efficacy time classes,34 clinical efficacy rates,24 quality of life evaluations,17 symptoms and signs,16 safety evaluations,3 TCM syndromes and 3 other indicators.Conclusion:There are some problems in the selection of outcome indicators in stroke-associated pneumonia with TCM adjuvant therapy,such as no primary or secondary selection,emphasis on surrogate indicators,disregard for endpoint outcome indicators,non-standard evaluation criteria for composite outcome indicators,and insufficient attention to TCM syndrome efficacy evaluation,economic evaluation and safety outcome indicators.
基金项目
国家自然科学基金面上项目(81774222)
国家自然科学基金面上项目(82074411)
河南省高校科技创新团队支持计划(22IRTSTHN029)
河南省中医药科学研究重大专项(20-21ZYZD04)
国家科技期刊平台
NSTL
万方数据