摘要
该研究探析中医药治疗阿尔茨海默病随机对照试验(RCT)结局指标的现状,为建立该领域核心指标集提供参考依据。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)、EMbase、PubMed、Medline、Cochrane Library,根据纳入、排除标准独立筛选文献并提取信息,采用Ro B 2.0工具进行偏倚风险评估。共纳入78篇RCTs,涉及患者6379例,累计结局指标122种。结局指标根据功能属性分为中医病证(3种,13次)、症状/体征(26种,196次)、理化检测(68种,149次)、生活质量(1种,2次)、远期预后(2种,2次)、经济学评估(0种)、安全性事件(21种,194次)、其他指标(1种,1次)7个领域。结果表明,中医药治疗阿尔茨海默病RCT的文献评估总体呈“有一定风险”,结局指标选择存在缺乏中医药特色、主次结局指标区分不显著、远期预后与经济学评估指标匮乏、安全性事件报告不规范等问题。建议未来研究者建立突出中医药特色的阿尔茨海默病核心指标集,继而提升临床试验的质量。
This study aims to analyze the current situation of outcome indicators in randomized controlled trial(RCT)of traditional Chinese medicine(TCM)treatment for Alzheimer′s disease(AD),so as to provide a reference for establishing a core indicator set in this field.The researchers systematically searched CNKI,Wanfang,VIP,SinoMed,EMbase,PubMed,Medline,and Cochrane Library.Independent screening of literature and extraction of information was conducted according to the inclusion and exclusion criteria.In addition,the RoB 2.0 tool was used for bias risk assessment.A total of 78 RCTs were included,involving 6379 patients,with 122 kinds of outcome indicators.According to functional attributes,the outcome indicators could be categorized into seven groups:TCM diseases(3 kinds,13 times),symptoms and signs(26 kinds,196 times),physical and chemical tests(68 kinds,149 times),qua-lity of life(1 kind,2 times),long-term prognosis(2 kinds,2 times),economic evaluation(0 kind),safety events(21 kinds,194 times),and other indicators(1 kind,1 time).The results show that the literature evaluation of RCTs of TCM treatment for AD is generally risky,and there are some problems in the selection of outcome indicators,such as lack of TCM characteristics,insignificant distinction between primary and secondary outcome indicators,lack of long-term prognosis and economic evaluation indicators,and non-standard safety event reports.It is suggested that future researchers should establish a core indicator set for AD that highlights the characteristics of TCM and then work to improve the quality of clinical trials.
作者
吴千言
徐小港
张清源
黄晟赫
章德林
WU Qian-yan;XU Xiao-gang;ZHANG Qing-yuan;HUANG Sheng-he;ZHANG De-lin(College of Traditional Chinese Medicine,Jiangxi University of Chinese Medicine,Nanchang 330004,China;College of Clinical Medicine,Jiangxi University of Chinese Medicine,Nanchang 330004,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第11期3113-3124,共12页
China Journal of Chinese Materia Medica
基金
国家自然科学基金项目(81860874)
中医药古籍文献和特色技术传承专项(GZY-KJS-2021-034)
江西中医药大学首批校级科技创新团队项目(CXTD22016)。
关键词
中医药
阿尔茨海默病
随机对照试验
结局指标
traditional Chinese medicine
Alzheimer′s disease
randomized controlled trial
outcome indicator
