摘要
通过评价补肾活血法治疗膝骨关节炎(knee osteoarthritis,KOA)的临床随机对照试验(randomized controlled trial,RCT)结局指标的现状,为制定中医药治疗KOA核心指标集提供理论基础。检索中国知网(CNKI)、万方(Wanfang)、中国生物医学文献服务系统(SinoMed)、维普(VIP)、PubMed、EMbase、Cochrane Library、Web of Science 8个数据库,以及ClinicalTrials.gov和中国临床试验注册中心,检索时限为建库至2023年8月,纳入主题为补肾活血法治疗KOA的RCT,2名评价员进行文献筛选和数据采集,采用定性分析对结局指标进行总结。最终纳入350篇RCTs,涉及165种结局指标,累计出现频次1462次。指标可分为6个领域:症状/体征指标23种,出现频次718次,占49.1%;中医症状/证候指标3种,出现频次53次,占3.6%;理化检查指标130种,出现频次506次,占34.6%;生活质量评价指标4种,出现频次20次,占1.3%;远期疗效指标2种,出现频次6次,占0.4%;安全性指标3种,出现频次159次,占10.9%。此外,有53篇RCTs采用中医证候/症状积分作为疗效指标,使用了8种不同的测量工具。当前中医药采用补肾活血法治疗KOA的RCT存在诸多问题,如结局指标主次不分、测量工具多样、部分指标缺乏统一评判标准、使用不规范等,影响了研究的质量和可靠性。因此,建议借鉴国际经验,加强研究设计,将中医药的疗效特点与临床研究相结合,以构建适用于中医药特色的KOA核心指标集。
This study assesses the status of outcome measures in the randomized controlled trial(RCT)involving the kidney⁃tonif⁃ying and blood⁃activating method for treating knee osteoarthritis(KOA),aiming to establish a theoretical foundation for the develop⁃ment of a core set of outcome measures in traditional Chinese medicine(TCM)treatment of KOA.The relevant articles were retrieved from CNKI,Wanfang,VIP,SinoMed,PubMed,EMbase,Cochrane Library,and Web of Science,in addition to ClinicalTrials.gov and the China Clinical Trial Registration Center,with the time interval from inception to August 2023.The RCT of treating KOA with the kidney⁃tonifying and blood⁃activating method was included.Two assessors independently conducted literature screening,data col⁃lection,and qualitative analysis to compile the outcome measure results.A total of 350 RCTs were included,involving 165 outcome measures with the total frequency of 1462.These outcome measures were categorized into six domains:symptom and sign measures(23)with the frequency of 718(49.1%),TCM symptom and syndrome measures(3)with the frequency of 53(3.6%),physical examination measures(130)with the frequency of 506(34.6%),quality of life measures(4)with the frequency of 20(1.3%),long⁃term efficacy measures(2)with the frequency of 6(0.4%),and safety measures(3)with the frequency of 159(10.9%).Ad⁃ditionally,53 studies used TCM syndrome and symptom scores as indicators of efficacy,employing eight distinct measurement tools.The RCTs involving the kidney⁃tonifying and blood⁃activating method for treating KOA had a variety of problems,such as unclear prio⁃ritization of outcome measures,diversity in measurement tools,absence of standardized assessment criteria for specific measures,and non⁃standardized usage.These problems affected the research quality and reliability.Hence,it is advisable to draw upon international expertise,improve research design,and merge TCM efficacy characteristics with clinical research to establish a core set of KOA out⁃come measure
作者
陈继鑫
周沁心
余伟杰
郭天赐
牛朴钰
叶云天
刘爱峰
CHEN Ji-xin;ZHOU Qin-xin;YU Wei-jie;GUO Tian-ci;NIU Pu-yu;YE Yun-tian;LIU Ai-feng(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Shaoxing Traditional Chinese Medicine Hospital,Shaoxing 312000,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第6期1661-1672,共12页
China Journal of Chinese Materia Medica
基金
国家自然科学基金项目(81873316)
天津市卫健委津门医学英才项目(TJSJMYXYC⁃D2⁃028)
中华中医药学会骨病防治交叉研究项目(2023⁃GBJC⁃04)。
关键词
膝骨关节炎
补肾活血法
随机对照试验
结局指标
研究现状
核心指标集
knee osteoarthritis
kidney⁃tonifying and blood⁃activating method
randomized controlled trial
outcome measures
research status
core outcome set
