建立中医药治疗缺血性卒中核心结局指标集的初步研究

Development of A Core Outcome Set(COS)for Ischemic Stroke in Clinical Trials of Chinese Medicine

目的初步建立中医药治疗缺血性卒中临床试验核心结局指标集,为缺血性卒中的中医药临床研究提供参考。方法系统检索中国生物医学文献服务系统(CBM)、中国知网期刊全文数据库(CNKI)、万方数据库(WF)、维普中文科技期刊全文数据库(VIP)、PubMed、The Cochrane Library、Embase及临床研究注册平台,收集中医药治疗缺血性卒中的随机对照试验、系统评价及注册方案中包含的结局指标,构建结局指标条目池,通过患者调查对条目池进行补充,最后采用德尔菲专家咨询和共识会议筛选结局指标并达成共识。结果共收集到9805篇文献和1139项研究方案,最终纳入719篇已发表文献和196项研究方案,452位卒中患者参与调查,整理指标收集结果,共有72项结局指标进入德尔菲法专家咨询;两轮调查初步纳入24项结局指标;通过共识会议,最终确定6项指标域的12项结局指标,包括临床终点指标(全因死亡率、病死率、复发率、心脑血管事件发生率)、身体功能受损评价(残疾水平、神经功能缺损、运动功能障碍、认知障碍)、身体结构受损评价(脑血管病变、颈动脉和椎动脉病变)、活动与参与受限评价(包括日常生活活动能力评价)、安全性(不良事件)和中医证候评价。结论根据有效性试验核心结局指标计划工作组(COMET)手册,初步建立了中医药治疗缺血性卒中临床研究核心结局指标集,方便相关研究者选择合适且规范的结局指标,有利于研究结论的推广与同类研究的比较与合并,进而提高研究结果的证据质量。

Objective To establish a core outcome set(COS)for clinical trials of Chinese medicine(CM)in the treatment of ischemic stroke(IS),which could provide references for further clinical studies.Methods A pool of outcomes was firstly established by searching CBM,CNKI,Wanfang,VIP,PubMed,Cochrane Library,EmBase,and the clinical trial registries for related randomized controlled trails,systematic reviews and registered protocols,and was then supplemented through questionnaire survey among patients;after Delphi survey and consensus meeting,the COS for IS was finalized.Results Totally,9805 papers and 1139 protocols were collected,and 719 published arti⁃cles,196 clinical trials registration protocols were included,and 452 IS patients'opinion,72 outcomes were assem⁃bled for Delphi survey.After two-round Delphi survey,24 outcomes were included in the COS.Through the expert consensus meeting,the COS was finalized including 12 outcomes in six outcome domains,which were clinical end⁃point outcomes(all-cause mortality,mortality,recurrence rate,incidence of cardiovascular and cerebrovascular events),body function impairment outcomes(level of disability,neurological deficit.motor dysfunction,and cogni⁃tive impairment),body structure impairment outcomes(cerebrovascular diseases,carotid and vertebral artery diseas⁃es),activity limitations and participation restrictions(activities of daily living assessment),safety outcomes(adverse events)and outcomes related to CM syndromes.Conclusion Following the core outcome measures in effectiveness trials(COMET)handbook,the COS of CM in the treatment of IS was established,which may help clinical research⁃ers to select standardized outcomes,improve the application of research outcomes,promote the homogeneity between clinical researches for further comparison.