近5年针刺治疗血管性认知障碍随机对照试验结局指标分析  

Outcomes in randomized controlled trials of acupuncture for vascular cognitive impairment during recent five years

作　　者：曾心昀 廖星[1] 张允岭 曾子修 申伟 詹敏 王莹 韩富华 石静资 鲁喜悦 ZENG Xin-yun;LIAO Xing;ZHANG Yun-ling;ZENG Zi-xiu;SHEN Wei;ZHAN Min;WANG Ying;HAN Fu-hua;SHI Jing-zi;LU Xi-yue(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Graduate School,Beijing University of CM,Beijing 100029;Xiyuan Hospital of China Academy of Chinese Medical Sciences;Graduate School,China Academy of Chinese Medical Sciences)

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]北京中医药大学研究生院,北京100029 [3]中国中医科学院西苑医院 [4]中国中医科学院研究生院

出　　处：《中国针灸》2022年第5期590-594,共5页Chinese Acupuncture & Moxibustion

基　　金：中国中医药循证医学中心“业务研究室主任专项”项目:2020YJSZX-2;中央级公益性科研院所基本科研业务费专项项目:ZZ13-024-3。

摘　　要：分析近5年针刺治疗血管性认知障碍(VCI)的随机对照试验(RCT)结局指标中存在的问题,并提出建议。选取2015年1月1日至2020年9月14日PubMed、EMbase、Cochrane Library、美国临床试验数据库(Clinical Trials)、中国期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang)、维普资讯中文期刊服务平台(VIP)、中国生物医学文献数据库(SinoMed)及中国临床试验注册中心(ChiCTR)中针刺治疗VCI的RCT文献,提取纳入文献的结局指标并进行分析。共纳入21篇文献,结局指标可分为9类:临床症状/体征指标、生活质量指标、神经影像学指标、神经电生理指标、血液生化学指标、血液流变学指标、中医证候积分指标、临床疗效指标、安全性指标。其中报告数量最多的3类指标为临床症状/体征指标(21篇,100.0%),临床疗效指标(14篇,66.7%)和生活质量指标(12篇,57.1%)。针刺治疗VCI的RCT应注意区分主要结局指标和次要结局指标,采取客观、统一的疗效评定标准,兼顾安全性、卫生经济学及中医特色指标的报道。The existing problems in the outcomes of randomized controlled trials(RCTs) of acupuncture for vascular cognitive impairment(VCI) during recent five years are analyzed and suggestions are proposed. The RCTs of acupuncture for VCI were selected in PubMed, EMbase, Cochrane Library, Clinical Trials, CNKI database, Wanfang database, VIP database,SinoMed database and Chinese Clinical Trial Registry(ChiCTR) from January 1, 2015 to September 14, 2020. The outcomes were extracted and analyzed. As a result, 21 RCTs were included and the outcomes used were divided into 9 categories:clinical symptom/sign indexes, quality of life indexes, neuroimaging indexes, neuroelectrophysiology indexes, blood biochemical indexes, hemorheology indexes, TCM syndrome score indexes, clinical efficacy indexes, and safety indexes.Among them, the top three of the most used outcomes were clinical symptoms/signs indexes(21, 100.0%), clinical efficacy indexes(14, 66.7%) and quality of life indexes(12, 57.1%). In the RCTs of acupuncture for VCI, attention should be paid to distinguish the primary outcomes and secondary outcomes, adopt objective and standardized efficacy evaluation, and give consideration to report the outcomes of safety, health economic and TCM characteristic indexes.

关 键 词：血管性认知障碍 针刺 随机对照试验(RCT) 结局指标 

分 类 号：R246.6[医药卫生—针灸推拿学]