摘要
目的分析针刺治疗血管性痴呆(VD)随机对照试验(RCT)结局指标现状,推动构建标准化结局指标集。方法检索中华医学期刊全文数据库、中国生物医学文献服务系统、中国知网、万方数据知识服务平台、维普网、PubMed、Embase、Cochrane Library、MEDLINE、Web of Science 10个中英文数据库,以及中国临床试验注册中心、国际传统医学临床试验注册平台2个注册系统,由2名研究人员独立筛选2015年1月1日—2025年1月1日针刺治疗VD的RCT文献,采用Cochrane Risk of Bias 2工具评估偏倚风险。提取文献基本信息、干预措施、中西医诊断标准、中医证候结局指标,总结针刺治疗VD的RCT研究指标域,并对纳入文献的基本信息及结局指标进行分析。结果初步检索到2898篇文献,经筛选后最终纳入93篇RCTs,涉及84种结局指标,涵盖症状体征20种(23.81%)、中医证候3种(3.57%)、医学检查51种(60.71%)、生活质量5种(5.95%)、安全评估4种(4.76%),以及预后随访1种(1.19%)6个指标域。其中,91篇(97.85%)RCTs报告了治疗周期,时间跨度在2~24周之间;72篇(77.42%)RCTs将临床疗效作为结局指标;11篇(11.83%)报告了安全性评估。结论目前针刺治疗VD的RCT研究设计尚未形成统一规范,方法学质量存在诸多问题,同时,个体化辨证论治特点未充分体现,安全性评估和随访机制较为薄弱。未来研究应聚焦VD疾病本质,建立符合中医药临床特色的核心指标集,推动针刺治疗VD的临床研究科学化、规范化发展,为临床实践提供更具说服力的循证依据。
Objective To analyze the current status of outcome measures in randomized controlled trials(RCTs)of acupuncture treatment for vascular dementia(VD)and promote the development of a standardized set of outcome measures.Methods Chinese and English literature databases were searched,including the Chinese Medical Periodical Full-Text Database,the Chinese Biology Medicine disc,China National Knowledge Infrastructure,Wanfang Data,VIP Database,PubMed,Embase,the Cochrane Library,MEDLINE,Web of Science,Chinese Clinical Trials Registry,and the International Traditional Medicine Clinical Trial Registry.Two researchers independently screened RCT literature on acupuncture treatment for VD between January 1,2015 and January 1,2025,risk of bias was assessed using the Cochrane Risk of Bias 2 tool.Extract basic study information,intervention measures,diagnostic criteria for both Chinese and Western medicine,TCM syndromes,and outcome measures.Summarize the indicator domains of RCT studies on acupuncture treatment for VD,and analyze the basic information and outcome measures of the included studies.Results A preliminary search identified 2,898 articles,of which 93 RCTs were ultimately included.These studies involved 84 outcome measures,covering six indicator domains:symptoms/signs(23.81%),traditional Chinese medicine(TCM)syndromes(3.57%),medical checkups(60.71%),quality of life(5.95%),safety assessment(4.76%),and prognosis follow-up(1.19%).A total of 91(97.85%)RCTs reported treatment duration,ranging from 2 to 24 weeks;72(77.42%)RCTs used clinical efficacy as the outcome indicator;11 studies(11.83%)reported safety assessments and adverse events.Conclusion Currently,the RCT study design for acupuncture treatment of VD lacks unified standards and has numerous methodological issues.These include insufficient description of sample size estimation processes,strong reliance on subjective rating scales,ambiguous definitions of primary and secondary outcome measures,incomplete integration of Chinese and Western medical indicators,and insufficient reflection of individualized syndrome differentiation and treatment characteristics.In addition,safety assessments and follow-up mechanisms remain relatively weak.Future research should focus on the essential nature of VD,establish a core set of indicators aligned with the clinical characteristics of traditional Chinese medicine,promote the scientific and standardized development of acupuncture research for VD,and provide more compelling evidence-based support for clinical practice.
作者
鲍亮
丁雪纯
张振丰
鲁政纲
李春宁
徐文帅
郭秋成
李飞
BAO Liang;DING Xuechun;ZHANG Zhenfeng;LU Zhenggang;LI Chunning;XU Wenshuai;GUO Qiucheng;LI Fei(Anhui University of Chinese Medicine,Hefei 230012,China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China;Guizhou University of Traditional Chinese Medicine,Guiyang 550025,China;The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine,Hefei 230061,China;Anhui Huatuo Institute of Traditional Chinese Medicine,Bozhou 236800,China)
出处
《北京中医药大学学报》
北大核心
2025年第10期1470-1480,共11页
Journal of Beijing University of Traditional Chinese Medicine
基金
安徽省高校自然科学研究项目(No.KJ2020A0982)
国家青年岐黄学者支持项目(国中医药人教函〔2022〕256号)
安徽中医药大学科研基金项目(No.2024LC085)。
关键词
血管性痴呆
针刺
结局指标
随机对照试验
指标域
vascular dementia
acupuncture
outcome indicators
randomized controlled trials
indicator domain
