摘要
目的:本研究旨在采用证据图对中医药治疗颈动脉粥样硬化斑块的临床研究进行系统梳理及质量评价。方法:计算机检索8个中英文数据库、常用指南库及指南相关网站。检索时限为建库至2025年2月20日。由2位研究人员进行独立筛选、信息提取及质量评价,利用文字结合图表的形式展示临床研究证据分布及证据质量。结果:最终纳入文献1019篇,其中临床研究997篇、系统综述/Meta分析20篇、指南/共识2篇。近两年该病总体发文量呈下降趋势。临床研究中有43.03%的研究聚焦颈动脉粥样硬化合并病研究,有324篇(32.49%)提到纳入患者的中医证型,痰瘀互结证为出现频次最高的证型。临床研究样本量多为60~300例,干预时长多为8~32周。中医药干预措施中,通心络胶囊、半夏白术天麻汤和参芪柔脉合剂是使用最多的中成药、中药经方和自拟方。对照措施以他汀类药物为主。结局指标以临床有效率、Crouse积分、颈动脉斑块内-中膜厚度(carotid intima-media thickness,c IMT)、斑块面积为主。在随机对照试验的方法学设计方面,明确提及随机序列产生方法的有379篇(40.53%),提及分配隐藏的有12篇(1.28%);提及盲法的有28篇(2.99%)。在系统评价/Meta分析的方法学评价方面,AMSTAR 2量表评分普遍不高。结论:中医药治疗颈动脉粥样硬化斑块具有一定优势,研究数量可观。但研究质量较低,中医辨证论治方案及疗效指标明显不足,方法学设计存在缺陷。未来需要更多高质量且在中医理论指导下完成的RCT以提高循证证据级别。
Objective:This study aims to systematically review and evaluate the quality of clinical research on the treatment of carotid atherosclerotic plaques with traditional Chinese medicine(TCM)using evidence mapping.Methods:Eight Chinese and English databases,commonly used guideline databases,and guideline related websites were searched.The search period ranged from database inception to February 20,2025.Two researchers independently conducted screening,data extraction,and quality assessment,presenting the distribution and quality of clinical evidence using text combined with charts.Results:A total of 1019 articles were included,comprising 997 clinical studies,20 systematic reviews/meta analyses,and 2 guidelines/consensus documents.In recent years,the overall number of publications on this disease has shown a declining trend.Among clinical studies,43.03%focused on comorbid conditions associated with carotid atherosclerosis,and 324 studies(32.49%)mentioned the TCM syndrome types of the included patients,with phlegm stasis intermingled syndrome being the most frequently observed.The sample sizes of clinical studies mostly ranged from 60 to 300 cases,and the intervention duration mostly ranged from 8 to 32 weeks.In Traditional Chinese Medicine(TCM)interventions,Tongxinluo Capsule,Banxia Baizhu Tianma Decoction and Shenqi Roumai Mixture are the most commonly used Chinese patent medicines,classic formulas,and self devised formulas.Control measures mainly involved statins.Outcome indicators primarily included clinical efficacy,Crouse score,carotid intima-media thickness(cIMT),and plaque area.Regarding the methodological design of randomized controlled trials(RCTs),379 studies(40.53%)clearly mentioned the method of random sequence generation,12 studies(1.28%)mentioned allocation concealment,and 28 studies(2.99%)mentioned blinding.In the methodological assessment of systematic reviews/meta analyses,AMSTAR 2 scores were generally low.Conclusion:TCM has certain advantages in treating carotid atherosclerotic plaques,and the number of studies is substantial.However,the quality of studies is relatively low,with noticeable deficiencies in syndrome differentiation based treatment plans and efficacy indicators,and methodological design flaws exist.In the future,more high quality RCTs conducted under the guidance of TCM theory are needed to improve the level of evidence.
作者
杨玉涵
仝彤
左文茜
王擎擎
王泽祺
姚魁武
YANG Yuhan;TONG Tong;ZUO Wenxi;WANG Qingqing;WANG Zeqi;YAO Kuiwu(Graduate School,Beijing University of Chinese Medicine,Beijing China 100029;Guanganmen Hospital,China Academy of Chinese Medical Sciences,Beijing China 100053;Eye Hospital,China Academy of Chinese Medical Sciences,Beijing China 100040)
出处
《中医学报》
2026年第1期25-32,共8页
Acta Chinese Medicine
基金
癌症、心脑血管、呼吸和代谢性疾病防治研究国家科技重大专项项目(四大慢病重大专项)(2024ZD0528300,2024ZD0528304)
中国中医科学院眼科医院中央高水平中医医院项目(GSP2-02)。
关键词
颈动脉粥样硬化斑块
中医药
临床研究
证据图
随机对照试验
系统评价
方法学
carotid atherosclerotic plaque
traditional Chinese medicine
clinical research
evidence map
randomized controlled trial
systematic review
methodology
