中医药治疗颈动脉粥样硬化临床随机对照研究的概括性评价

Traditional Chinese Medicine for carotid atherosclerosis:a scoping review of clinical randomized controlled trial study

目的采用图表与证据图相结合的方法,对中医药治疗颈动脉粥样硬化(CAS)的临床随机对照试验(RCTs)进行系统梳理与概括性评价,了解该领域的研究现状。方法计算机检索PubMed、EMbase、Cochrane、Web of Science、中国知网(CNKI)、万方(Wan-fang)、维普(VIP)、中国生物医学文献服务系统(CBM)数据库,检索时间限定为各数据库建库至2022年9月。纳入中医药治疗CAS临床RCTs,对临床研究的年度发表趋势、治疗方案、结局指标等进行总结分析。结果共纳入200篇临床RCTs,发文量自2005年后呈波动式上升,研究样本量多集中在60~100例,中医药治疗CAS干预措施多以中药汤剂或中成药为主,研究结局指标关注较多的包括颈动脉内-中膜厚度、斑块面积、血脂水平、中医证候积分及安全性结局指标。结论中医药治疗CAS具有一定特色和优势,但RCTs普遍质量不高,未来需多中心、大样本的临床随机双盲对照试验进一步证实其疗效和安全性。

Objective This study used a combination of charts and evidence maps to systematically review and summarize clinical randomized controlled trials(RCTs)of Chinese medicine for the treatment of carotid atherosclerosis(CAS)and to understand the current state of research in this field.Methods Computer searches were conducted to retrieve PubMed,EMbase,Cochrane,Web of Science,China Knowledge Network(CNKI),Wan-fang,VIP,and China Biomedical Literature Service(CBM)databases,and the search time limit was from the establishment of each database to September 2022.Clinical RCTs of CAS treated with TCM were included,and the annual publication trends,treatment protocols,and outcome indicators of clinical studies were summarized and analyzed.Results A total of 200 clinical RCTs were included,with a fluctuating increase in the number of publications since 2005,a study sample size mostly focused on 60~100 cases,TCM interventions for CAS mostly based on Chinese herbal tonics or proprietary Chinese medicines,and more attention to study outcome indicators including carotid intra-medial membrane thickness,plaque area,lipid level,TCM evidence score,and safety outcome indicators.Conclusion Chinese medicine has certain characteristics and advantages in the treatment of CAS,but the quality science of RCTs is generally not of high quality,and multicenter,large-sample randomized double-blind controlled clinical trials are needed in the future to further confirm its efficacy and safety.