摘要
[目的]本研究借助证据图系统梳理了中成药治疗卒中后抑郁的临床证据,评价有关中成药治疗卒中后抑郁的现状,了解该领域的证据分布现状,为后续临床研究开展、指南及共识制定提供参考。[方法]系统检索中国知网(CNKI)、维普数据库(VIP)、万方数据库(Wanfang)、中国生物医学文献服务系统、PubMed、EMbase和Cochrane Library数据库,纳入近年来中成药治疗卒中后抑郁的随机对照试验(RCTs)、系统评价/Meta分析和指南/共识,分别采用Cochrane偏倚评估工具、AMSTAR-2、AGREEⅡ进行质量评价,采用文字描述结合图表、气泡图、饼状图、柱状图等形式对展示并分析分布特征。[结果]共纳入225篇RCTs,11篇系统评价/Meta分析,2篇网状Meta分析,7篇指南/共识。[结论]近年来,中成药治疗卒中后抑郁整体上呈增长趋势,中成药种类繁多,但文献总体质量普遍较低,以小样本、单中心、疗程短的RCT居多,在结局指标选择方面,未形成规范统一的核心结局,以神经缺损、精神心理、日常生活能力评估及临床有效率和神经系统疾病生物学标记物为主,中医特色优势体现不明确;系统评价/Meta分析整体质量较低,缺乏中成药治疗卒中后抑郁的疗效证据。结果表明:中成药治疗卒中后抑郁有效性及安全性方面存在一定优势,但缺乏高质量循证证据提供支撑,未来研究应重视解决以上问题,规范相关系统评价/Meta分析、指南/共识制定流程,提高临床研究质量,实施临床评价,为中成药治疗卒中后抑郁提供更完善的科学依据。
[Objective]In this study,evidence mapping was employed to systematically sort out the evidence from clinical studies of Chinese patent medicines for post-stroke depression evaluate the current situation of Chinese patent medicine in the treatment of post-stroke depression,understand the current situation of evidence distribution in this field,and provide reference for the development of follow-up clinical research,guidelines and consensus formulation.[Methods]CNKI,VIP,Wanfang Database,SinoMed,PubMed,EMbase and Cochrane Library databases were systematically searched to collect randomized controlled trials(RCTs),systematic reviews/Meta-analysises,and guidelines/consensus of Chinese patent medicine in the treatment of post-stroke depression in recent years.The Cochrane bias assessment tool,AMSTAR-2 and AGREEⅡwere used to evaluate the quality,and the distribution characteristics were displayed and analyzed by text description combined with charts,bubble charts,pie charts and histograms.[Results]A total of 225 RCTs,11 systematic reviews/Meta-analysis,2 network Meta-analysis,and 7 guidelines/consensus were included.[Conclusion]In recent years,the research on the treatment of post-stroke depression with Chinese patent medicine has shown an increasing trend.There are many kinds of Chinese patent medicine,but the quality of the literature is generally low.Most of the RCTs are small sample,single center and short course of treatment.In terms of the selection of outcome indicators,the outcome indicators have not been standardized and unified.The evaluation of neurological deficits,mental psychology,daily living ability,clinical efficiency and biological markers of neurological diseases are the main ones,and the characteristic advantages of traditional Chinese medicine are not clear.The overall quality of systematic review/Meta-analysis is low,and there is a lack of evidence for the efficacy of Chinese patent medicines in the treatment of post-stroke depression.The results showed that there were some advantages in the efficacy and safety of Chinese patent medicine in the treatment of post-stroke depression,but there was a lack of high-quality evidence-based evidence to provide support.Future research should pay attention to solving the above problems,standardize the relevant systematic review/Meta-analysis,guidelines/consensus-making process,improve the quality of clinical research,and carry out comprehensive clinical evaluation,so as to provide a more sound scientific basis for the treatment of post-stroke depression with Chinese patent medicine.
作者
王小琳
季昭臣
王小燕
史梦龙
李肇基
赵含笑
张赤道
赵敏
WANG Xiaolin;JI Zhaochen;WANG Xiaoyan;SHI Menglong;LI Zhaoji;ZHAO Hanxiao;ZHANG Chidao;ZHAO Min(Department of Encephalopathy,The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,China;The First Clinical Medical College of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,China;Center of Evidence-Based Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)
出处
《天津中医药》
2025年第9期1157-1167,共11页
Tianjin Journal of Traditional Chinese Medicine
基金
科技部国家级十四五重点研发计划项目(2022YFC 3501103)
河南中医药大学科技协同创新项目(14207678)
河南省中医学“双一流”创建科学研究专项课题(HSRP-DFCTCM-2023-1-07,HSRP-DFCTCM-2023-6-07)。
关键词
中成药
卒中后抑郁
随机对照试验
证据图
系统评价
Chinese patent medicine
post-stroke depression
randomized controlled trial
evidence mapping
systematic review
