口服中成药干预血管性痴呆的临床研究证据图分析OA
Analysis of clinical research evidence diagrams on intervention of vascular dementia with oral Chinese patent medicines
该研究旨在系统检索与梳理口服中成药治疗血管性痴呆(VaD)的临床研究证据,了解该领域现有证据分布及质量.通过检索PubMed、Web of Science、Cochrane Library、EMbase、中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献服务系统(SinoMed)数据库,检索时间自建库至 2024 年 11 月 5 日口服中成药治疗VaD的临床研究,采用证据图呈现数据分布特征.共纳入 211 篇文献,其中 176 篇RCTs,11 篇non-RCTs,3 篇回顾性研究,1 篇队列研究,17 篇系统评价/Meta分析,指南/专家共识 3 篇.涉及 45 种中成药,其中银杏叶片/胶囊使用最广泛,多数研究周期在 8~12 周,样本量 51~100 例,主要结局指标包括临床疗效、认知功能评价、生活质量评价、安全性指标、神经功能指标、血液流变学指标等,RCT、non-RCT、系统评价/Meta分析的文献质量普遍不高,证据质量等级偏低.多数研究显示口服中成药治疗VaD具有潜在疗效,但缺乏高质量临床证据.结果表明,中成药治疗VaD具有优势,但缺乏高质量研究,提示今后需开展大样本、多中心的RCT,同时根据相关指南或工具规范临床研究设计与报告,挖掘口服中成药治疗VaD特色优势,选取合理的结局指标,致力于提高中医药临床研究质量,规范研究方案,产出具备严谨性及科学性的高级循证医学证据,为中医药防治VaD提供有力支撑.
This study aims to systematically retrieve and sort out the clinical research evidence of oral Chinese patent medicines in the treatment of vascular dementia(VaD)and understand the distribution and quality of the existing evidence in this field.PubMed,Web of Science,Cochrane Library,EMbase,CNKI,VIP,Wanfang,and SinoMed databases were retrieved from their establishment to November 5,2024.Evidence diagrams were used to comprehensively present the data distribution characteristics.A total of 211 pieces of literature were included,among which 176 were RCTs,11 were non-RCTs,3 were retrospective studies,1 was cohort study,17 were systematic reviews/Meta-analyses,and 3 were expert recommendations or consensuses.It involves 45 kinds of Chinese patent medicines.Among them,Ginkgo Leave Tablets/Capsules are the most widely used.Most of the research periods are 8-12 weeks,and the sample size is 51-100 cases.The main outcome indicators include clinical efficacy,cognitive function evaluation,quality of life evaluation,safety indicators,neurological function indicators,hemorheological indicators,etc.The literature quality of RCTs,non-RCTs,and systematic reviews/Meta-analyses are generally not high,and the quality level of evidence is relatively low.Most studies have shown that oral Chinese patent medicines have potential efficacy in the treatment of VaD,but there is a lack of high-quality clinical evidence.Chinese patent medicines have advantages in the treatment of VaD,but there is still a lack of high-quality studies.This suggests that in future clinical research,large-sample and multi-center RCTs need to be carried out.Meanwhile,clinical research design and reporting should be standardized in accordance with relevant guidelines or tools to explore the characteristic advantages of oral Chinese patent medicines in the treatment of VaD,select reasonable outcome indicators,and strive to improve the quality of clinical research in TCM.This will help standardize the research plan,produce advanced evidence-based medical evidence with rigor and scientificity,and provide strong support for the prevention and treatment of VaD with TCM.
韩瑾;孙永康;徐方飚;宋研博;吴易俊;王新志
河南中医药大学 第一附属医院 脑病中心,河南 郑州 450099河南中医药大学 第一临床医学院,河南 郑州 450046河南中医药大学 第一附属医院 脑病中心,河南 郑州 450099中西医防治重大疾病河南省协同创新中心,河南 郑州 450046郑州大学 第一附属医院,河南 郑州 450000河南中医药大学 第一附属医院 脑病中心,河南 郑州 450099
血管性痴呆证据图中成药临床研究
vascular dementiaevidence diagramChinese patent medicineclinical research
《中国中药杂志》 2026 (2)
579-587,9
中医药传承与创新"百千万"人才工程(岐黄工程)岐黄学者项目(国中医药人教函[2018]284号)河南省"双一流"创建学科中医学科学研究专项(HSRP-DFCTCM-2023-5-07,HSRP-DFCTCM-2023-8-29)河南省中医药科学院院属研究所2025年首批"揭榜挂帅"项目——河南省中医药科研专项(2025ZKY004)
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