中国中药杂志

口服中成药干预血管性痴呆的临床研究证据图分析

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韩瑾 ¹^,² , 孙永康 ¹^,³ , 徐方飚 ⁵ , 宋研博 ¹^,² , 吴易俊 ¹^,² , 王新志 ¹^,³^,⁴^,^*

中国中药杂志 | 临床 2026,51(2): 579-587

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中国中药杂志 |临床 2026 , 51 (2) : 579 -587

口服中成药干预血管性痴呆的临床研究证据图分析

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韩瑾¹^,², 孙永康¹^,³, 徐方飚⁵, 宋研博¹^,², 吴易俊¹^,², 王新志¹^,³^,⁴^,^*

作者信息

^1．河南中医药大学第一附属医院脑病中心，河南郑州 450099

^2．河南中医药大学第一临床医学院，河南郑州 450046

^3．中西医防治重大疾病河南省协同创新中心，河南郑州 450046

^4．河南省中医药科学院脑病研究所，河南郑州 451163

^5．郑州大学第一附属医院，河南郑州 450000

通讯作者:

王新志，教授，主任医师，博士生导师，主要从事中医药防治脑病研究，E-mail: znqznq@163.com

Analysis of clinical research evidence diagrams on intervention of vascular dementia with oral Chinese patent medicines

Jin HAN¹^,², Yong-kang SUN¹^,³, Fang-biao XU⁵, Yan-bo SONG¹^,², Yi-jun WU¹^,², Xin-zhi WANG¹^,³^,⁴^,^*

Affiliations

^1.Encephalopathy Center, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou 450099, China

^2.the First Clinical Medical School of Henan University of Chinese Medicine, Zhengzhou 450046, China

^3.Collaborative Innovation Center of Prevention and Treatment of Major Diseases by Chinese and Western Medicine, Zhengzhou 450046, China

^4.Institute of Encephalopathy, Henan Academy of Chinese Medicine Sciences, Zhengzhou 451163, China

^5.the First Affiliated Hospital of Zhengzhou University, Zhengzhou 450000, China

出版时间: 2026-01-15 doi: 10.19540/j.cnki.cjcmm.20251014.501

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摘要

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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。

关键词

血管性痴呆 / 证据图 / 中成药 / 临床研究

Abstract

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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.

Key words

vascular dementia / evidence diagram / Chinese patent medicine / clinical research

引用本文

韩瑾, 孙永康, 徐方飚, 宋研博, 吴易俊, 王新志. 口服中成药干预血管性痴呆的临床研究证据图分析. 中国中药杂志, 2026 , 51 (2) : 579 -587 . DOI: 10.19540/j.cnki.cjcmm.20251014.501

Jin HAN, Yong-kang SUN, Fang-biao XU, Yan-bo SONG, Yi-jun WU, Xin-zhi WANG. Analysis of clinical research evidence diagrams on intervention of vascular dementia with oral Chinese patent medicines[J]. Chinese Journal of Traditional Chinese Medicine, 2026 , 51 (2) : 579 -587 . DOI: 10.19540/j.cnki.cjcmm.20251014.501

基金

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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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2026年第51卷第2期

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文章信息

doi: 10.19540/j.cnki.cjcmm.20251014.501

接收时间：2025-04-28
首发时间：2026-06-25
出版时间：2026-01-15

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出版历史

收稿日期：2025-04-28

基金

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)

作者信息

^1．河南中医药大学第一附属医院脑病中心，河南郑州 450099

^2．河南中医药大学第一临床医学院，河南郑州 450046

^3．中西医防治重大疾病河南省协同创新中心，河南郑州 450046

^4．河南省中医药科学院脑病研究所，河南郑州 451163

^5．郑州大学第一附属医院，河南郑州 450000

通讯作者:

王新志，教授，主任医师，博士生导师，主要从事中医药防治脑病研究，E-mail: znqznq@163.com

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https://castjournals.cast.org.cn/joweb/zgzyzz/CN/10.19540/j.cnki.cjcmm.20251014.501

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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