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中华脑科疾病与康复杂志(电子版)

中华脑科疾病与康复杂志(电子版) ›› 2026, Vol. 16 ›› Issue (02) : 77 -83. doi: 10.3877/cma.j.issn.2095-123X.2026.02.003

临床研究

血管性认知障碍临床试验注册现状分析
李瑞雨1, 王新亮2, 徐丛丛2, 刘严泽3, 张雪竹2,†()   
  1. 1518172　深圳，北京中医药大学深圳医院（龙岗）疼痛推拿中心
    2300380　天津，天津中医药大学第一附属医院针灸部/国家中医针灸临床医学研究中心
    3301617　天津，天津中医药大学中医学院
  • 收稿日期:2025-11-17 出版日期:2026-04-15
  • 通信作者: 张雪竹

Analysis of the current status of clinical trial registries for vascular cognitive impairment

Ruiyu Li1, Xinliang Wang2, Congcong Xu2, Yanze Liu3, Xuezhu Zhang2,†()   

  1. 1Pain Management and Massage Center, Beijing University of Chinese Medicine Shenzhen Hospital (Longgang), Shenzhen 518172, China
    2Department of Acupuncture, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300380, China
    3College of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
  • Received:2025-11-17 Published:2026-04-15
  • Corresponding author: Xuezhu Zhang
  • Supported by:
    National Natural Science Foundation of China(82174492, 30630074); Tianjin Key R&D Programme of Science and Technology Support Key Project(20YFZCSY00810); Longgang Medical Discipline Construction Fund
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引用本文：

李瑞雨, 王新亮, 徐丛丛, 刘严泽, 张雪竹. 血管性认知障碍临床试验注册现状分析[J/OL]. 中华脑科疾病与康复杂志(电子版), 2026, 16(02): 77-83.

Ruiyu Li, Xinliang Wang, Congcong Xu, Yanze Liu, Xuezhu Zhang. Analysis of the current status of clinical trial registries for vascular cognitive impairment[J/OL]. Chinese Journal of Brain Diseases and Rehabilitation(Electronic Edition), 2026, 16(02): 77-83.

目的

基于世界卫生组织国际临床试验注册平台（ICTRP）、中国临床试验注册中心（ChiCTR）和美国国立卫生研究院临床试验注册平台（ClinicalTrials.gov）数据，对血管性认知障碍（VCI）临床试验注册情况及发展趋势进行总结和分析。

方法

检索ICTRP、ChiCTR及ClinicalTrials.gov平台自建库至2024年12月31日VCI的临床试验资料。由2名研究者独立筛选文献、提取资料后，从纳入试验的注册概况、研究设计、干预措施、观察指标等方面进行描述性分析。

结果

经筛选，最终纳入229项VCI相关临床试验，整体注册情况呈波动式增长趋势，ClinicalTrials.gov（106项）和ChiCTR（87项）是其主要注册平台，中国（140项）在申请VCI相关临床试验中占主要地位，北京（46项）、上海（16项）、广东（12项）、湖北（9项）、台湾（8项）为我国VCI研究主要热点省市；该领域研究以干预性研究为主（175项），随机、盲法运用较普遍，设计模式以随机平行对照（143项）为主，各研究间样本量差异较大，且大多研究未注明临床试验阶段（109项），干预措施以药物疗法对比安慰剂为主，非药物疗法研究占比较少，观察指标主要采用认知能力量表及日常生活质量测评量表。

结论

目前VCI研究处于上升发展阶段，非痴呆型VCI、轻度VCI研究及非药物疗法研究待拓展空间较大，国际及国内地区间应加强合作以产出更多VCI研究高质量循证证据。

关键词: 血管性认知障碍, 临床试验注册, 国际临床试验注册平台, 中国临床试验注册中心, 美国国立卫生研究院临床试验注册平台
Objective

To analyze the registration status and development trend of clinical trials for vascular cognitive impairment (VCI) based on data from the WHO International Clinical Trials Registry Platform (ICTRP), China Clinical Trials Registry (ChiCTR) and National Institutes of Health Clinical Trial Registry Platform (ClinicalTrials.gov) registry platform.

Methods

The clinical trial information of VCI on ICTRP, ChiCTR, and ClinicalTrials.gov platforms since the creation of the databases until December 31, 2024. After the literature was independently screened and data extracted by 2 investigators, descriptive analyses were conducted in terms of enrollment profiles, study design, interventions, and observational indicators of the included trials.

Results

After screening, 229 VCI-related clinical trials were finally included, and the overall enrolment showed a fluctuating growth trend. ClinicalTrials.gov (106 trials) and ChiCTR (87 trials) were the main enrolment platforms. China (140 trials) dominated the applications for VCI-related clinical trials, with Beijing (46 trials), Shanghai (16 trials), Guangdong (12 trials), Hubei (9 trials) and Taiwan (8 trials) as the main hotspot provinces and cities for VCI research in China. Research in this field is dominated by interventional studies (175 trials). Randomised and blinded methods were more commonly used. The design mode was mainly randomised parallel control (143 trials). The sample size varied widely among studies, and most of them did not specify the clinical trial stage (109 trials). Interventions were predominantly pharmacological therapies versus placebo, with a relatively small proportion of non-pharmacological therapy studies. The main observational indicators were cognitive performance scales and quality of daily life scales.

Conclusions

At present, research on VCI is on the rise, and there is much room for research on VCI not dementia, vascular mild cognitive impairment disease types and non-pharmacological therapies. China should continue to strengthen international and domestic inter-regional cooperation to produce more high-quality evidence-based evidence for VCI.

Key words: Vascular cognitive impairment, Clinical trial registration, International Clinical Trial Registration Platform, China Clinical Trial Registry, National Institutes of Health Clinical Trial Registry Platform
图1 血管性认知障碍临床试验注册时间分布
Fig.1 Time distribution of vascular cognitive impairment clinical trial registrations
图2 各注册分中心血管性认知障碍临床试验数量ClinicalTrials.gov：美国临床试验注册中心；ChiCTR：中国临床试验注册中心；ISRCTN：英国国际标准随机对照试验号注册库；CRIS：韩国临床试验注册中心；JPRN：日本临床试验注册中心；CTRI：印度临床试验注册中心；IRCT：伊朗临床试验注册中心；ITMCTR：国际传统医学临床试验注册平台；DRKS：德国临床试验注册中心；NTR：荷兰临床试验注册中心；ANZCTR：澳大利亚新西兰临床试验注册中心；EU-CTR：欧洲临床试验注册中心；ReBEC：巴西临床试验注册中心；TCTR：泰国临床试验注册中心
Fig.2 Number of vascular cognitive impairment clinical trials by registry subcenters
表1 血管性认知障碍相关注册临床试验的设计模式及总样本量
Tab.1 Design patterns and total sample sizes of vascular cognitive impairment-related registered clinical trials
研究/设计类型 注册数量（项） 占比（%） 总样本量（例） 样本量区间（例）
随机平行对照研究 143 62.4 30 476 4~3 200
队列研究 15 6.6 10 076 77~2 000
单臂研究 14 6.1 4 225 9~3 000
非随机对照研究 12 5.2 3 987 50~2 000
析因研究 12 5.2 1 635 30~300
病例对照研究 11 4.8 2 030 60~600
随机交叉对照研究 5 2.2 618 18~486
横断面研究 5 2.2 2 105 100~1 000
顺序研究 4 1.7 1 440 20~1 000
病例研究 3 1.3 826 50~600
未注明 3 1.3 395 80~200
半随机对照研究 1 0.4 82 82
随机抽样研究 1 0.4 75 75
表2 血管性认知障碍相关注册临床试验排名前10位的干预措施
Tab.2 Top 10 interventions in vascular cognitive impairment-related registry clinical trials
试验组 注册数量（项） 对照组 注册数量（项）
西药 51 安慰剂 59
中药 42 西药 28
针刺 11 假干预/假刺激 13
认知疗法+运动训练 8 运动训练 11
远程干预 7 认知疗法 7
运动训练 6 常规治疗 4
行为疗法 5 西药联合疗法 4
认知疗法 4 远程干预 2
经颅电刺激 4 护理 2
经颅磁刺激 3 针刺 2
表3 血管性认知障碍相关注册临床试验排名前10位的观察指标
Tab.3 Top 10 observations of vascular cognitive impairment-related registered clinical trials
主要指标 注册数量（项） 次要指标 注册数量（项）
MoCA 62 MMSE 42
MMSE 49 ADL 31
ADAS-cog 27 NPI 25
VaDAS-cog 25 MoCA 24
CDR 18 TMT 18
TMT 17 EQ-5D 15
ADL 14 CDR 13
SCWT 12 CDT 12
CDT 8 CIBIC-Plus 12
HVLT 7 IADL 11
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