| 摘要: |
| [目的] 分析中国临床试验注册中心、美国临床试验注册中心和国际传统医学临床试验注册平台中医药治疗头颈部动脉粥样硬化的注册现状与特征。[方法] 检索建库至2025年5月的头颈部动脉粥样硬化相关中医药临床试验，采用Excel、SPSS27.0软件收集临床试验的相关资料并汇总分析。[结果] 最终纳入68项研究，涉及3个一级注册中心，覆盖11个省级行政区、73个医疗机构；58项试验为预注册，59项试验通过伦理学审查，41项试验声明公开统计结果，37项试验声明共享原始数据。研究类型以干预性研究为主，经统计共54项随机平行对照试验，其中37项采用简单化随机，31项应用了盲法。干预措施多为经验方/院内制剂和中成药，结局指标选择以颈动脉超声检查情况、细胞因子和血生化指标为主。纳入研究的注册质量较低，平均报告完成度为89.28%。[结论] 目前中医药治疗头颈部动脉粥样硬化临床试验的发展趋势较好，但在地域分布均衡化、试验设计规范化、研究信息透明化方面有待提升。 |
| 关键词: 头颈部动脉粥样硬化 中医药 临床试验 注册登记 分析 |
| DOI：10.11656/j.issn.1673-9043.2026.08.12 |
| 分类号:R543.5;R2-03 |
| 基金项目:国家自然科学基金面上项目（82174340）。 |
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| Analysis of the current situation of clinical trial registration of traditional Chinese medicine for treating atherosclerosis of head and neck arteries |
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SHI Naixin, WU Shengxian
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Department of Encephalopathy Ⅱ, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
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| Abstract: |
| [Objective] To characterize the registration patterns and methodological features of traditional Chinese medicine（TCM）-based clinical trials for the treatment of head and neck atherosclerosis，as registered in the Chinese Clinical Trial Registry，ClinicalTrials. gov，and the International Clinical Trials Registry Platform for Traditional Medicine. [Methods] TCM-related clinical trials targeting head and neck atherosclerosis were retrieved from the above databases，covering the period from database inception to May 2025. Relevant trial data were collected using Excel and SPSS 27.0 software，followed by descriptive summary and analysis. [Results] A total of 68 eligible trials were identified，registered across three primary platforms. These trials originated from 11 provincial level administrative regions and involved 73 distinct healthcare institutions. Of these，58 were prospectively registered； 59 reported having obtained formal ethical approval；41 committed to publicly disclosing statistical results；and 37 pledged to share individual participant-level data. The majority of the studies were interventional trials；specifically， 54 were randomized parallel controlled trials，of which 37 employed simple randomization and 31 implemented blinding. Interventions consisted primarily of empirical TCM formulas，hospital-prepared formulations，and Chinese patent medicines. Primary outcome measures centered on carotid ultrasound findings，circulating cytokine concentrations，and serum metabolic parameters. The registration quality of the included studies was suboptimal， with a mean completeness rate of 89.28%. [Conclusion] Currently，clinical trials investigating TCM for the prevention and treatment of head and neck atherosclerosis exhibit a favorable development trend. Nevertheless， improvements are warranted in three key areas：balanced geographical distribution，standardized trial design，and enhanced transparency of research information. |
| Key words: head and neck atherosclerosis traditional Chinese medicine clinical trial registration and filing analysis |
