基于ChiCTR的经皮耳迷走神经刺激疗法的试验注册现状分析

Analysis of the Current Status of Trial Enrollment for ChiCTR-Based Transcutaneous Auricular Vagus Nerve Stimulation Therapy

摘要: 目的：通过分析中国临床试验注册中心(Chinese Clinical Trial Registry, ChiCTR)登记注册的经皮耳迷走神经刺激(transcutaneous auricular vagus nerve stimulation, taVNS)疗法的临床试验，探究taVNS的临床研究现状及发展趋势。方法：检索从建库至2025年8月31日登记注册的taVNS临床试验，采用Excel 2019建立数据库进行数据分析，归纳、总结taVNS临床试验的现状及发展趋势。结果：研究共纳入204项taVNS的临床试验，包括202项干预性研究和2项观察性研究，国内注册地区涉及20个省级行政区120家注册机构，分布最多的三个地区分别是江苏、浙江和北京，经费来源主要是地方财政和自筹为主，研究病种以术后综合征、脑血管病及其后遗症、胃肠道疾病、疼痛和睡眠障碍为主，151项研究使用了盲法。结论：我国taVNS疗法临床试验注册数量呈上升趋势，近几年研究者对taVNS疗法的重视程度越来越高，但也存在地区发展欠均衡、研究者在盲法的表达上不够具体、注册信息填写欠规范等问题。

Abstract: Objective: To investigate the current status and development trends of transcutaneous auricular vagus nerve stimulation (taVNS) through analyzing clinical trials registered in the Chinese Clinical Trial Registry (ChiCTR). Methods: We retrieved taVNS trials registered from the registry’s inception to August 31, 2025. Data analysis was conducted using a database created in Microsoft Excel 2019 to summarize the current status and development trends of taVNS clinical trials. Results: The study included 204 taVNS clinical trials, comprising 202 interventional studies and 2 observational studies. Domestic registrations spanned 120 institutions across 20 provincial-level administrative regions, with the highest concentrations in Jiangsu, Zhejiang, and Beijing. Funding primarily originated from local government budgets and self-raised funds. Targeted conditions predominantly included postoperative syndromes, cerebrovascular diseases and their sequelae, gastrointestinal disorders, pain, and sleep disorders. Blinding was employed in 151 studies. Conclusion: The number of registered clinical trials for transcutaneous vagus nerve stimulation (taVNS) therapy in China shows an upward trend, reflecting increasing researcher interest in recent years. However, challenges persist, including uneven regional development, insufficient specificity in researchers’ descriptions of blinding methods, and non-standardized completion of registration information.