中国鼻用喷雾剂注册临床试验近10年现状分析

Analysis of Clinical Trials of Nasal Sprays Registration in China in the Past 10 Years

关键词:  鼻喷雾剂  临床试验  登记与信息公示平台

Key words:  nasal sprays  clinical trials  registration and information disclosure platform

摘要:

目的 分析中国近10年鼻用喷雾剂注册临床试验现状及特点，结合国际研究现状，探讨中国鼻用喷雾剂药物的未来发展趋势。方法 检索国家药品监督管理局药物临床试验登记与信息公示平台（http：//www.chinadrugtrials.org.cn/index.html），收集开放注册日（2012年11月1日）至2023年3月29日中国鼻用喷雾剂药物临床试验信息，使用Microsoft Office Excel软件进行系统性分析，从临床试验状态、适应证、地域分布和试验分期、试验设计类型等多个方面分析鼻用喷雾剂临床试验的现状与特点。结果 共80项鼻用喷雾剂临床试验，均为国内试验，其中Ⅰ期24项（30.0%），Ⅱ期15项（18.8%），Ⅲ期13项（16.3%），Ⅳ期3项（3.8%），生物等效性试验17项（21.3%），其他（药动学/药效学研究）共8项（10.0%）。临床试验状态有进行中（尚未招募）13项（16.3%）、进行中（招募完成）7项（8.8%）、进行中（招募中）15项（18.8%）、已完成44项（55.0%）、主动终止1项（1.3%）。Ⅰ~Ⅳ期临床试验共56项，其中平行分组试验41项（73.2%），交叉设计试验14项（25.0%），单臂试验1项（1.8%）。化学药品共65项（81.3%）、生物制品7项（8.8%）和中药/天然药物8项（10.0%）。适应证包括过敏性鼻炎、镇静、干眼、阵发性室上心动过速等共15种。结论 中国鼻用喷雾剂研发尚处于早期阶段，但紧跟国际，自主创新能力不断加强，未来应探索更多新的鼻用喷雾剂临床研究方向与策略，助力鼻用喷雾剂发展，满足更多患者的需求。

Abstract:

OBJECTIVE To analyze the current situation and characteristics of clinical trials of nasal spray registration in China in the past 10 years, and to discuss the future development trend of nasal spray drugs in China, taking into account the current situation of international research. METHODS By accessing the State Drug Administration's drug clinical trial registration and information disclosure platform(http://www.chinadrugtrials.org.cn/index.html), collected information on clinical trials of nasal spray drugs in China from the open registration date(November 1, 2012) to March 29, 2023, in terms of clinical trial status, analyzed the status and characteristics of clinical trials of nasal sprays in terms of clinical trial status, indications, geographical distribution and trial phases, and trial design types by Microsoft Office Excel. RESULTS A total of 80 clinical trials of nasal sprays were conducted in China, of which 24 (30.0%) were phase I, 15 (18.8%) were phase II, 13(16.3%) were phase III, 3(3.8%) were phase IV, 17(21.3%) were bioequivalence trials, and 8(10.0%) were other(pharmacokinetic/pharmacodynamic studies). The status of clinical trials included 13(16.3%) in progress(not yet enrolled), 7(8.8%) in progress (enrollment completed), 15(18.8%) in progress (enrollment in progress), 44(55.0%) completed, and 1(1.3%) voluntarily terminated. There were 56 phase I-IV clinical trials, including 41(73.2%) parallel group trials, 14(25.0%) crossover design trials, and 1(1.8%) single-arm trial. A total of 65(81.3%) were chemicals, 7(8.8%) were biologics and 8(10.0%) were traditional Chinese medicine/natural drugs. A total of 15 indications were identified, which included allergic rhinitis, sedation, dry eye, paroxysmal supraventricular tachycardia, etc. CONCLUSION The research and development of nasal sprays in China is still at an early stage, but it keeps up with the international and independent innovation ability is being strengthened, and more new clinical research directions and strategies of nasal sprays should be explored in the future to help the development of nasal sprays and meet the needs of more patients.