国内儿科人群吸入制剂药物临床试验现状分析

Clinical trials of inhalation in pediatric population in China

目的:调研国内儿科人群吸入制剂药物临床试验的开展现状,为我国儿科人群吸入制剂药物临床试验的发展提供参考。方法:在中国药物临床试验登记与信息公示平台和Clinical Trials平台检索截至2021年11月20日的中国儿科人群吸入制剂药物临床试验项目,从临床试验的分期、适应证、药物类型等方面分析其特点。结果:截至2021年11月20日,在中国药物临床试验登记与信息公示平台检索到儿科人群吸入制剂药物临床试验项目21项,占所有人群吸入制剂药物临床试验项目8.9%(21/235),试验药物主要为仿制药(47.6%),集中在化痰药和抗哮喘的吸入制剂,占试验项目71.4%(15/21)。在Clinical Trials平台检索到34项中国儿科人群吸入制剂临床试验项目,占全球儿科人群吸入制剂临床试验总数5.7%,适应证主要为哮喘和麻醉用药,占试验项目76.5%(26/34)。结论:我国儿科人群吸入制剂药物临床试验起步较晚,总体数量较少,以仿制药为主,需重视吸入制剂新药研发和儿科人群吸入制剂药物临床试验的规范性及顺利进展。

AIM:To investigate the characteristics of clinical trials of inhalation in pediatric population in China.METHODS:The pediatric clinical trials of inhaled drugs in China registered on the www.Chinadrugtrials.org.cn and Clinical Trials in USA respectively until November 20,2021 were reviewed.The characteristics of pediatric clinical trials of inhaled drugs including the clinical trial phases,drug indications and classificatio etc.were analyzed.RESULTS:There were 21 pediatric clinical trials of inhaled drugs registered on the www.Chinadrugtrials.org.cn,accounted for 8.9%(21/235)of inhalation clinical trials in all populations.47.6%of them were generic drugs,mainly focusing on expectorants for Phlegm symptoms and inhaled preparations for asthma,which accounting for 71.4%(15/21).There were 34 pediatric clinical trials of inhaled drugs registered on the Clinical Trials in USA,the drug indications of which were mainly asthma and anesthesia,accounting for 76.5%(26/34).CONCLUSION:The pediatric clinical trials of inhalations in China started later,and the total number is small compared to adults,mainly focusing on generic drugs.We should pay attention to the research and development of new inhalation drugs,standardizing and promoting the clinical trials of inhaled drugs in pediatric population actively.