摘要
目的:评价吸入用盐酸氨溴索溶液改善儿童下呼吸道感染疾病黏痰症状的安全性和有效性。方法:本研究为开放、单臂的上市后临床试验。纳入中国科学技术大学附属第一医院2021年8月至2022年4月收治入院的下呼吸道感染疾病黏痰症状的患儿(年龄≥6个月的住院患儿),使用吸入用盐酸氨溴索溶液干预治疗7 d(共接受8次访视),采取咳嗽评分、喉中痰鸣评分、肺部听诊评分等进行临床疗效评价,并进行药物安全监测。结果:共192例受试患儿的临床资料用于有效性数据分析,年龄(50.84±34.23)月(最小年龄6个月,最大年龄12岁1个月),其中男102例(53.13%)、女90例(46.87%)。咳嗽改善率为98.96%(190/192),喉中痰鸣音改善率为97.27%(178/183),肺部听诊改善率为96.53%(167/173),临床应答率为97.92%(188/192);随用药时间延长,咳嗽症状、喉中痰鸣症状以及肺部听诊体征均呈好转趋势。用于安全性数据分析的安全数据集共192例患儿,其中2例受试者发生药物相关不良反应,未见重度不良反应。结论:吸入用盐酸氨溴索溶液可明显改善儿童下呼吸道感染疾病黏痰症状,且安全性良好。
Objective:To assess the efficacy and safety of inhaled ambroxol hydrochloride solution in improving mucous sputum symptoms in children with lower respiratory tract infections.Methods:This open-label,single-arm,post-marketing clinical trial was conducted in the First Affiliated Hospital of the University of Science and Technology of China from Aug.2021 to Apr.2022.Hospitalized children aged⩾6 months presenting with mucous sputum symptoms and lower respiratory tract infections were enrolled.Participants received inhaled ambroxol hydrochloride solution for a 7-day treatment period,during which eight clinical assessments were conducted.Clinical efficacy was evaluated by using standardized scores for cough,pharyngeal mucus score,and pulmonary auscultation score.Adverse events were monitored to assess medication safety.Results:A total of 192 patients were included in the efficacy analysis.The mean age was(50.84±34.23)months(from 6 months to 12 years and 1 month),with 102 males(53.13%)and 90 females(46.87%).Improvement in cough was observed in 98.96%(190/192)of patients,while improvement in pharyngeal mucus and pulmonary auscultation was noted in 97.27%(178/183)and 96.53%(167/173)of patients,respectively.The overall clinical response rate was 97.92%(188/192).The symptoms of cough,pharyngeal mucus and pulmonary auscultation showed a trend of improvement with the prolongation of treatment duration.The safety dataset used for safety data analysis included 192 children.Among them,2 subjects experienced drug-related adverse drug reactions,but no severe adverse drug reactions were observed.Conclusion:Inhaled ambroxol hydrochloride solution can significantly alleviate the mucous sputum symptoms in children with lower respiratory tract infections with higher safety.
作者
陈冶
刘小会
陈名武
Chen Ye;Liu Xiaohui;Chen Mingwu(The First Affiliated Hospital of University of Science and Technology of China,Anhui Provincial Hospital,HeFei 230001,China;National Center for Children’s Health,National Clinical Research Center for Respiratory Diseases,Beijing Children’s Hospital,Capital Medical University,Beijing 100000,China)
出处
《儿科药学杂志》
2025年第9期35-38,共4页
Journal of Pediatric Pharmacy
关键词
吸入用盐酸氨溴索
儿童
下呼吸道感染
黏痰症状
inhaled ambroxol hydrochloride solution
children
lower respiratory tract infection
mucous sputum symptoms
