| 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。 |
| 关键词: 吸入用盐酸氨溴索 儿童 下呼吸道感染 黏痰症状 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2025.09.010 |
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| 基金项目: |
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| Evaluation on Safety and Efficacy of Inhaled Ambroxol Hydrochloride Solution in Improving Mucous Sputum Symptoms in Children with Lower Respiratory Tract Infections |
| Chen Ye1 , Liu Xiaohui2 , Chen Mingwu1 |
| (1. The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Hospital, HeFei 230001, China; 2. National Center for Children’s Health, National Clinical Research Center for Respiratory Diseases, Beijing Children’s Hospital, Capital Medical University, Beijing 100000, China) |
| Abstract: |
| 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. |
| Key words: inhaled ambroxol hydrochloride solution children lower respiratory tract infection mucous sputum symptoms |
