Cheng Lu, Liu Min, Wang Rong, Cao Sufen, Li Rui, Su Bo, Wei Hongyan, Yang Haijuan, Hou Lingyun, Geng Chunyu, Han Yuling, Yang Tianrui
Department of Pediatrics, Children's Hospital Affiliated to Shandong University, Jinan Children's Hospital, Jinan, Shandong, China.
Department of Pediatrics, Jinan City People's Hospital, Jinan, Shandong, China.
Front Pediatr. 2024 Sep 5;12:1380189. doi: 10.3389/fped.2024.1380189. eCollection 2024.
Cough and sputum are the most common clinical symptoms of acute respiratory tract infection. Ambroxol is a mucolytic expectorant commonly used in clinical practice. This study aimed to evaluate the efficacy, safety, and compliance of ambroxol hydrochloride spray (Luo Runchang ®) for the treatment of acute respiratory tract diseases in children.
This was a multicenter, open-labeled, randomized controlled study. The experimental group received ambroxol hydrochloride oral sprays, and the control group received ambroxol hydrochloride oral solutions. The primary endpoint was the change in cough symptom scores from baseline. Secondary endpoints include changes in cough severity score, quality of life, adherence, and adverse events.
A total of 154 subjects were randomized and included in the analysis. The mean change of total cough symptom score of the spray group at the end of treatment was -4.7 (1.54) compared to -4.2 (1.62) in the solution group ( = 0.0005). The mean change of cough severity score was -5.7 (2.09) in the spray group compared to -5.2(2.04) in the solution group ( = 0.012). Quality of life scores significantly improved in the spray group ( < 0.0001) compared to the oral solution group. Medication adherence markers were significantly better in the spray group ( < 0.0001). The incidence of adverse events in the experimental group (1.33%) was lower than that in the control group (6.33%), but the difference between the groups was not statistically significant.
Ambroxol hydrochloride spray significantly improved cough symptom score, cough severity score, and quality of life score compared to ambroxol hydrochloride oral solution.
咳嗽和咳痰是急性呼吸道感染最常见的临床症状。氨溴索是临床常用的黏液溶解祛痰剂。本研究旨在评估盐酸氨溴索喷雾剂（罗润畅®）治疗儿童急性呼吸道疾病的疗效、安全性和依从性。
这是一项多中心、开放标签、随机对照研究。实验组接受盐酸氨溴索口腔喷雾剂，对照组接受盐酸氨溴索口服溶液。主要终点是咳嗽症状评分相对于基线的变化。次要终点包括咳嗽严重程度评分、生活质量、依从性和不良事件的变化。
共有154名受试者被随机分组并纳入分析。治疗结束时，喷雾剂组总咳嗽症状评分的平均变化为-4.7（1.54），而溶液组为-4.2（1.62）（P = 0.0005）。喷雾剂组咳嗽严重程度评分的平均变化为-5.7（2.09），溶液组为-5.2（2.04）（P = 0.012）。与口服溶液组相比，喷雾剂组的生活质量评分显著改善（P < 0.0001）。喷雾剂组的用药依从性指标明显更好（P < 0.0001）。实验组的不良事件发生率（1.33%）低于对照组（6.33%），但两组之间的差异无统计学意义。
与盐酸氨溴索口服溶液相比，盐酸氨溴索喷雾剂显著改善了咳嗽症状评分、咳嗽严重程度评分和生活质量评分。
