Xu Baoping, Han Peng, Shang Yunxiao, Cheng Huanji, Han Zhiying, Zhao Lin, He Shaoru, Lu Min, Liu Enmei, Shen Kunling
Respiratory Department, Beijing Children's Hospital, Capital Medical University, China National Clinical Research Center of Respiratory Diseases, National Center for Children's Health, Beijing, China.
Department of Respiratory, Shenzhen Children's Hospital, Shenzhen, China.
BMC Pulm Med. 2025 Aug 8;25(1):382. doi: 10.1186/s12890-025-03845-0.
To evaluate the efficacy and safety of inhaled ambroxol solution in improving sputum of lower respiratory tract infections (LRTIs) in children.
This study was a randomized, double-blind, parallel-group, placebo-controlled, multicenter trial. The patients were administered inhaled ambroxol or a placebo twice a day for 7 days. And researchers collected efficacy and (or) safety indicators every day during the course.
A total of 236 children were randomly assigned to receive ambroxol or placebo (1:1). At all visit points after the medication, the mean difference of cough score with the baseline between the two groups was statistically significant (P < 0.05). Compared with the baseline, the phlegm-sound scores in the throat of the experimental group decreased more on the 1st, 2nd, and 3rd days after administration (P < 0.05). But there was no difference in pulmonary rale scores. The occurrence of adverse events in the experimental group was lower (21.37% vs. 35.59%, P = 0.021), and the incidence of adverse reactions was similar between the two groups (2.56% vs. 5.08%, P = 0.499).
Inhaled ambroxol solution could improve the sticky sputum symptoms in children with LRTIs and is safe in clinical application. Further research is needed to confirm these findings.
The study was retrospectively registered on June 14, 2023, at https://www.chictr.org.cn/ under the number ChiCTR2300072466.
评估吸入用氨溴索溶液改善儿童下呼吸道感染（LRTIs）痰液的疗效和安全性。
本研究为随机、双盲、平行组、安慰剂对照、多中心试验。患者每天吸入两次氨溴索或安慰剂，共7天。研究人员在疗程中每天收集疗效和（或）安全指标。
共236名儿童被随机分配接受氨溴索或安慰剂（1:1）。用药后的所有访视点，两组咳嗽评分与基线的平均差值有统计学意义（P < 0.05）。与基线相比，实验组给药后第1、2和3天咽喉部痰鸣音评分下降更明显（P < 0.05）。但肺部啰音评分无差异。实验组不良事件发生率较低（21.37% 对 35.59%，P = 0.021），两组不良反应发生率相似（2.56% 对 5.08%，P = 0.499）。
吸入用氨溴索溶液可改善LRTIs患儿的黏痰症状，临床应用安全。需要进一步研究以证实这些发现。
该研究于2023年6月14日在https://www.chictr.org.cn/进行回顾性注册，注册号为ChiCTR2300072466。
