Wu Di, Fu Xiuhua, Jin Faguang, Li Hui, Qin Zhiqiang, Wang Haoyan, Yue Hongmei, Zhang Jie, Cao Zhaolong
Department of General Medicine, Peking University People's Hospital, Beijing, 100044, China.
Department of Respiratory Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010030, China.
BMC Infect Dis. 2025 Jul 1;25(1):830. doi: 10.1186/s12879-025-11194-w.
Ambroxol is a widely used mucoactive agent, but the efficacy of inhaled ambroxol in patients with lower respiratory tract infectious (LRTI) disease is poorly understood. This trial aimed to compare the efficacy and safety of inhaled ambroxol with those of placebo in patients with LRTI diseases.
In this randomized, double-blind, placebo-controlled, multicentre clinical trial, 240 patients with LRTI diseases were randomized to receive inhaled ambroxol hydrochloride solution (ambroxol group, N = 120) or placebo (placebo group, N = 120) twice daily for 7 days.
Compared with the placebo group, the ambroxol group had lower sputum trait scores and greater changes in sputum trait scores from Day 2 to Day 8. Compared with the placebo group, the ambroxol group presented lower expectoration difficulty scores and greater changes in expectoration difficulty scores on Days 2, 3, and 6. The sputum volume scores on Days 6, 7, and 8 were lower in the ambroxol group than in the placebo group, but the change in the sputum volume score was not different between the groups. Compared with the placebo group, the ambroxol group had lower cough scores on Days 3, 5, 6, and 7, as well as greater changes in cough scores on Days 2, 3, and 5. The incidences of adverse events (10.8% versus 6.7%), serious adverse events (0.8% versus 0.0%), and adverse reactions (4.2% versus 3.3%) were not different between the ambroxol group and the placebo group.
Inhaled ambroxol is better at ameliorating respiratory symptoms and has comparable safety to placebo in patients with LRTI diseases.
氨溴索是一种广泛使用的黏液溶解剂，但吸入性氨溴索在治疗下呼吸道感染（LRTI）疾病患者中的疗效尚不清楚。本试验旨在比较吸入性氨溴索与安慰剂在LRTI疾病患者中的疗效和安全性。
在这项随机、双盲、安慰剂对照、多中心临床试验中，240例LRTI疾病患者被随机分为两组，分别接受吸入性盐酸氨溴索溶液（氨溴索组，N = 120）或安慰剂（安慰剂组，N = 120），每日两次，共7天。
与安慰剂组相比，氨溴索组痰液性状评分更低，且从第2天到第8天痰液性状评分变化更大。与安慰剂组相比，氨溴索组在第2、3和6天的咳痰困难评分更低，咳痰困难评分变化更大。氨溴索组在第6、7和8天的痰液量评分低于安慰剂组，但两组间痰液量评分变化无差异。与安慰剂组相比，氨溴索组在第3、5、6和7天的咳嗽评分更低，且在第2、3和5天的咳嗽评分变化更大。氨溴索组与安慰剂组的不良事件发生率（10.8%对6.7%）、严重不良事件发生率（0.8%对0.0%）和不良反应发生率（4.2%对3.3%）无差异。
吸入性氨溴索在改善LRTI疾病患者的呼吸道症状方面效果更好，且安全性与安慰剂相当。
