分析雾化吸入盐酸氨溴索(ambroxol hydrochloride)溶液治疗慢性阻塞性肺疾病(chronic obstructive pulmonary disease, COPD)黏痰症患者的临床疗效和安全性。

选择2021年5月至2022年4月来自32家医院收治的COPD患者316例为对象。COPD患者给予吸氧、消炎、舒张支气管等常规治疗基础上，伴有黏痰症状和咳痰困难的COPD患者采用雾化吸入盐酸氨溴索溶液，每次3 ml(2 ml︰15 mg)，一日2次，持续治疗7天。比较治疗前后患者呼吸道黏痰性状、咳痰难易程度、痰量和咳嗽、生活质量的变化，同时进行敏感性分析和按临床是否属于COPD急性加重期进行亚组分析。

共纳入符合筛选标准的COPD患者316例。与治疗前相比，治疗结束时患者痰液性状、咳痰难易程度、痰液量、咳嗽症状和痰液黏稠度均有明显改善，评分分别下降1.64分(95%CI：－1.73，－1.56)、1.41分(95%CI：－1.50，－1.33)、1.10分(95%CI：－1.19，－1.01)、1.22分(95%CI：－1.30，－1.13)和1.73分(95%CI：－1.83，－1.64)，生活质量评分则增加0.06分(95%CI：0.05，0.07)，差异具有统计学意义(P<0.05)。治疗时间越长临床综合总疗效高(P<0.05)，治疗后第1天、第3天、第5天和治疗结束时临床总疗效的例数分别为125例(39.56%)、215例(68.04%)、265例(83.86%)和285例(90.19%)。亚组分析和敏感性分析结果与总体结果一致。不良反应发生率为4.75%，未发生严重不良反应。

雾化吸入盐酸氨溴索溶液能有效改善COPD患者黏痰症，安全性及耐受性好。

This study aims to analyse the efficacy and safety of nebulization inhalation of ambroxol hydrochloride solution in the treatment of chronic obstructive pulmonary disease (COPD) patients with phlegm.

A total of 316 COPD patients meeting the screening criteria were enrolled in 32 hospitals from May 2021 to April 2022, conducted to administer nebulized inhalation of ambroxol hydrochloride solution 3 ml (2 ml︰15 mg) twice a day for up to seven days to adult COPD patients with symptoms of phlegm and difficulty in expectoration. Changes in respiratory sputum characteristics, difficulty of expectoration, sputum volume, cough, and quality of life of patients before and after treatment were compared, and sensitivity analysis and subgroup analysis were also performed based on whether they belong to an acute exacerbation stage in clinical practice.

A total of 316 COPD patients meeting the screening criteria were enrolled. Compared with the condition prior to treatment, the patient showed significant improvement in sputum characteristics, difficulty in coughing up sputum, sputum volume, cough symptoms, and sputum viscosity at the completion of treatment. The scores decreased by 1.64 (95%CI: -1.73, -1.56), 1.41(95%CI: -1.50, -1.33), 1.10(95%CI: -1.19, -1.01), 1.22(95%CI: -1.30, -1.13), and 1.73(95%CI: -1.83, -1.64) respectively. Additionally, the quality of life score increased by 0.06 points (95%CI: 0.05, 0.07). These differences were statistically significant (P<0.05). Furthermore, a longer treatment duration correlated with a higher overall clinical efficacy rate (P<0.05). The number of cases exhibiting overall clinical efficacy on the first, third, fifth day post-treatment, and at the completion of treatment were 125 (39.56%), 215 (68.04%), 265 (83.86%), and 285 (90.19%), respectively. The results of subgroup analysis and sensitivity analysis were consistent with the overall results. The incidence of adverse reactions was 4.75%, and there were no serious adverse reactions.

Nebulization inhalation of ambroxol hydrochloride solution can effectively improve phlegm in COPD patients and is safe and well-tolerated.