盐酸氨溴索雾化吸入治疗慢性阻塞性肺疾病黏痰症患者的疗效和安全性分析  

Efficacy and safety of inhaled ambroxol hydrochloride solution in treating chronic obstructive pulmonary disease patients with phlegm

作　　者：马锦芳[1] 何正光 郑劲平[3] Ma Jinfang;He Zhengguang;Zheng Jinping(Department of Respiratory and Critical Care Medicine,The First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,China;Department of Respiratory and Critical Care Medicine,The Third People′s Hospital of Suining,Suining 629099,China;National Clinical Research Center for Respiratory Diseases,The First Affiliated Hospital of Guangzhou Medical University,Guangzhou 510120,China)

机构地区：[1]广州医科大学附属第一医院呼吸与危重症医学科,广州510120 [2]遂宁市第三人民医院呼吸与危重症医学科,四川629099 [3]广州医科大学附属第一医院国家呼吸系统疾病临床医学研究中心,广州510120

出　　处：《中华肺部疾病杂志（电子版）》2024年第4期568-574,共7页Chinese Journal of Lung Diseases(Electronic Edition)

摘　　要：目的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。方法选择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。结果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。结论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。Objective 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.Methods 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.Results 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.Conclusion Nebulization inhalation of ambroxol hydrochloride solution can effectiv

关 键 词：肺疾病 慢性阻塞性 盐酸氨溴索 雾化吸入 黏痰症 生活质量 

分 类 号：R563[医药卫生—呼吸系统]