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雾化吸入盐酸氨溴索治疗支气管扩张症的有效性和安全性:一项多中心、开放的上市后临床研究

Efficacy and safety of aerosol inhalation of ambroxol hydrochloride in the treatment of bronchiectasis: a multi-center, open-label, post-approval clinical studies

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【作者】 马锦芳郑劲平何正光陈丽萍杨晓红何志义肖祖克孟婕张晓菊梁伟权王天立杨汀张天托薛克营宋元林陈瑞叶贤伟谢宝松俞万钧朱丹章锐锋朱慧莉毛良平王玮赵建清陈公平王镇山金发光陈刚陈小红胡轶任小平

【Author】 MA Jin-fang;ZHENG Jin-ping;HE Zheng-guang;Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Guangzhou Medical University;

【通讯作者】 郑劲平;

【机构】 广州医科大学附属第一医院呼吸与危重症医学科遂宁市第三人民医院呼吸科沈阳医学院附属第二医院呼吸科新疆维吾尔自治区人民医院呼吸科广西医科大学第一附属医院呼吸与危重症医学科江西省人民医院呼吸与危重症医学科中南大学湘雅三医院呼吸与危重病医学科河南省人民医院呼吸与危重症医学科佛山市第二人民医院呼吸与危重症医学科常德市第一人民医院呼吸内科中日友好医院呼吸与危重症医学科中山大学附属第三医院呼吸与危重症医学科厦门医学院附属第二医院呼吸内科复旦大学附属中山医院呼吸科中山大学孙逸仙纪念医院呼吸内科贵州省人民医院呼吸与危重症医学科福建省立医院呼吸与危重症医学科宁波大学附属人民医院 ( 宁波市鄞州人民医院 ) 呼吸与危重症医学科金华市中心医院呼吸内科东南大学附属中大医院呼吸与危重症医学科复旦大学附属华东医院呼吸科重庆大学附属三峡医院呼吸科中国医科大学附属第一医院呼吸与危重症医学科河北北方学院附属第一医院呼吸与危重症医学科福建医科大学附属第一医院呼吸与重症医学科大连医科大学附属第二医院呼吸与危重症医学科空军军医大学附属唐都医院呼吸与危重症医学科河北医科大学第三医院呼吸科永州市中心医院呼吸与危重症医学科武汉市中心医院呼吸内科陕西省人民医院呼吸与危重症医学科

【摘要】 目的 研究雾化吸入盐酸氨溴索治疗支气管扩张症(支扩)的临床效果和安全性。方法 183例支扩患者,均采用雾化吸入盐酸氨溴索治疗。比较患者治疗前后呼吸道疾病症状与体征(痰液性状、咳痰难度、痰液量、咳嗽症状、痰液粘稠度)评分、欧洲五维健康量表(EQ-5D)评分,分析临床疗效、治疗期间安全性、用药时长及用药量。结果 治疗前、治疗第4天及治疗结束,患者痰液性状评分分别为(2.37±0.48)、(1.45±0.80)、(0.69±0.81)分,咳痰难度评分分别为(2.19±0.39)、(1.16±0.60)、(0.85±0.68)分,痰液量评分分别为(1.71±0.61)、(1.00±0.72)、(0.63±0.71)分,咳嗽症状评分分别为(1.97±0.54)、(1.12±0.69)、(0.81±0.68)分,痰液粘稠度评分分别为(2.69±0.65)、(1.67±0.82)、(0.97±0.84)分;治疗第4天及治疗结束,患者痰液性状、咳痰难度、痰液量、咳嗽症状、痰液粘稠度评分均低于治疗前,差异有统计学意义(P<0.05);治疗结束,患者总评分(2.99±2.39)分低于治疗前的(8.25±1.33)分,差异有统计学意义(P<0.05)。患者治疗前EQ-5D评分为(0.89±0.15)分,治疗结束为(0.95±0.12)分;患者治疗结束EQ-5D评分高于治疗前,差异有统计学意义(P<0.05)。患者临床控制56例(30.60%),显效42例(22.95%),有效61例(33.33%),无效24例(13.11%),总有效率为86.89%(159/183)。183例支扩患者中,共有42例(22.95%)患者发生59例次不良事件, 18例(9.84%)患者发生18例次不良反应, 3例(1.64%)患者发生3例次严重不良事件(骨折、支扩伴感染加重、咯血)。不良反应发生率为10.38%(19/183),未发生严重不良反应。患者用药时长达(6.55±1.53)d,用药量为(37.86±8.99)ml。结论 雾化吸入盐酸氨溴索溶液对于支扩患者有明显的临床疗效,还可改善患者的生活质量,并且安全可靠。

【Abstract】 Objective To study the clinical effect and safety of aerosol inhalation of ambroxol hydrochloride in the treatment of bronchiectasis. Methods 183 patients with branchial dilatation were treated with aerosol inhalation of ambroxol hydrochloride. The scores of respiratory symptoms and signs(sputum character, sputum difficulty, sputum volume, cough symptom, sputum viscosity) and the scores of the EuroQol five-dimensional questionnaire(EQ-5D) before and after treatment were compared, and the clinical efficacy,safety during the treatment period, the duration and dosage of medication were analyzed. Results Before treatment, on the 4th day of treatment and at the end of treatment, the sputum characterization scores were(2.37±0.48),(1.45±0.80) and(0.69±0.81) points, the sputum difficulty scores were(2.19±0.39),(1.16±0.60)and(0.85±0.68) points, the sputum volume scores were(1.71±0.61),(1.00±0.72) and(0.63±0.71) points,the cough symptom scores were(1.97±0.54),(1.12±0.69) and(0.81±0.68) points, the sputum viscosity scores were(2.69±0.65),(1.67±0.82) and(0.97±0.84) points. On the 4th day of treatment and at the end of treatment,the scores of sputum character, sputum difficulty, sputum volume, cough symptom, and sputum viscosity of patients were lower than those before treatment, and the difference was statistically significant(P<0.05). At the end of treatment, the total score of(2.99±2.39) points was lower than(8.25±1.33) points before treatment,and the difference was statistically significant(P<0.05). EQ-5D score was(0.89±0.15) points before treatment and(0.95±0.12) points at the end of treatment; EQ-5D score at the end of treatment was higher than that before treatment, and the difference was statistically significant(P<0.05). Patients were clinically controlled in 56 cases(30.60%), apparently effective in 42 cases(22.95%), effective in 61 cases(33.33%), and ineffective in 24 cases(13.11%), with a total effective rate of 86.89%(159/183). Among 183 patients with bronchiectasis, a total of 42 patients(22.95%) experienced 59 adverse events, 18 patients(9.84%) experienced 18 adverse reactions, and 3 patients(1.64%) experienced 3 serious adverse events(fracture, bronchiectasis with aggravation of infection,hemoptysis). The incidence of adverse reactions was 10.38%(19/183) and no serious adverse reactions occurred.The duration of drug administration in patients was up to(6.55±1.53) d, and the dosage was(37.86±8.99) ml.Conclusion Aerosol inhalation of ambroxol hydrochloride solution has obvious clinical effect on patients with bronchiectasis, and can also improve the quality of life of patients, and is safe and reliable.

  • 【文献出处】 中国实用医药 ,China Practical Medicine , 编辑部邮箱 ,2024年21期
  • 【分类号】R562.22
  • 【下载频次】43
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