厄多司坦胶囊对慢性支气管炎祛痰疗效的临床研究  

Clinical Sdudy on Apophlegmatic Efficacy of Erdosteine Capsule for Treatment of Chronic Bronchitis

作　　者：刘进[1] 王选锭[1] 刘富光[1] 钮善福[2] 周建英[3] 

机构地区：[1]浙江大学医学院附属第二医院,杭州310009 [2]复旦大学医学院附属中山医院,上海200032 [3]浙江大学医学院附属第一医院,杭州310006

出　　处：《中国临床药理学杂志》2002年第1期26-29,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的：评价厄多司坦胶囊对慢性支气管炎的祛痰疗效及其安全性。方法：采用随机对照、双盲双模拟试验方法。以安溴索（ａｍｂｒｏｘｏｌ）片作对照药，对比研究厄多司坦胶囊对慢性支气管炎祛痰的临床疗效和安全性。试验组１０５例，厄多司坦胶囊 ３００ｍｇ，每日二次；对照组 ９３例，安澳索片 ３０ｍｇ，每日三次；两组疗程７～１０ｄ。结果：试验组与对照组临床疗效分别为５７．１％和５８．１％；祛痰疗效有效率分别为８３．８％与８３．９％；综合临床疗效（临床疗效与祛痰疗效的结合）有效率分别为６０．０％与６０．２％。药物不良反应发生率试验组与对照组分别为８．６％与５．４％。两组有效率和不良反应发生率比较均无统计学差异。结论：厄多司坦胶囊对慢性支气管炎咳嗽、咳痰的临床疗效明显，特别是痰液粘稠、排痰困难患者其祛痰疗效确切，使用安全。OBJECTIVE: To evaluate the apophlegmatic efficacy and safety of erdosteine capsule in the treatment of chronic bronchitis. METHODS: A randomized, double-blind and double-simulation controlled clinical trial was carried out. Erdosteine, 300mg capsules, as a trial drug was administered orally 300mg,bid. Ambroxol,3Omg tablets, as a controlled drug was administered orally 3Omg,tid.The treatment lasted 7-40 days.RESULTS: 105 patients were treated with erdosteine and 93 patients were treated with ambroxol. The clinical efficacy rates of the two groups were 57.1% and 58.1%, and the apophlegmatic efficacy rates of two groups were 83.8% and 83.9%,and the comprehensive clinical efficacy (clinical efficacy with apophlegmatic efficacy ) rates of two groups were 60.0% and 60.2%, respectively.There were no statistical differences. The adverse drug reaction rates were 8.6% and 5.4% respectively and no statistical differences. CONCLUTIONS: The erdosteine is a safe and effective drug in the treatment of cough and expectoration for chronic bronchitis, especially for the difficulty to expectoration of mucopurulent sputum.

关 键 词：厄多司坦 安溴索 慢性支气管炎 

分 类 号：R974.1[医药卫生—药品] R969.4[医药卫生—药学]