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[多中心、对照、双盲研究:Vectrine(厄多司坦)与安慰剂治疗稳定期分泌过多型慢性支气管炎的疗效与耐受性比较]

[Multicenter, controlled, double-blind study of the efficacy and tolerance of Vectrine (erdostein) versus placebo in the treatment of stabilized chronic bronchitis with hypersecretion].

作者信息

Aubier M, Berdah L

机构信息

Service de Pneumologie, Hôpital Bichat, Paris.

出版信息

Rev Mal Respir. 1999 Sep;16(4):521-8.

Abstract

The clinical efficacy of vectrine (erdosteine) was evaluated in the treatment of chronic bronchitis patients with hypersecretion during a controlled clinical trial having included 170 patients. For inclusion, the bronchitis patients had to be in a stable status (no exacerbation since at least three months). The patients received, in double-blind protocol, vectrine, one capsule b.i.d. or placebo, one similar capsule b.i.d. during a period treatment of 21 days. The results of the main evaluation criteria, the global index of efficacy (frequency of the cough + severity of the cough + difficulty in breathing + dyspnea) but also on the intensity and frequency of the cough were statistically significant in favor of vectrine. The safety of the treatment was excellent.

摘要

在一项纳入170例患者的对照临床试验中,评估了威可沁(厄多司坦)治疗分泌过多的慢性支气管炎患者的临床疗效。纳入标准为支气管炎患者必须处于稳定状态(至少三个月内无病情加重)。患者采用双盲方案,在为期21天的治疗期间,每日两次,每次服用一粒威可沁胶囊或一粒外观相似的安慰剂胶囊。主要评估标准的结果,即总体疗效指数(咳嗽频率+咳嗽严重程度+呼吸困难+气短)以及咳嗽的强度和频率,在统计学上均显著表明威可沁更具优势。该治疗的安全性极佳。

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