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一项针对哮喘住院患者进行的两种茶碱缓释制剂单剂量双盲对照试验。

A double-blind comparative trial between two sustained-release theophylline preparations with individual doses in asthmatic in-patients.

作者信息

Van der Meer Y G, Van Alphen A C, Van Altena R, Van Loenen A C

出版信息

Pharm Weekbl Sci. 1982 Dec 17;4(6):183-90. doi: 10.1007/BF01959137.

Abstract

Twenty-one patients, suffering from bronchial asthma, with a moderate and clearly reversible airway obstruction, completed a double-blind cross-over trial of two theophylline sustained-release preparations, Theolair Retard (= Theolair S.R. = Nuelin S.R.) and Theolin Retard (= Theo-Dur). The serum theophylline concentration curves of Theolin Retard were significantly flatter than the curves of Theolair Retard, with less peak-trough variation. Pulmonary function in both treatment groups appeared to be the same. There were no differences in side effects, nor in asthma symptoms. However, patients complained significantly more of coughing during treatment with Theolin Retard. In two patients using antacids, the peak-trough variation with Theolair Retard was considerably larger than average. The favourable theophylline concentration profile of Theolin Retard is not reflected in pulmonary function, side effects or asthma symptoms. For this group of asthmatic hospitalized inpatients the practical differences between the two preparations are not distinctive.

摘要

21名患有支气管哮喘且气道阻塞程度为中度且明显可逆的患者,完成了两种茶碱缓释制剂(Theolair Retard(=Theolair S.R.=Nuelin S.R.)和Theolin Retard(=Theo-Dur))的双盲交叉试验。Theolin Retard的血清茶碱浓度曲线明显比Theolair Retard的曲线更平缓,峰谷变化更小。两个治疗组的肺功能似乎相同。副作用和哮喘症状方面均无差异。然而,患者在使用Theolin Retard治疗期间抱怨咳嗽的情况明显更多。在两名使用抗酸剂的患者中,Theolair Retard的峰谷变化明显大于平均水平。Theolin Retard有利的茶碱浓度曲线在肺功能、副作用或哮喘症状方面并未体现出来。对于这组住院的哮喘患者而言,这两种制剂之间的实际差异并不显著。

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