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一项关于马来酸溴苯那敏缓释片与富马酸氯马斯汀治疗慢性荨麻疹的安慰剂对照比较研究。

A placebo-controlled comparative study of sustained-release brompheniramine maleate against clemastine fumarate in the treatment of chronic urticaria.

作者信息

Jolliffe D S, Sim-Davis D, Templeton J S

出版信息

Curr Med Res Opin. 1985;9(6):394-9. doi: 10.1185/03007998509109610.

Abstract

A partially-blind, three-way crossover study was carried out in 24 patients suffering from chronic urticaria to compare the efficacy and tolerance of brompheniramine maleate with that of clemastine fumarate. Patients received 4-week courses of treatment with 1 tablet twice daily of either 12 mg brompheniramine, 1 mg clemastine or placebo, in random order. Assessments were made by the physician of the patients' condition on entry and of response to treatment at the end of each 2-week period throughout the 12-week study period. At the end of the trial, patients were asked to state their preference, if any, for the different treatments. The results showed that both antihistamines were significantly effective compared to placebo and that at the dosage used brompheniramine was considered significantly better than clemastine in long-term control. Drowsiness was experienced by 4 patients whilst taking brompheniramine compared to 3 patients whilst taking clemastine. One patient experienced anorexia and vomiting with brompheniramine and 4 patients developed gastro-intestinal upsets whilst taking the placebo.

摘要

对24名慢性荨麻疹患者进行了一项部分盲法的三交叉研究,以比较马来酸溴苯那敏和富马酸氯马斯汀的疗效及耐受性。患者随机接受为期4周的治疗,每日两次,每次1片,药物分别为12毫克马来酸溴苯那敏、1毫克富马酸氯马斯汀或安慰剂。在整个12周的研究期间,医生在患者入组时评估其病情,并在每2周治疗期结束时评估治疗反应。试验结束时,询问患者对不同治疗方法的偏好(如有)。结果显示,与安慰剂相比,两种抗组胺药均有显著疗效,且在所使用的剂量下,马来酸溴苯那敏在长期控制方面被认为明显优于富马酸氯马斯汀。服用马来酸溴苯那敏时有4名患者出现嗜睡,而服用富马酸氯马斯汀时有3名患者出现嗜睡。1名患者服用马来酸溴苯那敏时出现厌食和呕吐,4名患者服用安慰剂时出现胃肠道不适。

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