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富马酸氯马斯汀、氯苯那敏和安慰剂对脱敏及未脱敏患者季节性变应性鼻炎症状治疗的双盲对照研究。

Double-blind, controlled study of clemastine fumarate, chlorpheniramine and placebo in the symptomatic treatment of seasonal allergic rhinitis in desensitized and nondesensitized patients.

作者信息

Thomas J S, Heurich A E, Huh C, Crane R, Shepherd D A

出版信息

Ann Allergy. 1977 Mar;38(3):175-81.

PMID:320917
Abstract

In double-blind trials clemastine fumarate 2.68 mg. chlorpheniramine 4 mg and placebo were randomly assigned to two groups of patients with seasonal allergic rhinitis. Thirty-nine desensitized patients were given one of the three test drugs in a parallel design; 67 nondesensitized patients each received two of the three drugs in a crossover design. Assessment of drug activity in each study was by whole body plethysmography and intranasal color photography as well as by subjective methods. Objective measurements showed clemastine fumarate was significantly superior to placebo and often better than chlorpheniramine in decreasing true nasal resistance and relieving nasal congestion. High placebo responses characterized the subjective evaluations, although the active drugs were clearly better. Responses varied somewhat between desensitized and nondesensitized patients. The number of reports of sedative effect, high in all groups, seemed to be more closely related to these antihistamine conditioned patients than to activity of the drugs themselves, based on previous reports of low sedation with clemastine fumarate. The techniques described proved very useful in distinguishing relative activity of antihistamines. Clemastine fumarate, the new antihistamine studied, appears to offer certain advantages over the older drug, chlorpheniramine.

摘要

在双盲试验中,将2.68毫克富马酸氯马斯汀、4毫克氯苯那敏和安慰剂随机分配给两组季节性变应性鼻炎患者。39名脱敏患者以平行设计接受三种试验药物之一;67名未脱敏患者以交叉设计各自接受三种药物中的两种。每项研究中药物活性的评估采用全身体积描记法、鼻内彩色摄影以及主观方法。客观测量结果显示,富马酸氯马斯汀在降低真实鼻阻力和缓解鼻塞方面明显优于安慰剂,且常常优于氯苯那敏。主观评估的特点是安慰剂反应较高,尽管活性药物明显更好。脱敏患者和未脱敏患者的反应略有不同。根据先前关于富马酸氯马斯汀镇静作用较低的报道,所有组中镇静作用报告的数量似乎与这些抗组胺药适应的患者关系更为密切,而非与药物本身的活性有关。所描述的技术在区分抗组胺药的相对活性方面非常有用。所研究的新型抗组胺药富马酸氯马斯汀似乎比旧药氯苯那敏具有某些优势。

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