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一种缓释减充血剂组合及其成分与安慰剂在变应性鼻炎患者中的生理/临床比较

Physiologic/clinical comparisons of a sustained-release decongestant combination, its components and placebo in patients with allergic rhinitis.

作者信息

Cohen B M

出版信息

J Asthma Res. 1975 Sep;13(1):7-13. doi: 10.3109/02770907509104153.

Abstract

Fifteen subjects with chronic allergic rhinitis had measurements of nasal airways flow/resistance (Rn) made before, and for 12 hours after, single doses of a sustained release decongestant combination, some of its components given alone or together, and placebo, in a randomized double-blind trial. The magnitude of improvement in Rn was statistically greater for the the four active preparations than for placebo over the first 8 hours; the effects of phenylpropanolamine/chlorpheniramine were still present after 10 hours, while at the end of 12 hours only the full triple-drug capsule had significant activity. Patient-estimates of symptomatic improvement generally mirrored these physiologic changes although statistical differences among the active capsules were not delineated. The data confirm the ability of electronic posterior rhinometry to discriminate between the effects of active medications and placebo at the 95 per cent confidence level or better and suggest that observed decreases in elevated Rn mean reflected helpful clinical activity as well as increased nasal patency.

摘要

在一项随机双盲试验中,对15名慢性变应性鼻炎患者在单次服用一种缓释减充血剂组合、其某些成分单独或联合服用以及安慰剂之前和之后12小时进行鼻气道流量/阻力(Rn)测量。在前8小时,四种活性制剂使Rn改善的幅度在统计学上比安慰剂更大;苯丙醇胺/氯苯那敏的作用在10小时后仍然存在,而在12小时结束时,只有完整的三联药物胶囊具有显著活性。患者对症状改善的估计总体上反映了这些生理变化,尽管活性胶囊之间的统计学差异未明确显示。数据证实,电子后鼻测量法能够在95%置信水平或更高水平上区分活性药物和安慰剂的效果,并表明观察到的Rn升高值下降意味着反映了有益的临床活性以及鼻腔通畅性增加。

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