一些关于新型抗组胺药特非那定的临床药理学研究。
Some clinical pharmacological studies with terfenadine, a new antihistamine drug.
作者信息
Kulshrestha V K, Gupta P P, Turner P, Wadsworth J
出版信息
Br J Clin Pharmacol. 1978 Jul;6(1):25-9. doi: 10.1111/j.1365-2125.1978.tb01677.x.
Abstract
1 A double-blind cross-over trial between placebo, chlorpheniramine, and terfenadine, a new antihistamine drug, was performed in healthy male volunteers to determine and compare their CNS and autonomic effects. 2 Terfenadine and chlorpheniramine were administered orally in therapeutic doses. 3 In objective tests of critical flicker frequency, pursuit rotor, reaction time, salivary volume and pupillary diameter, no statistically significant difference was observed between the treatments. 4 On analogue rating scales, chlorpheniramine produced a statistically significant (P less than 0.05) degree of sedation and impaired concentration as compared to placebo and terfenadine. 5 The results obtained in analogue rating scales were not normally distributed and, therefore, use of non-parametric statistical methods for analysis of such data is strongly advocated.
摘要
- 在健康男性志愿者中进行了一项安慰剂、氯苯那敏和新型抗组胺药特非那定之间的双盲交叉试验，以确定并比较它们对中枢神经系统和自主神经系统的影响。2. 特非那定和氯苯那敏均以治疗剂量口服给药。3. 在临界闪烁频率、追踪转子、反应时间、唾液分泌量和瞳孔直径的客观测试中，各治疗组之间未观察到统计学上的显著差异。4. 在模拟评分量表上，与安慰剂和特非那定相比，氯苯那敏产生了具有统计学显著性（P小于0.05）的镇静程度，并损害了注意力。5. 在模拟评分量表上获得的结果呈非正态分布，因此，强烈建议使用非参数统计方法分析此类数据。
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