Janssens M M, Lins R L
Janssen Research Foundation, Beerse, Belgium.
J Int Med Res. 1995 May-Jun;23(3):167-74. doi: 10.1177/030006059502300303.
This randomized, double-blind, double-dummy, parallel-group trial was initiated to evaluate and compare the tolerability of once-daily astemizole-D capsules (10 mg astemizole/240 mg pseudoephedrine) and twice-daily loratadine-D tablets (5 mg loratadine/120 mg pseudoephedrine), with particular reference to the impact of treatment on quality of sleep. A total of 240 healthy volunteers participated in this study with a treatment duration of 3 days. Astemizole-D consistently produced less sleep impairment than loratadine-D with statistically significant differences in favour of astemizole-D reported for night-time waking on days 4 and 5 (P = 0.004 and P = 0.006, respectively), as well as for night-time restlessness on day 4 and the total score for all sleep parameters on day 4 (P < 0.05). Global evaluations of overall sleep quality at the end of the trial also revealed some statistically significant differences in favour of astemizole-D. Both drugs were well tolerated and there were no differences in the incidence and type of adverse events reported in the two treatment groups. Slight changes in heart rate and blood-pressure were observed in both treatment groups, but these were small and were not considered to be of clinical significance. In conclusion, once-daily astemizole-D is well tolerated and appears to cause less sleep impairment than twice-daily loratadine-D.
这项随机、双盲、双模拟、平行组试验旨在评估和比较每日一次的阿司咪唑-D胶囊（10毫克阿司咪唑/240毫克伪麻黄碱）和每日两次的氯雷他定-D片剂（5毫克氯雷他定/120毫克伪麻黄碱）的耐受性，特别关注治疗对睡眠质量的影响。共有240名健康志愿者参与了这项为期3天的研究。与氯雷他定-D相比，阿司咪唑-D持续产生的睡眠损害较少，在第4天和第5天夜间觉醒方面（分别为P = 0.004和P = 0.006）以及第4天夜间不安和第4天所有睡眠参数总分方面（P < 0.05），阿司咪唑-D具有统计学显著差异。试验结束时对总体睡眠质量的整体评估也显示出一些有利于阿司咪唑-D的统计学显著差异。两种药物耐受性良好，两个治疗组报告的不良事件发生率和类型没有差异。两个治疗组均观察到心率和血压有轻微变化，但这些变化很小，不被认为具有临床意义。总之，每日一次的阿司咪唑-D耐受性良好，似乎比每日两次的氯雷他定-D引起的睡眠损害更少。
