Patel A G, Gura R, Kurian T, Lambert M T, Steinert J, Priest R G
Ealing Hospital, Southall, Middx, UK.
Int Clin Psychopharmacol. 1991 Spring;6(1):1-9. doi: 10.1097/00004850-199100610-00001.
The effect of temazepam as a hypnotic was assessed with two different formulations, the solution-filled soft gelatin capsule and the more recently introduced elixir. Sixty psychiatric in-patients were included in the trial and 59 completed it. The study followed a double-blind crossover design for two consecutive nights. Patients took a capsule and elixir each night, but only one would contain the active ingredient (in a dose of 20 mg temazepam). In contrast to earlier work with volunteers, the elixir failed to reveal more of the characteristics of an ideal hypnotic. In fact, in those measures that were statistically significant, the balance favoured the capsule. We conclude that although there are many situations where an elixir is clearly clinically preferable, the essential hypnotic effect of the elixir is not conspicuously different to that of the capsule.
采用两种不同剂型(溶液填充软胶囊和最近推出的酏剂)评估了替马西泮作为催眠药的效果。60名精神科住院患者纳入试验,59人完成试验。该研究采用双盲交叉设计,连续进行两晚。患者每晚服用一粒胶囊和一剂酏剂,但只有一种含有活性成分(替马西泮剂量为20mg)。与早期针对志愿者的研究不同,酏剂未能展现出更多理想催眠药的特性。事实上,在具有统计学意义的指标方面,结果更倾向于胶囊。我们得出结论,尽管在许多情况下酏剂在临床上明显更具优势,但酏剂的基本催眠效果与胶囊并无显著差异。