Stanley R O, Tiller J W, Adrian J
Department of Psychiatry, University of Melbourne, Austin Hospital, Heidelberg, Australia.
Int Clin Psychopharmacol. 1987 Oct;2(4):317-23. doi: 10.1097/00004850-198710000-00004.
Benzodiazepine hypnotics are used for short periods in low doses in healthy people when stressed and in patients with insomnia. This study examined psychomotor impairment in healthy young males and females after 1 and 7 nights of flunitrazepam (1 mg), nitrazepam (2.5 mg) and temazepam (10 mg). There were substantial inter-individual variations. Results showed that no drug significantly affected psychomotor performance at these doses after single or repeated administration. The number and severity of side-effects were significantly greater after the first night with temazepam and 7 nights with nitrazepam, although this may reflect a statistical artefact rather than a significant clinical finding. The difficulties in performing adequately controlled psychopharmacological studies at low doses are highlighted. Given the large intra- and inter-subject variances, small drug effects would necessitate large sample sizes (21 to 600 subjects at the 95% level of chance of detection) depending on the variable. The study suggests there is minimal impairment with low dose hypnotic drugs and a need to individualize treatment.
苯二氮䓬类催眠药在健康人处于应激状态时以及失眠患者中以低剂量短期使用。本研究检测了健康年轻男性和女性在服用氟硝西泮（1毫克）、硝西泮（2.5毫克）和替马西泮（10毫克）1晚及7晚后的精神运动功能损害情况。个体间存在显著差异。结果显示，单次或重复给药后，这些剂量的药物均未对精神运动表现产生显著影响。替马西泮用药第一晚和硝西泮用药7晚后，副作用的数量和严重程度显著更高，不过这可能反映的是一种统计假象，而非显著的临床发现。研究凸显了在低剂量下进行充分对照的精神药理学研究存在的困难。鉴于受试者内和受试者间存在较大差异，根据变量不同，小的药物效应将需要大样本量（在95%的检测概率水平下，样本量为21至600名受试者）。该研究表明，低剂量催眠药物造成的损害极小，且有必要进行个体化治疗。
