Lines C, Traub M, Raskin S, Mant T, Reines S
Merck Sharp & Dohme Research Laboratories, Neuroscience Research Centre, Harlow, Essex, UK.
J Psychopharmacol. 1997;11(4):325-9. doi: 10.1177/026988119701100407.
A double-blind, in-clinic, placebo-controlled, randomized, three-period crossover study was undertaken to investigate the potential sedative and cognitive effects of diphenhydramine 50 mg, p.o. and cyclobenzaprine 5 mg, p.o. in elderly volunteers. Subjects were given 10 doses of each treatment over a 4-day period according to a t.i.d. schedule. A battery of cognitive tests was administered 2 h after the first and last dose of each treatment period and subjects also completed visual analogue scale subjective ratings at regular intervals. There was no evidence that either drug caused drowsiness or affected cognitive test performance. These findings contrast with previous data using similar assessments in young volunteers, which indicated clear diphenhydramine-induced impairments. Contrary to commonly held belief, the elderly appear to be less sensitive than the young to the central nervous system effects of oral diphenhydramine.
开展了一项双盲、临床、安慰剂对照、随机、三阶段交叉研究，以调查口服50毫克苯海拉明和5毫克氯苯氨丁酸对老年志愿者的潜在镇静和认知作用。在4天内，按照每日三次的给药方案，给受试者每种治疗药物各服用10剂。在每个治疗阶段的首剂和末剂服药后2小时进行一系列认知测试，受试者还定期完成视觉模拟量表主观评分。没有证据表明这两种药物会导致嗜睡或影响认知测试表现。这些发现与之前在年轻志愿者中使用类似评估方法得到的数据形成对比，之前的数据表明苯海拉明显然会导致功能受损。与普遍看法相反，老年人似乎比年轻人对口服苯海拉明的中枢神经系统作用更不敏感。
