France K G, Blampied N M, Wilkinson P
Department of Education, University of Canterbury, Christchurch, New Zealand.
Exp Clin Psychopharmacol. 1999 Nov;7(4):502-13. doi: 10.1037//1064-1297.7.4.502.
Infant sleep disturbance involving chronic night waking and resistance to settling to sleep or returning to sleep is a common problem for families with children 6-27 months old. Prescription and nonprescription sedatives are frequently administered without clear evidence that they are effective as either long-term or short-term palliatives. Trimeprazine tartrate, administered either 15 mg/5 mL or 30 mg/5 mL, was compared with both baseline and placebo in a multiple-baseline-across participants, double-blind study. No clinically significant effects of the low dose were detected, whereas the effects of the high dose were not consistently replicated across nor within participants. During active drug treatment, only 2 of 12 children achieved Sleep Behaviour Scale scores indicative of nonproblem sleep. Trimeprazine tartrate is not recommended as a pharmacological treatment for infant sleep disturbance unless as an adjunct to a behavioral therapy program.
婴儿睡眠障碍，包括长期夜间醒来以及难以入睡或重新入睡，是有6至27个月大孩子的家庭普遍面临的问题。在没有明确证据表明其作为长期或短期缓解药物有效的情况下，处方和非处方镇静剂仍经常被使用。在一项针对多名参与者的多基线、双盲研究中，将15毫克/5毫升或30毫克/5毫升的酒石酸三甲嗪与基线和安慰剂进行了比较。未检测到低剂量的临床显著效果，而高剂量的效果在参与者之间和参与者内部均未得到一致重现。在积极药物治疗期间，12名儿童中只有2名获得了表明睡眠无问题的睡眠行为量表分数。除非作为行为治疗方案的辅助手段，否则不建议将酒石酸三甲嗪作为婴儿睡眠障碍的药物治疗方法。
