Bruni Oliviero, Ferri Raffaele, Miano Silvia, Verrillo Elisabetta
Centre for Paediatric Sleep Disorders, Department of Developmental Neurology and Psychiatry, University of Rome "La Sapienza", Via dei Sabelli 108, 00185 Rome, Italy.
Eur J Pediatr. 2004 Jul;163(7):402-7. doi: 10.1007/s00431-004-1444-7. Epub 2004 May 14.
To test the hypothesis that the administration of L -5-hydroxytryptophan (L -5-HTP) might exert beneficial effects on sleep terrors, we carried out an open pharmacological trial in a group of children with sleep terrors compared to a group of children with the same disorder but without L -5-HTP treatment. Participants in the trial were 45 children (34 males and 11 females; age range 3.2-10.6 years), referred to the Sleep Centre of the Department of Developmental Neurology and Psychiatry of the University of Rome "La Sapienza", affected by sleep terrors. All subjects underwent: (1) complete medical and sleep history; (2) complete neurological examination and EEG recording whilst awake and sleeping, (3) a structured sleep diary for 2 months, (4) after 1 month, all subjects were examined again from the clinical and EEG points of view and (5) after 6 months, a structured interview in order to evaluate the clinical outcome. After the first visit, L -5-HTP was administered (2 mg/kg per day) at bedtime to 31 randomly selected patients for a single period of 20 consecutive days. After 1 month of treatment, 29/31 (93.5%) of patients showed a positive response. In the comparison group without drug therapy, after 1 month, the episodes disappeared only in four children (28.6%) while ten children (71.4%) showed the persistence of episodes with the same frequency as before. After 6 months, 26/31 (83.9%) of children treated with L -5HTP were sleep terror-free, while in five children (16.1%) sleep terror episodes persisted. Of the children in the comparison group, ten (71.4%) continued to show sleep terrors at 6-month follow-up.
to our knowledge, this is the first study demonstrating the efficacy of a new drug treatment for sleep terrors. These results confirm our initial hypothesis and represent evidence that treatment with L -5-hydroxytryptophan is able to modulate the arousal level in children and to induce a long-term improvement of sleep terrors.
为检验给予L - 5 - 羟色氨酸(L - 5 - HTP)可能对夜惊产生有益影响这一假设,我们对一组患有夜惊的儿童进行了一项开放性药理学试验,并与另一组患有相同病症但未接受L - 5 - HTP治疗的儿童进行比较。试验参与者为45名儿童(34名男性和11名女性;年龄范围3.2 - 10.6岁),他们被转诊至罗马第一大学“La Sapienza”发育神经学与精神病学系睡眠中心,患有夜惊。所有受试者均接受了:(1)完整的病史和睡眠史;(2)清醒和睡眠时的完整神经学检查及脑电图记录;(3)为期2个月的结构化睡眠日记;(4)1个月后,从临床和脑电图角度对所有受试者再次进行检查;(5)6个月后,进行结构化访谈以评估临床结果。首次就诊后,对31名随机选择的患者在睡前给予L - 5 - HTP(每日2 mg/kg),持续20天。治疗1个月后,29/31(93.5%)的患者显示出阳性反应。在未接受药物治疗的对照组中,1个月后,仅4名儿童(28.6%)的发作消失,而10名儿童(71.4%)的发作频率与之前相同。6个月后,接受L - 5 - HTP治疗的儿童中有26/31(83.9%)无夜惊,而5名儿童(16.1%)仍有夜惊发作。在对照组儿童中,10名(71.4%)在6个月随访时仍有夜惊。
据我们所知,这是第一项证明一种新药治疗夜惊有效性的研究。这些结果证实了我们最初的假设,并表明用L - 5 - 羟色氨酸治疗能够调节儿童的唤醒水平,并长期改善夜惊症状。