Gelsomini S
Division of Pediatrics-Civitanova Marche Hospital, Macerata, Italy.
Arzneimittelforschung. 1997 Nov;47(11A):1332-5.
A double-blind, placebo-controlled study was performed in order to evaluate the efficacy of pivagabine (4-[(2,2-dimethyl-1-oxopropyl)amino]butanoic acid, CAS 69542-93-4, Tonerg) on "distress" in children hospitalized for acute disorders. Ninety children (43 boys and 47 girls) aged between 2 and 13 years were randomly distributed into two groups of equal size. The first group was treated with 450-900 mg/d of pivagabine by oral route, whereas the second group was given identical quantities of placebo. Treatment was continued for 21 days, with a medical examination after 7 days and another at its termination. Diurnal behaviour, motor activity, attention, sleep disturbances (insomnia) and sleep characteristics and behaviour upon awakening were assessed during treatment by means of a semiquantitative rating scale. Pivagabine induced significantly greater improvement in all the items listed above as compared to the control group. In many cases complete remission of the symptoms of "distress" was recorded. The results obtained therefore confirm the hypothesis that pivagabine acts by intervening on the biochemical mechanisms that regulate the CNS adjustment response to stress. It is likely that the intervention consists in the inhibition of the release of hypothalamic corticotropin releasing factor.
为评估匹伐加宾（4-[(2,2-二甲基-1-氧代丙基)氨基]丁酸，化学物质登记号69542-93-4，商品名Tonerg）对因急性疾病住院儿童“精神痛苦”的疗效，进行了一项双盲、安慰剂对照研究。90名年龄在2至13岁之间的儿童（43名男孩和47名女孩）被随机分成两组，每组人数相等。第一组口服450 - 900毫克/天的匹伐加宾，而第二组给予等量的安慰剂。治疗持续21天，7天后进行一次医学检查，治疗结束时再进行一次。在治疗期间，通过半定量评分量表评估昼夜行为、运动活动、注意力、睡眠障碍（失眠）以及睡眠特征和醒来时的行为。与对照组相比，匹伐加宾在上述所有项目上均带来了显著更大的改善。在许多病例中，记录到“精神痛苦”症状完全缓解。因此，所获得的结果证实了这样一种假设，即匹伐加宾通过干预调节中枢神经系统对应激的调节反应的生化机制起作用。这种干预可能在于抑制下丘脑促肾上腺皮质激素释放因子的释放。
