Franzoni E, Masoni P, Mambelli M, Marzano P, Donati C
Clinica Pediatrica I, Università di Bologna, Italia.
Pediatr Med Chir. 1987 Mar-Apr;9(2):185-7.
The results of a randomized, double blind clinical trial are described. Niaprazine (1.5 mg/kg/day) or placebo were administered for 1 month to 20 patients (17 M-3 F; age range 6-11 years) suffering from behaviour disorders. Both the active drug and placebo induced an improvement of behaviour in the various conditions assessed in the family, during the play, at school, in the doctor's office but the percent variation induced by niaprazine was always higher than that with placebo (mean -49.4% vs. -24.6). The difference between the treatments was highly significant. No relevant side effects were observed: only in two cases treated with niaprazine the daily dose was reduced due to drowsiness. The authors conclude confirming the therapeutic efficacy of niaprazine in the treatment of behaviour disorders.
本文描述了一项随机双盲临床试验的结果。对20名患有行为障碍的患者（17名男性，3名女性；年龄范围6 - 11岁）给予尼亚普拉嗪（1.5毫克/千克/天）或安慰剂，持续给药1个月。活性药物和安慰剂均使患者在家庭、玩耍、学校、医生办公室等各种评估环境中的行为得到改善，但尼亚普拉嗪引起的百分比变化始终高于安慰剂（平均 - 49.4%对 - 24.6%）。两种治疗方法之间的差异非常显著。未观察到相关副作用：仅在两名接受尼亚普拉嗪治疗的患者中，因嗜睡而减少了每日剂量。作者得出结论，证实了尼亚普拉嗪在治疗行为障碍方面的治疗效果。
