de Koning P, Mak M, de Vries M H, Allsopp L F, Stevens R B, Verbruggen R, Van den Borre R, van Peteghem P, Kohen D, Arumainayagam M
Department of Clinical Pharmacology, Solvay Duphar BV, Weesp, The Netherlands.
Int Clin Psychopharmacol. 1994 Sep;9(3):187-94.
The efficacy of eltoprazine, a mixed 5-HT1 agonist, in treating aggressive behaviour in mentally handicapped patients was evaluated in a double-blind, placebo- and baseline-controlled study. In the total sample of 160 patients who entered the 8 week double-blind treatment phase, efficacy was not demonstrated. Also in a 28 week double-blind follow-up study, efficacy could not be demonstrated. Post-hoc exploratory analyses suggested eltoprazine was significantly better than placebo in reducing aggression scores of a subgroup of severely aggressive patients. There was no evident relationship between the plasma level of eltoprazine and therapeutic effect or safety and tolerance. The overall safety and tolerance of chronic eltoprazine treatment was good. In the discussion, several issues and pitfalls of aggression research are dealt with.
在一项双盲、安慰剂和基线对照研究中，对混合5-羟色胺1激动剂依托哌嗪治疗智力障碍患者攻击行为的疗效进行了评估。在进入8周双盲治疗阶段的160例患者的总样本中，未显示出疗效。同样，在一项28周的双盲随访研究中，也未能证明其疗效。事后探索性分析表明，依托哌嗪在降低一组严重攻击性行为患者的攻击得分方面明显优于安慰剂。依托哌嗪的血浆水平与治疗效果、安全性和耐受性之间没有明显关系。依托哌嗪长期治疗的总体安全性和耐受性良好。在讨论中，涉及了攻击行为研究的几个问题和陷阱。
