Hesso R, Retterstol N, Torp H
Behav Neuropsychiatry. 1975;7(1-12):13-7.
The objectives of the study have been to evaluate the therapeutic efficacy of PLP 100-127 (6-(4-methyl-l-piperazinyl) morphanthridin) on patients with moderate to severe insomnia, to evaluate safety and tolerance of the drug and to investigate whether or not the drug may have dependence producing properties through the possible development of mental and/or physical dependence. A clinical-therapeutical long-term comparsion as a double blind cross-over investigation between PLP 100-127 and nitrazepan is presented. 30 patients at Gaustad hospital, mainly long-term patients with the diagnosis of schizophrenia, were selected for the trial, which lasted for 38 weeks. There were 9 drop outs, mainly due to relapse of psychotic symptoms. PLP 100-127 seems to have a favorable effect on moderate and severe insomnia in patients suffering from severe mental diseases. It seems to be well tolerated in these groups of patients. No signs of dependence producing properties have been observed by the observation method here presented.
本研究的目的是评估PLP 100 - 127(6 -(4 - 甲基 - 1 - 哌嗪基)吗啉氮杂蒽)对中重度失眠患者的治疗效果,评估该药物的安全性和耐受性,并通过可能出现的精神和/或身体依赖来研究该药物是否具有产生依赖性的特性。本文呈现了一项作为双盲交叉试验的PLP 100 - 127与硝西泮之间的临床治疗长期比较。奥斯陆大学医院的30名患者被选入该试验,这些患者主要是长期诊断为精神分裂症的患者,试验持续了38周。有9名患者退出,主要原因是精神病症状复发。PLP 100 - 127似乎对患有严重精神疾病的患者的中重度失眠有良好效果。在这些患者群体中,它似乎耐受性良好。通过本文所采用的观察方法,未观察到产生依赖性的迹象。