Höschl C, Filip V, Bornová L, David I, Karen P, Seifertová D
Psychiatrické centrum 3. LF UK Praha.
Cesk Psychiatr. 1992 Jun;88(2):97-105.
The authors submit results of a double blind clinical trial of levoprotiline controlled by maprotiline. In the multicentre study (which is processed and interpreted in stages) participated after written informed consent 58 patients with the diagnosis of a major depressive disorder. During the first three weeks the results of levoprotiline and maprotiline (from 26 patients each) were processed. The trial lasted 42 days. The psychopathology of the patients was evaluated by independent blind raters by means of Montgomery and Asberg's scale (MADRS), Hamilton's scale for depression (HRDS) and general clinical impression (CGI). In all patients also the pharmacological and EEG response was assessed. In comparison to maprotiline, levoprotiline was clinically ineffective. Its plasma levels (40 ng/ml) were one third to one half of the values obtained with maprotiline in the same daily dosage (150 mg). Although levoprotiline has an EEG profile typical for classical thymoleptics, its clinical antidepressive action is negligible.
作者提交了一项由麦普替林对照的左普替林双盲临床试验结果。在这项多中心研究(分阶段进行处理和解读)中,58例被诊断为重度抑郁症的患者在签署书面知情同意书后参与研究。在前三周,对左普替林和麦普替林(各26例患者)的结果进行了处理。试验持续42天。由独立的盲法评估者通过蒙哥马利和阿斯伯格量表(MADRS)、汉密尔顿抑郁量表(HRDS)以及总体临床印象(CGI)对患者的精神病理学进行评估。对所有患者还评估了药理学和脑电图反应。与麦普替林相比,左普替林在临床上无效。其血浆水平(40纳克/毫升)仅为相同日剂量(150毫克)麦普替林所获值的三分之一到二分之一。尽管左普替林具有经典抗抑郁药典型的脑电图特征,但其临床抗抑郁作用微不足道。