Saletu B, Grünberger J, Saletu M, Mader R, Volavka J
Int Pharmacopsychiatry. 1978;13(3):177-92. doi: 10.1159/000468338.
The efficacy of EMD 21657--a derivative of a pyritinolmetabolite--with regard to the improvement of the organic brain syndrome (OBS) of chronic alcoholics was investigated in a double-blind study utilizing clinical, psychometric and quantitative EEG evaluation. Nineteen patients received 3 x 300 mg EMD and 21 patients 3 x 1 dragee placebo for 6 weeks. The groups did not differ in regard to age, sex, weight, height, alcohol anamnesis or IQ. The hospitalized patients were examined before as well as at the end of the second, fourth and sixth week of drug treatment. While the overall evaluation by the psychiatrist and patients at the end of the period of treatment did not show marked intergroup differences, the clinical global impression scale and the OBS rating scale demonstrated that both groups showed a significant reduction in their OBS and that improvement with EMD 21657 therapy was significantly superior to the one with placebo. Psychometric analysis also exhibited a significant superiority of EMD in regard to the general, associative, numeric and total verbal memory, concentration and attention variability. Psychovisual memory and the quantative aspects of attention showed opposite findings. Flickerlight fusion frequency, reaction time and after-image did not change significantly. The psychomotor activity improved significantly more with EMD than placebo; this was especially pronounced in the left hand. Affect and mood improved also more with EMD than placebo. Side effects were observed more frequently under active treatment and were characterized by temporary headaches. Power spectral density analysis of the EEG revealed in both groups a decrease of delta, fast alpha and beta activities and an increase in theta and slow alpha activity, but changes during EMD treatment more frequently reached the level of statistical significance than with placebo. The most consistant finding was the theta augmentation under EMD treatment. It was concluded that EMD 21657 is a CNS-effective drug with pronounced nootropic and slight thymotropic properties.
在一项采用临床、心理测量和定量脑电图评估的双盲研究中，对吡硫醇代谢物衍生物EMD 21657改善慢性酒精中毒患者器质性脑综合征（OBS）的疗效进行了研究。19名患者接受3×300mg EMD，21名患者接受3×1片安慰剂，疗程为6周。两组在年龄、性别、体重、身高、饮酒史或智商方面无差异。住院患者在药物治疗的第二、第四和第六周结束时以及治疗前均接受检查。虽然治疗期结束时精神科医生和患者的总体评估未显示出明显的组间差异，但临床总体印象量表和OBS评定量表显示，两组的OBS均显著降低，且EMD 21657治疗的改善明显优于安慰剂。心理测量分析还显示，EMD在一般、联想、数字和总言语记忆、注意力集中和注意力变异性方面具有显著优势。心理视觉记忆和注意力的定量方面显示出相反的结果。闪光融合频率、反应时间和后像无明显变化。与安慰剂相比，EMD使精神运动活动改善更为显著；这在左手尤为明显。与安慰剂相比，EMD对情感和情绪的改善也更大。在积极治疗下观察到的副作用更频繁，其特征为暂时性头痛。脑电图的功率谱密度分析显示，两组的δ波、快α波和β波活动均减少，θ波和慢α波活动增加，但EMD治疗期间的变化比安慰剂更频繁地达到统计学显著水平。最一致的发现是EMD治疗下θ波增强。得出的结论是，EMD 21657是一种对中枢神经系统有效的药物，具有明显的促智和轻微的促胸腺作用。
