Noël G, Jeanmart M, Reinhardt B
Neuropsychobiology. 1983;10(2-3):90-3. doi: 10.1159/000117991.
100 inpatients of both sexes, most of them older than 65 years and suffering from symptoms of the organic brain syndrome (OBS), primarily associated with aging were included in a 6-week double-blind study. Patients were randomly assigned to two treatment groups of 50 patients each and received either a neurotropic drug (3 X 200 mg EMD 21657) or placebo coated tablets of identical appearance. Patients were evaluated at the beginning of the study and after 6 weeks of treatment using a physician's symptom rating, the Nurses' Observation Scale for Inpatient Evaluation ( NOSIE ), EEG, and a psychometric test battery to assess level of mental and memory functioning ( Rey test, Benton visual retention test, block design test by Kohs ). At the final assessment global response and overall tolerance were rated by the physician. The therapeutic effects of EMD 21657 were shown to be statistically significant compared to placebo in global response (p less than or equal to 0.05), in the factor 'cognitive disturbances' (p less than or equal to 0.05 doctor's symptom rating) and in the negative factors of the NOSIE (p less than or equal to 0.05). In the other parameters of the scales, the EEG and the mental ability tests no statistically significant changes could be demonstrated in the two groups after 6 weeks of treatment. The drugs were well tolerated. EMD 21657 treatment was interrupted because of side effects (increased aggressiveness, rash) in 2 cases.
100名男女住院患者被纳入一项为期6周的双盲研究，他们大多年龄超过65岁，患有主要与衰老相关的器质性脑综合征（OBS）症状。患者被随机分为两个治疗组，每组50人，分别接受一种神经营养药物（3次，每次200毫克EMD 21657）或外观相同的安慰剂包衣片。在研究开始时和治疗6周后，使用医生症状评分、护士住院患者评估观察量表（NOSIE）、脑电图以及一套心理测量测试来评估患者的精神和记忆功能水平（雷伊测试、本顿视觉保持测试、科斯方块设计测试）。在最终评估中，由医生对总体反应和总体耐受性进行评分。与安慰剂相比，EMD 21657在总体反应（p≤0.05）、“认知障碍”因素（医生症状评分，p≤0.05）以及NOSIE的负面因素（p≤0.05）方面显示出统计学上的显著治疗效果。在量表的其他参数、脑电图和心理能力测试方面，治疗6周后两组均未显示出统计学上的显著变化。这些药物耐受性良好。有2例因副作用（攻击性增强、皮疹）中断了EMD 21657治疗。
