Guez D
Institut de Recherches Internationales Servier, Courbevoie, France.
Clin Neuropharmacol. 1990;13 Suppl 3:S109-16. doi: 10.1097/00002826-199013003-00012.
Twenty elderly patients (8 men, 12 women, mean age 67.5 years, range 59-74 years) with age-associated cognitive decline (memory impairment, slowing of thought and inability to concentrate, mean Mini Mental State score 22.0, range 18-24) were included by their general practitioners in an open study of the efficacy and safety of long-term combination therapy with almitrine and raubasine. After a 2-week washout period, patients received almitrine-raubasine for 13 months. Efficacy was evaluated at 2-month intervals using two well-being scales (visual analog and psychoaffective profile) and two behavioral scales (Widlocher's scale, and a scale derived from the Sandoz Clinical Assessment Geriatric scale). Memory was assessed every 6 months. Safety was evaluated by full medical examination and routine laboratory parameters at 2- and 6-month intervals, respectively. On treatment, scores on all scales improved significantly (two-way analysis of variance) throughout the study, as did scores in the two objective memory tests (Friedman test). Safety was demonstrated by the lack of any changes in clinical or laboratory parameters outside the normal range.
20名患有年龄相关性认知衰退（记忆力减退、思维迟缓及注意力不集中，简易精神状态平均评分为22.0，范围为18 - 24）的老年患者（8名男性，12名女性，平均年龄67.5岁，范围为59 - 74岁）被其全科医生纳入一项关于阿米三嗪和萝巴新长期联合治疗疗效及安全性的开放性研究。经过2周的洗脱期后，患者接受阿米三嗪 - 萝巴新治疗13个月。每隔2个月使用两种幸福感量表（视觉模拟量表和心理情感量表）及两种行为量表（维德洛赫量表和源自山德士临床老年评估量表的一种量表）评估疗效。每6个月评估一次记忆力。分别在2个月和6个月时通过全面医学检查及常规实验室参数评估安全性。在整个研究过程中，治疗期间所有量表的评分均显著改善（双向方差分析），两项客观记忆测试的评分也是如此（弗里德曼检验）。临床或实验室参数未出现超出正常范围的变化，证明了安全性良好。
