Poitrenaud J, Piette F, Malbezin M, Sebban C, Guez D
Centre de Gérontologie, Association Claude Bernard, Paris, France.
Clin Neuropharmacol. 1990;13 Suppl 3:S100-8. doi: 10.1097/00002826-199013003-00011.
Two-hundred four patients between 70 and 85 years of age were included in a double-blind randomized controlled multicenter study (almitrine-raubasine/placebo). Inclusion criteria were a complaint of cognitive disorders and an objective cognitive impairment evaluated by Folstein et al. "Mini-Mental State" (MMS) and by Sandoz Clinical Assessment for Geriatrics (SCAG). Patients were treated for 6 months and evaluations were performed at the beginning of the trial (T0), then 3 (T3) and 6 (T6) months later. Evaluations included a visual analogic self-rating scale and the following psychometric tests: Trail Making A (TMA), Shopping List Task, Word Fluency, Crossing Out Letters, Logical Memory, Digit Span, and Visual Retention. Anxiety and Depression Scales were also used to assess the effects of almitrine-raubasine on affective status. Statistical analysis involving the whole sample did not show any significant difference between the almitrine-raubasine and placebo groups concerning changes in assessment criteria from T0 to T6. However, these results may have been due to the wide heterogeneity of baseline performances in psychometric tests. To prevent this possible bias, further statistical analysis was performed for each psychometric test after patients had been divided into three classes according to baseline score levels. Considering scores on TMA and Digit Span for patients with scores in the intermediate class on TMA, almitrine-raubasine induced a significantly higher improvement in performance from T0 to T6 than that induced by placebo. On the other hand, no side effects were noted with almitrine-raubasine when compared with placebo. These data suggest that almitrine-raubasine enhances concentrated attention in patients with mild to moderate impairment of this function.
204名年龄在70至85岁之间的患者被纳入一项双盲随机对照多中心研究（阿米三嗪萝巴新/安慰剂）。纳入标准为有认知障碍主诉，且经Folstein等人的“简易精神状态检查”（MMS）和山德士老年临床评估（SCAG）评估存在客观认知障碍。患者接受治疗6个月，并在试验开始时（T0）、3个月后（T3）和6个月后（T6）进行评估。评估包括视觉模拟自评量表以及以下心理测量测试：连线测验A（TMA）、购物清单任务、词语流畅性、划消字母、逻辑记忆、数字广度和视觉记忆。焦虑和抑郁量表也用于评估阿米三嗪萝巴新对情感状态的影响。对整个样本进行的统计分析未显示阿米三嗪萝巴新组和安慰剂组在从T0到T6的评估标准变化方面有任何显著差异。然而，这些结果可能是由于心理测量测试中基线表现的广泛异质性所致。为防止这种可能的偏差，在根据基线分数水平将患者分为三类后，对每项心理测量测试进行了进一步的统计分析。考虑TMA分数处于中间类别的患者在TMA和数字广度上的得分，从T0到T6，阿米三嗪萝巴新导致的表现改善显著高于安慰剂。另一方面，与安慰剂相比，未观察到阿米三嗪萝巴新有任何副作用。这些数据表明，阿米三嗪萝巴新可增强轻度至中度注意力功能受损患者的集中注意力。
