Pantoni L, Bianchi C, Beneke M, Inzitari D, Wallin A, Erkinjuntti T
Department of Neurological and Psychiatric Sciences, University of Florence, Viale Morgagni 85, 50134, Florence, Italy.
J Neurol Sci. 2000 Apr 15;175(2):116-23. doi: 10.1016/s0022-510x(00)00301-4.
Vascular dementia is a major cause of mental and physical disability in Western countries. Treatment of vascular dementia is currently based on the recognition and control of vascular risk factors, while specific drugs have not been approved yet. The aim of the present multinational, double-blind, placebo-controlled study was to evaluate the safety and efficacy of nimodipine administered for as long as 26 weeks in improving cognition or slowing cognitive deterioration in patients defined as having multi-infarct dementia (DSM-III-R criteria). Two hundred and fifty-nine patients were included (128 nimodipine, 131 placebo), and 251 were available for the intention-to-treat analysis. No significant difference between drug-treated and placebo patients was noted on the Gottfries-Brâne-Steen scale score (primary efficacy criterion), the remaining neuropsychological tests (Zahlen-Verbindungs-Test, Fuld-Object-Memory Evaluation, Word Fluency Test, Digit Span, Mini-Mental State Examination), and the functional scales (index of Activity of Daily Living, Instrumental Activity of Daily Living, Rapid Disability Scale, Clinical Dementia Rating), although the majority of changes were in favor of the active drug group. A lower incidence of cerebrovascular and cardiac events was observed in the nimodipine-treated patients in comparison with the placebo group. This study failed to show a significant effect of nimodipine on cognitive, social or global assessments in patients defined as affected by multi-infarct dementia according to the DSM-III-R criteria. A post-hoc analysis (presented in an accompanying paper) suggests that nimodipine may have a favorable effect in the subgroup of patients defined as affected by subcortical (small vessel) vascular dementia.
血管性痴呆是西方国家导致精神和身体残疾的主要原因。目前血管性痴呆的治疗基于对血管危险因素的识别和控制，而特定药物尚未获批。本项多国、双盲、安慰剂对照研究的目的是评估尼莫地平治疗长达26周对改善符合多梗死性痴呆（DSM-III-R标准）患者的认知或减缓认知衰退的安全性和有效性。纳入了259例患者（128例使用尼莫地平，131例使用安慰剂），251例可用于意向性分析。在Gottfries-Brâne-Steen量表评分（主要疗效标准）、其余神经心理学测试（数字连线试验、福尔迪物体记忆评估、词语流畅性测试、数字广度、简易精神状态检查表）以及功能量表（日常生活活动指数、工具性日常生活活动、快速残疾量表、临床痴呆评定）方面，药物治疗组和安慰剂组患者之间未发现显著差异，尽管大多数变化有利于活性药物组。与安慰剂组相比，尼莫地平治疗组患者脑血管和心脏事件的发生率较低。本研究未能显示尼莫地平对符合DSM-III-R标准的多梗死性痴呆患者的认知、社会或整体评估有显著影响。一项事后分析（在随附论文中呈现）表明，尼莫地平可能对被定义为受皮质下（小血管）血管性痴呆影响的患者亚组有有利影响。
