Pantoni L, Rossi R, Inzitari D, Bianchi C, Beneke M, Erkinjuntti T, Wallin A
Department of Neurological and Psychiatric Sciences, University of Florence, Viale Morgagni 85, 50134, Florence, Italy.
J Neurol Sci. 2000 Apr 15;175(2):124-34. doi: 10.1016/s0022-510x(00)00300-2.
In Western countries, vascular dementia (VaD) is the most common form of cognitive deterioration after Alzheimer's disease. Therapeutic trials in VaD have so far failed to yield satisfactory results. One explanation of this failure may be the etiological and clinical heterogeneity of the included patients. Patients with subcortical VaD, defined on a clinical and radiological basis, may constitute a more homogeneous group. Thus, we conducted a post-hoc subgroup analysis of the Scandinavian Multi-Infarct Dementia Trial that evaluated the efficacy and safety of oral nimodipine administered for 6 months in 259 patients. The original patients sample was divided on the basis of head CT in those with subcortical VaD (n=92, 45 nimodipine, 47 placebo) and those with multi-infarct dementia (n=167, 83 nimodipine, 84 placebo). While in the total trial population a treatment effect could not be proved, in this subgroup analysis, the subcortical VaD patients treated with nimodipine performed better on the majority of neuropsychological tests and functional scales in comparison with patients on placebo. No trend could be evidenced in the multi-infarct dementia patients. Treatment efficacy was in particular suggested for the Zahlen-Verbindungs-Test, Fuld-Object-Memory Evaluation, Word Fluency, and for the Instrumental Activities of Daily Living scale. The results did not reach statistical significance in this small sample. Our study preliminarily indicates that nimodipine could be effective in patients with small vessel subcortical VaD and supports the rationale for a further controlled and adequately powered trial to test nimodipine in patients with subcortical VaD.
在西方国家，血管性痴呆（VaD）是仅次于阿尔茨海默病的最常见认知功能衰退形式。迄今为止，针对VaD的治疗试验均未取得令人满意的结果。对此失败的一种解释可能是纳入患者的病因和临床异质性。基于临床和影像学定义的皮质下VaD患者可能构成一个更具同质性的群体。因此，我们对斯堪的纳维亚多梗死性痴呆试验进行了事后亚组分析，该试验评估了259例患者口服尼莫地平6个月的疗效和安全性。根据头部CT将原始患者样本分为皮质下VaD患者（n = 92，45例服用尼莫地平，47例服用安慰剂）和多梗死性痴呆患者（n = 167，83例服用尼莫地平，84例服用安慰剂）。虽然在整个试验人群中未能证明有治疗效果，但在该亚组分析中，与服用安慰剂的患者相比，接受尼莫地平治疗的皮质下VaD患者在大多数神经心理学测试和功能量表上表现更好。在多梗死性痴呆患者中未发现明显趋势。尤其在数字连接试验、福尔兹物体记忆评估、词语流畅性以及日常生活能力量表方面显示出治疗效果。在这个小样本中，结果未达到统计学显著性。我们的研究初步表明，尼莫地平可能对小血管皮质下VaD患者有效，并支持进一步开展有对照且样本量充足的试验来测试尼莫地平在皮质下VaD患者中的疗效。
