Fischhof P K, Möslinger-Gehmayr R, Herrmann W M, Friedmann A, Russmann D L
Department of Psychiatry, Karl Franzens University of Graz, Austria.
Neuropsychobiology. 1996;34(1):29-35. doi: 10.1159/000119288.
This trial was performed to investigate the therapeutic efficacy of vincamine in the treatment of primary degenerative and vascular dementia. 152 male and female patients aged between 50 and 85 years from two psychogeriatric centers and two nursing homes were initially included in the trial and screened for eligibility. 142 patients completed the trial. Clinical diagnosis was established according to DSM-III-R criteria. Allocation of the patients to the primary degenerative dementia of the Alzheimer type (DAT) group or the multi-infarct dementia (MID) group was based on computed tomography scans, electroencephalographic findings and the Hachinski Ischemic Score. In a 12-week double-blind treatment either 30 mg vincamine or placebo was given twice daily. Confirmatory statistics included item 2 of the Clinical Global Impression (CGI), the total score of the Sandoz Clinical Assessment Geriatric (SCAG) scale, the subscale 'need for help' of the nurse's rating of geriatric patients (Beurteilungsskala für geriatrische Patienten; BGP) and the total score of the Short Cognitive Performance Test (Syndrom-Kurztest; SKT). In addition, data on tolerance and on therapy response were evaluated based on descriptive statistics. The therapeutic efficacy of vincamine was clearly demonstrated by confirmatory analysis as the drug was statistically significantly superior to placebo in all four target variables. The clinical relevance of the outcome was further underlined by the results of the responder analysis of the variables SCAG, BGP and SKT. Based on the results of this trial, it can be accepted that the therapeutic effect of vincamine is superior to placebo in patients with mild to moderate dementia of degenerative and vascular etiologies.
进行该试验是为了研究长春胺治疗原发性退行性和血管性痴呆的疗效。最初，来自两个老年精神病中心和两个养老院的152名年龄在50至85岁之间的男性和女性患者被纳入试验并进行资格筛查。142名患者完成了试验。临床诊断依据DSM-III-R标准确定。根据计算机断层扫描、脑电图检查结果和哈金斯基缺血评分，将患者分配至阿尔茨海默型原发性退行性痴呆（DAT）组或多发梗死性痴呆（MID）组。在为期12周的双盲治疗中，每天两次给予30毫克长春胺或安慰剂。确证性统计分析包括临床总体印象（CGI）的第2项、桑多兹老年临床评估（SCAG）量表的总分、护士对老年患者评分（老年患者评估量表；BGP）的“需要帮助”子量表以及简短认知功能测试（综合征简短测试；SKT）的总分。此外，基于描述性统计分析评估了耐受性和治疗反应的数据。确证性分析清楚地表明了长春胺的治疗效果，因为该药物在所有四个目标变量上在统计学上均显著优于安慰剂。变量SCAG、BGP和SKT的反应者分析结果进一步强调了该结果的临床相关性。基于该试验结果，可以认为长春胺对患有轻度至中度退行性和血管性病因痴呆的患者的治疗效果优于安慰剂。
