Bottini G, Vallar G, Cappa S, Monza G C, Scarpini E, Baron P, Cheldi A, Scarlato G
Department of Neurology, University of Milan, Italy.
Acta Neurol Scand. 1992 Sep;86(3):237-41. doi: 10.1111/j.1600-0404.1992.tb05077.x.
A multicentre, double-blind, between-patient study was carried out to evaluate the efficacy and tolerability of oxiracetam (800 mg tablet), in comparison with placebo, each given twice daily for 12 weeks to patients suffering from primary degenerative, multi-infarct or mixed dementia. Efficacy was assessed by a neuropsychological battery (simple reaction time, controlled associations, short story, Raven's Progressive Matrices, token test, digit span, word list learning), administered at the beginning and at the end of the study, and by a quality of life scale, administered at entry and after 6 and 12 weeks treatment. Sixty-five patients (28 men, 37 women, mean age 71 yrs) were enrolled; 58 completed the study: 2 on oxiracetam were withdrawn because of poor tolerability, 2 (one in each group) were withdrawn for poor compliance, one (on oxiracetam) for the occurrence of a transient ischaemic attack (defined as not related to the treatment) and 2 for administrative reasons. A significantly (p < 0.01) different effect in favour of oxiracetam was observed on the quality of life scale, and confirmed by significant (defined according to the Bonferroni technique) differences in some neuropsychological tests (e.g. controlled associations, short story). Four patients in the oxiracetam group complained of a total of 5 unwanted effects, and 1 on placebo complained of 3 unwanted effects, but none of them was withdrawn from the study.
开展了一项多中心、双盲、患者间对照研究，以评估奥拉西坦（800毫克片剂）与安慰剂相比的疗效和耐受性。对患有原发性退行性、多发性梗死性或混合性痴呆的患者，二者均每日服用两次，持续12周。通过在研究开始和结束时进行的一套神经心理学测试（简单反应时间、受控联想、短篇故事、瑞文渐进性矩阵测验、标记测验、数字广度、单词表学习）以及在入组时和治疗6周及12周后进行的生活质量量表来评估疗效。共招募了65名患者（28名男性，37名女性，平均年龄71岁）；58名患者完成了研究：2名服用奥拉西坦的患者因耐受性差而退出，2名（每组各1名）因依从性差而退出，1名（服用奥拉西坦）因发生短暂性脑缺血发作（定义为与治疗无关）而退出，2名因行政原因退出。在生活质量量表上观察到奥拉西坦有显著（p < 0.01）更优的效果，并且在一些神经心理学测试（如受控联想、短篇故事）中也有显著（根据邦费罗尼技术定义）差异证实了这一点。奥拉西坦组有4名患者共抱怨了5种不良事件，安慰剂组有1名患者抱怨了3种不良事件，但他们均未退出研究。
