奥拉西坦胶囊治疗痴呆临床试验研究

目的研究和评价奥拉西坦胶囊对老年人器质性智能障碍及其伴随症状的轻、中度痴呆的治疗作用。方法与结果试验分两阶段进行，第一阶段采用随机双盲阳性药物对照方法，口服给药，奥拉西坦胶囊及埘照药吡拉西坦胶囊，用量为800mg，3次／d，疗程为两个月。奥拉西坦胶囊组／04例，显效29例，有效54例，总有效率79．8％；吡拉西坦胶囊组96例，显效32例，有效47例，总有效率82．3％，两组统计处理后无显著性差异（P〉0．05）。第二阶段采用开放方法观察了223例，其中男173例，女50例，服用奥拉西坦胶囊后，认知、记忆、语言等各项指标均比治疗前明显改善（P〈0．01）。显效52例，有效130例，总有效率81．6％。第一阶段和第二阶段共完成试验药327例，总有效率81．0％。用药期间，无任何不良反应。结论奥拉西坦胶囊是安全，有效的促智药。

A Clinical Study on Oxiracetam Capsule for Dementia Therapy

Objective To study and evaluate the effect of Oxiracetam Capsule on organic disturbance of intelligence, together with light or midrange dementia. Method and Result The tests progressed in two steps. First, using random double-blind Positive Drug contrast method, orally administrated Oxiracetam Capsule and Positive Drug Piracetam Capsule respectively, for two months, with three times per day and 800 mg per time. Oxiracetam Capsule group had 104 cases, Signifcant curative effect occurred in 29 case, curative effect in 54 cases. The total effective rate reaching 79. 8%. Piracetam Capsule group had 96 cases, Significant curative effect occurred in 32 case, curative effect in 47 cases. The total effective rate reaching 82. 3%. Compared to the control group,the difference wash＇ t significant （ P 〉 0.05 ）. The second step observed 233cases, 173 males and 50 females, with open method. After oral administration, the ability of recognition, memory, speech and so on had been obviously improved than pretherapy （ P 〈 0.01 ） , Significant curative effect occurred in 52 case, curative effect in 130 cases. The total effective rate reaching 81.6%. There were 327 cases studied and the total effective rate was 81.0% in the two steps, without any adverse effect in medication period. Conclusion Oxiracetam Capsule was a kind of safe and effective nootropics.