摘要
目的评价奥拉西坦对卒中后认知功能障碍的疗效及安全性。方法采用随机、双盲的方法，将200例卒中后认知功能障碍受试者分为奥拉西坦干预组100例（每日口服奥拉西坦胶囊800mg／次＋吡拉西坦模拟片4片／次，3次／d，连续服用6个月）和对照组100例（每日口服吡拉西坦片1600mg／次＋奥拉西坦模拟胶囊2粒／次，3次／d，连续服用6个月），随访6个月，使用蒙特利尔认知评估量表（MoCA）、MMSE及日常生活能力（ADL）量表在试验期间进行认知功能评价并记录相关数据。结果治疗6个月后，MMSE量表评分显示，奥拉西坦干预组分数提高的均数为3．24分，总有效率为91．6％，高于对照组的2．30分，两组间的评分变化差异及总有效率的比较有统计学意义（t=2．079，P=0．039）。MoCA量表评分显示，奥拉西坦干预组分数提高的均数为5．82分，高于对照组的4．76分，ADL量表的疗效分析显示奥拉西坦干预组分数降低的均数为6．44分，高于对照组的4．39分，组间比较差异无统计学意义（t=1．798，P=0．074；t=-1．914，P=0．057）。奥拉西坦治疗1、2、4、6个月，其认知障碍评分改善情况及总有效率变化情况，均随着用药时间的延长而提升。结论奥拉西坦对卒中后认知功能障碍患者有效，随着用药时间延长，疗效改善情况更佳，改善认知功能障碍程度优于吡拉西坦。奥拉西坦无严重不良反应，安全性好。
Objective To assess the efficacy and safety of oxiracetam in the treatment of patients with post-stroke cognitive impairment. Methods In this randomized, double-blind trial, 200 patients with post-stroke cognitive impairment were randomized 1：1 to receive： oxiracetam 800 mg and 4 piracetam simulation tablets three times daily for 6 months, or piracetam 1600 mg and 2 oxiracetam simulation capsules, three times daily for 6 months. These clinical parameters were tested by Montreal Cognitive Assessment （MoCA）, Mini-mental State Examination （MMSE） and Activity of Daily Living Scale （ADL） during a 6-month follow-up period. Results After 6 months of treatment, the MMSE score showed that the oxiracetam-intervention group＇s score improved by a mean of 3.24 points, with a total effective rate of 91.6% ,which was higher than that of the control group（2. 30 points）, and the difference in point change between the 2 groups was statistically significant （ t = 2. 079, P = 0. 039）, MoCA score showed that the oxiracetam-intervention group＇s score improved by a mean of 5.82 points,which was higher than that of the control group（4. 76 points）. The ADL efficacy analysis showed that the oxiracetam-intervention group＇s score decreased by a mean of 6.44 points, which was higher than that of the control group （4. 39 points）, and the score ratio change differences between the 2 groups was not statistically significant（ t = 1. 798, P = 0. 074;t = - 1. 914, P -- 0. 057 ）. The situation of patients＇ cognitive impairment got better along with the oxiracetam treatment for 1, 2, 4, 6 months, so was the total effective rate （P 〈 0. 01 ）. Conclusions This research proves that oxiracetam has definitely therapeutic effect on patient with post-stroke cognitiveimpairment. With the extension of treatment time, the situation of patients gets even better. MMSE score shows that oxiracetam has better effect on improving post-stroke cognitive impairment than piracetam, and oxiracetam does not show any serious adverse reactions. Oxiracetam has little adverse reactions and it shows impressive safety.
出处
《中华神经科杂志》
CAS
CSCD
北大核心
2013年第7期489-493,共5页
Chinese Journal of Neurology
关键词
卒中
吡咯烷类
认知障碍
可重复性
结果
Stroke
Pyrrolidines
Cognition disorders
Reproducibility of results
