CAJ | 학술논문

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800 mg/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1600 mg/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.
목적 평개오랍서탄대졸중후인지공능장애적료효급안전성.방법 채용수궤、쌍맹적방법,장200례졸중후인지공능장애수시자분위오랍서탄간예조100례(매일구복오랍서탄효낭800 mg/차+필랍서탄모의편4편/차,3차/d,련속복용6개월)화대조조100례(매일구복필랍서탄편1600 mg/차+오랍서탄모의효낭2립/차,3차/d,련속복용6개월),수방6개월,사용몽특리이인지평고량표(MoCA)、MMSE급일상생활능력(ADL)량표재시험기간진행인지공능평개병기록상관수거.결과 치료6개월후,MMSE량표평분현시,오랍서탄간예조분수제고적균수위3.24분,총유효솔위91.6％,고우대조조적2.30분,량조간적평분변화차이급총유효솔적비교유통계학의의(t=2.079,P=0.039).MoCA량표평분현시,오랍서탄간예조분수제고적균수위5.82분,고우대조조적4.76분,ADL량표적료효분석현시오랍서탄간예조분수강저적균수위6.44분,고우대조조적4.39분,조간비교차이무통계학의의(t=1.798,P=0.074;t=-1.914,P=0.057).오랍서탄치료1、2、4、6개월,기인지장애평분개선정황급총유효솔변화정황,균수착용약시간적연장이제승.결론 오랍서탄대졸중후인지공능장애환자유효,수착용약시간연장,료효개선정황경가,개선인지공능장애정도우우필랍서탄.오랍서탄무엄중불량반응,안전성호.
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 cognitive impairment.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.