奥扎格雷钠改善急性纯运动型腔隙性脑梗死患者的运动功能:随机、双盲、安慰剂对照  

Effect of ozagrel sodium in ameliorating the motor function of patients with acute lacunar infarct of dyskinesias:a randomized,double-blind,placebo-controlled trial

作　　者：李国毅[1] 林亚新[1] 周茵[1] 宋雷凤[1] 李宝春[1] 

机构地区：[1]黑龙江省医院神经内科,黑龙江省哈尔滨市150036

出　　处：《中国临床康复》2005年第21期4-5,共2页Chinese Journal of Clinical Rehabilitation

摘　　要：目的:采用随机、双盲、安慰剂对照方法观察血栓素合成酶抑制剂奥扎格雷钠对急性运动型腔隙性脑梗死患者运动功能、血小板活性、血浆炎症因子及纤溶活性的影响。方法:以2003-10/2004-10黑龙江省医院收治的急性运动型腔隙性脑梗死患者212例为观察对象,所有患者发病24h内入院,无出血倾向,2周内未使用过抗凝或抗血小板聚集药物。212例患者按药物编号随机抽签分为奥扎格雷钠组115例,对照组97例。所有患者的基础治疗(银杏叶注射液20mL加胞二磷胆碱0.5g静脉滴注)相同,在此基础上,对照组应用安慰剂80mg、奥扎格雷钠组加用奥扎格雷钠80mg静脉滴注,2次/d,连用14d。①治疗前后采用Fugl-Meyer运动功能评分法(共50项,上肢33项,下肢17项,每项2分,满分100分,<50分为有严重运动障碍)评估运动功能。②观察不良事件和副反应。③采血测血小板聚集率、血栓素合成酶B2、血浆Ⅷ因子相关抗原、白细胞介素6、组织型纤溶酶原激活物及其抑制物活性测定。干预和评估均采用盲法。结果:按实际处理分析,201例(奥扎格雷钠组109例,对照组92例)进入结果分析。①Fugl-Meyer运动功能评分结果:奥扎格雷钠组治疗后患者上肢功能较治疗前和对照组明显提高(53.27±7.44,18.93±7.60,29.88±7.94,P<0.01);奥扎格雷钠组治疗后患者下肢功能较治疗前和对照组治疗后明显提高(28.14±4.97,11.94±4.76,17.83±3.08,P<0.01)。②奥扎格雷钠组治疗后血小板聚集率、血栓素合成酶B2、血浆Ⅷ因子相关抗原、白细胞介素6和组织型纤溶酶原激活物抑制物活性明显低于治疗前和对照组治疗后(P<0.01),组织型纤溶酶原激活物活性明显高于治疗前和对照组治疗后(P<0.05)。③两组在治疗过程中均无脑出血和消化道出血倾向,奥扎格雷钠组发生轻度副反应共6例。结论:奥扎格雷钠能明显抑制急性运动型腔隙性脑梗死患者血小板聚集及AIM:To observe the influence of ozagrel sodium,which is the thromboxane synthase inhibitor,on motor function, platelet activity,plasma inflammatory cytokines and fibrinolytic activity in patients with acute lacunar infarct of dyskinesias by using a randomized,doubleblind,placebocontrolled method.METHODS:Totally 212 patients with acute lacunar infarct of dyskinesias, who were treated in Heilongjiang Provincial Hospital between October 2003 and October 2004,were involved in this study. All the patients were hospitalized with 24 hours after attack, had no hemorrhagic tendency,and had not taken any drugs of anticoagulation or against platelet aggregation within 2 weeks. According to the serial number of the drugs, the 212 patients were randomly divided into ozagrel sodium group(n=115) and control group(n=97); They all received basic treatment (venous drip of 20 mL ginkgo leaf injection plus 0.5 g corenalin);Besides,placebo(80 mg) in the control group and venous drip of 80 mg ozagrel sodium in the ozagrel sodium were given respectively,twice a day for 14 continuous days.①Before and after treatment,the motor function was assessed with FuglMeyer motor function score (a total of 50 items including 33 for upper limb and 17 for lower limb,2 points for each item,the total score was 100 points,< 50 points was taken as severe motor disorder);②Adverse events and side effects were observed;③Blood samples were taken to determine the platelet aggregative rate, thromboxane synthase B2,von Willebrand factor related antigen,interleukin6, tissuetype plasminogen activator and inhibitor activities.Blind method was used for the intervention and evaluation in this study. RESULTS:According to the analysis of actual treatment,201 cases (109 in the ozagrel sodium group and 92 in the control group) were involved in the analysis of results.①Results of FuglMeyer motor function score: It was obviously improved in the ozagrel sodium group after treatment as compared with that before treatment and that in the control

关 键 词：脑梗塞/药物疗法 功能恢复 随机对照试验 

分 类 号：R743[医药卫生—神经病学与精神病学]