降纤酶治疗急性脑梗死的随机双盲对照研究  

A randomized double-blind placebo-controlled study of defibrase in the treatment of cerebral infraction

作　　者：汪银洲[1] 孙柏松[1] 许文华[1] 余峰[1] 王国平[1] 赵江民[1] 丁小灵[1] 薛迎红[1] 

机构地区：[1]安徽省立医院神经内科,合肥230001

出　　处：《安徽医学》2004年第2期92-94,共3页Anhui Medical Journal

摘　　要：目的　为了评价国产降纤酶治疗急性脑梗死 (ACI)的临床疗效及其安全性。方法　采用随机、双盲、安慰剂对照的前瞻性研究方法 ,用国产降纤酶治疗 90例ACI患者 ,分两种给药方案 ,方案一 ,降纤酶首剂量为 10U ,第三、第五天各 5U ;方案二 ,首剂量为 15U ,以后根据用药 2 4小时血浆纤维蛋白原 (fibrinogen ,FIB)水平隔日或隔两日 (FIB<0 .5 /L时 )一次 ,每次 5U ,共 5次。对照组按同样方法给药。用药前后分别对患者进行临床神经功能缺损评分和 3个月时Barthel指数评定 ,另外还检测用药前后血浆FIB、凝血酶元时间 (PT)、凝血酶元活动度 (PA)、肝、肾功能等。结果　方案一 ,与对照组相比降纤酶组治疗后血浆FIB水平明显下降 (P <0 .0 5 ) ,但 14d时临床神经功能缺损评分和 3个月时Barthel指数与对照组相比差异无显著性 ;方案二 ,与对照组相比降纤酶组治疗后血浆FIB水平明显下降 (P <0 .0 0 1) ,且 14d时临床神经功能缺损评分和 3个月时Barthel指数与治疗组相比差异有显著性 (P <0 .0 1～ 0 .0 0 1)。两种治疗方案均未增加出血事件及其他副作用的发生率。结论　降纤酶能够显著降低血浆FIB水平 ,掌握好用药的时间窗、用药剂量和方法 ,降纤酶能够改善ACI患者的近期和Objective In order to assess the efficacy and safety of native-manufactured defibrase in the treatment of acute cerebral infraction(ACI).Methods 90 cases of ACI patients were treated with native-manufactured defibrase by means of a randomized double-blind placebo-controlled prospected study. Two drug-infusion regimen were used,10 units defibrase was intravenously infused at first dosage, at the third and fifth day 5 units were infused respectively. The second regimen, 15 units was used at first and afterwards 5 units were used according to plasma fibrinogen(FIB) level at 24 hours after treatment at a interval of one or two day for 5 times. Clinical Nerve Function Deficit Scales and Barthel Index were assessed before and after treatment, otherwise plasma FIB, PT, PA, liver and kidney function were checked.Results In the first regimen, FIB decreased obviously as compared with control group,but the Clinical Nerve Function Deficit Scales and Barthel Index remained no significant change as compared with control group; In the second regimen, plasma defibrase levels decreased were obviously, and Clinical Nerve Function Scales and Barthel Index were significantly different as compared with control group. Hemorrhage events and other side effects didn't increase in the two regimens.Conclusions If only used at the exact time window and dosage,Defibrase can obviously decrease plasma FIB level, and can improve patient's prognosis in the near future and metaphase.

关 键 词：降纤酶 药物治疗 急性脑梗死 安全性 给药方法 

分 类 号：R743.33[医药卫生—神经病学与精神病学] R973.2[医药卫生—临床医学]