降纤治疗超急性期脑梗死随机对照研究

目的评价降纤药巴曲酶治疗超急性期颈内动脉系统脑梗死的疗效和安全性。方法选取100例超急性期颈内动脉系统脑梗死患者，随机分成巴曲酶降纤组和安慰剂对照组各50例，经头颅CT排除脑出血。主要终点事件为第3，6个月时的病死率、明显依赖生存状态及死亡／残疾，次要评价指标为美国国立卫生研究院卒中量表评分。结果随访期末病死率两组无差异（4．0％对2．0％，P=1．00），相对危险度（Relative Risk，RR）为2．00，95％可信区间（Confidence Interval，CI）为0．19—21．36。随访期末明显依赖生存率两组无差别，3个月为22．9％对34．7％（P=0．201，RR=0．66，95％CI为O．35～1．26）；6个月20．8％对32．7％（P：0．189，RR=0．64，95％CI为O．32～1．26）。随访期末死亡／残疾率两组亦无差别，3个月为34．0％对46．O％（P=0．221，RR=0．74，95％CI为0．45—1．21）；6个月为28．0％对40．0％（P=0．205，RR=0．70，95％CI为0．40～1．23）。随访期末两组均未发生症状性颅内出血；颅外出血率降纤组较对照组高（22．0％对6．0％，P=0．021，RR=3．67，95％CI为1．09～12．36。结论本研究显示巴曲酶能安全有效的降低血浆纤维蛋白原，但未能使超急性期颈内动脉系统脑梗死患者获益。降纤治疗脑梗死是否有效目前还不能得出最后结论，尚需进一步进行大样本的随机对照研究证实。

A Randomized Controlled Trial of Effect of Defibrination on Treatment of Acute Cerebral Infarction of Internal Carotid Artery System

Objective To evaluate the efficacy and safety of the defibrinogenating agent Batroxobin in patients with acute cere- bral infarction（ACI） of internal carotid arterial system （ICAS） within 24 hours of ictus. Methods 100 patients with ACI of ICAS within 24 hours of ictus were included in this randomized placebo-controlled trial. Brain CT scans were done to exclude intracranial haemorrhages. Patients were randomly assigned to receive Batroxobin group（ n = 50） and placebo group （n = 50 ）. The primary outcome was the death rate, obvious dependent survival status （ Barthel Index ≤ 60 ） and disability （ modified Rankin Scale≥3） at the third month and sixth month. The National Institutes of Health Stroke Scale was used as secondary endpoints. Results Mortality was not different between treatment groups （ in 6 months,4.0% for the batroxobin group and 2.0% for the placebo group;P = 1.00 RR =2.00,95% CI：0.19 to 21.36）. The proportion of obvious dependent survival status did not differ between patients given batroxobin and those given placebo at 3 months（22.9% vs 34.7% P = 0.201, RR = 0.66,95% C1：0.35 to 1.26） and at 6 months （20.8% vs 32.7%, P = O. 189, RR = O. 64,95 % CI： O. 32 to 1.26 ）. The proportion of death or disability did not differ in the Batroxobin group and the placebo group at 3 months（34.0% vs 46.0% P = O. 221, RR = O. 74,95% CI： 0.45 to 1.21 ）and at 6 months（28.0% vs 40.0% ,P =0. 205 ,RR =0.70,95% CI：O. 40 to 1.23）. No symptomatic intracra- nial hemorrhages were observed in two groups. There was a trend toward more extracranial hemorrhages in the Batroxobin group vs placebo group（22.0% vs 6.0% ,P=O. 021） ,RR=3.67,95% CI： 1.09 to 12.36）. Conclusion Batroxobin appears safe and effective in degrading plasma FIB. At the same time, this study did not show that clinical efficacy of batroxobin was superior to placebo for ACI of ICAS within 24 hours of ictus ,but we need a large sample,randomized and control study to confirm.