降纤治疗超急性期脑梗死临床再评价——前瞻性随机对照研究

Defibrination on treatment of acute cerebral infarction of internal carotid artery system:a prospective randomized controlled trial

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150例超急性期颈内动脉系统脑梗死患者随机分为巴曲酶降纤组和安慰剂对照组,各75例,均经头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2.7%,P=1.00),相对危险度(Relative Risk,RR)为1.50,95%可信区间(ConfidenceInterval,CI)为0.26～8.72。3个月时明显依赖生存率和死亡/残疾率两组无差别,23.6%对38.4%(P=0.055,RR=0.49,95%CI为0.24～1.02);33.3%对46.7%(P=0.096,RR=0.57,95%CI为0.29～1.11)。6个月时明显依赖生存率和死亡/残疾率降纤组好于对照组,16.7%对32.9%(P=0.024,RR=0.41,95%CI为0.19～0.89);24.0%对40.0%(P=0.022,RR=0.44,95%CI为0.22～0.89)。随访期末2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(16.0%对5.3%,P=0.034,RR=3.00,95%CI为1.01～8.88)。结论降纤治疗超急性期颈内动脉系统脑梗死安全有效。

Objective To evaluate the efficacy and safety of the defibrinogenating agent Batroxobin for patients with acute cerebral infarction（ACI） of internal carotid artery system（ICAS） within 24 hours of ictus.Methods 150 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 ran-domly divided into Batroxobin group（n=75） and placebo group（n=75）.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 2.7% for the placebo group,P=1.00,RR=1.50,95%CI： 0.26～8.72）.The proportion of obvious dependent survival status and death or disability did not differ between patients given Batroxobin and those given placebo at 3 months（23.6% vs 38.4%,P=0.055,RR=0.49,95%CI： 0.24～1.02 and 33.3% vs 46.7%,P=0.096,RR=0.57,95%CI：0.29～1.11）.In the 180th day after the therapy,the Batroxobin group showed a remarkable improvement in obvious dependent survival status and death or disability（16.7% vs 32.9%,P=0.024,RR=0.41,95%CI： 0.19～0.89 and 24.0% vs 40.0%,P =0.022,RR=0.44,95%CI： 0.22～0.89）.No symptomatic intracranial hemorrhages were observed in two groups.There was a trend toward more extracranial hemorrhages in the Batroxobin group vs placebo group（16.0% vs 5.3%,P=0.034,RR=3.00,95%CI： 1.01～8.88）.Conclusions This study showed that itappears safe and effective of defibrination on treatment of ACI of ICAS within 24 hours of ictus.