巴曲酶治疗脑梗死血浆纤维蛋白原动态变化——一项前瞻性随机对照研究

Changes of plasma level of fibrinogen in patients with acute cerebral infarction after batroxobin treatment

目的:研究降纤药巴曲酶治疗脑梗死患者时其纤维蛋白原(FIB)的动态变化。方法:超急性期前循环脑梗死患者100例被随机入组到巴曲酶组和对照组,每组各50例,头颅CT排除颅内出血。观察用药前及巴曲酶治疗后第3、5、7天血浆FIB定量、不良反应和第2、7、14天美国国立卫生研究院卒中量表评分。结果:两组治疗前FIB无区别;治疗后第3、5、7天,巴曲酶组较对照组FIB下降明显(1.89±1.23vs3.72±1.05,1.49±0.92vs3.69±1.03,2.66±1.25vs3.90±1.26,P<0.0005)。两组均未发生症状性颅内出血,巴曲酶组颅外出血率较对照组高(22.0%vs6.0%,P=0.021)。两组病死率差异无统计学意义(4.0%vs2.0%,P=1.00)。美国国立卫生研究院卒中量表评分两组差异无统计学意义。结论:巴曲酶降能低脑梗死患者血浆FIB,且安全有效。

Objective To observe the changes of plasma level of fibrinogen in patients with acute cerebral infarction after batroxobin treatment. Methods 100 patients with an acute anterior circulation territory infarction within 24 hours of ictus were included in this trial, and were randomly assigned to receive batroxobin （batroxobin group, n = 50） orplacebo （control group, n = 50）. hemorrhages. Plasma levels of fibrinogen were measured, Brain CT scans were administered to exclude intracranial and the side effects and the score of National Institutes of Health Stroke Scale were recorded in 100 patients before and 3, 5, and 7 days after treatment. Results Plasma levels of fibrinogen were not different between the two groups before the treatment, but those in batroxobin group at 3, 5, and 7 days after treatment were significantly lower than those in control group （ 1.89 ± 1.23 vs. 3.72± 1.05, 1.49± 0.92 vs. 3.69 ± 1.03, 2.66 ±1.25 vs. 3.90±1.26, P〈 0.000 5）. No symptomatic intracranial hemorrhages were observed in the two groups. The incidence of extracranial hemorrhages in batroxobin group was higher than that in control group （22.0% vs. 6.0%, P = 0.021）. Mortality （4.0% vs. 2.0%, P = 1.00） and the score of National Institutes of Health Stroke Scale was not different between the two groups. Conclusion The batroxobin showed a confirmative effect on degrading plasma level of fibrinogen in patients with an acute anterior circulation territory infarction.