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纤溶酶治疗急性期脑梗死的随机双盲对照研究 被引量:12

A Randomized Double-blind Placebo-controlled Trial of Fibrinolysin for Acute Cerebral Infarction
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摘要 目的:评价纤溶酶治疗急性期脑梗死的疗效及安全性。方法:采用随机、双盲、安慰剂对照的前瞻性研究,纳入非溶栓治疗的急性期脑梗死患者115例,随机分为纤溶酶组55例和对照组60例;在脑梗死基本治疗的基础上,纤溶酶组给予纤溶酶200~300 U,静脉滴注7 d,对照组给予生理盐水(安慰剂)250 mL,静脉滴注7 d。比较2组发病后90 d的死亡率及生活依赖率,住院期间神经功能缺损评分及发生出血性转化(HT)情况。结果:2组发病后90 d死亡率差异无统计学意义,但纤溶酶组生活依赖率低于对照组(P<0.05);住院期间纤溶酶组神经功能缺损恢复程度优于对照组(P<0.05);2组HT发生率差异无统计学意义;伴HT患者的预后不劣于不伴HT的患者。结论:纤溶酶治疗急性期脑梗安全、有效。 Objective: To investigate the efficacy and safety of fibrinolysin on treatment of acute cerebral infarction. Methods: A randomized, double-blind, placebo-controlled study was carried out. One hundred and fifty-one patients with acute cerebral infarction have been recruited for the study and divided into fibrinolysin group (55 cases) and the control group (60 cases) by random number created by computer. The patients in the fibrinolysin group were treated with fibrinolysin 200-300 U for 7 days after the skin test was negative, plus the basic treatment of cerebral infarction. The cases in the control group were treated with 0.9% saline (place- bo) 250 mL for 7 days, plus the basic treatment of cerebral infarction. The mortality and life dependent rate at day 90 after onset were compared between the two groups. The neurological deficit scores and the incidence of hemorrhagic transformation (HT) during hospitalization were compared between the two groups. Results: No significant difference was found in mortality rate at day 90 between two groups, The life dependent rate of fib- rinolysin group at day 90 was lower than that in the control group (P〈0.05). The improvement of neurological deficit scores during hospitalization in the fibrinolysin group was significantly evident than that in the control group (P〈0.05). No significant difference was found in the incidence rate of liT during hospitalization between two groups. The incidence of HT did not affect the prognosis of patients with cerebral ischemia. Conclusion: Fibrinolysin is effective and safe to treat patients with cerebral ischemia.
出处 《神经损伤与功能重建》 2013年第2期118-120,共3页 Neural Injury and Functional Reconstruction
关键词 纤溶酶 脑梗死 疗效 出血性转化 fibrinolysin cerebral infarction efficacy hemorrhagic transformation
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