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[摘要]
目的 研究脑梗死患者于重组组织型纤溶酶原激活物(rt-PA)静脉溶栓后联用注射用丹参多酚酸的有效性和安全性。方法 将2017年1月-2018年6月入住涿州市医院rt-PA静脉溶栓后的急性脑梗死患者100例,随机分为治疗组和对照组,每组各50例。对照组予以常规治疗,观察组在常规治疗的基础上静滴注射用丹参多酚酸(130 mg),1次/d,共14 d。观察两组14 d时美国国立卫生院卒中量表(NIHSS)、3个月时改良Rankin量表(mRS)评分,14 d内出现的颅内外出血及死亡在内的所有不良事件。结果 治疗14 d时观察组的NIHSS小于对照组(P<0.05);3个月时观察组预后良好(mRS=0~2)患者的比例(32/50)高于对照组(22/50)。14 d内的总不良事件例数、症状性颅内出血例数两组比较无统计学差异;14 d内两组均无死亡病例。结论 脑梗死患者于rt-PA静脉溶栓后联用注射用丹参多酚酸具有很好的安全性和有效性。
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[Abstract]
Objective To investigate the efficacy and safety of Salvianolic Acids for Injection (SAFI) after rt-PA in the treatment of patients with cerebral infarction. Methods 100 patients with acute cerebral infarction in Zhuozhou City Hospital from January 2017 to June 2018 were selected and infused intravenously rt-PA, and then were randomized into two groups. 50 patients received routine treatment as control group. The patients in the observation group combined with SAFI 130 mg/time, intravenous drip, once a day, continuous treatment for 14 days. The National Institutes of Health stroke scale score at 14 days and modified Rankin scale at 3 months were assessed. The incidences of adverse events including intracranial or extracranial hemorrhage and death during the 14 days were recorded. Results At 14 days the average National Institutes of Health stroke scale score in the observation group was significantly lower than the control group (5.45 vs 6.83, P<0.001), and at 3 months more patients in the observation group had favorable outcomes of modified Rankin scale 0 to 2 (32/50 vs 22/50, P=0.045). There were no statistical differences in the incidences of total adverse events and in the incidence of symptomatic intracranial hemorrhage during the 14 days (P>0.05) between two groups. During the first 14 days there was no death case in each group. Conclusion s Intravenous SAFI after rt-PA has good efficacy and safety in patients with acute cerebral infarction.
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