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[摘要]
目的 研究腦梗死患者于重組組織型纖溶酶原激活物(rt-PA)靜脈溶栓后聯(lián)用注射用丹參多酚酸的有效性和安全性。方法 將2017年1月-2018年6月入住涿州市醫(yī)院rt-PA靜脈溶栓后的急性腦梗死患者100例,隨機(jī)分為治療組和對(duì)照組,每組各50例。對(duì)照組予以常規(guī)治療,觀察組在常規(guī)治療的基礎(chǔ)上靜滴注射用丹參多酚酸(130 mg),1次/d,共14 d。觀察兩組14 d時(shí)美國國立衛(wèi)生院卒中量表(NIHSS)、3個(gè)月時(shí)改良Rankin量表(mRS)評(píng)分,14 d內(nèi)出現(xiàn)的顱內(nèi)外出血及死亡在內(nèi)的所有不良事件。結(jié)果 治療14 d時(shí)觀察組的NIHSS小于對(duì)照組(P<0.05);3個(gè)月時(shí)觀察組預(yù)后良好(mRS=0~2)患者的比例(32/50)高于對(duì)照組(22/50)。14 d內(nèi)的總不良事件例數(shù)、癥狀性顱內(nèi)出血例數(shù)兩組比較無統(tǒng)計(jì)學(xué)差異;14 d內(nèi)兩組均無死亡病例。結(jié)論 腦梗死患者于rt-PA靜脈溶栓后聯(lián)用注射用丹參多酚酸具有很好的安全性和有效性。
[Key word]
[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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