急性脑梗死不同剂量阿替普酶静脉溶栓安全性分析

Safety of different doses of alteplase for intravenous thrombolysis in patients with acute cerebral infarction

目的比较不同剂量阿替普酶静脉溶栓的安全性,为临床合理用药提供依据。方法选取2012年3月至2015年8月期间在徐州市中心医院神经内科接受静脉阿替普酶溶栓治疗的急性脑梗死患者283例随机分为2组,低剂量组140例,标准剂量组143例,采集所有患者的病历资料,以改良Rankin量表评分0~2分为预后良好,采用卡方检验或者Mann-Whitney U检验比较2组患者临床疗效及病死率,评估急性脑梗死不同剂量阿替普酶静脉溶栓的安全性。结果 (1)2组患者在溶栓24 h、3 d的美国国立卫生研究院卒中量表(NIHSS评分)相比,差异无统计学意义[6(2,12)vs 5(2,10),U=0.361,P=0.718;4(2,11)vs 4(2,10),U=0.118,P=0.906];溶栓后7、28、90 d,2组预后良好率比较差异无统计学意义(52.86%vs 53.85%,χ~2=0.002,P=0.962;64.29%vs62.94%,χ~2=0.013,P=0.911;70.00%vs 72.03%,χ~2=0.06,P=0.807)。(2)2组患者溶栓后出血转化率无明显差异(6.43%vs 7.69%,χ~2=0.040,P=0.842),溶栓后90 d内低剂量组死亡11例,标准剂量组死亡12例,2组死亡率无明显差异(χ~2=0.120,P=0.73)。结论不同剂量阿替普酶静脉溶栓治疗急性脑梗死安全性和疗效相似,低剂量阿替普酶静脉溶栓值得临床推广应用。

Objective To compare the safety of different doses of alteplase for intravenous thrombolysis in patients with acute cerebral infarction to provide a basis for clinical rational use of this drug.Methods A total of 283 acute cerebral infarction patients were randomly divided into a low dose group(n=140)and a standard dose group(n=143).The medical records of all patients were collected,and the prognosis of patients was evaluated with the modified Rankin scale(mRS),with an mRS score of 0-2 indicating a good prognosis.The chi-square test or Mann-Whitney U test was used to compare the clinical efficacy and mortality of the two groups,and to evaluate the safety of different doses of alteplase for intravenous thrombolysis in patients with acute cerebral infarction.Results At 24 h and 3 days after thrombolysis,there was no significant difference in the National Institute of Health stroke scale(NIHSS)between the two groups[6(2,12)vs 5(2,10),Z=0.361,P=0.718;4(2,11)vs 4(2,10),Z=0.118,P=0.906].At 7,28,and 90 d after thrombolysis,there was no significant difference in the proportion of patients with a good prognosis between the two groups(52.86%vs 53.85%,χ2=0.002,P=0.962;64.29%vs 62.94%,χ2=0.013,P=0.911;70.00%vs 72.03%,χ2=0.06,P=0.807).There was no significant difference in the rate of hemorrhagic transformation between the two groups after thrombolysis(6.43%vs 7.69%,χ2=0.040,P=0.842).By 90 days after thrombolysis,11 patients in the low dose group and 12 patients in the standard dose group died,and there was no significant difference in mortality between the two groups(χ2=0.120,P=0.73).Conclusion Different doses of alteplase for intravenous thrombolysis in patients with acute cerebral infarction have similar safety and efficacy,and low doses of alteplase for intravenous thrombolysis is worthy of clinical application.