摘要
目的：对不同剂量阿替普酶静脉溶栓治疗人群进行比较，探讨对于中国急性缺血性卒中人群，标准剂量与低剂量阿替普酶是否具有一样的安全性及有效性。方法本研究的入选患者来自中国急性缺血性卒中溶栓监测登记研究，从中选取发病4.5h内且阿替普酶使用剂量约为0.6 mg/kg（0.5～0.7 mg/kg）及0.9 mg/kg（0.85～0.95 mg/kg）的静脉溶栓患者，对溶栓后症状性颅内出血（symptomatic intracranial hemorrhage，SICH）、死亡率及90 d随访结局等进行比较。结果共入选753例患者，0.5～0.7 mg/kg组75例，0.85～0.95 mg/kg组678例，两组剂量中位数分别为0.64 mg/kg及0.90 mg/kg，发病-给药时间中位数分别为2.92 h及2.79 h。在校正了基线变量差异后，两组的死亡率（5.41% vs 7.36%，P=0.603）及SICH（0% vs 1.62%，P=0.972）均无显著差异，而0.5～0.7 mg/kg 组90 d随访获得良好预后的比例显著低于0.85～0.95 mg/kg组[41.89% vs 53.83%，比值比（odds ratio，OR）=0.58，P=0.031）]。结论本研究提示，在中国人群中，标准剂量（0.9 mg/kg）较低剂量（0.6 mg/kg）阿替普酶静脉溶栓具有更好的有效性，且不会显著增加SICH风险。
Objective To investigate whether lower-dose intravenous alteplase is as effective and safe as the standard-dose for Chinese population of acute ischemic stroke by comparing different doses of alteplase used in China. Methods We analyzed data from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China （TIMS-China）. Patients who were treated within 4.5 h after symptom onset and with dose of about 0.6 mg/kg （0.5-0.7 mg/kg） or 0.9 mg/kg （0.85-0.95 mg/kg） were included. Symptomatic intracranial hemorrhage （SICH）, mortality and 90-day outcome of these patients were analyzed. Results A total of 753 patients were enrolled into the study. Among them, 75 had 0.5-0.7 mg/kg and 678 had 0.85-0.95 mg/kg. Median alteplase doses were 0.64 mg and 0.90 mg, respectively. Median stroke onset to treatment time were 2.92 h and 2.79 h （P=0.252）. After adjustment for the baseline variables, there were no signiifcant differences in mortality （5.41%vs 7.36%, P=0.603） and SICH （0%vs 1.62%, P=0.972）. The 0.5-0.7 mg/kg group had less good functional outcome than that in the 0.85-0.95 mg/kg group （41.89%vs 53.83%, [odds ratio, OR]=0.58, P=0.031） at 90 day. Conclusion Our study suggests that stroke patients receiving standard-dose （0.9 mg/kg） alteplase had more favorable outcome without increasing the risk of SICH than those receiving low-dose （0.6 mg/kg）＆amp;nbsp;alteplase. For Chinese people, 0.9 mg/kg should be the optimal dose of alteplase to treat acute ischemic stroke.
出处
《中国卒中杂志》
2014年第7期551-556,共6页
Chinese Journal of Stroke
基金
"十二五"国家科技支撑计划(2011BAI08B02)
"十一五"国家科技支撑计划(2006BAI01A11)
北京市科委2011年度科技计划重大项目--<缺血性脑卒中高危预警体系建立和规范研究>(No.D111107003111007)
关键词
急性缺血性卒中
溶栓
有效性
安全性
Acute ischemic stroke
Thrombolytic treatment
Efifcacy
Safety
