CAJ | 학술논문

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。
목적：대불동제량아체보매정맥용전치료인군진행비교，탐토대우중국급성결혈성졸중인군，표준제량여저제량아체보매시부구유일양적안전성급유효성。방법본연구적입선환자래자중국급성결혈성졸중용전감측등기연구，종중선취발병4.5h내차아체보매사용제량약위0.6 mg/kg（0.5～0.7 mg/kg）급0.9 mg/kg（0.85～0.95 mg/kg）적정맥용전환자，대용전후증상성로내출혈（symptomatic intracranial hemorrhage，SICH）、사망솔급90 d수방결국등진행비교。결과공입선753례환자，0.5～0.7 mg/kg조75례，0.85～0.95 mg/kg조678례，량조제량중위수분별위0.64 mg/kg급0.90 mg/kg，발병-급약시간중위수분별위2.92 h급2.79 h。재교정료기선변량차이후，량조적사망솔（5.41% vs 7.36%，P=0.603）급SICH（0% vs 1.62%，P=0.972）균무현저차이，이0.5～0.7 mg/kg 조90 d수방획득량호예후적비례현저저우0.85～0.95 mg/kg조[41.89% vs 53.83%，비치비（odds ratio，OR）=0.58，P=0.031）]。결론본연구제시，재중국인군중，표준제량（0.9 mg/kg）교저제량（0.6 mg/kg）아체보매정맥용전구유경호적유효성，차불회현저증가SICH풍험。
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) alteplase. For Chinese people, 0.9 mg/kg should be the optimal dose of alteplase to treat acute ischemic stroke.