4.5小时内低剂量与标准剂量阿替普酶治疗缺血性卒中：一项比较有效性和安全性的研究。
Low-Versus Standard-Dose Alteplase for Ischemic Strokes Within 4.5 Hours: A Comparative Effectiveness and Safety Study.
作者信息
Kim Beom Joon, Han Moon-Ku, Park Tai Hwan, Park Sang-Soon, Lee Kyung Bok, Lee Byung-Chul, Yu Kyung-Ho, Oh Mi Sun, Cha Jae Kwan, Kim Dae-Hyun, Lee Jun, Lee Soo Joo, Ko Youngchai, Park Jong-Moo, Kang Kyusik, Cho Yong-Jin, Hong Keun-Sik, Kim Joon-Tae, Choi Jay Chol, Kim Dong-Eog, Shin Dong-Ick, Kim Wook-Joo, Lee Juneyoung, Lee Ji Sung, Yoon Byung-Woo, Gorelick Philip B, Bae Hee-Joon
机构信息
From the Department of Neurology and Cerebrovascular Center, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Republic of Korea (B.J.K., M.-K.H., H.-J.B.); Department of Neurology, Seoul Medical Center, Seoul, Republic of Korea (T.H.P., S.-S.P.); Department of Neurology, Soonchunhyang University Hospital Seoul, Seoul, Republic of Korea (K.B.L.); Department of Neurology, Hallym University Sacred Heart Hospital, Anyang-si Republic of Korea (B.-C.L., K.-H.Y., M.S.O.); Department of Neurology, Dong-A University Hospital, Busan, Republic of Korea (J.K.C., D.-H.K.); Department of Neurology, Yeungnam University Medical Center, Daegu, Republic of Korea (J.L.); Department of Neurology, Eulji University Hospital, Eulji University School of Medicine, Daejeon, Republic of Korea (S.J.L., Y.K.); Department of Neurology, Eulji General Hospital, Seoul, Republic of Korea (J.-M.P., K.K.); Department of Neurology, Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, Republic of Korea (Y.-J.C., K.-S.H.); Department of Neurology, Chonnam National University Hospital, Gwangju, Republic of Korea (J.-T.K.); Department of Neurology, Jeju National University, Jeju, Republic of Korea (J.C.C.); Department of Neurology, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi-do, Republic of Korea (D.-E.K.); Department of Neurology, Chungbuk National University Hospital, Chungbuk National University School of Medicine, Cheongju, Republic of Korea (D.-I.S.); Department of Neurology, Ulsan University Hospital, Ulsan, Republic of Korea (W.-J.K.); Department of Biostatistics, Korea University College of Medicine, Seoul, Republic of Korea (J.L.); Clinical Trial Center, Asan Medical Center, Seoul, Republic of Korea (J.S.L.); Department of Neurology, Seoul National University Hospital, Seoul, Republic of Korea (B.-W.Y.); and Department of Translational Science and Molecular Medicine, Michigan State University College of Human Medicine, and Mercy Health Hauenstein Neuroscienc
出版信息
Stroke. 2015 Sep;46(9):2541-8. doi: 10.1161/STROKEAHA.115.010180. Epub 2015 Aug 4.
BACKGROUND AND PURPOSE
The low-dose (0.6 mg/kg) alteplase strategy to treat acute ischemic stroke patients became widespread in East Asian countries, without rigorous testing against standard-dose (0.9 mg/kg) alteplase treatment. Our aim was to investigate the comparative effectiveness and safety of the low-dose versus standard-dose intravenous alteplase strategy.
METHODS
A total of 1526 acute ischemic stroke patients who qualified for intravenous alteplase and treated within 4.5 hours were identified from a prospective, multicenter, and nationwide stroke registry database. Primary outcomes were a modified Rankin scale score of 0 to 1 at 3 months after stroke and occurrence of symptomatic hemorrhagic transformation. Inverse probability of low-dose alteplase weighting by propensity scores was used to remove baseline imbalances between the 2 groups, and variation among centers were also accounted using generalized linear mixed models with a random intercept.
RESULTS
Low-dose intravenous alteplase was given to 450 patients (29.5%) and standard-dose intravenous alteplase to 1076 patients (70.5%). Low-dose alteplase treatment was comparable to standard-dose therapy according to the following adjusted outcomes and odds ratios (95% confidence intervals): modified Rankin scale score 0 to 1 at 3 months and 0.95 (0.68-1.32); modified Rankin scale 0 to 2 at 3 months and 0.84 (0.62-1.15); symptomatic hemorrhagic transformation and 1.05 (0.65-1.70); and 3-month mortality and 0.54 (0.35-0.83). The associations were unchanged when the analysis was limited to those without endovascular recanalization.
CONCLUSIONS
The low-dose alteplase strategy was comparable to the standard-dose treatment in terms of the effectiveness and safety.
背景与目的
低剂量（0.6mg/kg）阿替普酶治疗急性缺血性脑卒中患者的策略在东亚国家广泛应用，但未与标准剂量（0.9mg/kg）阿替普酶治疗进行严格对比试验。我们的目的是研究低剂量与标准剂量静脉注射阿替普酶策略的相对有效性和安全性。
方法
从一个前瞻性、多中心、全国性的卒中登记数据库中，识别出1526例符合静脉注射阿替普酶条件且在4.5小时内接受治疗的急性缺血性脑卒中患者。主要结局指标为卒中后3个月时改良Rankin量表评分为0至1分以及症状性出血转化的发生情况。采用倾向评分法对低剂量阿替普酶进行加权，以消除两组间的基线不平衡，并使用具有随机截距项的广义线性混合模型来考虑中心间的差异。
结果
450例患者（29.5%）接受了低剂量静脉注射阿替普酶治疗，1076例患者（70.5%）接受了标准剂量静脉注射阿替普酶治疗。根据以下调整后的结局指标和比值比（95%置信区间）显示低剂量阿替普酶治疗与标准剂量治疗相当：卒中后3个月改良Rankin量表评分为0至1分且比值比为0.95（0.68 - 1.32）；卒中后3个月改良Rankin量表评分为0至2分且比值比为0.84（0.62 - 1.15）；症状性出血转化且比值比为1.05（(0.65 - 1.70)；3个月死亡率且比值比为0.54（0.35 - 0.83）。当分析仅限于未进行血管内再通治疗的患者时，上述关联不变。
结论
低剂量阿替普酶策略在有效性和安全性方面与标准剂量治疗相当。
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