Lancet:替奈普酶 vs 阿替普酶治疗急性缺血性卒中的效果

2022-07-03 MedSci原创 MedSci原创

对于所有符合溶栓标准的急性缺血性卒中患者,静脉注射替奈普酶(0.25mg/kg)是阿替普酶的合理替代方案、

阿替普酶静脉推注溶栓后维持静滴是急性缺血性卒中患者的全球标准疗法。该研究目的是明确与这种标准疗法相比,单次推注替奈普酶是否能增加栓塞部位的再灌注量。

这是一项多中心、开放标签、平行组的随机对照试验,从加拿大的22个卒中中心招募了年满18岁明确诊断的缺血性卒中患者,且要求在症状出现后4.5小时内就诊。受试患者被(1:1)随机分成两组,接受静推替奈普酶(0.25mg/kg,最大剂量25mg)或阿替普酶(0.9mg/kg,最大剂量90mg;先推注0.09mg/kg,随后在60分钟内输注剩余的0.81mg/kg)。主要终点是治疗后第90-120天时改良的Rankin量表(mRS)评分0-1分患者的比例。

2019年12月10日至2022年1月25日,共招募了1600位患者,随机分至两组:替奈普酶组 816位,阿替普酶组 784位,其中1577位(替奈普酶组 806位,阿替普酶组 771位)倍纳入了意向治疗人群。


两组mRS评分分布情况

在意向治疗人群中,中位年龄是74岁,755位(47.9%)女性。截止2022年1月21日,治疗后第90-120天时,替奈普酶组和阿替普酶组分别有296位(36.9%)和266位(34.8%)患者的mRS评分为0-1分(校正风险差 2.1%),达到了预定的非劣效性阈值。

在安全性分析中,替奈普酶组800位患者中有27位(3.4%)、阿替普酶组763位患者中有24位(3.2%)发生了24h有症状的颅内出血,分别有122位(15.3%)和117位(15.4%)患者在开始治疗的90天内死亡。

总之,对于所有符合溶栓标准的急性缺血性卒中患者,静脉注射替奈普酶(0.25mg/kg)是阿替普酶的合理替代方案。

 

原始出处:

Bijoy K Menon, et al. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial. Lancet. June 29, 2022. https://doi.org/10.1016/S0140-6736(22)01054-6

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    2022-09-27 howi
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    2022-07-04 学医无涯

    学习一下

    0

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    2022-07-01 younei

    lancet上果然牛,感谢梅斯更新及时

    0

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