Announcement of protocol change in thrombolysis in myocardial infarction trial.
Announcement of protocol change in thrombolysis in myocardial infarction trial.
复制标题
心肌梗死试验中溶栓治疗方案变更的公告。
DOI：
10.1016/s0735-1097(87)80407-2
复制
发表时间：
1987
影响因子：
24
通讯作者：
T. Robertson
中科院分区：
文献类型：
--
作者：
E. Braunwald;G. Knatterud;E. Passamani;T. Robertson
国家之心。龙和血液研究所的心肌梗死溶栓（TIMO研究）已经将组织纤溶酶原激活剂（rt-PA）的使用剂量从6小时内150 mg减少到6小时内100 mg。该方案变更是在独立的安全性和数据监查委员会审查和建议后进行的。这一建议很大程度上是基于在一项预随机化初步研究中，311例患者中有5例（1.6%）发生脑出血。这5起事件中有3起发生在治疗开始后24小时内，3起在住院期间致死。在311例患者中观察到41例（13.2%）严重出血事件，定义为脑内出血或血红蛋白下降<5 g/dl。然而，该系列中的总住院死亡率为15/311（4.8%）。所有TIMI患者除rt-PA输注外均接受全剂量肝素抗凝治疗。这些脑内血肿的病因可能与多种因素有关，包括既往神经系统疾病。只有在仔细筛查禁忌症（如既往神经系统事件）后，才应给予个体溶栓治疗。严重高血压和潜在出血部位。
The National Heart. Lung. and Blood Institute's Thrombolysis in Myocardial Infarction (TIMO Study has reduced the dose of tissue plasminogen activator (rt-PA) used from 150 mg over 6 hours to 100 mg over 6 hours. This protocol change was taken after review and recommendation by an independent Safety and Data Monitoring Committee. This recommendation was based in large part on the occurrence of intracerebral hemorrhage in 5 of 311 patients (1.6%) during a prerandomization pilot study. Three of these five events occurred within 24 hours of onset of treatment and three were fatal during hospitalization. Major hemorrhagic events defined as either intracerebral hemorrhage or a decline in hemoglobin of"" 5 g/dl were observed in 41 of 311 patients (13.2%), However, the overall in-hospital mortality in this series was 15of 311 (4.8%), Intracerebral hemorrhage occurred in only I of 386 patients treated with rt-PA in prior TIMI protocols. All TIMI patients received full dose heparin anticoagulation in addition to rt-PA infusion. The etiology of these intracerebral hemorrhages could be related to multiple factors including prior neurologic disease. Thrombolytic therapy should be given to individuals only after careful screening for contraindications such as prior neurologic events. serious hypertension and potential bleeding sites.