爱通立疾病知识培训——脑卒中培训瞬间溶栓,生机再现.ppt

* 研究方案中规定在接受溶栓治疗的最初24小时内不使用静脉用肝素、口服抗凝剂、抗血小板药、血液制品、神经保护药物、扩容药等，但是为了预防深静脉血栓形成可皮下注射肝素（不超过10000IU）；如颅内压升高可以使用渗透性药物。 * 研究的主要终点为治疗后90天时改良Rankin分级获得改善（积分为0-1）的患者比例。 * 改良Rankin分级是在ECASS研究中的一个评价指标，共分为1-6分，其意义如下： 0分为无症状；1分为尽管有症状但无显著的残疾，能完成所有常规工作和活动； 2分为轻度残疾，不能完成以往所有活动，但能独立照顾自己； 3分为中度残疾，需要帮助，但能独立行走；4分为中-重度残疾，不能独立行走和如愿活动； 5分为重度残疾卧床、失禁、需要常规看护；6分为死亡。 * ECASS Ⅱ研究同样证实，按照修改后的Rankin 分级，发病后6小时内注射爱通立的患者在3个月时与安慰剂组相比的0，1差别=3.7%，p=0.277；0、1、2差别=8.3%，爱通立组疗效显著优于安慰剂组，p=0.024。 * 由此我们看出，ECASS研究同样证实：患者在接受治疗后，神经功能改善明显，因此我们可以得出这样的结论：急性缺血性脑卒中发生6小时内应用爱通立溶栓治疗对改善患者的神经功能依然有利，溶栓治疗时间窗可以视情况拓宽到6小时。 * Both the international scientific society and the European health authorities would like to know whether thrombolysis initiated between 3 and 4.5 hours after stroke onset is effective and safe as suggested by a pooled analysis of the ATLANTIS, ECASS and NINDS rt-PA trials. Therefore ECASS III aims to evaluate efficacy and safety in the 3–4.5-hour time window.20 ECASS III is be a double-blind, randomised, placebo-controlled trial in the 3–4.5-hour time window with approximately 400 patients per study arm and the ECASS II dose of rt-PA.40–41 * Both the international scientific society and the European health authorities would like to know whether thrombolysis initiated between 3 and 4.5 hours after stroke onset is effective and safe as suggested by a pooled analysis of the ATLANTIS, ECASS and NINDS rt-PA trials. Therefore ECASS III aims to evaluate efficacy and safety in the 3–4.5-hour time window.20 ECASS III is be a double-blind, randomised, placebo-controlled trial in the 3–4.5-hour time window with approximately 400 patients per study arm and the ECASS II dose of rt-PA.40–41 * * A post-hoc adjusted ITT analysis (logistic regression) for the primary endpoint was undertaken for sensitivity purposes. This was conducted by including all baseline variables in the model and retaining those that were significant at P0.1. Thus treatment, baseline NIHSS, stroke onset to treatment time, smoking history and