Jason P. Appleton, Mark Dixon, Lisa J. Woodhouse, Craig S. Anderson, Sandeep Ankolekar, Lesley Cala, Timothy J. England, Peter J. Godolphin, Kailash Krishnan, Grant Mair, Keith W. Muir, John Potter, Chris I. Price, Marc Randall, Thompson G. Robinson, Christine Roffe, Peter M. Rothwell, Else Charlotte Sandset, Jeffrey L. Saver, A. Niroshan Siriwardena, Joanna M. Wardlaw, Nikola Sprigg, Philip M. Bath, the RIGHT-2 Investigators
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The safety and efficacy of glyceryl trinitrate (GTN) in the pre-specified subgroup of patients with TIA in the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial 2 (RIGHT-2) was assessed.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>RIGHT-2 was a pre-hospital-initiated multicentre randomized sham-controlled blinded-endpoint trial that randomized patients with presumed ultra-acute stroke within 4 h of symptom onset to transdermal GTN or sham. Final diagnosis was determined by site investigators. The primary outcome was a shift in modified Rankin Scale (mRS) scores at 90 days analysed using ordinal logistic regression reported as adjusted common odds ratio with 95% confidence intervals (CIs). 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引用次数: 0
摘要
背景和目的:对疑似脑卒中患者进行干预评估的救护车试验将招募目前有活动性症状并将缓解为短暂性脑缺血发作(TIA)的患者。在高血压脑卒中三硝酸甘油快速干预试验 2(RIGHT-2)中,对预先指定的 TIA 患者亚组中三硝酸甘油(GTN)的安全性和有效性进行了评估:RIGHT-2是一项院前启动的多中心随机假对照盲法终点试验,将症状出现后4小时内推测为超急性卒中的患者随机分为经皮GTN或假对照。最终诊断由现场研究人员确定。主要结果是 90 天后改良 Rankin 量表 (mRS) 评分的变化,采用序数逻辑回归进行分析,报告为调整后的普通几率比率和 95% 置信区间 (CI)。次要结果包括死亡或依赖(mRS >2):1149名患者中有109人(9.5%)最终诊断为TIA(GTN 57人,假性52人),平均年龄73岁(SD 13),19人(17.4%)病前mRS>2,从发病到随机化的时间为80分钟(四分位间范围49-105)。与假血压相比,GTN可在到达医院时将血压降低7.4/5.2 mmHg。第 90 天时,GTN 对 mRS 评分的变化没有影响(依赖性增加的常见几率比 1.47,95% CI 0.70-3.11),但与死亡或依赖性增加(mRS >2)有关:GTN29例(51.8%)与假23例(46.9%)相比,几率比为3.86(95% CI 1.09-13.59):结论:与假治疗相比,院前超急性经皮GTN并不能改善研究者诊断的TIA患者的总体功能预后。
Pre-hospital transdermal glyceryl trinitrate for transient ischaemic attack: Data from the RIGHT-2 trial
Background and purpose
Ambulance trials assessing interventions in suspected stroke patients will recruit patients with currently active symptoms that will resolve into transient ischaemic attack (TIA). The safety and efficacy of glyceryl trinitrate (GTN) in the pre-specified subgroup of patients with TIA in the Rapid Intervention with Glyceryl Trinitrate in Hypertensive Stroke Trial 2 (RIGHT-2) was assessed.
Methods
RIGHT-2 was a pre-hospital-initiated multicentre randomized sham-controlled blinded-endpoint trial that randomized patients with presumed ultra-acute stroke within 4 h of symptom onset to transdermal GTN or sham. Final diagnosis was determined by site investigators. The primary outcome was a shift in modified Rankin Scale (mRS) scores at 90 days analysed using ordinal logistic regression reported as adjusted common odds ratio with 95% confidence intervals (CIs). Secondary outcomes included death or dependence (mRS >2).
Results
In all, 109 of 1149 (9.5%) patients had a final diagnosis of TIA (GTN 57, sham 52) with mean age 73 (SD 13) years, 19 (17.4%) had pre-morbid mRS >2, and onset to randomization was 80 min (interquartile range 49, 105). GTN lowered blood pressure by 7.4/5.2 mmHg compared with sham by hospital arrival. At day 90, GTN had no effect on shift in mRS scores (common odds ratio for increased dependence 1.47, 95% CI 0.70–3.11) but was associated with increased death or dependence (mRS >2): GTN 29 (51.8%) versus sham 23 (46.9%), odds ratio 3.86 (95% CI 1.09–13.59).
Conclusions
Pre-hospital ultra-acute transdermal GTN did not improve overall functional outcome in patients with investigator-diagnosed TIA compared with sham treatment.
期刊介绍:
The European Journal of Neurology is the official journal of the European Academy of Neurology and covers all areas of clinical and basic research in neurology, including pre-clinical research of immediate translational value for new potential treatments. Emphasis is placed on major diseases of large clinical and socio-economic importance (dementia, stroke, epilepsy, headache, multiple sclerosis, movement disorders, and infectious diseases).