ISC 2015：卒中6小时内硝酸甘油治疗可改善患者预后

卒中患者急性期高血压(BP)常见，并与其转归不佳有关。RIGHT研究显示，硝酸甘油(GTN)可降压并改善功能转归。 国际卒中大会(ISC2015)公布的一项研究表明，卒中发病后6小时内给予患者GTN治疗与患者预后较好(包括改善失能和较少的死亡率)有关。

该项名为ENOS研究是国际前瞻性、随机、单盲的盲法终点研究。研究者们随机将急性卒中患者(起病在48小时以内，收缩压140-220 mmHg)随机分为GTN组(5 mg经皮给药)或非GTN组。转归为3个月时改良Rankin量表(mRS)评分变化(主要转归)、巴氏指数(BI)和死亡。

结果显示，在纳入的4011例患者中，有273例是起病6小时之内，其中GTN和非GTN组患者分别为144和129例，这些患者年龄70岁(标准差13)。BP 167 (18)/91 (13) mmHg;斯堪地那维亚卒中量表(Scandinavian Stroke Scale )32 (12); 缺血76%, ICH 22%; 卒中随机化4.6 小时。GTN治疗与mRS改善有关 (OR 0.51), 还与BI和死亡减少有关 (OR 0.31)。研究者们还观察到了GTN治疗者的情绪、生活质量和认知情况有显著的改善。

英文摘要：

Abstract 156: Glyceryl Trinitrate for Hyperacute Stroke: Results from the Efficacy of Nitric Oxide in Stroke (ENOS) Trial

Abstract

Background: High blood pressure (BP) is common during the acute phase of stroke and is associated with a poor outcome. Administration of glyceryl trinitrate (GTN), a nitric oxide donor that lowers BP, improved functional outcome in the small ambulance-based paramedic-delivered RIGHT trial.

Methods: ENOS was an international prospective randomised single-blind blinded-endpoint trial. Patients with acute (<48 hours) stroke and systolic BP 140-220 mmHg were randomised to GTN (5 mg transdermal) or no GTN. Outcomes included shift in modified Rankin Scale (mRS, primary), Barthel Index (BI) and death at 3 months. Analyses are by regression (binary, ordinal or multiple) with adjustment for baseline covariates; results are odds ratio (OR)/mean difference (MD) with 95% confidence intervals (95% CI).

Results: Of 4,011 enrolled patients, 273 were randomised (GTN 144, no GTN 129) within 6 hours of onset of stroke: age 70 (SD 13); BP 167 (18)/91 (13) mmHg; Scandinavian Stroke Scale 32 (12); ischaemic 76%, ICH 22%; stroke-randomisation 4.6 hours. Treatment with GTN was associated with improved mRS (OR 0.51, 95% CI 0.32-0.80), BI (MD 13.5, 95% CI 4.6 to 22.5), and reduced death (OR 0.31, 95% CI 0.11-0.91). Significant improvements in mood, quality of life and cognition were also seen.

Summary: In the subgroup of patients randomised within 6 hours of stroke onset, treatment with GTN was associated with less dependency, disability and death. These positive results mirror those seen in the RIGHT pilot trial.