Therapeutic-induced hypertension in patients with noncardioembolic acute stroke
Therapeutic-induced hypertension in patients with noncardioembolic acute stroke
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DOI：
10.1212/wnl.0000000000008520
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发表时间：
2019-11-19
期刊：
影响因子：
9.9
通讯作者：
Han, Moon-Ku
中科院分区：
文献类型：
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作者：
Bang, Oh Young;Chung, Jong-Won;Han, Moon-Ku
目的评价诱导性高血压治疗急性缺血性脑卒中的安全性和有效性。方法在这项多中心随机临床试验中，将发病24小时内不适合血运重建治疗的急性非心源性缺血性脑卒中患者和住院期间进展性脑卒中患者按1：1随机分为对照组和干预组。在干预组中，静脉注射去氧肾上腺素，将收缩压 (SBP) 升高至 200 mm Hg。主要疗效终点是早期神经系统改善（前 7 天内 NIH 卒中量表 [NIHSS] 评分降低 >= 2 分）。次要疗效终点是 90 天时改良的 Rankin 量表评分为 0 至 2。安全性结果包括有症状的颅内出血/水肿、心肌梗死和死亡。结果在改良的意向治疗分析中，干预组和对照组分别纳入了 76 名和 77 名患者。调整年龄和初始卒中严重程度后，诱发性高血压增加了主要疗效终点（比值比 2.49，95% 置信区间 [CI] 1.25-4.96，p = 0.010）和次要疗效终点（比值比 2.97，95% CI 1.32-6.68，p = 0.009）的发生率。干预组中有 67 名 (88.2%) 患者在诱发高血压期间表现出 NIHSS 评分≥ 2 分的改善（平均 SBP 179.7 +/- 19.1 mm Hg）。安全性结果在各组之间没有显着差异。结论在不适合血运重建治疗的非心源性卒中患者和进行性卒中患者中，去氧肾上腺素诱导的高血压是安全的，并导致早期神经系统改善和长期功能独立。ClinicalTrials.gov 标识符 NCT01600235。证据分类本研究提供了 III 类证据，表明对于急性缺血性卒中患者，治疗引起的高血压增加了早期神经系统改善的可能性。
ObjectiveTo evaluate the safety and efficacy of induced hypertension in patients with acute ischemic stroke.MethodsIn this multicenter randomized clinical trial, patients with acute noncardioembolic ischemic stroke within 24 hours of onset who were ineligible for revascularization therapy and those with progressive stroke during hospitalization were randomly assigned (1:1) to the control and intervention groups. In the intervention group, phenylephrine was administered intravenously to increase systolic blood pressure (SBP) up to 200 mm Hg. The primary efficacy endpoint was early neurologic improvement (reduction in NIH Stroke Scale [NIHSS] score of >= 2 points during the first 7 days). The secondary efficacy endpoint was a modified Rankin Scale score of 0 to 2 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage/edema, myocardial infarction, and death.ResultsIn the modified intention-to-treat analyses, 76 and 77 patients were included in the intervention and control groups, respectively. After adjustment for age and initial stroke severity, induced hypertension increased the occurrence of the primary (odds ratio 2.49, 95% confidence interval [CI] 1.25-4.96, p = 0.010) and secondary (odds ratio 2.97, 95% CI 1.32-6.68, p = 0.009) efficacy endpoints. Sixty-seven (88.2%) patients of the intervention group exhibited improvements in NIHSS scores of >= 2 points during induced hypertension (mean SBP 179.7 +/- 19.1 mm Hg). Safety outcomes did not significantly differ between groups.ConclusionAmong patients with noncardioembolic stroke who were ineligible for revascularization therapy and those with progressive stroke, phenylephrine-induced hypertension was safe and resulted in early neurologic improvement and long-term functional independence.ClinicalTrials.gov identifier NCT01600235.Classification of evidenceThis study provides Class III evidence that for patients with acute ischemic stroke, therapeutic-induced hypertension increases the probability of early neurologic improvement.