诱导高血压治疗动脉瘤性蛛网膜下腔出血后迟发性脑缺血：一项随机临床试验。
Induced Hypertension for Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage: A Randomized Clinical Trial.
机构信息
From the Department of Intensive Care Medicine, Brain Center Rudolf Magnus (C.S.G., A.J.C.S.), Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus (C.S.G., B.H.V., G.J.E.R.), and Department of Radiology (J.W.D.), University Medical Center Utrecht, Utrecht University, the Netherlands; Department of Critical Care, University Medical Center Groningen, University of Groningen, the Netherlands (W.M.v.d.B.); Department of Intensive Care and Erasmus MC Stroke Center, Erasmus MC University Medical Center, Rotterdam, the Netherlands (M.v.d.J.); Department of Intensive Care, Academic Medical Center Amsterdam, University of Amsterdam, the Netherlands (M.C.M.); and Department of Intensive Care, Elisabeth-TweeSteden Hospital (ETZ), Tilburg, the Netherlands (A.W.O.).
出版信息
Stroke. 2018 Jan;49(1):76-83. doi: 10.1161/STROKEAHA.117.017956. Epub 2017 Nov 20.
BACKGROUND AND PURPOSE
Induced hypertension is widely used to treat delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage, but a literature review shows that its presumed effectiveness is based on uncontrolled case-series only. We here report clinical outcome of aneurysmal subarachnoid hemorrhage patients with DCI included in a randomized trial on the effectiveness of induced hypertension.
METHODS
Aneurysmal subarachnoid hemorrhage patients with clinical symptoms of DCI were randomized to induced hypertension or no induced hypertension. Risk ratios for poor outcome (modified Rankin Scale score >3) at 3 months, with 95% confidence intervals, were calculated and adjusted for age, clinical condition at admission and at time of DCI, and amount of blood on initial computed tomographic scan with Poisson regression analysis.
RESULTS
The trial aiming to include 240 patients was ended, based on lack of effect on cerebral perfusion and slow recruitment, when 21 patients had been randomized to induced hypertension, and 20 patients to no hypertension. With induced hypertension, the adjusted risk ratio for poor outcome was 1.0 (95% confidence interval, 0.6-1.8) and the risk ratio for serious adverse events 2.1 (95% confidence interval, 0.9-5.0).
CONCLUSIONS
Before this trial, the effectiveness of induced hypertension for DCI in aneurysmal subarachnoid hemorrhage patients was unknown because current literature consists only of uncontrolled case series. The results from our premature halted trial do not add any evidence to support induced hypertension and show that this treatment can lead to serious adverse events.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01613235.
背景与目的
诱导高血压被广泛用于治疗蛛网膜下腔出血后迟发性脑缺血（DCI），但文献综述表明，其假定的有效性仅基于未对照的病例系列研究。在此，我们报告了一项随机试验中纳入的 DCI 动脉瘤性蛛网膜下腔出血患者的临床结局，该试验旨在评估诱导高血压的有效性。
方法
有 DCI 临床症状的动脉瘤性蛛网膜下腔出血患者被随机分为诱导高血压组或无诱导高血压组。使用泊松回归分析计算并调整年龄、入院时和 DCI 时的临床状况以及初始 CT 扫描上的血液量等因素后，计算 3 个月时不良结局（改良 Rankin 量表评分>3）的风险比及其 95%置信区间。
结果
该试验旨在纳入 240 例患者，但由于对脑灌注无影响且招募缓慢，当 21 例患者被随机分配到诱导高血压组，20 例患者被分配到无高血压组时，试验提前终止。在诱导高血压组，不良结局的调整风险比为 1.0（95%置信区间，0.6-1.8），严重不良事件的风险比为 2.1（95%置信区间，0.9-5.0）。
结论
在本试验之前，由于目前的文献仅包括未对照的病例系列研究，因此诱导高血压治疗动脉瘤性蛛网膜下腔出血后 DCI 的有效性尚不清楚。我们过早停止的试验结果没有提供任何证据支持诱导高血压，并表明这种治疗可能导致严重的不良事件。
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