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急性脑出血患者血压降低幅度与临床结局:急性脑出血强化降压试验研究

Magnitude of blood pressure reduction and clinical outcomes in acute intracerebral hemorrhage: intensive blood pressure reduction in acute cerebral hemorrhage trial study.

作者信息

Wang Xia, Arima Hisatomi, Heeley Emma, Delcourt Candice, Huang Yining, Wang Jiguang, Stapf Christian, Robinson Thompson, Woodward Mark, Chalmers John, Anderson Craig S

机构信息

From the George Institute for Global Health, Neurological and Mental Health Division, University of Sydney, Royal Prince Alfred Hospital, Sydney, Australia (X.W., H.A., E.H., C.D., M.W., J.C., C.S.A.); Department of Neurology, Peking University First Hospital, Beijing, China (Y.H.); Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China (J.W.); Department of Neurology, APHP-Hôpital Lariboisière and DHU NeuroVasc Paris-Sorbonne, Université Paris Diderot-Sorbonne Paris Cité, Paris, France (C.S.); and Department of Cardiovascular Sciences and NIHR Biomedical Research Unit in Cardiovascular Disease, University of Leicester, Leicester, United Kingdom (T.R.).

出版信息

Hypertension. 2015 May;65(5):1026-32. doi: 10.1161/HYPERTENSIONAHA.114.05044. Epub 2015 Mar 23.

DOI:10.1161/HYPERTENSIONAHA.114.05044
PMID:25801872
Abstract

UNLABELLED

Evidence supports early intensive blood pressure (BP) lowering in acute intracerebral hemorrhage, but uncertainty persists over whether potential benefits and harms vary according to the magnitude of BP reduction. We aimed to determine whether larger systolic BP (SBP) reductions were associated with better outcomes in participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2). INTERACT2 was an international, open, blinded end point, randomized controlled trial of patients with spontaneous intracerebral hemorrhage (<6 hours) and elevated SBP (150-220 mm Hg) assigned to intensive (target SBP <140 mm Hg) or guideline-recommended (SBP <180 mm Hg) treatment. Associations of BP reduction (baseline minus average of achieved SBP) during 3 time periods post randomization (15-60 minutes, 1-24 hours, and 2-7 days) on poor outcome (death or major disability) at 90 days were analyzed in multivariable logistic regression models with odds ratios and 95% confidence intervals. Larger SBP reductions within the first hour after randomization were associated with lower risks of poor outcome: compared with minimal reduction (<10 mm Hg), odds ratios were 0.80 (95% confidence interval, 0.63-1.02) for moderate (10-20 mm Hg) and 0.65 (0.52-0.82) for large (≥20 mm Hg) reductions (P trend <0.01). Similar associations were also observed for SBP reductions during 1 to 24 hours (P<0.01) and 2 to 7 days (P 0.02). No heterogeneity in associations for patients above or below baseline SBP 180 mm Hg was reported (P>0.30). Optimal recovery from intracerebral hemorrhage was observed in hypertensive patients who achieved the greatest SBP reductions (≥20 mm Hg) in the first hour and maintained for 7 days.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00716079.

摘要

未标注

有证据支持在急性脑出血时早期强化降低血压(BP),但对于潜在益处和危害是否会因血压降低幅度不同而有所差异仍存在不确定性。我们旨在确定在急性脑出血强化降压试验(INTERACT2)的参与者中,收缩压(SBP)降低幅度更大是否与更好的预后相关。INTERACT2是一项国际性、开放性、终点设盲的随机对照试验,纳入自发性脑出血(<6小时)且SBP升高(150 - 220 mmHg)的患者,将其随机分配至强化治疗组(目标SBP <140 mmHg)或指南推荐治疗组(SBP <180 mmHg)。在多变量逻辑回归模型中分析随机分组后3个时间段(15 - 60分钟、1 - 24小时和2 - 7天)内血压降低幅度(基线减去达到的SBP平均值)与90天时不良预后(死亡或严重残疾)的关联,得出比值比和95%置信区间。随机分组后第一小时内SBP降低幅度更大与不良预后风险较低相关:与最小降低幅度(<10 mmHg)相比,中度降低(10 - 20 mmHg)的比值比为0.80(95%置信区间,0.63 - 1.02),大幅降低(≥20 mmHg)的比值比为0.65(0.52 - 0.82)(P趋势<0.01)。在1至24小时(P<0.01)和2至7天(P 0.02)期间SBP降低也观察到类似关联。未报告基线SBP 180 mmHg以上或以下患者关联存在异质性(P>0.30)。在第一小时内SBP降低幅度最大(≥20 mmHg)并持续7天的高血压患者中观察到脑出血的最佳恢复情况。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00716079。

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