血肿周围水肿对急性脑出血的预后意义：强化降压治疗急性脑出血试验研究的荟萃分析。
Prognostic significance of perihematomal edema in acute intracerebral hemorrhage: pooled analysis from the intensive blood pressure reduction in acute cerebral hemorrhage trial studies.
机构信息
From the Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China (J.Y., J.Z.); The George Institute for Global Health, Central Clinical School, University of Sydney and Department of Neurology, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia (J.Y., H.A., G.W., E.H., C.D., G.C., X.W., S.Z., S.Y., J.C., C.S.A.); Department of Neurology, Hebei Yutian Hospital, Tangshan, China (G.W.); Department of Neurology, Xuzhou Central Hospital, Xuzhou, China (G.C.); Department of Neurology, West China Hospital, Sichuan University, Chengdu, China (S.Z.); and Department of Neurology, Korea University College of Medicine, Seoul, Republic of Korea (S.Y.).
出版信息
Stroke. 2015 Apr;46(4):1009-13. doi: 10.1161/STROKEAHA.114.007154. Epub 2015 Feb 24.
BACKGROUND AND PURPOSE
Controversy exists over the prognostic significance of perihematomal edema (PHE) in intracerebral hemorrhage. We aimed to determine the association of early PHE and clinical outcome among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT) studies.
METHODS
Pooled analyses of computed tomographic substudies in the pilot phase (INTERACT1) and main phase (INTERACT2), both international, prospective, open, blinded end point, randomized controlled trials, of patients with spontaneous intracerebral hemorrhage (<6 hours) and elevated systolic blood pressure, randomly assigned to intensive (target systolic blood pressure, <140 mm Hg) or guideline-based (systolic blood pressure, <180 mm Hg) blood-pressure management. Substudy participants (n=1310; 346 INTERACT1, 964 INTERACT2) had blinded central analyses of digital images from standardized baseline and 24-hour computed tomography. Predictors of death or dependency (modified Rankin scale scores, ≥3) at 90 days were assessed in logistic regression models and reported with odds ratios and 95% confidence intervals. INTERACT studies are registered at ClinicalTrials.gov (NCT00226096 and NCT00716079).
RESULTS
Of 1138 (87%) patients with 2 CTs available for edema analysis and outcome information, time from intracerebral hemorrhage onset to baseline computed tomography, baseline hematoma volume, 24-hour hematoma growth, and intraventricular extension were independent predictors of 24-hour PHE growth. Absolute growth in PHE volume was significantly associated with death or dependency (adjusted odds ratio, 1.17; 95% confidence interval, 1.02-1.33 per 5 mL increase from baseline; P=0.025) at 90 days after adjustment for demographic, clinical, and hematoma parameter prognostic factors. Associations were consistent across various sensitivity analyses.
CONCLUSION
PHE growth is an independent prognostic factor in intracerebral hemorrhage.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00226096 and NCT00716079.
背景与目的
关于血肿周围水肿（PHE）对颅内出血的预后意义，目前仍存在争议。本研究旨在确定脑出血患者强化血压降低颅内出血试验（INTERACT）研究中早期 PHE 与临床结局的相关性。
方法
对该国际、前瞻性、开放、盲终点、随机对照试验的计算机断层扫描亚组研究（INTERACT1 和 INTERACT2 的试行阶段和主要阶段）进行汇总分析，纳入发病时间<6 小时且收缩压升高的自发性脑出血患者，将其随机分配至强化（目标收缩压<140mmHg）或基于指南（收缩压<180mmHg）的降压管理。亚组研究参与者（n=1310；INTERACT1 组 346 例，INTERACT2 组 964 例）对基线和 24 小时计算机断层扫描的数字图像进行了盲法中心分析。采用 logistic 回归模型评估 90 天时死亡或依赖（改良 Rankin 量表评分≥3）的预测因素，并报告比值比和 95%置信区间。INTERACT 研究在 ClinicalTrials.gov 注册（NCT00226096 和 NCT00716079）。
结果
在 1138 例（87%）患者中，1138 例患者（87%）有 2 次 CT 扫描用于水肿分析和结局信息，脑出血发病至基线 CT 时间、基线血肿量、24 小时血肿增长和脑室扩展是 24 小时 PHE 增长的独立预测因素。PHE 体积的绝对增长与 90 天后的死亡或依赖显著相关（校正比值比，1.17；95%置信区间，0.12-1.02 每增加 5ml；P=0.025），校正人口统计学、临床和血肿参数预后因素后。在各种敏感性分析中，相关性一致。
结论
PHE 增长是脑出血的独立预后因素。
临床试验注册
网址：http://www.clinicaltrials.gov。唯一标识符：NCT00226096 和 NCT00716079。
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