急性脑出血中按血肿部位降压治疗的效果。
完整摘要 · 中文译文
背景与目的：早期强化降压（BP）目前被认为是改善急性脑出血（ICH）后结局的有效方法。然而，其效果是否因血肿部位不同而存在差异尚不确定。我们旨在确定强化降压对功能结局的治疗效果在不同血肿部位间的异质性。 方法：我们对来自全部4项急性脑出血强化降压试验（INTERACT）和第二项急性脑出血降压治疗试验（ATACH-II）的个体患者水平数据（IPD）进行了汇总分析。这些均为国际性、随机、开放、盲法终点评估的对照试验，旨在探讨急性ICH早期强化血压控制的有效性。ICH部位分为脑叶、大脑半球深部或幕下。主要结局为90天或6个月（INTERACT3）时的死亡或残疾（改良Rankin量表评分3～6分）。采用广义线性混合模型估计强化降压对主要结局的治疗效果在不同ICH部位间的异质性，将试验作为随机效应，并校正预设的临床协变量及“治疗×部位”交互项。 结果：在11,288例患者中（平均年龄62.5岁[SD 12.7]；女性4,056例[35.9%]），1,141例（10.1%）为脑叶ICH，9,202例（81.5%）为深部ICH，945例（8.4%）为幕下ICH。与深部或幕下ICH相比，脑叶ICH患者年龄更大，较少伴有脑室内 cular出血，且血肿体积更大（均p < 0.001）。强化降压对死亡或残疾这一主要结局的影响因脑出血部位而异（交互作用p = 0.033）。仅在深部脑出血中观察到明确获益（校正后比值比0.81，95% CI 0.74-0.89；p < 0.001）。 讨论：血肿部位可改变脑出血后强化降压对功能结局的治疗效果，其获益仅在深部脑出血中观察到。 试验注册信息：这些试验已在ClinicalTrials.gov注册（INTERACT1 NCT00226096；INTERACT2 NCT00716079；INTERACT3 NCT03209258；INTERACT4 NCT03790800；以及ATACH-II NCT01176565）。
完整摘要 · 英文原文
BACKGROUND AND OBJECTIVES: Early intensive blood pressure (BP) lowering is now recognized as an effective approach to improve outcome after acute intracerebral hemorrhage (ICH). However, whether the effect varies by hematoma location is uncertain. We aimed to determine the heterogeneity of the treatment effect of intensive BP lowering on functional outcome by hematoma location. METHODS: We conducted a pooled analysis of individual patient-level data (IPD) from all 4 Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT) and the second Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH-II) trial, which were international, randomized, open, blinded end point assessed, controlled trials that investigated the effectiveness of early intensive BP control in acute ICH. ICH location was classified as lobar or deep hemisphere or infratentorial. The primary outcome was death or disability (modified Rankin Scale scores 3-6) at 90 days or 6 months (for INTERACT3). The heterogeneity of the treatment effect of intensive BP lowering on the primary outcome by ICH location was estimated using generalized linear mixed models with trial as a random effect and adjustment for prespecified clinical covariates and an interaction term of "treatment-by-location." RESULTS: Among 11,288 patients (mean age 62.5 years [SD 12.7]; 4,056 [35.9%] women), 1,141 (10.1%) had lobar ICH, 9,202 (81.5%) had deep ICH and 945 (8.4%) had infratentorial ICH. Compared with deep or infratentorial ICH, lobar ICH occurred in older patients, was less often associated with intraventricular hemorrhage, and had larger hematoma volumes (all p < 0.001). The effect of intensive BP lowering on the primary outcome of death or disability differed by ICH location (p for interaction = 0.033). A clear benefit was only seen in deep ICH (adjusted odds ratio 0.81, 95% CI 0.74-0.89; p < 0.001). DISCUSSION: Hematoma location modifies the treatment effect of intensive BP lowering on functional outcome after ICH, with the benefit observed only in deep ICH. TRIAL REGISTRATION INFORMATION: These trials are registered at ClinicalTrials.gov (INTERACT1 NCT00226096; INTERACT2 NCT00716079; INTERACT3 NCT03209258; INTERACT4 NCT03790800; and ATACH-II NCT01176565).