Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage.
Intensive Blood-Pressure Lowering in Patients with Acute Cerebral Hemorrhage.
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DOI：
10.1056/nejmoa1603460
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发表时间：
2016-09-15
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影响因子：
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通讯作者：
ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network
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作者：
Qureshi AI;Palesch YY;Barsan WG;Hanley DF;Hsu CY;Martin RL;Moy CS;Silbergleit R;Steiner T;Suarez JI;Toyoda K;Wang Y;Yamamoto H;Yoon BW;ATACH-2 Trial Investigators and the Neurological Emergency Treatment Trials Network
在治疗脑出血患者的急性高血压反应时，可用于指导收缩压水平目标选择的数据有限。我们将符合条件的脑出血患者随机分组，（体积，<60 cm 3）和格拉斯哥昏迷量表（GCS）评分为5分或更高（以3至15分计，分数越低，表明病情越差），收缩压目标值为110 - 139 mm Hg（强化治疗）或140至179 mm Hg的目标（标准治疗），以检验收缩压强化降低相对于标准降低的优越性;在症状发作后4.5小时内静脉注射尼卡地平以降低血压。主要结局为随机化后3个月时的死亡或残疾（改良兰金量表评分为4 - 6，量表范围为0 [无症状]至6 [死亡]），由不了解治疗分配的研究者确定。在1000名基线时平均（±SD）收缩压为200.6±27.0 mm Hg的受试者中，500名被分配到强化治疗组，500名被分配到标准治疗组。患者的平均年龄为61.9岁，56.2%为亚洲人。在预先规定的中期分析后，由于无效而停止入组。在38.7%的参与者中观察到死亡或残疾的主要结局（186/481）在强化治疗组和37.7%（181/480）标准治疗组（相对危险度，1.04; 95%置信区间，0.85 - 1.27;校正年龄、初始GCS评分和是否存在脑室内出血）。随机化后72小时内发生的严重不良事件，临床试验机构研究者认为与治疗相关，强化治疗组和标准治疗组分别有1.6%和1.2%的患者报告。随机化后7天内，强化治疗组的肾脏不良事件发生率显著高于标准治疗组（9.0% vs. 4.0%，P = 0.002）。治疗脑出血参与者以达到110至139 mm Hg的目标收缩压并没有导致死亡或残疾率低于标准降低至140至179 mm Hg的目标。（由国家神经疾病和中风研究所和国家脑和心血管中心资助; ATACH-2 ClinicalTrials.gov编号，NCT 01176565。
Limited data are available to guide the choice of a target for the systolic blood-pressure level when treating acute hypertensive response in patients with intracerebral hemorrhage. We randomly assigned eligible participants with intracerebral hemorrhage (volume, <60 cm3) and a Glasgow Coma Scale (GCS) score of 5 or more (on a scale from 3 to 15, with lower scores indicating worse condition) to a systolic blood-pressure target of 110 to 139 mm Hg (intensive treatment) or a target of 140 to 179 mm Hg (standard treatment) in order to test the superiority of intensive reduction of systolic blood pressure to standard reduction; intravenous nicardipine to lower blood pressure was administered within 4.5 hours after symptom onset. The primary outcome was death or disability (modified Rankin scale score of 4 to 6, on a scale ranging from 0 [no symptoms] to 6 [death]) at 3 months after randomization, as ascertained by an investigator who was unaware of the treatment assignments. Among 1000 participants with a mean (±SD) systolic blood pressure of 200.6±27.0 mm Hg at baseline, 500 were assigned to intensive treatment and 500 to standard treatment. The mean age of the patients was 61.9 years, and 56.2% were Asian. Enrollment was stopped because of futility after a prespecified interim analysis. The primary outcome of death or disability was observed in 38.7% of the participants (186 of 481) in the intensive-treatment group and in 37.7% (181 of 480) in the standard-treatment group (relative risk, 1.04; 95% confidence interval, 0.85 to 1.27; analysis was adjusted for age, initial GCS score, and presence or absence of intraventricular hemorrhage). Serious adverse events occurring within 72 hours after randomization that were considered by the site investigator to be related to treatment were reported in 1.6% of the patients in the intensive-treatment group and in 1.2% of those in the standard-treatment group. The rate of renal adverse events within 7 days after randomization was significantly higher in the intensive-treatment group than in the standard-treatment group (9.0% vs. 4.0%, P = 0.002). The treatment of participants with intracerebral hemorrhage to achieve a target systolic blood pressure of 110 to 139 mm Hg did not result in a lower rate of death or disability than standard reduction to a target of 140 to 179 mm Hg. (Funded by the National Institute of Neurological Disorders and Stroke and the National Cerebral and Cardiovascular Center; ATACH-2 ClinicalTrials.gov number, NCT01176565.)