Qureshi Adnan I, Huang Wei, Lobanova Iryna, Barsan William G, Hanley Daniel F, Hsu Chung Y, Lin Cheng-Li, Silbergleit Robert, Steiner Thorsten, Suarez Jose I, Toyoda Kazunori, Yamamoto Haruko
Zeenat Qureshi Stroke Institute, University of Missouri, Columbia.
Department of Neurology, University of Missouri, Columbia.
JAMA Neurol. 2020 Nov 1;77(11):1355-1365. doi: 10.1001/jamaneurol.2020.3075.
The safety and efficacy of intensive systolic blood pressure reduction in patients with intracerebral hemorrhage who present with systolic blood pressure greater than 220 mm Hg appears to be unknown.
To evaluate the differential outcomes of intensive (goal, 110-139 mm Hg) vs standard (goal, 140-179 mm Hg) systolic blood pressure reduction in patients with intracerebral hemorrhage and initial systolic blood pressure of 220 mm Hg or more vs less than 220 mm Hg.
DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage-II trial was performed in November 2019 on data from the multicenter randomized clinical trial, which was conducted between May 2011 to September 2015. Patients with intracerebral hemorrhage and initial systolic blood pressure of 180 mm Hg or more, randomized within 4.5 hours after symptom onset, were included.
Intravenous nicardipine infusion titrated to goals.
Neurological deterioration and hematoma expansion within 24 hours and death or severe disability at 90 days, plus kidney adverse events and serious adverse events until day 7 or hospital discharge.
A total of 8532 patients were screened, and 999 individuals (mean [SD] age, 62.0 [13.1] years; 620 men [62.0%]) underwent randomization and had an initial SBP value. Among 228 participants with initial systolic blood pressures of 220 mm Hg or more, the rate of neurological deterioration within 24 hours was higher in those who underwent intensive (vs standard) systolic blood pressure reduction (15.5% vs 6.8%; relative risk, 2.28 [95% CI, 1.03-5.07]; P = .04). The rate of death and severe disability (39.0% vs 38.4%; relative risk, 1.02 [95% CI, 0.73-1.78]; P = .92) was not significantly different between the 2 groups. There was a significantly higher rate of kidney adverse events in participants randomized to intensive systolic blood pressure reduction (13.6% vs 4.2%; relative risk, 3.22 [95% CI, 1.21-8.56]; P = .01), but no difference was observed in the rate of kidney serious adverse events.
The higher rate of neurological deterioration within 24 hours associated with intensive treatment in patients with intracerebral hemorrhage and initial systolic blood pressure of 220 mm Hg or more, without any benefit in reducing hematoma expansion at 24 hours or death or severe disability at 90 days, warrants caution against generalization of recommendations for intensive systolic blood pressure reduction.
脑出血患者收缩压高于220 mmHg时强化降低收缩压的安全性和有效性似乎尚不清楚。
评估脑出血且初始收缩压为220 mmHg及以上与低于220 mmHg的患者强化（目标值110 - 139 mmHg）与标准（目标值140 - 179 mmHg）降低收缩压的不同结果。
设计、地点和参与者：本对急性脑出血降压治疗-II试验的事后分析于2019年11月根据2011年5月至2015年9月进行的多中心随机临床试验数据开展。纳入脑出血且初始收缩压为180 mmHg及以上、症状发作后4.5小时内随机分组的患者。
静脉输注尼卡地平并滴定至目标值。
24小时内神经功能恶化和血肿扩大情况，以及90天时的死亡或严重残疾情况，外加至第7天或出院时的肾脏不良事件和严重不良事件。
共筛查了8532例患者，999例（平均[标准差]年龄，62.0[13.1]岁；620例男性[62.0%]）进行了随机分组并具有初始收缩压值。在228例初始收缩压为220 mmHg及以上的参与者中，强化（相对于标准）降低收缩压的患者24小时内神经功能恶化率更高（15.5%对6.8%；相对风险，2.28[95%CI，1.03 - 5.07]；P = 0.04）。两组间死亡和严重残疾率（39.0%对38.4%；相对风险，1.02[95%CI，0.73 - 1.78]；P = 0.92）无显著差异。随机接受强化降低收缩压的参与者中肾脏不良事件发生率显著更高（13.6%对4.2%；相对风险，3.22[95%CI，1.21 - 8.56]；P = 0.01），但肾脏严重不良事件发生率无差异。
脑出血且初始收缩压为220 mmHg及以上的患者强化治疗与24小时内更高的神经功能恶化率相关，在24小时内减少血肿扩大或90天时降低死亡或严重残疾方面无任何益处，因此在推广强化降低收缩压的建议时应谨慎。
