美国杜兰大学Jiang He团队比较了轻中度急性缺血性脑卒中患者早期和延迟抗高血压治疗的预后。2023年10月9日出版的《英国医学杂志》发表了这项成果。

为了比较脑卒中发作后24-48小时内开始的早期降压治疗与延迟至第8天治疗对减少功能依赖或死亡的影响，2018年6月13日至2022年7月10日，研究组在中国106家医院进行了一项多中心、随机、开放标签试验，共招募了4810例（≥40岁）急性缺血性卒中患者，均为发作后24-48小时内、收缩压升高至140- 220 mm Hg。

将这些患者随机分配为立即接受降压治疗（目标是在最初24小时内将收缩压降低10%-20%，并在7天内将平均血压降至140/90 mm Hg）或停用降压药物（如果正在服用）7天，然后在第8天接受治疗（目标是达到平均血压140/90 mm Hg）。主要终点为90天内功能依赖或死亡（修正Rankin量表评分≥3）的复合终点。并对患者进行意向治疗分析。

早期治疗组2413例，延迟治疗组2397例。随机分组后24小时内，早期治疗组的平均收缩压降低了9.7%（从162.9 mm Hg降至146.4 mm Hg），延迟治疗组的平均收缩压降低了4.9%（从162.8 mm Hg降至154.3 mm Hg），组间差异显著。第7天，早期治疗组平均收缩压为139.1 mm Hg，显著低于延迟治疗组的150.9 mm Hg。

此外，早期治疗组54.6%的患者和延迟治疗组22.4%的患者在第7天血压低于140/90 mm Hg，组间差异显著。第90天，早期治疗组中289名患者（12.0%）、延迟治疗组中250名患者（10.5%）死亡或功能依赖，优势比为1.18。两组患者卒中复发或不良事件风险无显著差异。

研究结果表明，对于收缩压在140-220 mm Hg之间且未接受静脉溶栓治疗的轻中度急性缺血性卒中患者，早期降压治疗并没有降低90天功能依赖或死亡的风险。

附：英文原文

Title: Early versus delayed antihypertensive treatment in patients with acute ischaemic stroke: multicentre, open label, randomised, controlled trial

Author: Liping Liu, Xuewei Xie, Yuesong Pan, Aili Wang, Yufei Wei, Jingyi Liu, Ximing Nie, Dacheng Liu, Zilin Zhao, Penglian Wang, Suwen Shen, Chongke Zhong, Tan Xu, Dali Wang, Gui-Chun Wang, Denghua Song, Yunsheng Ma, Jinguo Zhao, Yong Jiang, Jing Jing, Xia Meng, Katherine Obst, Chung-Shiuan Chen, David Wang, Yilong Wang, Yonghong Zhang, Yongjun Wang, Jiang He

Issue&Volume: 2023/10/09

Abstract:

Objectives To compared the effect of early antihypertensive treatment started within 24-48 h of stroke onset versus delaying treatment until day eight on reducing dependency or death.

Design Multicentre, randomised, open label trial.

Setting 106 hospitals in China between 13 June 2018 and 10 July 2022.

Participants 4810 patients (≥40 years) were enrolled with acute ischaemic stroke within 24-48 h of symptom onset and elevated systolic blood pressure between 140 mm Hg and <220 mm Hg.

Interventions Patients were randomly assigned to receive antihypertensive treatment immediately after randomisation (aimed at reducing systolic blood pressure by 10%-20% within the first 24 h and a mean blood pressure <140/90 mm Hg within seven days) or to discontinue antihypertensive medications for seven days if they were taking them, and then receive treatment on day 8 (aimed at achieving mean blood pressure <140/90 mm Hg).

Main outcome measures The primary outcome was the combination of functional dependency or death (modified Rankin scale score ≥3) at 90 days. Intention to treat analyses were conducted.

Results 2413 patients were assigned to the early treatment group and 2397 were assigned to the delayed treatment group. Mean systolic blood pressure was reduced by 9.7% (from 162.9 mm Hg to 146.4 mm Hg) in the early treatment group and by 4.9% (from 162.8 mm Hg to 154.3 mm Hg) in the delayed treatment group within 24 h after randomisation (P for group difference <0.001). Mean systolic blood pressure was 139.1 mm Hg in the early treatment group and 150.9 mm Hg in the delayed treatment group on day seven (P for group difference <0.001). Additionally, 54.6% of patients in the early treatment group and 22.4% in the delayed treatment group had blood pressure of less than 140/90 mm Hg (P<0.001 for group difference) on day seven. At day 90, 289 trial participants (12.0%) in the early treatment group, compared with 250 (10.5%) in the delayed treatment group, had died or experienced a dependency (odds ratio 1.18 (95% confidence interval 0.98 to 1.41), P=0.08). No significant differences in recurrent stroke or adverse events were reported between the two groups.

Conclusions Among patients with mild-to-moderate acute ischaemic stroke and systolic blood pressure between 140 mm Hg and <220 mm Hg who did not receive intravenous thrombolytic treatment, early antihypertensive treatment did not reduce the odds of dependency or death at 90 days.

DOI: 10.1136/bmj-2023-076448

Source: https://www.bmj.com/content/383/bmj-2023-076448