中国医学科学院北京协和医学院阜外医院李静教授团队，报道了心血管风险较高的高血压患者将收缩压降至低于120毫米汞柱的预后是否优于低于140毫米汞柱。2024年6月27日出版的《柳叶刀》杂志发表了这项成果。

将收缩压降至低于120毫米汞柱是否优于低于140毫米汞柱存在不确定性，尤其是在糖尿病患者和既往中风患者中。

在这项开放标签、盲法结果、随机对照试验中，来自中国116家医院或社区的心血管高危参与者被纳入研究。研究组使用最小化随机化将参与者分配到针对低于120 mm Hg的标准办公室收缩压的强化治疗或针对低于140 mm Hg的目标治疗。主要结局是根据意向治疗原则评估的心肌梗死、血运重建、心力衰竭住院、中风或心血管原因死亡的综合结果。

2019年9月17日至2020年7月13日，11255名参与者（4359名糖尿病患者和3022名既往中风患者）被分配接受强化治疗（n=5624）或标准治疗（n=5631）。平均年龄64.6岁（SD 7.1）。在整个随访期间（除滴药的前3个月外），强化治疗组的平均收缩压为119.1 mm Hg（SD 1.1），标准治疗组为134.8 mm Hg（10.5）。在平均3.4年的随访中，主要结局事件发生在强化治疗组的547名（9.7%）参与者和标准治疗组的623名（11.1%）参与者中（危险比[HR]0.88，95%CI0.78-0.99；p=0.028）。糖尿病状态、糖尿病持续时间或中风史的影响没有异质性。强化治疗组晕厥的严重不良事件发生率（5624例中24例【0.4%】）高于标准治疗组（5631例中8例【0.1%】；HR 3.00，95%CI 1.35-6.68）。低血压、电解质异常、伤害性跌倒或急性肾损伤等严重不良事件的组间差异无统计学意义。

研究结果表明，对于心血管风险较高的高血压患者，无论其糖尿病状况或中风史如何，与低于140毫米汞柱的治疗策略相比，将收缩压目标定为低于120毫米汞柱可以预防重大血管事件，但有轻微的额外风险。

附：英文原文

Title: Lowering systolic blood pressure to less than 120 mm Hg versus less than 140 mm Hg in patients with high cardiovascular risk with and without diabetes or previous stroke: an open-label, blinded-outcome, randomised trial

Author: Jiamin Liu, Yan Li, Jinzhuo Ge, Xiaofang Yan, Haibo Zhang, Xin Zheng, Jiapeng Lu, Xi Li, Yan Gao, Lubi Lei, Jing Liu, Jing Li, Xinyue Ai, Chun An, Yuhong An, Shiru Bai, Xueke Bai, Jingao Bi, Xiaoling Bin, Miaomiao Bu, Peili Bu, Wei Bu, Lvping Cai, Nana Cai, Shuhui Cai, Ting Cai, Wenjing Cai, Bin Cao, Bingbing Cao, Huaping Cao, Libo Cao, Xiancun Cao, Hui Chai, Yonggui Chai, Zhiyong Chai, Chunduo Chang, Jianbao Chang, Shuyue Chang, Yunling Chang, Huanhuan Chao, Hang Che, Qianqiu Che, Danlin Chen, Dongsheng Chen, Faxiu Chen, Guang Chen, Hairong Chen, Hao Chen, Huahua Chen, Huijun Chen, Jiafu Chen, Jian Chen, Jian Chen, Jiasen Chen, Jing Chen, Jinzi Chen, Junrong Chen, lichun Chen, Lijuan Chen, Liyuan Chen, Qun Chen, Run Chen, Shaoxing Chen, Song Chen, Tieshuang Chen, Xianghong Chen, Xiaowu Chen, Xudong Chen, Xue Chen, Xunchun Chen, Yao Chen, Yongli Chen, Yuanyue Chen, Yuhong Chen, Yuyi Chen, Zhangying Chen, Zhidong Chen, Zuyi Chen, Caiming Cheng, Jianbin Cheng, Xiaoxia Cheng, Junjie Chu, Ruifeng Cui, Xiaolin Cui, Xuechen Cui, Yang Cui, Zhonghua Cui, Wanhong Dai, Xing Dai, Chunxia Ding, Huihong Ding, Qiuhong Ding, Yaozong Ding, Yingjie Ding, Jiajia Dong, Lei Dong, Qi Dong, Yumei Dong, Bing Du, Hong Du, Jie Du, Laijing Du, Meiling Du, Qiong Du, Tianmin Du, Xue Du, Ru Duan, Xiaojing Duan, Xiaoting Duan, Dandan Fan, Xiaohong Fan, Xin Fan, Fang Fang, Jing Fang, Xibo Fang, Yang Fang, Erke Feng, Hejin Feng, Ling Feng, Rui Feng, Zhaohui Feng, Hongmei Fu, Qiuai Fu, Haofei Gao, Li Gao, Lina Gao, Liwei Gao, Lu Gao, Min Gao, Min Gao, Qian Gao, Yan Gao, Yuan Gao, Jinzhuo Ge, Hongxu Geng

Issue&Volume: 2024-06-27

Abstract:

Background

Uncertainty exists about whether lowering systolic blood pressure to less than 120 mm Hg is superior to that of less than 140 mm Hg, particularly in patients with diabetes and patients with previous stroke.

Methods

In this open-label, blinded-outcome, randomised controlled trial, participants with high cardiovascular risk were enrolled from 116 hospitals or communities in China. We used minimised randomisation to assign participants to intensive treatment targeting standard office systolic blood pressure of less than 120 mm Hg or standard treatment targeting less than 140 mm Hg. The primary outcome was a composite of myocardial infarction, revascularisation, hospitalisation for heart failure, stroke, or death from cardiovascular causes, assessed by the intention-to-treat principle. This trial was registered with ClinicalTrials.gov, NCT04030234.

Findings

Between Sept 17, 2019, and July 13, 2020, 11255 participants (4359 with diabetes and 3022 with previous stroke) were assigned to intensive treatment (n=5624) or standard treatment (n=5631). Their mean age was 64·6 years (SD 7·1). The mean systolic blood pressure throughout the follow-up (except the first 3 months of titration) was 119·1 mm Hg (SD 11·1) in the intensive treatment group and 134·8 mm Hg (10·5) in the standard treatment group. During a median of 3·4 years of follow-up, the primary outcome event occurred in 547 (9·7%) participants in the intensive treatment group and 623 (11·1%) in the standard treatment group (hazard ratio [HR] 0·88, 95% CI 0·78–0·99; p=0·028). There was no heterogeneity of effects by diabetes status, duration of diabetes, or history of stroke. Serious adverse events of syncope occurred more frequently in the intensive treatment group (24 [0·4%] of 5624) than in standard treatment group (eight [0·1%] of 5631; HR 3·00, 95% CI 1·35–6·68). There was no significant between-group difference in the serious adverse events of hypotension, electrolyte abnormality, injurious fall, or acute kidney injury.

Interpretation

For hypertensive patients at high cardiovascular risk, regardless of the status of diabetes or history of stroke, the treatment strategy of targeting systolic blood pressure of less than 120 mm Hg, as compared with that of less than 140 mm Hg, prevents major vascular events, with minor excess risk.

DOI: 10.1016/S0140-6736(24)01028-6

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01028-6/abstract