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强化收缩压降低与肾脏及心血管结局:一项随机临床试验的二次分析

Intensive Systolic Blood Pressure Reduction and Kidney and Cardiovascular Outcomes: A Secondary Analysis of a Randomized Clinical Trial.

作者信息

Sun Guozhe, Miao Wei, Liu Songyue, Yin Yangzhi, Geng Danxi, Ye Ning, Xie Ziyi, Zhang Linlin, Zhou Shiyu, Wang Chang, Qiao Lixia, Pei Sitong, Ouyang Nanxiang, Shi Chuning, Guo Xiaofan, Sun Yingxian

机构信息

Department of Cardiology, The First Hospital of China Medical University, Shenyang, Liaoning, China.

Department of Clinical Epidemiology and Evidence-Based Medicine, The First Hospital of China Medical University, Shenyang, China.

出版信息

JAMA Netw Open. 2025 Jul 1;8(7):e2519604. doi: 10.1001/jamanetworkopen.2025.19604.

DOI:10.1001/jamanetworkopen.2025.19604
PMID:40643915
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12254891/
Abstract

IMPORTANCE

Intensive blood pressure (BP) control is effective in reducing major cardiovascular events. However, whether the reduction of systolic BP may lead to kidney injury remains controversial.

OBJECTIVE

To elucidate the association of intensive BP control with kidney and cardiovascular outcomes in individuals with hypertension without chronic kidney disease.

DESIGN, SETTING, AND PARTICIPANTS: This study is a secondary analysis of the China Rural Hypertension Control Project (CRHCP), an open-label, blind-end-point cluster randomized trial conducted from May 8, 2018, to March 15, 2023, in 326 villages in China. Patients with a baseline estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73 m2 or greater were randomized to an intervention or usual care group, stratified according to eGFR level.

EXPOSURES

A nonphysician community health care professional implemented a multifaceted intervention program after training to achieve a BP treatment goal of less than 130/80 mm Hg.

MAIN OUTCOMES AND MEASURES

Kidney outcome was defined as an eGFR decrease of 30% to a rate less than 60 mL/min/1.73 m2. Composite cardiovascular outcomes included cardiovascular death, stroke, myocardial infarction, and heart failure.

RESULTS

A total of 33 332 patients with a baseline eGFR of 60 mL/min/1.73 m2 or greater were included in this subgroup analysis (mean [SD] age, 62.8 [9.1] years; 61.3% female). After 36 months of follow-up, in 7562 participants with eGFRs between 60 and 90 mL/min/1.73 m2, 121 participants in the intervention group and 101 in the usual care group (risk ratio, 1.17; 95% CI, 0.82-1.62; P = .36) experienced kidney outcome, which was not statistically significant. As for cardiovascular outcomes, 210 participants (2.0% per year) in the intervention group and 346 participants (3.3% per year) in the usual care group had the composite cardiovascular disease outcome, and the disparity between the 2 groups was statistically significant (hazard ratio, 0.57; 95% CI, 0.47-0.68; P < .001).

CONCLUSIONS AND RELEVANCE

This secondary analysis of the CRHCP study suggests that intensive BP control was associated with reduced incidence of the composite cardiovascular disease outcome but not increased risk of kidney injury in patients without chronic kidney disease. These findings provide further evidence supporting the implementation of intensive BP control in patients without chronic kidney disease.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03527719.

摘要

重要性

强化血压控制在降低主要心血管事件方面是有效的。然而,收缩压的降低是否会导致肾损伤仍存在争议。

目的

阐明强化血压控制与无慢性肾脏病的高血压患者的肾脏及心血管结局之间的关联。

设计、地点和参与者:本研究是对中国农村高血压控制项目(CRHCP)的二次分析,该项目是一项开放标签、盲终点整群随机试验,于2018年5月8日至2023年3月15日在中国326个村庄开展。基线估计肾小球滤过率(eGFR)为60 mL/min/1.73 m²或更高的患者被随机分为干预组或常规治疗组,并根据eGFR水平进行分层。

暴露因素

一名非医生社区卫生保健专业人员在接受培训后实施了一项多方面的干预计划,以实现血压治疗目标低于130/80 mmHg。

主要结局和测量指标

肾脏结局定义为eGFR下降30%至低于60 mL/min/1.73 m²的速率。复合心血管结局包括心血管死亡、中风、心肌梗死和心力衰竭。

结果

本亚组分析共纳入33332例基线eGFR为60 mL/min/1.73 m²或更高的患者(平均[标准差]年龄为62.8[9.1]岁;61.3%为女性)。经过36个月的随访,在7562例eGFR在60至90 mL/min/1.73 m²之间的参与者中,干预组有121例,常规治疗组有101例(风险比为1.17;95%置信区间为0.82 - 1.62;P = 0.36)发生肾脏结局,差异无统计学意义。至于心血管结局,干预组有210例参与者(每年2.0%),常规治疗组有346例参与者(每年3.3%)发生复合心血管疾病结局,两组之间的差异具有统计学意义(风险比为0.57;95%置信区间为0.47 - 0.68;P < 0.001)。

结论与意义

对CRHCP研究的这项二次分析表明,强化血压控制与无慢性肾脏病患者的复合心血管疾病结局发生率降低相关,但不会增加肾损伤风险。这些发现为在无慢性肾脏病患者中实施强化血压控制提供了进一步的证据支持。

试验注册

ClinicalTrials.gov标识符:NCT03527719。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/280e/12254891/2b2cd1f0baae/jamanetwopen-e2519604-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/280e/12254891/47936f5fb924/jamanetwopen-e2519604-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/280e/12254891/2b2cd1f0baae/jamanetwopen-e2519604-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/280e/12254891/47936f5fb924/jamanetwopen-e2519604-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/280e/12254891/2b2cd1f0baae/jamanetwopen-e2519604-g002.jpg

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