虚弱、强化血压治疗和不良临床结果风险的变化：SPRINT试验的事后分析

IF 8.3 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

BMC Medicine Pub Date : 2025-10-06 DOI:10.1186/s12916-025-04382-7

Xiaoyun Zhang, Xi Meng, Siyu Wang, Qing Lin, Yueyue Wang, Yu Xiang, Kan Wang, Xuan Zhao, Mian Li, Tiange Wang, Zhiyun Zhao, Jieli Lu, Min Xu, Jie Zheng, Yufang Bi, Yu Xu

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引用次数: 0

摘要

背景：虚弱正在成为一个普遍的健康问题，其状态随着时间的推移而变化。然而，虚弱状态的改变对临床结果的影响尚不清楚。我们的目的是评估虚弱状态的变化与不良临床结果之间的关系，并确定这些变化是否会改变强化血压治疗的效果。方法：使用收缩压干预试验（SPRINT）定义的虚弱指数（FI），将参与者分为虚弱（FI≤0.21）和健壮（FI≤0.21）两组。通过基线和12个月时的衰弱状态来评估衰弱的变化。参与者被分类为稳定-健壮、健壮-脆弱、脆弱-健壮和稳定-脆弱。结果包括心血管疾病事件（CVD）、全因死亡率和严重不良事件（SAEs）。使用Cox比例风险模型来评估虚弱变化与结局之间的关系，以及强化降血压治疗变化的潜在修改。结果：总共纳入7924名符合条件的SPRINT参与者。与稳定健壮的参与者相比，健壮到虚弱的参与者的心血管疾病（风险比[HR] = 1.70, 95%可信区间[CI] 1.20-2.41）、全因死亡率（HR = 2.03, 95% CI 1.22-3.37）和SAEs （HR = 1.47, 95% CI 1.17-1.84）的风险分别增加了70%、103%和47%。与稳定虚弱的参与者相比，在虚弱到健壮的参与者中，观察到全因死亡率降低了52% （HR = 0.48, 95% CI 0.24-0.95）。虚弱的改变并没有改变强化降压治疗对CVD、死亡率和SAEs的影响（相互作用的P值均为0.05）。在稳定稳健的参与者中，与标准降压治疗相比，强化降压治疗与主要CVD事件风险降低41% (HR = 0.59, 95% CI 0.42-0.83)，全因死亡率风险降低46% (HR = 0.54, 95% CI 0.31-0.95)， SAEs风险增加22% （HR = 1.22, 95% CI 1.00-1.48）相关。强化降压治疗与标准降压治疗在健壮到虚弱、虚弱到健壮和稳定虚弱状态的参与者中发现了相似的效果。结论：虚弱的变化与临床结果的风险变化相关。强化降压治疗降低了CVD和死亡率，而不考虑虚弱状态的改变。

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Changes in frailty, intensive blood pressure treatment, and risks of adverse clinical outcomes: a post hoc analysis of the SPRINT trial.

Background: Frailty is becoming a common health issue and its status changes overtime. However, the impact of the frailty status changes on clinical outcomes is unknown. We aimed to evaluate the association between changes in frailty status and adverse clinical outcomes, and to determine whether the changes modify the effects of intensive blood pressure (BP) treatment.

Methods: Using frailty index (FI) defined by the Systolic Blood Pressure Intervention Trial (SPRINT), participants were categorized as frail (FI > 0.21) or robust (FI ≤ 0.21). Changes in frailty were evaluated by frailty status at baseline and at 12 months. Participants were categorized as stable-robust, robust-to-frail, frail-to-robust, and stable-frail. Outcomes included incident cardiovascular disease (CVD), all-cause mortality, and serious adverse events (SAEs). Cox proportional hazard models were used to evaluate the association between frailty changes and outcomes, and potential modifications of the changes on intensive BP-lowering treatment.

Results: Overall, 7924 eligible SPRINT participants were included. Compared with stable-robust participants, robust-to-frail participants had 70%, 103%, and 47% increased risks of CVD (hazard ratio [HR] = 1.70, 95% confidence interval [CI] 1.20-2.41), all-cause mortality (HR = 2.03, 95% CI 1.22-3.37), and SAEs (HR = 1.47, 95% CI 1.17-1.84), respectively. Compared with stable-frail participants, a 52% decreased risk of all-cause mortality (HR = 0.48, 95% CI 0.24-0.95) was observed in frail-to-robust participants. Changes in frailty did not modify the effects of intensive BP-lowering treatment on CVD, mortality, and SAEs (all P values for interaction > 0.05). In stable-robust participants, intensive BP-lowering treatment was associated with a reduced risk of major CVD events by 41% (HR = 0.59, 95% CI 0.42-0.83), a reduced risk of all-cause mortality by 46% (HR = 0.54, 95% CI 0.31-0.95), and an increased risk of SAEs by 22% (HR = 1.22, 95% CI 1.00-1.48) compared with standard BP-lowering treatment. Similar effects of intensive vs. standard BP-lowering treatment were found in participants with robust-to-frail, frail-to-robust, and stable-frail status.

Conclusions: Changes in frailty were associated with changed risks of clinical outcomes. Intensive BP-lowering treatment reduced CVD and mortality regardless of frailty status changes.

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来源期刊

BMC Medicine 医学-医学：内科

CiteScore

13.10

自引率

1.10%

发文量

435

审稿时长

4-8 weeks

期刊介绍： BMC Medicine is an open access, transparent peer-reviewed general medical journal. It is the flagship journal of the BMC series and publishes outstanding and influential research in various areas including clinical practice, translational medicine, medical and health advances, public health, global health, policy, and general topics of interest to the biomedical and sociomedical professional communities. In addition to research articles, the journal also publishes stimulating debates, reviews, unique forum articles, and concise tutorials. All articles published in BMC Medicine are included in various databases such as Biological Abstracts, BIOSIS, CAS, Citebase, Current contents, DOAJ, Embase, MEDLINE, PubMed, Science Citation Index Expanded, OAIster, SCImago, Scopus, SOCOLAR, and Zetoc.