盐替代与复发性中风和死亡：一项随机临床试验。

Salt Substitution and Recurrent Stroke and Death: A Randomized Clinical Trial.

作者信息

Ding Xiong, Zhang Xinyi, Huang Liping, Xiong Shangzhi, Li Zhifang, Zhao Yi, Zhou Bo, Yin Xuejun, Xu Bingqing, Wu Yanfeng, Neal Bruce, Tian Maoyi, Yan Lijing L

机构信息

School of Public Health, Wuhan University, Wuhan, China.

Global Health Research Center, Duke Kunshan University, Kunshan, China.

出版信息

JAMA Cardiol. 2025 Apr 1;10(4):343-350. doi: 10.1001/jamacardio.2024.5417.

DOI:10.1001/jamacardio.2024.5417

PMID:39908026

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11800127/

Abstract

IMPORTANCE

The direct effect of consumption of salt substitutes on recurrent stroke and mortality among patients with stroke remains unclear.

OBJECTIVE

To evaluate the effects of salt substitutes vs regular salt on the incidence of recurrent stroke and mortality among patients with stroke.

DESIGN, SETTING, AND PARTICIPANTS: The Salt Substitute and Stroke Study (SSaSS), an open-label, cluster randomized clinical trial, was conducted in 600 northern Chinese villages (clusters). Patients who self-reported a hospital diagnosis of stroke were included in this prespecified subgroup analysis. Data were analyzed from November 2023 to August 2024.

INTERVENTIONS

Participants were assigned to use either a salt substitute, consisting of 75% sodium chloride and 25% potassium chloride by mass, or regular salt.

MAIN OUTCOMES AND MEASURES

The primary outcome was recurrent stroke.

RESULTS

After excluding 5746 persons without a baseline history of stroke, 15 249 patients with stroke (mean [SD] age, 64.1 [8.8] years; 6999 [45.9%] female; 8250 male [54.1%]) were included. Over a median (IQR) follow-up of 61.2 (60.9-61.6) months, the mean difference in systolic blood pressure was -2.05 mm Hg (95% CI, -3.03 to -1.08 mm Hg). A total of 2735 recurrent stroke events (691 fatal and 2044 nonfatal) and 3242 deaths were recorded. Recurrent stroke was significantly lower in the salt substitute vs regular salt group (rate ratio [RR], 0.86; 95% CI, 0.77-0.95; P = .005), with larger effects on hemorrhagic stroke (relative reduction, 30%; P = .002). Death rates were also significantly lower (RR, 0.88; 95% CI, 0.82-0.96; P = .003), with larger effects on stroke-related deaths (relative reduction 21%; P = .01). No significant difference was observed for hyperkalemia (RR, 1.01; 95% CI, 0.74-1.38; P = .96).

CONCLUSIONS AND RELEVANCE

Results of this cluster trial demonstrate that salt substitution was safe, along with reduced risks of stroke recurrence and death, which underscores large health gains from scaling up this low-cost intervention among patients with stroke.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02092090.

摘要

重要性

食用盐替代品对中风患者复发性中风和死亡率的直接影响尚不清楚。

目的

评估盐替代品与普通盐对中风患者复发性中风发生率和死亡率的影响。

设计、地点和参与者：盐替代品与中风研究（SSaSS）是一项开放标签、整群随机临床试验，在中国北方600个村庄（群组）开展。自我报告有医院诊断中风的患者纳入了这个预先指定的亚组分析。对2023年11月至2024年8月的数据进行了分析。

干预措施

参与者被分配使用一种盐替代品（按质量计由75%氯化钠和25%氯化钾组成）或普通盐。

主要结局和测量指标

主要结局是复发性中风。

结果

在排除5746名无中风基线病史的人后，纳入了15249例中风患者（平均[标准差]年龄为64.1[8.8]岁；6999例[45.9%]为女性；8250例男性[54.1%]）。在中位（四分位间距）随访61.2（60.9 - 61.6）个月期间，收缩压的平均差值为 -2.05 mmHg（95%置信区间，-3.03至 -1.08 mmHg）。共记录了2735例复发性中风事件（691例致命和2044例非致命）以及3242例死亡。盐替代品组的复发性中风显著低于普通盐组（率比[RR]，0.86；95%置信区间，0.77 - 0.95；P = 0.005），对出血性中风的影响更大（相对降低30%；P = 0.002）。死亡率也显著更低（RR，0.88；95%置信区间，0.82 - 0.96；P = 0.003），对中风相关死亡的影响更大（相对降低21%；P = 0.01）。高钾血症方面未观察到显著差异（RR，1.01；95%置信区间，0.74 - 1.38；P = 0.96）。