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

Background

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

评估盐替代品与普通盐对中风患者复发性中风和死亡率的影响。

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).

设计、环境与参与者：盐替代品与中风研究（SSaSS），是一项开放标签的群组随机临床试验，在中国北部的600个村庄（群组）中进行。

Patients who self-reported a hospital diagnosis of stroke were included in this prespecified subgroup analysis.

在这一预先设定的亚组分析中，包括了自我报告有医院诊断中风的患者。

Data were analyzed from November 2023 to August 2024.

数据分析时间为2023年11月至2024年8月。

Methods

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

参与者被分配使用一种盐替代品，该替代品由75%的氯化钠和25%的氯化钾按质量组成，或者使用普通盐。

main_outcomes_and_measures

The primary outcome was recurrent stroke.

主要结果是复发性中风。

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.

在排除了5746名没有基线中风病史的人后，共有15249名中风患者（平均[标准差]年龄为64.1[8.8]岁；6999名[45.9%]女性；8250名[54.1%]男性）被纳入研究。

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).

在中位随访时间（四分位数间距）为61.2（60.9-61.6）个月期间，收缩压的平均差异为-2.05毫米汞柱（95%置信区间，-3.03至-1.08毫米汞柱）。

A total of 2735 recurrent stroke events (691 fatal and 2044 nonfatal) and 3242 deaths were recorded.

共记录了2735次复发性中风事件（其中691次为致命性中风，2044次为非致命性中风）和3242例死亡。

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).

与普通盐相比，代盐组的再发性中风显著降低（率比[RR]，0.86；95%置信区间，0.77-0.95；P = .005），对出血性中风的影响更大（相对减少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).

死亡率也显著降低（RR，0.88；95%置信区间，0.82-0.96；P = .003），对中风相关死亡的影响更大（相对减少21%；P = .01）。

No significant difference was observed for hyperkalemia (RR, 1.01; 95% CI, 0.74-1.38; P = .96).

观察到高钾血症之间没有显著差异（相对风险，1.01；95%置信区间，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.

这项群组试验的结果表明，代盐是安全的，并且降低了中风复发和死亡的风险，这强调了在中风患者中扩大这种低成本干预措施的健康益处。

trial_registration

ClinicalTrials.gov Identifier: NCT02092090.

临床试验注册号：NCT02092090。