盐替代对心血管事件和死亡的影响。
Effect of Salt Substitution on Cardiovascular Events and Death.
作者信息
Neal Bruce, Wu Yangfeng, Feng Xiangxian, Zhang Ruijuan, Zhang Yuhong, Shi Jingpu, Zhang Jianxin, Tian Maoyi, Huang Liping, Li Zhifang, Yu Yan, Zhao Yi, Zhou Bo, Sun Jixin, Liu Yishu, Yin Xuejun, Hao Zhixin, Yu Jie, Li Ka-Chun, Zhang Xinyi, Duan Peifen, Wang Faxuan, Ma Bing, Shi Weiwei, Di Tanna Gian Luca, Stepien Sandrine, Shan Sana, Pearson Sallie-Anne, Li Nicole, Yan Lijing L, Labarthe Darwin, Elliott Paul
机构信息
From the George Institute for Global Health (B.N., M.T., L.H., Y.L., X.Y., J.Y., K.-C.L., G.L.D.T., S. Stepien, S. Shan) and the Centre for Big Data Research in Health (S.-A.P.), University of New South Wales, and George Clinical (N.L.) - all in Sydney; the School of Public Health (B.N., K.-C.L., P.E.), the U.K. Dementia Research Institute (P.E.), the British Heart Foundation Centre for Research Excellence (P.E.), and the NIHR Imperial Biomedical Research Centre (P.E.), Imperial College London, Health Data Research (P.E.), the NIHR Health Protection Research Unit in Chemical and Radiation Threats and Hazards (P.E.), and the Medical Research Council Centre for Environment and Health (P.E.) - all in London; Peking University Clinical Research Center, Peking University (Y.W.), the George Institute for Global Health at Peking University Health Science Center (Y.W., M.T., Z.H., X.Z., L.L.Y.), and the Department of Cardiology, Peking University Third Hospital (J.Y.), Beijing, the School of Public Health, Changzhi Medical College, Changzhi (X.F., Z.L., P.D.), the School of Public Health, Xi'an Jiaotong University, Xi'an (R.Z., Y.Y.), the School of Public Health and Management, Ningxia Medical University, Yinchuan (Y. Zhang, Y. Zhao, F.W.), the Department of Evidence-Based Medicine, First Hospital of China Medical University, Shenyang (J. Shi, B.Z., B.M.), the Department of Noncommunicable Disease Prevention and Control, Center for Disease Control of Hebei Province, Shijiazhuang (J.Z., J. Sun, W.S.), the School of Public Health, Harbin Medical University, Harbin (M.T.), the Global Health Research Center, Duke Kunshan University, Kunshan (L.L.Y.), and the School of Health Sciences, Wuhan University, Wuhan (L.L.Y.) - all in China; and the Feinberg School of Medicine, Northwestern University, Chicago (D.L.).
出版信息
N Engl J Med. 2021 Sep 16;385(12):1067-1077. doi: 10.1056/NEJMoa2105675. Epub 2021 Aug 29.
BACKGROUND
Salt substitutes with reduced sodium levels and increased potassium levels have been shown to lower blood pressure, but their effects on cardiovascular and safety outcomes are uncertain.
METHODS
We conducted an open-label, cluster-randomized trial involving persons from 600 villages in rural China. The participants had a history of stroke or were 60 years of age or older and had high blood pressure. The villages were randomly assigned in a 1:1 ratio to the intervention group, in which the participants used a salt substitute (75% sodium chloride and 25% potassium chloride by mass), or to the control group, in which the participants continued to use regular salt (100% sodium chloride). The primary outcome was stroke, the secondary outcomes were major adverse cardiovascular events and death from any cause, and the safety outcome was clinical hyperkalemia.
RESULTS
A total of 20,995 persons were enrolled in the trial. The mean age of the participants was 65.4 years, and 49.5% were female, 72.6% had a history of stroke, and 88.4% a history of hypertension. The mean duration of follow-up was 4.74 years. The rate of stroke was lower with the salt substitute than with regular salt (29.14 events vs. 33.65 events per 1000 person-years; rate ratio, 0.86; 95% confidence interval [CI], 0.77 to 0.96; P = 0.006), as were the rates of major cardiovascular events (49.09 events vs. 56.29 events per 1000 person-years; rate ratio, 0.87; 95% CI, 0.80 to 0.94; P<0.001) and death (39.28 events vs. 44.61 events per 1000 person-years; rate ratio, 0.88; 95% CI, 0.82 to 0.95; P<0.001). The rate of serious adverse events attributed to hyperkalemia was not significantly higher with the salt substitute than with regular salt (3.35 events vs. 3.30 events per 1000 person-years; rate ratio, 1.04; 95% CI, 0.80 to 1.37; P = 0.76).
CONCLUSIONS
Among persons who had a history of stroke or were 60 years of age or older and had high blood pressure, the rates of stroke, major cardiovascular events, and death from any cause were lower with the salt substitute than with regular salt. (Funded by the National Health and Medical Research Council of Australia; SSaSS ClinicalTrials.gov number, NCT02092090.).
背景
钠含量降低、钾含量增加的盐替代品已被证明可降低血压，但其对心血管和安全性结局的影响尚不确定。
方法
我们开展了一项开放标签、整群随机试验，纳入了来自中国农村600个村庄的人员。参与者有中风病史或年龄在60岁及以上且患有高血压。村庄按1:1的比例随机分配至干预组（参与者使用盐替代品，按质量计含75%氯化钠和25%氯化钾）或对照组（参与者继续使用普通盐，即100%氯化钠）。主要结局为中风，次要结局为主要不良心血管事件和任何原因导致的死亡，安全性结局为临床高钾血症。
结果
共有20995人参与试验。参与者的平均年龄为65.4岁，49.5%为女性，72.6%有中风病史，88.4%有高血压病史。平均随访时间为4.74年。使用盐替代品时中风发生率低于使用普通盐（每1000人年29.14例事件 vs. 33.65例事件；率比为0.86；95%置信区间[CI]为0.77至0.96；P = 0.006），主要心血管事件发生率（每1000人年49.09例事件 vs. 56.29例事件；率比为0.87；95%CI为0.80至0.94；P<0.001）和死亡发生率（每1000人年39.28例事件 vs. 44.61例事件；率比为0.88；95%CI为0.82至0.95；P<0.001）也较低。归因于高钾血症的严重不良事件发生率，使用盐替代品时并不显著高于使用普通盐（每1000人年3.35例事件 vs. 3.30例事件；率比为1.04；95%CI为0.80至1.37；P = 0.76）。
结论
在有中风病史或年龄在60岁及以上且患有高血压的人群中，使用盐替代品时中风、主要心血管事件和任何原因导致的死亡发生率低于使用普通盐。（由澳大利亚国家卫生与医学研究委员会资助；SSaSS临床试验注册号，NCT02092090。）
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