Mu Lihong, Li Chenglong, Liu Ting, Xie Wuxiang, Li Ge, Wang Meixian, Wang Ruoxi, Rao Huakun, He Qin, Wang Wen, Wu Yangfeng
Department of Epidemiology, School of Public Health and Management, Research Center for Medicine and Social Development, Innovation Center for Social Risk Governance in Health, Chongqing Medical University, Chongqing.
Peking University Clinical Research Institute, Peking University Health Science Center, Beijing.
Medicine (Baltimore). 2020 Feb;99(8):e19263. doi: 10.1097/MD.0000000000019263.
To understand the possible effect of a novel salt substitute with very low sodium in reducing blood pressure, salt intake and use of anti-hypertensive medications among patients on regular medications, to inform the future randomized trials.
Single-arm pilot trial.
A community health service center in Chongqing, China.
A total of 43 patients with hypertension taking anti-hypertensive medications regularly.
Patients received the salt substitute with 18% sodium chloride for 8 weeks.
Patients were followed up weekly for the use of antihypertensive medications and measurements of blood pressure. We collected 24-h urine before and after the trial to measure sodium and potassium intake.
Among 39 patients who completed the 8 weeks' intervention, 30.8% patients stopped or reduced anti-hypertensive medications during the trial. For patients that stopped or reduced medication, the mean SBP and DBP before intervention were 122.1 ± 9.6 and 68.9 ± 9.4 mm Hg and both did not increase after intervention (SBP change: 2.8 mm Hg (-5.1, 10.8), P = .48; DBP change: 1.8 mm Hg (-2.2, 5.7), P = .38). For the rest patients, the mean SBP and DBP before intervention were 141.6 ± 16.9 and 74.6 ± 6.6 mm Hg but reduced significantly after the intervention (SBP change: -16.0 mm Hg (-21.3, -10.6), P < .001; DBP change: -5.5 mm Hg (-8.1, -2.9), P < .001). The 24-h urine sodium decreased (P < .001) and potassium increased (P < .001) among all patients. No severe adverse events were reported.
The novel salt substitute showed potential in reducing blood pressure and use of antihypertensive medications. Further randomized double-blind controlled trial is warranted to validate these findings.Clinical Trial Registration-URL:http://www.clinicaltrials.gov. Unique identifier: NCT03226327.
了解一种新型低钠盐替代品对正在接受常规药物治疗的患者降低血压、减少盐摄入量及使用降压药物的可能效果，为未来的随机试验提供依据。
单臂试验。
中国重庆的一个社区卫生服务中心。
共有43例经常服用降压药物的高血压患者。
患者接受含18%氯化钠的盐替代品，为期8周。
每周对患者进行随访，记录降压药物的使用情况并测量血压。在试验前后收集24小时尿液，以测量钠和钾的摄入量。
在完成8周干预的39例患者中，30.8%的患者在试验期间停止或减少了降压药物的使用。对于停止或减少用药的患者，干预前收缩压和舒张压的平均值分别为122.1±9.6和68.9±9.4mmHg，干预后均未升高（收缩压变化：2.8mmHg（-5.1,10.8），P=0.48；舒张压变化：1.8mmHg（-2.2,5.7），P=0.38）。对于其余患者，干预前收缩压和舒张压的平均值分别为141.6±16.9和74.6±6.6mmHg，但干预后显著降低（收缩压变化：-16.0mmHg（-21.3,-10.6），P<0.001；舒张压变化：-5.5mmHg（-8.1,-2.9），P<0.001）。所有患者的24小时尿钠减少（P<0.001），尿钾增加（P<0.001）。未报告严重不良事件。
新型盐替代品在降低血压和减少降压药物使用方面显示出潜力。有必要进行进一步的随机双盲对照试验来验证这些发现。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符：NCT03226327。
