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慢性肾脏病患者的钠限制:自我管理支持的随机对照试验。

Sodium Restriction in Patients With CKD: A Randomized Controlled Trial of Self-management Support.

机构信息

Department of Health, Medical, and Neuropsychology, Institute of Psychology, Leiden University, Leiden, the Netherlands; Department of Medical Psychology, Leiden University Medical Center, Leiden, the Netherlands.

Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands; Department of Nephrology, VU University Medical Center, Amsterdam, the Netherlands.

出版信息

Am J Kidney Dis. 2017 May;69(5):576-586. doi: 10.1053/j.ajkd.2016.08.042. Epub 2016 Dec 16.

Abstract

BACKGROUND

To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease.

STUDY DESIGN

Open randomized controlled trial.

SETTING & PARTICIPANTS: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands.

INTERVENTION

Regular care was compared with regular care plus an intervention comprising education, motivational interviewing, coaching, and self-monitoring of blood pressure (BP) and sodium.

OUTCOMES

Primary outcomes were sodium excretion and BP after the 3-month intervention and at 6-month follow-up. Secondary outcomes were protein excretion, kidney function, antihypertensive medication, self-efficacy, and health-related quality of life (HRQoL).

RESULTS

At baseline, mean sodium excretion rate was 163.6±64.9 (SD) mmol/24 h; mean estimated glomerular filtration rate was 49.7±25.6mL/min/1.73m; median protein excretion rate was 0.8 (IQR, 0.4-1.7) g/24 h; and mean 24-hour ambulatory systolic and diastolic BPs were 129±15 and 76±9mmHg, respectively. Compared to regular care only (n=71), at 3 months, the intervention group (n=67) showed reduced sodium excretion rate (mean change, -30.3 [95% CI, -54.7 to -5.9] mmol/24 h), daytime ambulatory diastolic BP (mean change, -3.4 [95% CI, -6.3 to -0.6] mmHg), diastolic office BP (mean change, -5.2 [95% CI, -8.4 to -2.1] mmHg), protein excretion (mean change, -0.4 [95% CI, -0.7 to -0.1] g/24h), and improved self-efficacy (mean change, 0.5 [95% CI, 0.1 to 0.9]). At 6 months, differences in sodium excretion rates and ambulatory BPs between the groups were not significant, but differences were detected in systolic and diastolic office BPs (mean changes of -7.3 [95% CI, -12.7 to -1.9] and -3.8 [95% CI, -6.9 to -0.6] mmHg, respectively), protein excretion (mean changes, -0.3 [95% CI, -0.6 to -0.1] g/24h), and self-efficacy (mean change, 0.5 [95% CI, 0.0 to 0.9]). No differences in kidney function, medication, and HRQoL were observed.

LIMITATIONS

Nonblinding, relatively low response rate, and missing data.

CONCLUSIONS

Compared to regular care only, this self-management intervention modestly improved outcomes, although effects on sodium excretion and ambulatory BP diminish over time.

摘要

背景

评估慢性肾脏病患者自我管理钠限制的有效性和可持续性。

研究设计

开放随机对照试验。

设置和参与者

来自荷兰 4 家医院的肾功能中度下降的患者。

干预措施

常规护理与常规护理加教育、动机访谈、辅导和血压(BP)和钠自我监测的干预措施进行比较。

主要结局

主要结局是 3 个月干预后和 6 个月随访时的钠排泄和 BP。次要结局是蛋白质排泄、肾功能、降压药物、自我效能和健康相关生活质量(HRQoL)。

结果

基线时,平均钠排泄率为 163.6±64.9(SD)mmol/24 h;平均估计肾小球滤过率为 49.7±25.6mL/min/1.73m;中位蛋白排泄率为 0.8(IQR,0.4-1.7)g/24 h;24 小时动态收缩压和舒张压分别为 129±15 和 76±9mmHg。与仅常规护理(n=71)相比,干预组(n=67)在 3 个月时显示出较低的钠排泄率(平均变化-30.3[95%CI,-54.7 至-5.9]mmol/24 h)、日间动态舒张压(平均变化-3.4[95%CI,-6.3 至-0.6]mmHg)、舒张压办公室血压(平均变化-5.2[95%CI,-8.4 至-2.1]mmHg)、蛋白排泄(平均变化-0.4[95%CI,-0.7 至-0.1]g/24h)和自我效能改善(平均变化 0.5[95%CI,0.1 至 0.9])。6 个月时,两组间钠排泄率和动态血压的差异无统计学意义,但收缩压和舒张压办公室血压的差异有统计学意义(分别为-7.3[95%CI,-12.7 至-1.9]和-3.8[95%CI,-6.9 至-0.6]mmHg)、蛋白排泄(平均变化-0.3[95%CI,-0.6 至-0.1]g/24h)和自我效能(平均变化 0.5[95%CI,0.0 至 0.9])。肾功能、药物和 HRQoL 无差异。

局限性

非盲法、相对较低的应答率和缺失数据。

结论

与单纯常规护理相比,这种自我管理干预措施适度改善了结局,尽管钠排泄和动态血压的影响随时间推移而减弱。

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