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CONVINCE 随机试验发现血液透析滤过治疗慢性肾脏病患者的生活质量有积极影响。

The CONVINCE randomized trial found positive effects on quality of life for patients with chronic kidney disease treated with hemodiafiltration.

机构信息

Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany; German Center for Mental Health (DZPG), Berlin, Germany.

Department of Psychosomatic Medicine, Center of Internal Medicine and Dermatology, Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany; Center for Patient Centered Outcomes Research, Charité Universitätsmedizin Berlin (CPCOR), Berlin, Germany; German Center for Mental Health (DZPG), Berlin, Germany.

出版信息

Kidney Int. 2024 Nov;106(5):961-971. doi: 10.1016/j.kint.2024.07.014. Epub 2024 Jul 30.

Abstract

In the CONVINCE trial, the primary analysis demonstrated a survival benefit for patients receiving high-dose hemodiafiltration (HDF) as compared with high-flux hemodialysis (HD). A secondary objective was to evaluate effects on health-related quality of life (HRQoL); assessed in eight domains (physical function, cognitive function, fatigue, sleep disturbance, anxiety, depression, pain interference, social participation) applying instruments from the Patient-Reported Outcome Measurement Information System (PROMIS) before randomization and every three months thereafter. In total 1360 adults with dialysis-dependent chronic kidney disease, eligible to receive high-flux HDF (23 liters or more), were randomized (1:1); 84% response rate to all questionnaires. Both groups reported a continuous deterioration in all HRQoL domains. Overall, raw score changes from baseline were more favorable in the HDF group, resulting in a significant omnibus test after a median observation period of 30 months. Most relevant single raw score differences were reported for cognitive function. Patients receiving HDF reported a decline of -0.95 units (95% confidence interval - 2.23 to +0.34) whereas HD treated patients declined by -3.90 units (-5.28 to - 2.52). A joint model, adjusted for mortality differences, utilizing all quarterly assessments, identified a significantly slower HRQoL decline in physical function, cognitive function, pain interference, and social participation for the HDF group. Their physical health summary score declined -0.46 units/year slower compared to the HD group. Thus, the CONVINCE trial showed a beneficial effect of high-dose hemodiafiltration for survival as well as a moderate positive effect on patients' quality of life, most pronounced with respect to their cognitive function. REGISTRATION: NTR7138 on the International Clinical Trials Registry Platform.

摘要

在 CONVINCE 试验中,主要分析表明,与高通量血液透析(HD)相比,接受高剂量血液透析滤过(HDF)的患者有生存获益。次要目标是评估对健康相关生活质量(HRQoL)的影响;使用来自患者报告结局测量信息系统(PROMIS)的工具在随机分组前和此后每三个月评估 8 个领域(身体功能、认知功能、疲劳、睡眠障碍、焦虑、抑郁、疼痛干扰、社会参与)。共有 1360 名接受透析治疗的慢性肾脏病患者有资格接受高通量 HDF(23 升或以上),随机分组(1:1);对所有问卷的应答率为 84%。两组患者在所有 HRQoL 领域均报告持续恶化。总体而言,HDF 组的原始评分变化更为有利,在中位观察期 30 个月后进行了综合检验。最相关的单个原始评分差异报告发生在认知功能领域。接受 HDF 治疗的患者报告下降了 -0.95 个单位(95%置信区间 -2.23 至 0.34),而 HD 治疗的患者下降了 -3.90 个单位(-5.28 至 -2.52)。利用所有季度评估结果,调整死亡率差异的联合模型确定 HDF 组在身体功能、认知功能、疼痛干扰和社会参与方面的 HRQoL 下降速度明显较慢。与 HD 组相比,他们的身体健康综合评分每年下降速度慢 0.46 个单位。因此,CONVINCE 试验表明高剂量血液透析滤过不仅对生存有有益影响,而且对患者的生活质量有适度的积极影响,在认知功能方面最为明显。注册:在国际临床试验注册平台上注册为 NTR7138。

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