Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, NHC Key Laboratory of Nephrology (Sun Yat-sen University), Guangdong Provincial Key Laboratory of Nephrology, Guangzhou, China.
Department of Nephrology, The First Affiliated Hospital of Nanchang University, China.
Perit Dial Int. 2022 May;42(3):246-258. doi: 10.1177/08968608221088638. Epub 2022 Apr 8.
Little is known about the impact of haemodialysis (HD) and peritoneal dialysis (PD) on health-related quality of life (HRQoL). We compared HRQoL between conventional in-centre HD and home-based PD in 1082 newly diagnosed kidney failure patients.
This was an open-label, randomised, non-inferiority trial of adult patients with a diagnosis of end-stage kidney disease (estimated glomerular filtration rate ≤ 15 mL/min/1.73 m) requiring maintenance dialysis from 36 sites in China randomised 1:1 to receive PD or conventional in-centre HD. The primary outcome was the 'Burden of Kidney Disease' assessed using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) survey over 48 weeks and the main secondary outcomes were the remaining scales of KDQoL-SF and all-cause mortality. The effect of PD versus HD on the primary outcome was compared by their geometric mean (GM) ratio, and non-inferiority was defined by the lower bound of a one-sided 95% confidence interval (CI) >0.9.
A total of 725 subjects completed the trial per protocol (395 PD and 330 HD, mean age 49.8 (standard deviation (SD) 14.4) years, 41.4% women). For the primary outcome, the mean (SD) change in 'Burden of Kidney Disease' over 48 weeks was 2.61 (1.27) in PD group and 2.58 (1.35) in HD group, and the GM ratio (95% CI) was 1.059 (0.908-1.234), exceeding the limit for non-inferiority. For the secondary outcomes, the PD and HD groups were similar in all scales. There were 17 and 31 deaths in PD and HD groups, respectively. Patients receiving PD had more adverse events, adverse event leading to hospitalisation and serious adverse events compared to those allocated to HD, but adverse events leading to death and discontinuation of the trial were not different between PD and HD.
In this trial, PD may be non-inferior to HD on the 'Burden of Kidney Disease' among Chinese kidney failure patients who are of younger age and have lower comorbidity after 48 weeks' follow-up.
关于血液透析（HD）和腹膜透析（PD）对健康相关生活质量（HRQoL）的影响知之甚少。我们比较了 1082 例新诊断为肾衰竭的患者中常规中心 HD 和家庭 PD 之间的 HRQoL。
这是一项在中国 36 个站点进行的、开放标签、随机、非劣效性试验，纳入了需要维持透析的终末期肾病（估计肾小球滤过率≤15mL/min/1.73m）的成年患者，按 1:1 随机分配接受 PD 或常规中心 HD。主要结局是使用肾脏病生活质量-短表（KDQoL-SF）在 48 周时评估的“肾脏疾病负担”，主要次要结局是 KDQoL-SF 的其余量表和全因死亡率。通过其几何均数（GM）比值比较 PD 与 HD 对主要结局的影响，定义非劣效性为单侧 95%置信区间（CI）下限>0.9。
共有 725 名受试者按方案完成试验（PD 组 395 名，HD 组 330 名，平均年龄 49.8（标准差 14.4）岁，41.4%为女性）。对于主要结局，PD 组 48 周时“肾脏疾病负担”的平均（SD）变化为 2.61（1.27），HD 组为 2.58（1.35），GM 比值（95%CI）为 1.059（0.908-1.234），超过非劣效性界限。对于次要结局，PD 组和 HD 组在所有量表上均相似。PD 组和 HD 组分别有 17 例和 31 例死亡。与接受 HD 的患者相比，接受 PD 的患者发生更多不良事件、导致住院的不良事件和严重不良事件，但导致死亡和试验停药的不良事件在 PD 和 HD 之间没有差异。
在这项试验中，在接受 48 周随访的年轻、合并症较少的中国肾衰竭患者中，PD 在“肾脏疾病负担”方面可能不劣于 HD。
