Paniagua Ramón, Ramos Alfonso, Ávila Marcela, Ventura María-de-Jesús, Nevarez-Sida Armando, Qureshi Abdul Rashid, Lindholm Bengt
Unidad de Investigación Médica en Enfermedades Nefrológicas, Hospital de Especialidades, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México 06720, Mexico.
Macrotech, Mexico City, Mexico.
Nephrol Dial Transplant. 2025 Feb 28;40(3):588-597. doi: 10.1093/ndt/gfae188.
Remote monitoring (RM) of patients on automated peritoneal dialysis (APD) prevents complications and improves treatment quality. We analyzed the effect of RM-APD on mortality and complications related to cardiovascular disease, fluid overload and insufficient dialysis efficiency.
In a cluster-randomized, open-label, controlled trial, 21 hospitals with APD programs were assigned to use either RM-APD (10 hospitals; 403 patients) or conventional APD (11 hospitals; 398 patients) for the treatment of adult patients starting PD. Primary outcomes were time to first event of: (i) Composite Index 1 comprising all-cause mortality, first adverse events and hospitalizations of any cause, and (ii) Composite Index 2 comprising cardiovascular mortality, first adverse event and hospitalizations related to cardiovascular disease, fluid overload and insufficient dialysis efficiency. Secondary outcomes were time to first event of individual components of the two composite indices, and rates of adverse events, hospitalizations, unplanned visits and transfer to hemodialysis. Patients were followed for a median of 9.5 months. Primary outcomes were evaluated by competing risk analysis and restricted mean survival time (RMST) analysis.
While time to reach Composite Index 1 did not differ between the groups, Composite Index 2 was reached earlier (ΔRMST: -0.86 months; P = .02), and all-cause mortality [55 vs 33 deaths, P = .01; sub-hazard ratio (sHR) 1.69 (95% confidence interval 1.39-2.05), P < .001] and hospitalizations of any cause were higher in APD group than in RM-APD as were cardiovascular deaths [24 vs 13 deaths, P = .05; sHR 2.44 (95% confidence interval 1.72-3.45), P < .001] and rates of adverse events and hospitalizations related to cardiovascular disease, fluid overload or insufficient dialysis efficiency. Dropouts were more common in the APD group (131 vs 110, P = .048).
This randomized controlled trial shows that RM may add significant advantages to APD, including improved survival and reduced rate of adverse events and hospitalizations, which can favorably impact the acceptance and adoption of the therapy.
对接受自动化腹膜透析（APD）的患者进行远程监测（RM）可预防并发症并提高治疗质量。我们分析了RM-APD对与心血管疾病、液体超负荷和透析效率不足相关的死亡率和并发症的影响。
在一项整群随机、开放标签、对照试验中，21家开展APD项目的医院被分配使用RM-APD（10家医院；403例患者）或传统APD（11家医院；398例患者）来治疗开始进行腹膜透析的成年患者。主要结局为首次发生以下事件的时间：（i）综合指数1，包括全因死亡率、首次不良事件和任何原因导致的住院；（ii）综合指数2，包括心血管疾病死亡率、首次不良事件以及与心血管疾病、液体超负荷和透析效率不足相关的住院。次要结局为两个综合指数各单个组成部分首次发生事件的时间，以及不良事件、住院、非计划就诊和转为血液透析的发生率。对患者进行了为期9.5个月的中位数随访。主要结局通过竞争风险分析和受限平均生存时间（RMST）分析进行评估。
虽然两组达到综合指数1的时间没有差异，但达到综合指数2的时间较早（RMST差值：-0.86个月；P = 0.02），APD组的全因死亡率[55例死亡对33例死亡，P = 0.01；亚风险比（sHR）1.69（95%置信区间1.39 - 2.05），P < 0.001]和任何原因导致的住院率均高于RM-APD组，心血管疾病死亡率[24例死亡对13例死亡，P = 0.05；sHR 2.44（95%置信区间1.72 - 3.45），P < 0.001]以及与心血管疾病、液体超负荷或透析效率不足相关的不良事件和住院率也更高。APD组的失访情况更常见（131例对110例，P = 0.048）。
这项随机对照试验表明，RM可能为APD带来显著优势，包括提高生存率以及降低不良事件和住院率，这可能对该治疗方法的接受度和采用率产生积极影响。
