Effect of starting with hemodialysis compared with peritoneal dialysis in patients new on dialysis treatment: A randomized controlled trial
Effect of starting with hemodialysis compared with peritoneal dialysis in patients new on dialysis treatment: A randomized controlled trial
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DOI：
10.1046/j.1523-1755.2003.00321.x
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发表时间：
2003-12-01
影响因子：
19.6
通讯作者：
Krediet, RT
中科院分区：
文献类型：
--
作者：
Korevaar, JC;Feith, GW;Krediet, RT
背景到目前为止，仅在观察性研究中比较了血液透析和腹膜透析患者的生存率和健康相关生活质量。这些研究报告了两种模式之间的小而相反的差异。本研究的目的是在一项随机对照试验中比较血液透析作为初始慢性透析治疗与腹膜透析的结局。来自荷兰38家透析中心的所有新透析患者均被邀请参加研究。患者被分配开始血液透析或腹膜透析。主要结局是平均质量调整生命年（QALY）评分。次要结果是生存率。由于入选率低，试验提前停止，之后38例患者被随机分配：18例患者接受血液透析，20例患者接受腹膜透析。血液透析患者前2年的平均QALY评分为59.1（SD 12），腹膜透析患者为54.0（SD 19），这构成了有利于血液透析的5.1的微小差异（95%CI 7.3 ~ 17.6）随访5年后，9例血液透析和5例腹膜透析患者死亡，生存率有显著差异;血液透析与腹膜透析的风险比为3.8（95% CI 1.1 - 12.6）。校正年龄、合并症和原发性肾脏疾病后，风险比为3.6（0.8 - 15.4）。与开始腹膜透析的患者相比，开始血液透析的患者之间仅观察到QALY评分的微小差异，支持等效性假设。长期生存率的显著差异有利于这一小群患者进行腹膜透析，这可以用来证明腹膜透析患者可能从腹膜透析中获益。
Background. Up-until-now, the survival and health-related quality of life of hemodialysis and peritoneal dialysis patients has only been compared in observational studies. These studies have reported small and opposing differences between both modalities. The aim of this study was to compare the outcome of hemodialysis as initial chronic dialysis treatment with that of peritoneal dialysis in a randomized controlled trial.Methods. All new dialysis patients from 38 dialysis centers in The Netherlands without indications against either modality were invited to participate. Patients were assigned to start with hemodialysis or peritoneal dialysis. The primary outcome was mean quality-adjusted life year (QALY) score. Secondary outcome was survival.Results. Due to the low inclusion rate, the trial was prematurely stopped after which 38 patients had been randomized: 18 patients to hemodialysis and 20 to peritoneal dialysis. The mean QALY score in the first 2 years was 59.1 (SD 12) for hemodialysis patients versus 54.0 (SD 19) for peritoneal dialysis patients, which constitutes a small difference in favor of hemodialysis of 5.1 (95% CI 7.3 to 17.6) After 5 years of follow-up, nine hemodialysis and five peritoneal dialysis patients had died, a significant difference in survival; hazard ration of hemodialysis versus peritoneal dialysis of 3.8 (95% CI 1.1 to 12.6). After adjustment for age, comorbidity, and primary kidney disease the hazard ratio was 3.6 (0.8 to 15.4).Conclusion. Only a small difference in QALY score was observed between patients who started with hemodialysis compared to patients who started with peritoneal dialysis, lending support for the equivalence hypothesis. The significant difference in longer-term survival, which favored peritoneal dialysis in this small group of patients, could be used to posit that incident dialysis patients might benefit from starting on peritoneal dialysis.