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每日三次与每日四次交换与新发生 CAPD 患者的残余肾功能下降:一项随机对照试验。

Three Versus 4 Daily Exchanges and Residual Kidney Function Decline in Incident CAPD Patients: A Randomized Controlled Trial.

机构信息

Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China; Shanghai Center for Peritoneal Dialysis Research, Shanghai, China.

Department of Nephrology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China; Shanghai Center for Peritoneal Dialysis Research, Shanghai, China.

出版信息

Am J Kidney Dis. 2017 Apr;69(4):506-513. doi: 10.1053/j.ajkd.2016.08.019. Epub 2016 Oct 15.

DOI:10.1053/j.ajkd.2016.08.019
PMID:27751610
Abstract

BACKGROUND

Incident patients treated with continuous ambulatory peritoneal dialysis (CAPD) are often prescribed either 3 or 4 exchanges per day. However, the effects on residual kidney function and clinical outcomes of 3 versus 4 exchanges are not known.

STUDY DESIGN

Prospective, randomized, controlled, open-label study.

SETTING & PARTICIPANTS: Incident CAPD patients aged 18 to 80 years with glomerular filtration rates (GFRs; mean of renal urea and creatinine clearance from a 24-hour urine collection) ≥ 2mL/min and urine volume ≥ 500mL/d. Exclusion criteria included refusal for informed consent, history of maintenance hemodialysis therapy or transplantation, or limited life expectancy.

INTERVENTION

24-month intervention with 3- or 4-exchange CAPD using glucose-based peritoneal dialysis fluids.

OUTCOMES

Primary outcomes were GFR, urine volume, and anuria-free survival. Secondary outcomes included peritonitis, patient survival, and technique survival.

RESULTS

The study recruited 139 patients, 70 in the 3-exchange group and 69 in the 4-exchange group. Baseline body mass indexes were 21.4±3.0 and 21.9±3.2kg/m for the 3- and 4-exchange groups, respectively (P=0.4). After 24 months, for 3 versus 4 exchanges, GFR (1.6±2.0 vs 1.7±1.9mL/min; P=0.8), urine volume (505±522 vs 474±442mL/d; P=0.8), and anuria-free survival (log-rank test statistic = 0.055; P=0.8) did not differ between groups, but Kt/V (1.95±0.39 vs 2.19±0.48; P=0.03) and ultrafiltration (404±499 vs 742±512mL/d; P=0.004) were lower in the 3-exchange group. The 3-exchange group had nominally longer peritonitis-free survival time (log-rank test statistic = 3.811; P=0.05), and nominally fewer patients had peritonitis in this group, though this was not statistically significant (13% vs 26%; P=0.06). Patient survival (log-rank test statistic = 0.978; P=0.3) and technique survival (log-rank test statistic = 0.347; P=0.6) were similar between groups.

LIMITATIONS

Single-center design; no formal sample-size calculations.

CONCLUSIONS

In this small trial, CAPD regimens with 3 and 4 exchanges had similar effects on residual GFR, urine volume, and time to anuria. Incremental peritoneal dialysis starts appear safe when patients are monitored.

摘要

背景

接受持续非卧床腹膜透析 (CAPD) 治疗的偶发患者通常每天接受 3 次或 4 次交换。然而,3 次与 4 次交换对残余肾功能和临床结局的影响尚不清楚。

研究设计

前瞻性、随机、对照、开放标签研究。

地点和参与者

年龄在 18 至 80 岁之间、肾小球滤过率 (GFR;24 小时尿液收集的尿素和肌酐清除率的平均值)≥2mL/min 和尿量≥500mL/d 的偶发 CAPD 患者。排除标准包括拒绝知情同意、维持性血液透析治疗或移植史或预期寿命有限。

干预

24 个月的 3 次或 4 次 CAPD 干预,使用基于葡萄糖的腹膜透析液。

结局

主要结局为 GFR、尿量和无尿生存。次要结局包括腹膜炎、患者生存和技术生存。

结果

该研究共招募了 139 名患者,其中 3 次交换组 70 名,4 次交换组 69 名。3 次和 4 次交换组的基线体重指数分别为 21.4±3.0 和 21.9±3.2kg/m²(P=0.4)。24 个月后,与 4 次交换相比,3 次交换时 GFR(1.6±2.0 与 1.7±1.9mL/min;P=0.8)、尿量(505±522 与 474±442mL/d;P=0.8)和无尿生存(对数秩检验统计量=0.055;P=0.8)无差异,但 3 次交换组的 Kt/V(1.95±0.39 与 2.19±0.48;P=0.03)和超滤量(404±499 与 742±512mL/d;P=0.004)较低。3 次交换组的腹膜炎无复发生存时间略有延长(对数秩检验统计量=3.811;P=0.05),且该组腹膜炎患者略少,但无统计学意义(13%与 26%;P=0.06)。两组患者的生存率(对数秩检验统计量=0.978;P=0.3)和技术生存率(对数秩检验统计量=0.347;P=0.6)相似。

局限性

单中心设计;未进行正式的样本量计算。

结论

在这项小型试验中,3 次和 4 次交换的 CAPD 方案对残余 GFR、尿量和无尿时间的影响相似。当患者接受监测时,递增腹膜透析似乎是安全的。

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