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三联试验——一项评估生物相容性腹膜透析液对残余肾功能影响的随机对照临床试验。

The Trio Trial - A Randomized Controlled Clinical Trial Evaluating the Effect of a Biocompatible Peritoneal Dialysis Solution on Residual Renal Function.

作者信息

Sikaneta Tabo, Wu George, Abdolell Mohamed, Ng Anita, Mahdavi Sara, Svendrovski Anton, Tu Tony, Mercer Trish, Tong Matthew, Oreopoulos Dimitrios, Tam Paul

机构信息

Department of Nephrology, The Scarborough Hospital, Scarborough, ON, Canada

Department of Medicine, Credit Valley Hospital, Mississauga, ON, Canada.

出版信息

Perit Dial Int. 2016;36(5):526-32. doi: 10.3747/pdi.2015.00090. Epub 2016 Jun 9.

DOI:10.3747/pdi.2015.00090
PMID:27282852
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5033628/
Abstract

UNLABELLED

♦

BACKGROUND AND OBJECTIVE

Residual renal function (RRF) correlates with mortality and morbidity rates in patients receiving peritoneal dialysis (PD). We examined the effect of a biocompatible PD solution (Gambrosol Trio; Gambro Lundia AB, Lund, Sweden) with lower concentrations of glucose degradation products on rates of decline in RRF. ♦

DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Incident patients at 2 centers in Canada and 1 in Hong Kong were randomized (by minimization) in an open-label parallel group trial to receive Gambrosol Trio or standard PD solution (Dianeal; Baxter Healthcare, Mississauga, Canada) for 2 years. Primary outcome was slope of RRF. Secondary outcomes were urine volumes, fluid and nutrition indices, PD and membrane characteristics, peritonitis rates, adverse events, and PD technique survival. ♦

RESULTS

Residual renal function declined by 0.132 mL/minute/1.73 m(2)/month in 51 patients allocated to biocompatible, and 0.174 mL/minute/1.73 m(2)/month in 50 patients allocated to standard PD solution (difference 0.042 mL/minute/1.73 m(2)/month, p = 0.001). Urine volume, body mass index, normalized protein catabolic rates, and fat mass were higher; total body water, peritoneal ultrafiltration, and D/P creatinine did not differ; and serum phosphate, rates of icodextrin, and automated cycler use were lower with Gambrosol Trio use. There were more peritonitis events with Gambrosol Trio use, while PD technique survival did not differ between groups. ♦

CONCLUSIONS

The use of the biocompatible PD solution Gambrosol Trio was associated with slower rates of decline in RRF, fluid and nutrition benefits, and increased peritonitis rates.

TRIAL NUMBER

ISRCTN26252543.

摘要

未标注

♦

背景与目的

残余肾功能(RRF)与接受腹膜透析(PD)患者的死亡率和发病率相关。我们研究了一种葡萄糖降解产物浓度较低的生物相容性腹膜透析液(Gambrosol Trio;瑞典隆德的甘布罗伦迪亚公司)对RRF下降速率的影响。♦

设计、地点、参与者及测量方法:在加拿大的2个中心和中国香港的1个中心,将新发病例患者(通过最小化法)随机分为开放标签平行组试验,接受Gambrosol Trio或标准腹膜透析液(Dianeal;加拿大密西沙加的百特医疗保健公司)治疗2年。主要结局是RRF的斜率。次要结局包括尿量、液体和营养指标、腹膜透析及膜特性、腹膜炎发生率、不良事件和腹膜透析技术生存率。♦

结果

分配至生物相容性腹膜透析液组的51例患者,RRF以0.132 mL/分钟/1.73 m²/月的速率下降;分配至标准腹膜透析液组的50例患者,RRF以0.174 mL/分钟/1.73 m²/月的速率下降(差异为0.042 mL/分钟/1.73 m²/月,p = 0.001)。使用Gambrosol Trio时,尿量、体重指数、标准化蛋白分解代谢率和脂肪量较高;总体水、腹膜超滤和D/P肌酐无差异;血清磷酸盐、艾考糊精使用率和自动循环器使用率较低。使用Gambrosol Trio时腹膜炎事件更多,而两组间腹膜透析技术生存率无差异。♦

结论

使用生物相容性腹膜透析液Gambrosol Trio与RRF下降速率较慢、液体和营养方面的益处以及腹膜炎发生率增加相关。

试验编号

ISRCTN26252543。

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Increasing the use of biocompatible, glucose-free peritoneal dialysis solutions.增加生物相容性无糖腹膜透析液的使用。
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Extracellular volume expansion, measured by multifrequency bioimpedance, does not help preserve residual renal function in peritoneal dialysis patients.多频生物电阻抗测量的细胞外液容量扩张并不能帮助腹膜透析患者保留残余肾功能。
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