Plum Joerg, Gentile Stella, Verger Christian, Brunkhorst Reinhart, Bahner Udo, Faller Bernadette, Peeters Jacky, Freida Philippe, Struijk Dick G, Krediet Raymond T, Grabensee Bernd, Tranaeus Anders, Filho José C Divino
Department of Nephrology and Rheumatology, Heinrich-Heine-University, Düsseldorf, Germany.
Am J Kidney Dis. 2002 Apr;39(4):862-71. doi: 10.1053/ajkd.2002.32009.
In a randomized, prospective, multicenter study, we compared the safety, efficacy, and metabolic effects of a 7.5% icodextrin solution (Extraneal) with a 2.27% glucose solution for long dwell exchanges in patients undergoing automated peritoneal dialysis. Thirty-nine stable patients on automated peritoneal dialysis were randomized to receive either icodextrin (n = 20) or glucose 2.27% solution (n = 19). The study included a 2-week baseline period followed by a 12-week icodextrin treatment phase and a 2-week follow-up period when switching back to glucose. The average net ultrafiltration during the long dwell period was 278 +/- 43 mL/d for the icodextrin group and -138 +/- 81 mL/d for the control group (P < 0.001). The higher ultrafiltration volume with icodextrin was associated with higher creatinine (2.59 +/- 0.09 mL/min versus 2.16 +/- 0.11 mL/min) and urea (2.67 +/- 0.09 mL/min versus 2.28 +/- 0.12 mL/min) peritoneal clearances for the long dwell (both P < 0.001). Ultrafiltration rate per mass of carbohydrate absorbed was +5.2 +/- 1.2 microL/min/g in the icodextrin group and -5.5 +/- 2.8 microL/min/g in the glucose group (P < 0.001). In the icodextrin group, there was a decrease in serum sodium and chloride compared with baseline (P < 0.01). Total dialysate sodium removal increased in the icodextrin group from 226.7 mEq to 269.6 mEq (week 12, P < 0.001). Serum alpha-amylase activity decreased from 103 U/L to 16 U/L (P < 0.001). The total icodextrin plasma levels reached a steady-state concentration of 6,187 +/- 399 mg/L after 1 week of treatment. Urine volume and residual renal function were not specifically affected by icodextrin compared with glucose. None of the laboratory changes resulted in any reported clinically meaningful side effect. Icodextrin produced increased, sustained ultrafiltration during the long dwell period, increasing (convective) peritoneal clearance and sodium removal in automated peritoneal dialysis patients.
在一项随机、前瞻性、多中心研究中，我们比较了7.5%艾考糊精溶液（Extraneal）与2.27%葡萄糖溶液用于接受自动化腹膜透析患者长时间留腹交换时的安全性、有效性及代谢影响。39例接受自动化腹膜透析的稳定患者被随机分为两组，分别接受艾考糊精治疗（n = 20）或2.27%葡萄糖溶液治疗（n = 19）。研究包括2周的基线期，随后是12周的艾考糊精治疗阶段，之后转回葡萄糖治疗2周的随访期。艾考糊精组长时间留腹期间的平均净超滤量为278±43 mL/d，对照组为-138±81 mL/d（P < 0.001）。艾考糊精较高的超滤量与较长时间留腹时较高的肌酐清除率（2.59±0.09 mL/min对2.16±0.11 mL/min）和尿素清除率（2.67±0.09 mL/min对2.28±0.12 mL/min）相关（均P < 0.001）。艾考糊精组每吸收单位质量碳水化合物的超滤率为+5.2±1.2 μL/min/g，葡萄糖组为-5.5±2.8 μL/min/g（P < 0.001）。艾考糊精组血清钠和氯水平较基线下降（P < 0.01）。艾考糊精组总透析液钠清除量从226.7 mEq增加至269.6 mEq（第12周，P < 0.001）。血清α淀粉酶活性从103 U/L降至16 U/L（P < 0.001）。治疗1周后，艾考糊精血浆总水平达到稳态浓度6187±399 mg/L。与葡萄糖相比，艾考糊精对尿量和残余肾功能无特异性影响。所有实验室指标变化均未导致任何有临床意义的副作用报告。艾考糊精可使自动化腹膜透析患者在长时间留腹期间超滤增加且持续，增加（对流）腹膜清除率和钠清除量。
