Department of Nephrology, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, QLD 4102, Australia.
J Am Soc Nephrol. 2012 Jun;23(6):1097-107. doi: 10.1681/ASN.2011121201. Epub 2012 Mar 22.
The clinical benefits of using "biocompatible" neutral pH solutions containing low levels of glucose degradation products for peritoneal dialysis compared with standard solutions are uncertain. In this multicenter, open-label, parallel-group, randomized controlled trial, we randomly assigned 185 incident adult peritoneal dialysis patients with residual renal function to use either biocompatible or conventional solution for 2 years. The primary outcome measure was slope of renal function decline. Secondary outcome measures comprised time to anuria, fluid volume status, peritonitis-free survival, technique survival, patient survival, and adverse events. We did not detect a statistically significant difference in the rate of decline of renal function between the two groups as measured by the slopes of GFR: -0.22 and -0.28 ml/min per 1.73 m(2) per month (P=0.17) in the first year in the biocompatible and conventional groups, respectively, and, -0.09 and -0.10 ml/min per 1.73 m(2) per month (P=0.9) in the second year. The biocompatible group exhibited significantly longer times to anuria (P=0.009) and to the first peritonitis episode (P=0.01). This group also had fewer patients develop peritonitis (30% versus 49%) and had lower rates of peritonitis (0.30 versus 0.49 episodes per year, P=0.01). In conclusion, this trial does not support a role for biocompatible fluid in slowing the rate of GFR decline, but it does suggest that biocompatible fluid may delay the onset of anuria and reduce the incidence of peritonitis compared with conventional fluid in peritoneal dialysis.
与标准溶液相比,使用含有低葡萄糖降解产物的“生物相容”中性 pH 溶液进行腹膜透析的临床益处尚不确定。在这项多中心、开放标签、平行组、随机对照试验中,我们将 185 名有残余肾功能的新发成年腹膜透析患者随机分为使用生物相容溶液或常规溶液组,治疗时间为 2 年。主要结局测量指标为肾功能下降斜率。次要结局指标包括无尿时间、液体容量状态、腹膜炎无生存、技术生存、患者生存和不良事件。我们没有检测到两组之间肾功能下降率的统计学显著差异,通过肾小球滤过率斜率来衡量:生物相容组和常规组在第一年分别为 -0.22 和 -0.28 ml/min per 1.73 m(2) per month(P=0.17),第二年分别为 -0.09 和 -0.10 ml/min per 1.73 m(2) per month(P=0.9)。生物相容组无尿时间明显延长(P=0.009)和首次腹膜炎发作时间(P=0.01)。该组发生腹膜炎的患者也更少(30% 比 49%),腹膜炎发生率更低(0.30 比 0.49 次/年,P=0.01)。总之,这项试验不支持生物相容液在减缓 GFR 下降速度方面的作用,但它表明与常规液相比,生物相容液可能延迟无尿的发生并降低腹膜炎的发生率腹膜透析。