Farhat Karima, Douma Caroline E, Ferrantelli E, Ter Wee Pieter M, Beelen Robert H J, van Ittersum Frans J
VU University Medical Center, Department of Nephrology, Amsterdam, The Netherlands
Spaarnegasthuis, Department of Internal Medicine, Hoofddorp, The Netherlands.
Perit Dial Int. 2017 May-Jun;37(3):273-282. doi: 10.3747/pdi.2015.00031. Epub 2017 Mar 27.
♦ BACKGROUND: The use of pH-neutral peritoneal dialysis (PD) fluids low in glucose degradation products (GDP) may better preserve the peritoneal membrane and have fewer systemic effects. The effects of conversion from conventional to neutral-pH, low-GDP PD fluids in prevalent patients are unclear. Few studies on the role of neutral-pH, low-GDP PD have studied residual renal function, ultrafiltration, peritonitis incidence and technique failure, transport characteristics, and local and systemic markers of inflammation in prevalent PD patients. ♦ METHODS: In a multi-center open-label randomized clinical trial (RCT), we randomly assigned 40 of 78 stable continuous ambulatory PD (CAPD) and automated PD (APD) patients to treatment with bicarbonate/lactate, neutral-pH, low-GDP PD fluid (Physioneal; Baxter Healthcare Corporation, Deerfield, IL, USA) and compared them with 38 patients continuing their current standard lactate-buffered PD fluid (PDF) (Dianeal; Baxter Healthcare Corporation, Deerfield, IL, USA) during 2 years. Primary outcome was residual renal function (RRF) and ultrafiltration (UF) during peritoneal equilibration test (PET); peritonitis incidence was a secondary outcome. Furthermore, clinical parameters as well as several biomarkers in effluents and serum were measured. ♦ RESULTS: During follow-up, RRF did not differ between the groups. In the Physioneal group ultrafiltration (UF) during PET remained more or less stable (-20 mL [confidence interval (CI): -163.5 - 123.5 mL]; = 0.7 over 24 months), whereas it declined in the Dianeal group (-243 mL [CI: -376.6 to -109.4 mL]; < 0.0001 over 24 months), resulting in a difference of 233.7 mL [95% CI 41.0 - 425.5 mL]; = 0.017 between the groups at 24 months. The peritonitis rate was lower in the Physioneal group: adjusted odds ratio (OR) 0.38 (0.15 - 0.97) = 0.043. No differences were observed between the 2 groups in peritoneal adequacy or transport characteristics nor effluent markers of local inflammation (cancer antigen [CA]125, hyaluronan [HA], vascular endothelial growth factor [VEGF], macrophage chemo-attractant protein [MCP]-1, HA and transforming growth factor [TGF]β-1). ♦ CONCLUSION: In prevalent PD patients, our study did not find a difference in RRF after conversion from conventional to neutral-pH, low-GDP PD fluids, although there is a possibility that the study was underpowered to detect a difference. Decline in UF during standardized PET was lower after 2 years in the Physioneal group.
♦ 背景：使用葡萄糖降解产物（GDP）含量低的pH中性腹膜透析（PD）液可能能更好地保护腹膜，且全身影响较小。在现患患者中，从传统PD液转换为pH中性、低GDP PD液的效果尚不清楚。很少有关于pH中性、低GDP PD作用的研究涉及现患PD患者的残余肾功能、超滤、腹膜炎发生率和技术失败情况、转运特性以及局部和全身炎症标志物。♦ 方法：在一项多中心开放标签随机临床试验（RCT）中，我们将78例稳定的持续性非卧床腹膜透析（CAPD）和自动化腹膜透析（APD）患者中的40例随机分配至接受碳酸氢盐/乳酸盐、pH中性、低GDP PD液（百特医疗保健公司，美国伊利诺伊州迪尔菲尔德市，Physioneal）治疗，并在2年期间将他们与38例继续使用当前标准乳酸缓冲PD液（PDF）（百特医疗保健公司，美国伊利诺伊州迪尔菲尔德市，Dianeal）的患者进行比较。主要结局是腹膜平衡试验（PET）期间的残余肾功能（RRF）和超滤（UF）；腹膜炎发生率是次要结局。此外，还测量了临床参数以及流出液和血清中的几种生物标志物。♦ 结果：在随访期间，两组之间的RRF没有差异。在Physioneal组中，PET期间的超滤（UF）基本保持稳定（-20 mL [置信区间（CI）：-163.5至123.5 mL]；24个月内P = 0.7），而在Dianeal组中则下降（-243 mL [CI：-376.6至-109.4 mL]；24个月内P < 0.0001），导致两组在24个月时相差233.7 mL [95% CI 41.0至425.5 mL]；P = 0.017。Physioneal组的腹膜炎发生率较低：校正比值比（OR）为0.38（0.15至0.97），P = 0.043。两组在腹膜充分性或转运特性以及局部炎症的流出液标志物（癌抗原[CA]125、透明质酸[HA]、血管内皮生长因子[VEGF]、巨噬细胞趋化蛋白[MCP]-1、HA和转化生长因子[TGF]β-1）方面未观察到差异。♦ 结论：在现患PD患者中，我们的研究未发现从传统PD液转换为pH中性、低GDP PD液后RRF有差异，尽管该研究可能因检验效能不足而无法检测到差异。在Physioneal组中，标准化PET期间2年后UF的下降幅度较小。
