Vychytil Andreas, Remón César, Michel Catherine, Williams Paul, Rodríguez-Carmona Ana, Marrón Belén, Vonesh Ed, van der Heyden Synke, Divino Filho Jose C
Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
Nephrol Dial Transplant. 2008 Nov;23(11):3711-9. doi: 10.1093/ndt/gfn322. Epub 2008 Jun 13.
Icodextrin is a glucose polymer derived by hydrolysis of cornstarch. The different biocompatibility profile of icodextrin-containing peritoneal dialysis (PD) solutions may have a positive influence on peritoneal host defence. Furthermore, cases of sterile peritonitis potentially associated with icodextrin have been reported.
The primary objective of this multicentre, longitudinal, observational, non-interventional, prospective cohort study, which included 722 PD patients, was to evaluate the incidence of overall peritonitis in patients treated with icodextrin-containing PD solutions (Extraneal) used during one long-dwell exchange/day compared with those treated with non-icodextrin-containing PD solutions. The secondary objective was to determine if culture-negative peritonitis rates differed between patients treated with icodextrin from two independent manufacturers. All peritonitis episodes were assessed by a Steering Committee in a blind manner.
There was no significant difference between icodextrin-treated and control patients in the adjusted overall, culture-positive or culture-negative peritonitis rates. When stratified by the icodextrin supplier, there was no significant difference in the adjusted rate of culture-negative peritonitis episodes between groups.
Subjects receiving icodextrin as part of their PD regimen experienced neither a higher rate of culture-negative peritonitis nor a lower rate of infectious peritonitis compared with non-icodextrin users. There was no significant influence of the icodextrin raw material supplier on peritonitis rates.
艾考糊精是一种通过玉米淀粉水解得到的葡萄糖聚合物。含艾考糊精的腹膜透析(PD)溶液不同的生物相容性特征可能对腹膜宿主防御有积极影响。此外,已有报道称存在可能与艾考糊精相关的无菌性腹膜炎病例。
这项多中心、纵向、观察性、非干预性前瞻性队列研究纳入了722例PD患者,其主要目的是评估每日进行一次长时间留腹交换时使用含艾考糊精的PD溶液(Extraneal)治疗的患者与使用不含艾考糊精的PD溶液治疗的患者相比,总体腹膜炎的发生率。次要目的是确定使用来自两个独立制造商的艾考糊精治疗的患者之间,培养阴性腹膜炎的发生率是否存在差异。所有腹膜炎发作均由指导委员会进行盲法评估。
在调整后的总体、培养阳性或培养阴性腹膜炎发生率方面,接受艾考糊精治疗的患者与对照组患者之间无显著差异。按艾考糊精供应商分层时,各组之间调整后的培养阴性腹膜炎发作率无显著差异。
与未使用艾考糊精的患者相比,接受艾考糊精作为其PD治疗方案一部分的患者,培养阴性腹膜炎发生率并未更高,感染性腹膜炎发生率也未更低。艾考糊精原材料供应商对腹膜炎发生率无显著影响。