Núñez-Moral M, Sánchez-Álvarez E, González-Díaz I, Peláez-Requejo B, Fernández-Viña A, Quintana-Fernández A, Rodríguez-Suárez C
Nephrology Service, Hospital Universitario Central de Asturias, Oviedo, Spain.
Perit Dial Int. 2014 May;34(3):271-7. doi: 10.3747/pdi.2012.00109. Epub 2014 Feb 4.
One of the most common and severe complications affecting peritoneal dialysis (PD) patients is exit-site infection of the peritoneal catheter; it is therefore of vital importance to prevent it. This complication has a negative impact on the success of the technique. In spite of this, there are no clear guidelines concerning how to take care of the exit site. The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period.
We designed a single-center, prospective, open-labeled, randomized controlled clinical trial with parallel groups. Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study. Patients were randomized to be daily cured as follows: Group A: traditional care with saline serum and povidone-iodine; and Group B: polyhexanide solution. Exit sites were evaluated at baseline and every four to six weeks or if any event occurred, according to the Twardowski criteria.
Of the 60 included patients, 46 completed the 12-month follow-up period. Six underwent transplantation, five died and three were transferred to hemodialysis (HD). The treatment was well tolerated, with no side effects nor abandonments due to such effects. Throughout the study period, six patients (20%) undergoing traditional care and only two (6,7%) receiving polyhexanide developed an exit-site infection (p = 0.032). There were a total number of 12 infections; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide (p = 0.037). The germs responsible for the infections were: S. aureus (six cases), Corynebacterium jeikeium (two cases) and P. aeruginosa (one case) in the saline serum and povidone-iodine group and P. aeruginosa (three cases) in the polyhexanide group. The mean rate of exit-site infection was 1 episode/36.6 patient-months for the traditional care group and 1 episode/102.7 patient-months for the polyhexanide group (p = 0.017). Patients following the traditional treatment required fewer days to get infected than those using polyhexanide (p = 0.033; log rank: 4.2).
These results show that using polyhexanide is efficient for the prevention of exit-site infections. Patients treated with this product suffer from fewer infections and need more time to become infected. Polyhexanide application is painless, no allergies have been described and it is well tolerated by patients. We therefore propose that it may be used routinely from now on for the care of healthy exit site.
影响腹膜透析（PD）患者的最常见且严重的并发症之一是腹膜导管出口处感染；因此预防该感染至关重要。这种并发症对该技术的成功有负面影响。尽管如此，关于如何护理出口处尚无明确的指导方针。本研究的目的是评估聚己缩胍在12个月期间预防出口处感染的疗效。
我们设计了一项单中心、前瞻性、开放标签、平行组随机对照临床试验。参与研究的要求包括在进入研究前至少六周植入腹膜导管，且在进入研究前至少三个月无需要住院或抗生素治疗的感染并发症。患者被随机分为以下每日治疗组：A组：用生理盐水和聚维酮碘进行传统护理；B组：聚己缩胍溶液。根据Twardowski标准，在基线时以及每四至六周或发生任何事件时对出口处进行评估。
纳入的60例患者中，46例完成了12个月的随访期。6例接受了移植，5例死亡，3例转为血液透析（HD）。治疗耐受性良好，无副作用，也没有因副作用而退出治疗的情况。在整个研究期间，接受传统护理的6例患者（20%）和仅接受聚己缩胍治疗的2例患者（6.7%）发生了出口处感染（p = 0.032）。总共发生了12次感染；9次发生在采用传统方法的患者中，仅3次发生在接受聚己缩胍治疗的患者中（p = 0.037）。感染的病原菌为：生理盐水和聚维酮碘组有金黄色葡萄球菌（6例）、杰氏棒状杆菌（2例）和铜绿假单胞菌（1例），聚己缩胍组有铜绿假单胞菌（3例）。传统护理组出口处感染的平均发生率为每36.6患者月1次，聚己缩胍组为每102.7患者月1次（p = 0.017）。采用传统治疗的患者比使用聚己缩胍的患者感染所需天数更少（p = 0.033；对数秩检验：4.2）。
这些结果表明，使用聚己缩胍对预防出口处感染有效。接受该产品治疗的患者感染较少，且需要更长时间才会感染。应用聚己缩胍无痛，未发现过敏反应，患者耐受性良好。因此，我们建议从现在起可将其常规用于健康出口处的护理。
