Division of Nephrology, University Health Network, Toronto, Canada.
Clin J Am Soc Nephrol. 2012 Feb;7(2):297-303. doi: 10.2215/CJN.07970811. Epub 2011 Dec 1.
Infectious complications remain a significant cause of peritoneal dialysis (PD) technique failure. Topical ointments seem to reduce peritonitis; however, concerns over resistance have led to a quest for alternative agents. This study examined the effectiveness of applying topical Polysporin Triple ointment (P(3)) against mupirocin in a multi-centered, double-blind, randomized controlled trial.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: PD patients routinely applied either P(3) or mupirocin ointment to their exit site. Patients were followed for 18 months or until death or catheter removal. The primary study outcome was a composite endpoint of exit-site infection (ESI), tunnel infection, or peritonitis.
Seventy-five of 201 randomized patients experienced a primary outcome event (51 peritonitis episodes, 24 ESIs). No difference was seen in the time to first event for P(3) (13.2 months; 95% confidence interval, 11.9-14.5) and mupirocin (14.0 months; 95% confidence interval, 12.7-15.4) (P=0.41). Twice as many patients reported redness at the exit site in the P(3) group (14 versus 6, P=0.10). Over the complete study period, a higher rate per year of fungal ESIs was seen in patients using P(3) (0.07 versus 0.01; P=0.02) with a corresponding increase in fungal peritonitis (0.04 versus 0.00, respectively; P<0.05).
This study shows that P(3) is not superior to mupirocin in the prophylaxis of PD-related infections. Colonization of the exit site with fungal organisms is of concern and warrants further study. As such, the use of P(3) over mupirocin is not advocated in the prophylaxis of PD-related infections.
感染并发症仍然是腹膜透析(PD)技术失败的一个重要原因。局部软膏似乎可以减少腹膜炎;然而,人们对耐药性的担忧导致了对替代药物的探索。本研究在一项多中心、双盲、随机对照试验中,考察了应用局部聚维酮碘三联软膏(P(3))对抗莫匹罗星的效果。
设计、地点、参与者和测量:PD 患者常规将 P(3)或莫匹罗星软膏涂抹于其出口部位。患者随访 18 个月或直至死亡或导管移除。主要研究终点是出口部位感染(ESI)、隧道感染或腹膜炎的复合终点。
201 名随机患者中有 75 名发生了主要结局事件(51 例腹膜炎发作,24 例 ESI)。P(3)(13.2 个月;95%置信区间,11.9-14.5)和莫匹罗星(14.0 个月;95%置信区间,12.7-15.4)的首次事件时间无差异(P=0.41)。P(3)组有 14 名患者报告出口部位发红,而莫匹罗星组有 6 名(P=0.10)。在整个研究期间,使用 P(3)的患者真菌性 ESI 的年发生率更高(0.07 比 0.01;P=0.02),真菌性腹膜炎的发生率也相应增加(0.04 比 0.00,分别;P<0.05)。
本研究表明,P(3)在预防 PD 相关感染方面并不优于莫匹罗星。出口部位真菌定植令人担忧,需要进一步研究。因此,在预防 PD 相关感染方面,不提倡使用 P(3)代替莫匹罗星。