Li P K, Szeto C C, Law M C, Chau K F, Fung K S, Leung C B, Li C S, Lui S F, Tong K L, Tsang W K, Wong K M, Lai K N
Department of Medicine and Therapeutics, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin.
Am J Kidney Dis. 1999 Mar;33(3):535-40. doi: 10.1016/s0272-6386(99)70191-5.
We performed a multicenter, single-blinded, prospective randomized study on the use of a double-bag disconnect system (B) versus a Y-set disconnect system (Y). The peritonitis rate, exit site infection, clinical outcome, and patients' acceptance to the procedure were assessed. A total of 120 new end-stage renal failure patients of three regional hospitals were randomized: 60 each to the B and the Y systems. The results of 60 patients on the B system and 51 on the Y system were analyzable. They were followed up for a median of 16 months. Peritonitis rates for the B and the Y systems were 33.5 and 29.4 patient-months per episode, respectively. Exit site infection rates for the B and Y systems were 17.4 and 16.0 patient-months per episode, respectively. Four catheters were removed in each group. Patients on the B system were hospitalized for 2.1 days per patient per year related to peritonitis and exit site infection, and those on the Y system were hospitalized for 1.2 days. There was no significant difference between the B and Y systems in the incidences of peritonitis (all causes and those due to coagulase-negative staphylococci), exit site infection, and in hospitalization days. However, there was a higher percentage of gram-positive infections in the Y system (52%) than in the B system (32%) and a lower percentage of gram-negative infections in the Y system (16%) than in the B system (32%). Patients on the B system had a better acceptance of the procedure than patients on the Y system, as assessed by a six-item, 10-point questionnaire (total score, 43.1 +/- 10.2 v 37.6 +/- 9.4; P < 0.005 at 1 month; 44.6 +/- 9.1 v 39.8 +/- 8.6; P < 0.01 at 6 months). From this study, it is concluded that the B and Y systems are similar in the incidences of peritonitis and exit site infection, although the B system is better accepted by patients. This is probably the first multicenter randomized study comparing the double-bag and Y-set disconnect system using only new patients who had never used other systems of continuous ambulatory peritoneal dialysis.
我们开展了一项多中心、单盲、前瞻性随机研究，比较双袋断开系统（B）与Y形管断开系统（Y）的使用情况。评估了腹膜炎发生率、出口处感染情况、临床结局以及患者对该操作的接受度。三家地区医院的120例新的终末期肾衰竭患者被随机分组：60例使用B系统，60例使用Y系统。60例使用B系统的患者和51例使用Y系统的患者的结果可进行分析。他们的中位随访时间为16个月。B系统和Y系统的腹膜炎发生率分别为每发作33.5和29.4患者-月。B系统和Y系统的出口处感染率分别为每发作17.4和16.0患者-月。每组均有4根导管被拔除。使用B系统的患者因腹膜炎和出口处感染每年每人住院2.1天，使用Y系统的患者住院1.2天。B系统和Y系统在腹膜炎发生率（所有原因导致的以及由凝固酶阴性葡萄球菌引起的）、出口处感染和住院天数方面无显著差异。然而，Y系统中革兰氏阳性菌感染的百分比（52%）高于B系统（32%），Y系统中革兰氏阴性菌感染的百分比（16%）低于B系统（32%）。通过一项包含6项、10分的问卷评估（总分，1个月时为43.1±10.2对37.6±9.4；P<0.005；6个月时为44.6±9.1对39.8±8.6；P<0.01），使用B系统的患者对该操作的接受度优于使用Y系统的患者。从这项研究得出结论，B系统和Y系统在腹膜炎发生率和出口处感染方面相似，尽管患者对B系统的接受度更高。这可能是第一项仅使用从未使用过其他持续非卧床腹膜透析系统的新患者比较双袋和Y形管断开系统的多中心随机研究。
