Department of Nephrology, University of Queensland, Brisbane, Australia.
Perit Dial Int. 2012 Sep-Oct;32(5):497-506. doi: 10.3747/pdi.2012.00052.
A multicenter, multi-country randomized controlled trial (the balANZ study) recently reported that peritonitis rates significantly improved with the use of neutral-pH peritoneal dialysis (PD) solutions low in glucose degradation products ("biocompatible") compared with standard solutions. The present paper reports a secondary outcome analysis of the balANZ trial with respect to peritonitis microbiology, treatment, and outcomes.
Adult incident PD patients with residual renal function were randomized to receive either biocompatible or conventional (control) PD solutions for 2 years.
The safety population analysis for peritonitis included 91 patients in each group. The unadjusted geometric mean peritonitis rates in those groups were 0.30 [95% confidence interval (CI): 0.22 to 0.41] episodes per patient-year for the biocompatible group and 0.49 (95% CI: 0.39 to 0.62) episodes per patient-year for the control group [incidence rate ratio (IRR): 0.61; 95% CI: 0.41 to 0.90; p = 0.01]. When specific causative organisms were examined, the rates of culture-negative, gram-positive, gram-negative, and polymicrobial peritonitis episodes were not significantly different between the biocompatible and control groups, although the biocompatible group did experience a significantly lower rate of non-pseudomonal gram-negative peritonitis (IRR: 0.41; 95% CI: 0.18 to 0.92; p = 0.03). Initial empiric antibiotic regimens were comparable between the groups. Biocompatible fluid use did not significantly reduce the risk of peritonitis-associated hospitalization (adjusted odds ratio: 0.80; 95% CI: 0.48 to 1.34), but did result in a shorter median duration of peritonitis-associated hospitalization (6 days vs 11 days, p = 0.05). Peritonitis severity was more likely to be rated as mild in the biocompatible group (37% vs 10%, p = 0.001). Overall peritonitis-associated technique failures and peritonitis-related deaths were comparable in the two groups.
Biocompatible PD fluid use was associated with a broad reduction in gram-positive, gram-negative, and culture-negative peritonitis that reached statistical significance for non-pseudomonal gram-negative organisms. Peritonitis hospitalization duration was shorter, and peritonitis severity was more commonly rated as mild in patients receiving biocompatible PD fluids, although other peritonitis outcomes were comparable between the groups.
一项多中心、多国随机对照试验（balANZ 研究）最近报道，与标准溶液相比，使用葡萄糖降解产物含量低的中性 pH 腹膜透析（PD）溶液（“生物相容性”）可显著降低腹膜炎发生率。本文报告了 balANZ 试验的次要结果分析，涉及腹膜炎的微生物学、治疗和结局。
具有残余肾功能的成年新发性 PD 患者被随机分配接受生物相容性或常规（对照）PD 溶液治疗 2 年。
腹膜炎安全性人群分析包括每组 91 例患者。生物相容性组和对照组患者年腹膜炎发生率分别为 0.30 [95%置信区间（CI）：0.22 至 0.41]和 0.49（95%CI：0.39 至 0.62）[发病率比（IRR）：0.61；95%CI：0.41 至 0.90；p = 0.01]。当检查特定的病原体时，生物相容性组和对照组的培养阴性、革兰阳性、革兰阴性和混合微生物腹膜炎发作率无显著差异，尽管生物相容性组的非假单胞菌革兰阴性腹膜炎发生率显著降低（IRR：0.41；95%CI：0.18 至 0.92；p = 0.03）。两组初始经验性抗生素方案无显著差异。生物相容性液的使用并未显著降低腹膜炎相关住院的风险（调整优势比：0.80；95%CI：0.48 至 1.34），但腹膜炎相关住院的中位时间缩短（6 天 vs 11 天，p = 0.05）。生物相容性组腹膜炎严重程度更可能被评为轻度（37% vs 10%，p = 0.001）。两组腹膜炎相关技术失败和腹膜炎相关死亡的总发生率相当。
生物相容性 PD 液的使用与革兰阳性、革兰阴性和培养阴性腹膜炎的广泛减少相关，非假单胞菌革兰阴性菌的减少具有统计学意义。使用生物相容性 PD 液的患者腹膜炎住院时间更短，腹膜炎严重程度更常见于轻度，但两组腹膜炎的其他结局相当。
