Cho Yeoungjee, Johnson David W, Craig Jonathan C, Strippoli Giovanni F M, Badve Sunil V, Wiggins Kathryn J
Department of Nephrology, Princess Alexandra Hospital, ARTS Building, Ipswich Rd, Woolloongabba, Queensland, Australia, 4012.
Cochrane Database Syst Rev. 2014 Mar 27(3):CD007554. doi: 10.1002/14651858.CD007554.pub2.
The longevity of peritoneal dialysis (PD) is limited by high rates of technique failure, some of which stem from peritoneal membrane injury. 'Biocompatible' PD solutions have been developed to reduce damage to the peritoneal membrane.
This review aimed to look at the benefits and harms of biocompatible PD solutions in comparison to standard PD solutions in patients receiving PD.
We searched the Cochrane Renal Group's Specialised Register (28 February 2013), through contact with the Trials Search Co-ordinator using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE and EMBASE, and handsearching conference proceedings.
All randomised controlled trials (RCTs) and quasi-RCTs in adults and children comparing the effects of biocompatible PD solutions (neutral pH, lactate-buffered, low glucose degradation product (GDP); neutral pH, bicarbonate (± lactate)-buffered, low GDP; glucose polymer (icodextrin)) in PD were included. Studies of amino acid-based PD solutions were excluded.
Two authors extracted data on study quality and outcomes (including adverse effects). The authors contacted investigators to obtain missing information. Summary estimates of effect were obtained using a random-effects model, and results were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for categorical variables, and mean difference (MD) or standardised mean difference (SMD) and 95% CI for continuous variables.
Thirty-six eligible studies (2719 patients) were identified: Neutral pH, lactate-buffered/bicarbonate (± lactate)-buffered, low GDP PD solution (24); icodextrin (12). Allocation methods and concealment were generally incompletely reported, and adequate in only ten studies (27.8%). Patients lost to follow-up ranged from 0% to 83.4%. Neutral pH, low GDP versus conventional glucose PD solutionBased on generally sub-optimal quality evidence, the use of neutral pH, low GDP PD solutions was associated with larger urine volumes at the end of the studies, up to three years of therapy duration (7 studies, 520 patients: MD 126.39 mL/d, 95% CI 26.73 to 226.05). Improved preservation of residual renal function was evident in studies with greater than 12 month follow-up (6 studies, 360 patients: SMD 0.31, 95% CI 0.10 to 0.52). There was no significant effect on peritonitis, technique failure or adverse events with the use of neutral pH, low GDP PD solutions. Glucose polymer (icodextrin) versus conventional glucose PD solutionThere was a significant reduction in episodes of uncontrolled fluid overload (2 studies, 100 patients: RR 0.30, 95% CI 0.15 to 0.59) and improvement in peritoneal ultrafiltration (4 studies, 102 patients, MD 448.54 mL/d, 95% CI 289.28 to 607.80) without compromising residual renal function (4 studies, 114 patients: SMD 0.12, 95% CI -0.26 to 0.49) or urine output (3 studies, 69 patients: MD -88.88 mL/d, 95% CI -356.88 to 179.12) with icodextrin use. A comparable incidence of adverse events with the icodextrin (four studies) was reported.
AUTHORS' CONCLUSIONS: Based on generally sub-optimal quality studies, use of neutral pH, low GDP PD solution led to greater urine output and higher residual renal function after use exceeded 12 months. Icodextrin prescription improved peritoneal ultrafiltration and mitigated uncontrolled fluid overload. There were no significant effects on peritonitis, technique survival, patient survival or harms identified with their use. Based on the best available evidence, the use of these 'biocompatible' PD solutions resulted in clinically relevant benefits without added risks of harm.
腹膜透析(PD)的长期效果受技术失败率的限制,其中一些源于腹膜损伤。已开发出“生物相容性”PD溶液以减少对腹膜的损伤。
本综述旨在探讨生物相容性PD溶液与标准PD溶液相比,在接受PD治疗的患者中的益处和危害。
我们检索了Cochrane肾脏组专业注册库(2013年2月28日),通过与试验检索协调员联系,使用与本综述相关的检索词。专业注册库中的研究通过专门为CENTRAL、MEDLINE和EMBASE设计的检索策略以及会议论文的手工检索来识别。
纳入所有比较生物相容性PD溶液(中性pH、乳酸缓冲、低葡萄糖降解产物(GDP);中性pH、碳酸氢盐(±乳酸)缓冲、低GDP;葡萄糖聚合物(艾考糊精))在PD中的效果的成人和儿童随机对照试验(RCT)和半随机对照试验。排除基于氨基酸的PD溶液的研究。
两位作者提取了关于研究质量和结果(包括不良反应)的数据。作者联系研究者以获取缺失信息。使用随机效应模型获得效应的汇总估计值,结果以分类变量的风险比(RR)及其95%置信区间(CI)表示,连续变量以均数差(MD)或标准化均数差(SMD)及其95%CI表示。
确定了36项符合条件的研究(2719例患者):中性pH、乳酸缓冲/碳酸氢盐(±乳酸)缓冲、低GDP PD溶液(24项);艾考糊精(12项)。分配方法和隐匿情况通常报告不完整,仅10项研究(27.8%)充分。失访患者比例从0%至83.4%不等。中性pH、低GDP与传统葡萄糖PD溶液相比基于总体质量欠佳的证据,使用中性pH、低GDP PD溶液在研究结束时(长达3年的治疗期)与更大的尿量相关(7项研究,520例患者:MD 126.39 mL/d,95%CI 26.73至226.05)。在随访超过12个月的研究中,残余肾功能的改善明显(6项研究,360例患者:SMD 0.31,95%CI 0.10至0.52)。使用中性pH、低GDP PD溶液对腹膜炎、技术失败或不良事件无显著影响。葡萄糖聚合物(艾考糊精)与传统葡萄糖PD溶液相比未控制的液体超负荷发作显著减少(2项研究,100例患者:RR 0.30,95%CI 0.15至0.59),腹膜超滤得到改善(4项研究,102例患者,MD 448.54 mL/d,95%CI 289.28至607.80),且不损害残余肾功能(4项研究,114例患者:SMD 0.12,95%CI -0.26至0.49)或尿量(3项研究,69例患者:MD -88.88 mL/d,95%CI -356.88至179.12)。报告了艾考糊精(四项研究)的不良事件发生率相当。
基于总体质量欠佳的研究,使用中性pH、低GDP PD溶液在使用超过12个月后导致更大的尿量和更高的残余肾功能。艾考糊精处方改善了腹膜超滤并减轻了未控制的液体超负荷。对腹膜炎、技术存活、患者存活或使用它们所识别的危害无显著影响。基于现有最佳证据,使用这些“生物相容性”PD溶液带来了临床相关益处且无额外的危害风险。