RATIONALE & OBJECTIVE The efficacy and safety of icodextrin versus glucose-only peritoneal dialysis (PD) regimens is unclear. The aim of this study was to compare once-daily long-dwell icodextrin versus glucose among patients with kidney failure undergoing PD. STUDY DESIGN Systematic review of randomized controlled trials (RCTs), enriched with unpublished data from investigator-initiated and industry-sponsored studies. SETTING & STUDY POPULATIONS Individuals with kidney failure receiving regular PD treatment enrolled in clinical trials of dialysate composition. SELECTION CRITERIA FOR STUDIES Medline, Embase, CENTRAL, Ichushi Web, 10 Chinese databases, clinical trials registries, conference proceedings, and citation lists from inception to November 2018. Further data were obtained from principal investigators and industry clinical study reports. DATA EXTRACTION 2 independent reviewers selected studies and extracted data using a prespecified extraction instrument. ANALYTIC APPROACH Qualitative synthesis of demographics, measurement scales, and outcomes. Quantitative synthesis with Mantel-Haenszel risk ratios (RRs), Peto odds ratios (ORs), or (standardized) mean differences (MDs). Risk of bias of included studies at the outcome level was assessed using the Cochrane risk-of-bias tool for RCTs. RESULTS 19 RCTs that enrolled 1,693 participants were meta-analyzed. Ultrafiltration was improved with icodextrin (medium-term MD, 208.92 [95% CI, 99.69-318.14] mL/24h; high certainty of evidence), reflected also by fewer episodes of fluid overload (RR, 0.43 [95% CI, 0.24-0.78]; high certainty). Icodextrin-containing PD probably decreased mortality risk compared to glucose-only PD (Peto OR, 0.49 [95% CI, 0.24-1.00]; moderate certainty). Despite evidence of lower peritoneal glucose absorption with icodextrin-containing PD (medium-term MD, -40.84 [95% CI, -48.09 to-33.59] g/long dwell; high certainty), this did not directly translate to changes in fasting plasma glucose (-0.50 [95% CI, -1.19 to 0.18] mmol/L; low certainty) and hemoglobin A1c levels (-0.14% [95% CI, -0.34% to 0.05%]; high certainty). Safety outcomes and residual kidney function were similar in both groups; health-related quality-of-life and pain scores were inconclusive. LIMITATIONS Trial quality was variable. The follow-up period was heterogeneous, with a paucity of assessments over the long term. Mortality results are based on just 32 events and were not corroborated using time-to-event analysis of individual patient data. CONCLUSIONS Icodextrin for once-daily long-dwell PD has clinical benefit for some patients, including those not meeting ultrafiltration targets and at risk for fluid overload. Future research into patient-centered outcomes and cost-effectiveness associated with icodextrin is needed.

中文翻译：

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Icodextrin与葡萄糖溶液在腹膜透析中的每日一次长期停留：随机对照试验的丰富系统评价和荟萃分析。

理由和目的目前尚不清楚艾考糊精与仅葡萄糖腹膜透析（PD）方案的疗效和安全性。这项研究的目的是比较接受PD治疗的肾衰竭患者中每天一次的长效艾考糊精与葡萄糖的比较。研究设计随机对照试验（RCT）的系统评价，其中包含来自研究者发起和行业资助研究的未发表数据。设置和研究人群接受常规PD治疗的肾衰竭患者参加了透析液成分的临床试验。从入学开始到2018年11月，Medline，Embase，CENTRAL，Ichushi Web的研究入选标准，10个中文数据库，临床试验注册表，会议记录和引文清单。从主要研究人员和行业临床研究报告中获得了进一步的数据。数据提取2名独立审阅者选择研究并使用预先指定的提取工具提取数据。分析方法人口统计，量表和结果的定性综合。使用Mantel-Haenszel风险比（RRs），Peto比值比（ORs）或（标准化）平均差（MDs）进行定量合成。使用Cochrane RCT的偏倚风险工具评估了纳入研究在结果水平上存在偏倚的风险。结果对纳入1693名参与者的19项RCT进行了荟萃分析。艾考糊精改善了超滤水平（中期MD，208.92 [95％CI，99.69-318.14] mL / 24h;高度确定的证据），也反映出较少的液体超负荷发作（RR，0.43 [95％CI，0.24- 0.78]；高确定性）。与仅含葡萄糖的PD相比，含艾考曲宁的PD可能降低了死亡风险（Peto OR，0.49 [95％CI，0.24-1.00]；中等确定性）。尽管有含艾考糊精的PD降低了腹膜葡萄糖吸收的证据（中期MD，-40.84 [95％CI，-48.09至-33.59] g /长住；高确定性），但这并未直接转化为空腹血浆的变化血糖（-0.50 [95％CI，-1.19至0.18] mmol / L;低确定性）和血红蛋白A1c水平（-0.14％[95％CI，-0.34％至0.05％];高确定性）。两组的安全性结果和残余肾功能相似。与健康有关的生活质量和疼痛评分尚无定论。局限性试验质量参差不齐。随访期是异质的，长期缺乏评估。死亡率结果仅基于32个事件，使用单个患者数据的事件发生时间分析并没有得到证实。结论每日一次长时PD的艾考曲宁对某些患者具有临床益处，包括那些未达到超滤目标且有液体超负荷风险的患者。需要进一步研究以艾考糊精为中心的以患者为中心的结果和成本效益。