Intervention Review

Biocompatible dialysis fluids for peritoneal dialysis

  1. Yeoungjee Cho1,*,
  2. David W Johnson1,
  3. Jonathan C Craig2,3,
  4. Giovanni FM Strippoli2,3,4,5,
  5. Sunil V Badve1,
  6. Kathryn J Wiggins6

Editorial Group: Cochrane Renal Group

Published Online: 27 MAR 2014

Assessed as up-to-date: 28 FEB 2013

DOI: 10.1002/14651858.CD007554.pub2


How to Cite

Cho Y, Johnson DW, Craig JC, Strippoli GFM, Badve SV, Wiggins KJ. Biocompatible dialysis fluids for peritoneal dialysis. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD007554. DOI: 10.1002/14651858.CD007554.pub2.

Author Information

  1. 1

    Princess Alexandra Hospital, Department of Nephrology, Woolloongabba, Queensland, Australia

  2. 2

    The University of Sydney, Sydney School of Public Health, Sydney, NSW, Australia

  3. 3

    The Children's Hospital at Westmead, Cochrane Renal Group, Centre for Kidney Research, Westmead, NSW, Australia

  4. 4

    University of Bari, Department of Emergency and Organ Transplantation, Bari, Italy

  5. 5

    Diaverum, Medical-Scientific Office, Lund, Sweden

  6. 6

    Royal Melbourne Hospital, Departments of Nephrology and General Medicine, Melbourne, VIC, Australia

*Yeoungjee Cho, Department of Nephrology, Princess Alexandra Hospital, ARTS Building, Ipswich Rd, Woolloongabba, Queensland, 4012, Australia. Yeoungjee_cho@health.qld.gov.au. yeoungjee.cho@gmail.com.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 27 MAR 2014

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論

Background

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.

Objectives

This review aimed to look at the benefits and harms of biocompatible PD solutions in comparison to standard PD solutions in patients receiving PD.

Search methods

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.

Selection criteria

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.

Data collection and analysis

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.

Main results

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 solution

Based 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 solution

There 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.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論

Biocompatible dialysis fluids for peritoneal dialysis

Peritoneal dialysis (PD) is a form of treatment for people with advanced kidney disease to an extent where their own kidney function is inadequate to meet the body's requirements. PD is flexible, and allows for therapy to be instituted by patients at home. After initial surgical insertion of a catheter into the abdomen, patients are required to perform regular exchange of PD solution at a prescribed rate to allow clearance of toxins and fluids across the peritoneal membrane. Unfortunately, the longevity of PD is limited, which is largely due to peritoneal membrane injury that results from the use of biologically 'unfriendly' PD solutions. The 'unfriendly' characteristics of these solutions include high glucose levels, glucose breakdown products and acidity. To overcome these hurdles, biocompatible PD solutions (i.e. neutral pH, lowered levels of glucose breakdown products, use of materials alternative to glucose such as icodextrin) have been manufactured that are designed to cause less damage to the peritoneal membrane. This review of interventions testing the benefits and harms of biocompatible PD solutions identified 36 studies (2719 patients).

When compared to conventional PD solutions, we found that neutral pH, low glucose breakdown product PD solution resulted in better preservation of patient's own kidney function including urine output (7 studies, 520 patients), with on average 126.39 mL greater urine output per day. Patients who received glucose polymer (icodextrin) PD solutions were 70% less likely to experience uncontrolled episodes of fluid overload (2 studies, 100 patients).

No significant harms with their use were reported by 10 studies. Many of the studies were of small size, short follow-up duration, poor quality, and had inconsistent reporting of outcomes. Further studies within this area are needed.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論

腹膜透析用的生物相容性透析液

背景

腹膜透析 (peritoneal dialysis, PD) 的壽命,因技術性失敗率偏高而受到限制,部分原因來自於腹膜損傷。目前已研發出「生物相容性」(Biocompatible) 腹膜透析液,可降低對腹膜的傷害。

目的

本次文獻回顧旨在瞭解相對於標準腹膜透析液生物相容性腹膜透析液對接受腹膜透析患者的效益和傷害。

搜尋策略

我們與試驗搜尋協調員聯絡,利用與此次文獻回顧相關的字彙,搜尋考科藍腎臟群組專業註冊 (Cochrane Renal Group's Specialised Register) (2013年2月28日),並採取專為CENTRAL、MEDLINE和EMBASE設計的搜尋策略,找尋專業註冊中的試驗。此外,我們也以人工搜尋的方式,尋找研討會的會議記錄。

選擇標準

此次文獻回顧的納入條件為所有隨機對照試驗 (randomized controlled trial, RCT) 和半隨機對照試驗 (quasi-RCT),試驗對象為成人與兒童,研究主題為比較生物相容性腹膜透析液 (酸鹼值中性、乳酸鹽緩衝、低葡萄糖代謝產物 [glucose degradation product, GDP];酸鹼值中性、重碳酸鹽 [±乳酸鹽] 緩衝、低GDP;葡萄糖聚合物 [icodextrin]) 的效果。我們排除採用含氨基酸腹膜透析液的試驗。

資料收集與分析

由2位作者負責萃取關於試驗品質和結果 (包含不良作用) 的資料。本文獻回顧的作者也聯絡試驗主持人,以收集遺漏的資訊。本次文獻回顧採用隨機效果模式 (random-effects model)來獲得試驗結果的摘要估計值,並以風險比 (risk ratio, RR) 和95%信賴區間 (confidence interval, CI)來呈現結果;以平均差 (mean difference, MD) 或標準化平均差 (standardised mean difference, SMD)以及95% CI計算連續變項。

主要結果

有36篇試驗符合本次文獻回顧的納入條件 (包含2719名患者):包括酸鹼值中性、乳酸鹽緩衝 / 重碳酸鹽 [±乳酸鹽] 緩衝、低GDP的腹膜透析液 (24篇);icodextrin (12篇)。這些試驗通常並未完整報告分組方法和隱匿方式 (concealment),而且只有10篇試驗採取適當程序 (27.8%)。未能接受追蹤的患者約佔0%至83.4%。

酸鹼值中性、低GPD透析液相對於傳統葡萄糖腹膜透析液

根據品質普遍不夠理想的證據,使用酸鹼值中性、低GPD的腹膜透析液,可能與試驗結束時的排尿量較多有關,治療持續時間長達3年 (7篇試驗,520名患者:MD為126.39 mL/d,95% CI為26.73至226.05)。追蹤超過12個月的試驗證實,可保留更多殘餘腎功能 (6篇試驗,360名患者:SMD為0.31,95% CI為0.10至0.52)。使用酸鹼值中性的低GDP腹膜透析液,對腹膜炎、技術性失敗或不良事件並無顯著影響。

葡萄糖聚合物 (icodextrin) 相對於傳統葡萄糖腹膜透析液

使用icodextrin可顯著降低控制不良的體液容積過量 (fluid overload) (2篇試驗,100名患者:RR為0.30,95% CI為0.15至0.59)、改善腹膜透析的超過濾作用 (ultrafiltration) (4篇試驗,102名患者:MD為448.54 mL/d,95% CI為289.28至607.80),且不會損及殘餘腎功能 (residual renal function) (4篇試驗,114名患者:SMD為0.12,95% CI為-0.26至0.49) 或排尿量 (3篇試驗,69名患者:MD為-88.88 mL/d,95% CI為-356.88至179.12)。不良事件發生率和icodextrin相似 (4篇試驗)。

作者結論

根據品質普遍不夠理想的試驗,使用酸鹼值中性的低GDP腹膜透析液超過12個月,可使患者的排尿量增加,也能保留較多的殘餘腎功能。使用icodextrin可改善腹膜透析的超過濾作用,並減輕控制不良的體液容積過量。對腹膜透析所引起的腹膜炎、技術有效期間 (technique survival)、患者存活期或對患者的傷害,並無顯著影響。依據現有的最佳證據,使用這些「生物相容性」腹膜透析液具有臨床相關效益,而且不會增加傷害風險。

 

淺顯易懂的口語結論

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論

腹膜透析用的生物相容性透析液

腹膜透析為晚期腎臟疾病患者的一種治療,這些患者的腎臟功能已經不足以應付身體需求。腹膜透析相當具有彈性,患者可在家中進行治療。剛開始時醫師需要以外科手術,將1條導管埋入患者的腹腔,手術後患者必須定期按醫師處方的速率進行腹膜透析液交換,以便透過腹膜清除體內的毒素和液體。遺憾的是,腹膜透析的使用壽命有限,主要導因於使用對身體「不利」的腹膜透析液所造成的傷害。透析液對身體「不利」的特性包括高葡萄糖濃度、葡萄糖分解產物和酸性。為了克服這些障礙,人們已製造出生物相容性腹膜透析液 (即酸鹼值中性、葡萄糖分解產物濃度偏低,以其他物質取代葡萄糖,例如icodextrin),試圖降低對腹膜的損傷。本篇針對介入法的文獻回顧,納入36篇試驗 (2719名患者),旨在檢視生物相容性腹膜透析液的效益和傷害。

我們發現,相較於傳統的腹膜透析液,酸鹼值中性且葡萄糖分解產物濃度偏低的腹膜透析液,有助於保留患者自身的腎功能,包括排尿量 (7篇試驗,520名患者),患者每天的排尿量平均增加126.39 mL。使用葡萄糖聚合物 (icodextrin) 腹膜透析液,可使患者的控制不良體液容積過量發生率降低70% (2篇試驗,100名患者)。

有10篇試驗指出,使用生物相容性腹膜透析液不會造成顯著傷害。上述許多試驗樣本數少、追蹤期短、品質不良,而且所得出的結果也不一致。這個領域還需要進行進一步的試驗。

譯註


翻譯者:臺北醫學大學實證醫學研究中心
本翻譯計畫由衛生福利部補助經費,臺北醫學大學實證醫學研究中心、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行。