Tam Ka-Wai, Wu Mei-Yi, Siddiqui Fahad Javaid, Chan Edwin Sy, Zhu Yanan, Jafar Tazeen H
Division of General Surgery, Department of Surgery, Taipei Medical University-Shuang Ho Hospital, 291, Zhongzheng Road, Zhonghe District, New Taipei City, Taiwan, 23561.
Cochrane Database Syst Rev. 2018 Nov 18;11(11):CD011353. doi: 10.1002/14651858.CD011353.pub2.
Maintaining long-term vascular access patency is necessary for high quality haemodialysis (HD) treatment of patients with the terminal and most serious stage of chronic kidney disease (CKD) - end-stage kidney disease (ESKD). Oral supplementation with omega-3 fatty acids (ω-3FA) may help to prevent blockage of the vascular access by reducing the risk of thrombosis and stenosis.
To evaluate the efficacy and safety of ω-3FA supplementation versus placebo or no treatment for maintaining vascular access patency in ESKD patients undergoing HD.
We searched the Cochrane Kidney and Transplant Register of Studies up to 23 July 2018 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.
Randomised controlled trials (RCTs) of omega-3 fatty acids versus placebo that assessed the patency of arteriovenous fistula (AVF) or arteriovenous graft (AVG) types of vascular access in ESKD patients.
We assessed the risk of bias of each eligible study using the Cochrane Risk of Bias tool and made separate overall risk of bias judgments for the efficacy and safety outcomes. The certainty of evidence was assessed using the GRADE approach. The primary efficacy outcome was loss of vascular patency and the primary safety outcomes were occurrences of serious adverse events (e.g. death, hospitalisation, cardiovascular events, major bleeding). Secondary outcomes were the occurrence of non-serious adverse events (e.g. minor bleeding, gastrointestinal events and other adverse events). Efficacy effects were reported as risk ratios (RR) and safety effects as risk differences (RD) with 95% confidence intervals (CI). Studies were pooled separately by type of vascular access using a random-effects model.
Five studies (833 participants) were included; one was a very small pilot study of 7 participants. All studies compared oral ω-3FA supplements against placebo. Four studies enrolled participants with arteriovenous grafts (AVGs), and the other had participants with arteriovenous fistulas (AVFs). The risk of bias for both efficacy and safety outcomes was unclear for all studies, due mainly to incomplete reporting for allocation concealment and incompleteness of study follow-up.In AVF patients, ω-3FA supplementation probably makes little or no difference to the 12-month risk of patency loss (1 study, 536 participants: RR 1.01, 95% CI 0.84 to 1.21; moderate certainty evidence), risk of death (1 study, 567 participants: RD 0.00, 95% CI -0.03 to 0.02; moderate certainty evidence) and risk of hospitalisation (1 study, 567 participants: RD 0.00, 95% CI -0.08 to 0.08; low certainty evidence). There was no information on cardiovascular events and major bleeding.In AVG patients, it is very uncertain whether ω-3FA supplementation reduces the risk of patency loss within 6 months (2 studies, 41 participants: RR 0.91, 95% CI 0.36 to 2.28; very low certainty evidence) or 12 months (2 studies, 220 participants: RR 0.59, 95% CI 0.27 to 1.31; very low certainty evidence). ω-3FA supplementation may make little or no difference to the risk of death within 6 to 12 months in AVG patients (4 studies, 261 participants: RD 0.01, 95% CI -0.05 to 0.07; low certainty evidence). It is very uncertain if ω-3FA supplementation increases the risk of hospitalisation (3 studies, 65 participants: RD 0.08, 95% CI -0.11 to 0.28; very low certainty evidence), changes the risk of cardiovascular events (4 studies, 261 participants: RD -0.02, 95% CI -0.11 to 0.07; very low certainty evidence), or increases the risk of major bleeding (3 studies, 65 participants: RD 0.08, 95% CI -0.11 to 0.28; very low certainty evidence) within 6 to 12 months in AVG patients. There may be an increase in the risk of mild gastrointestinal adverse reactions (3 studies, 65 participants: RD 0.25, 95% CI 0.07 to 0.43; low certainty evidence) such as a sensation of bloatedness, gas or a fishy aftertaste.
AUTHORS' CONCLUSIONS: In CKD patients with an AVF, there is moderate certainty that ω-3FA supplementation makes little or no difference to preventing patency loss; and in patients with an AVG, it is very uncertain that ω-3FA supplementation prevents patency loss within 12 months.
对于慢性肾脏病(CKD)终末期即终末期肾病(ESKD)患者的高质量血液透析(HD)治疗而言,维持长期血管通路通畅至关重要。口服补充ω-3脂肪酸(ω-3FA)可能有助于降低血栓形成和狭窄风险,从而预防血管通路堵塞。
评估在接受HD的ESKD患者中,补充ω-3FA与安慰剂或不治疗相比,对维持血管通路通畅的疗效和安全性。
我们通过与信息专员联系,使用与本综述相关的检索词,检索了截至2018年7月23日的Cochrane肾脏与移植研究注册库。注册库中的研究通过检索CENTRAL、MEDLINE、EMBASE、会议论文集、国际临床试验注册平台(ICTRP)检索门户和ClinicalTrials.gov来识别。
ω-3脂肪酸与安慰剂的随机对照试验(RCT),评估ESKD患者动静脉内瘘(AVF)或动静脉移植物(AVG)类型血管通路的通畅情况。
我们使用Cochrane偏倚风险工具评估每项合格研究的偏倚风险,并对疗效和安全性结局分别进行总体偏倚风险判断。使用GRADE方法评估证据的确定性。主要疗效结局是血管通路通畅性丧失,主要安全性结局是严重不良事件(如死亡、住院、心血管事件、大出血)的发生情况。次要结局是非严重不良事件(如轻微出血、胃肠道事件和其他不良事件)的发生情况。疗效效应以风险比(RR)报告,安全性效应以风险差(RD)报告,并给出95%置信区间(CI)。研究按血管通路类型使用随机效应模型分别进行汇总。
纳入了5项研究(833名参与者);其中1项是仅有7名参与者的非常小的试点研究。所有研究均将口服ω-3FA补充剂与安慰剂进行比较。4项研究纳入了动静脉移植物(AVG)参与者,另一项纳入了动静脉内瘘(AVF)参与者。所有研究中,疗效和安全性结局的偏倚风险均不明确,主要原因是分配隐藏报告不完整以及研究随访不完整。
在AVF患者中,补充ω-3FA可能对12个月内血管通路通畅性丧失风险几乎没有影响或影响不大(1项研究,536名参与者:RR 1.01,95%CI 0.84至1.21;中等确定性证据),对死亡风险(1项研究,567名参与者:RD 0.00,95%CI -0.03至0.02;中等确定性证据)和住院风险(1项研究,567名参与者:RD 0.00,95%CI -0.08至0.08;低确定性证据)也可能几乎没有影响或影响不大。没有关于心血管事件和大出血的信息。
在AVG患者中,补充ω-3FA是否能降低6个月内(2项研究,41名参与者:RR 0.91,95%CI 0.36至2.28;极低确定性证据)或12个月内(2项研究,220名参与者:RR 0.59,95%CI 0.27至1.31;极低确定性证据)血管通路通畅性丧失风险非常不确定。补充ω-3FA对AVG患者6至12个月内的死亡风险可能几乎没有影响或影响不大(4项研究,261名参与者:RD 0.(此处原文可能有误,应为0.01),95%CI -0.05至0.07;低确定性证据)。补充ω-3FA是否会增加住院风险(3项研究,65名参与者:RD 0.08,95%CI -0.11至0.28;极低确定性证据)、改变心血管事件风险(4项研究,261名参与者:RD -0.02,95%CI -0.11至0.07;极低确定性证据)或增加6至12个月内大出血风险(3项研究,65名参与者:RD 0.08,95%CI -0.11至0.28;极低确定性证据)在AVG患者中也非常不确定。可能会增加轻度胃肠道不良反应的风险(3项研究,65名参与者:RD 0.25,95%CI 0.07至0.43;低确定性证据),如腹胀感、气体或鱼腥味。
在患有AVF的CKD患者中,中等确定性地认为补充ω-3FA对预防血管通路通畅性丧失几乎没有影响或影响不大;而在患有AVG的患者中,非常不确定补充ω-3FA在12个月内能否预防血管通路通畅性丧失。