ω-3 脂肪酸补充剂对新合成动静脉血液透析移植物通畅率和心血管事件的影响：一项随机对照试验。
Effect of fish oil supplementation on graft patency and cardiovascular events among patients with new synthetic arteriovenous hemodialysis grafts: a randomized controlled trial.
机构信息
University of Toronto, and Division of Nephrology, Department of Medicine, Toronto General Hospital, 8NU-844, 200 Elizabeth St, Toronto, ON M5G 2C4, Canada.
出版信息
JAMA. 2012 May 2;307(17):1809-16. doi: 10.1001/jama.2012.3473.
CONTEXT
Synthetic arteriovenous grafts, an important option for hemodialysis vascular access, are prone to recurrent stenosis and thrombosis. Supplementation with fish oils has theoretical appeal for preventing these outcomes.
OBJECTIVE
To determine the effect of fish oil on synthetic hemodialysis graft patency and cardiovascular events.
DESIGN, SETTING, AND PARTICIPANTS: The Fish Oil Inhibition of Stenosis in Hemodialysis Grafts (FISH) study, a randomized, double-blind, controlled clinical trial conducted at 15 North American dialysis centers from November 2003 through December 2010 and enrolling 201 adults with stage 5 chronic kidney disease (50% women, 63% white, 53% with diabetes), with follow-up for 12 months after graft creation.
INTERVENTIONS
Participants were randomly allocated to receive fish oil capsules (four 1-g capsules/d) or matching placebo on day 7 after graft creation.
MAIN OUTCOME MEASURE
Proportion of participants experiencing graft thrombosis or radiological or surgical intervention during 12 months' follow-up.
RESULTS
The risk of the primary outcome did not differ between fish oil and placebo recipients (48/99 [48%] vs 60/97 [62%], respectively; relative risk, 0.78 [95% CI, 0.60 to 1.03; P = .06]). However, the rate of graft failure was lower in the fish oil group (3.43 vs 5.95 per 1000 access-days; incidence rate ratio [IRR], 0.58 [95% CI, 0.44 to 0.75; P < .001]). In the fish oil group, there were half as many thromboses (1.71 vs 3.41 per 1000 access-days; IRR, 0.50 [95% CI, 0.35 to 0.72; P < .001]); fewer corrective interventions (2.89 vs 4.92 per 1000 access-days; IRR, 0.59 [95% CI, 0.44 to 0.78; P < .001]); improved cardiovascular event-free survival (hazard ratio, 0.43 [95% CI, 0.19 to 0.96; P = .04]); and lower mean systolic blood pressure (-3.61 vs 4.49 mm Hg; difference, -8.10 [95% CI, -15.4 to -0.85]; P = .01).
CONCLUSIONS
Among patients with new hemodialysis grafts, daily fish oil ingestion did not decrease the proportion of grafts with loss of native patency within 12 months. Although fish oil improved some relevant secondary outcomes such as graft patency, rates of thrombosis, and interventions, other potential benefits on cardiovascular events require confirmation in future studies.
TRIAL REGISTRATION
isrctn.org Identifier: ISRCTN15838383.
背景
合成动静脉移植物是血液透析血管通路的重要选择，但容易出现复发性狭窄和血栓形成。鱼油补充剂在预防这些结果方面具有理论吸引力。
目的
确定鱼油对合成血液透析移植物通畅性和心血管事件的影响。
设计、地点和参与者：鱼油抑制血液透析移植物狭窄（FISH）研究是一项在北美 15 个透析中心进行的随机、双盲、对照临床试验，于 2003 年 11 月至 2010 年 12 月期间招募了 201 名患有 5 期慢性肾脏病的成年人（50%为女性，63%为白人，53%患有糖尿病），在移植物创建后进行了 12 个月的随访。
干预措施
参与者在移植物创建后第 7 天随机分配接受鱼油胶囊（每天 4 个 1 克胶囊）或匹配的安慰剂。
主要结局测量
在 12 个月的随访中，参与者发生移植物血栓形成或放射学或手术干预的比例。
结果
鱼油组和安慰剂组的主要结局风险无差异（分别为 48/99 [48%] 和 60/97 [62%]；相对风险，0.78 [95%CI，0.60 至 1.03；P =.06]）。然而，鱼油组的移植物失功率较低（3.43 与 5.95 每 1000 个血管通路日；发病率比[IRR]，0.58 [95%CI，0.44 至 0.75；P <.001]）。在鱼油组中，血栓形成的发生率较低（1.71 与 3.41 每 1000 个血管通路日；IRR，0.50 [95%CI，0.35 至 0.72；P <.001]）；纠正性干预措施较少（2.89 与 4.92 每 1000 个血管通路日；IRR，0.59 [95%CI，0.44 至 0.78；P <.001]）；心血管事件无事件生存率提高（风险比，0.43 [95%CI，0.19 至 0.96；P =.04]）；平均收缩压降低（-3.61 与 4.49 毫米汞柱；差异，-8.10 [95%CI，-15.4 至 -0.85]；P =.01）。
结论
在新接受血液透析移植的患者中，每天摄入鱼油并没有在 12 个月内降低移植物失去原生通畅性的比例。尽管鱼油改善了一些相关的次要结局，如移植物通畅性、血栓形成和干预措施的发生率，但其他潜在的心血管事件获益需要在未来的研究中得到证实。
试验注册
国际标准随机对照试验注册平台（ISRCTN）注册号：ISRCTN86146458。
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