Fish-Oil Supplementation and Cardiovascular Events in Patients Receiving Hemodialysis.

Supplementation with n-3 polyunsaturated fatty acids, especially eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may have cardiovascular benefits in the general population, but efficacy among patients receiving hemodialysis is uncertain.

补充n-3多不饱和脂肪酸，特别是二十碳五烯酸（EPA）和二十二碳六烯酸（DHA），可能对普通人群有心血管益处，但在接受血液透析的患者中的效果尚不确定。

Methods

In a double-blind, randomized, placebo-controlledtrial conducted at 26 sites in Canada and Australia, we assigned adult patients receiving maintenance hemodialysis to daily supplementation with fish oil (4 g of n-3 polyunsaturated fatty acids [1.6 g of EPA and 0.8 g of DHA]) or corn-oil placebo.

在加拿大和澳大利亚的26个地点进行的一项双盲、随机、安慰剂对照试验中，我们将接受维持性血液透析的成年患者分配到每天补充鱼油（4克n-3多不饱和脂肪酸[1.6克EPA和0.8克DHA]）或玉米油安慰剂。

The primary end point was a composite of all serious cardiovascular events including sudden and nonsudden cardiac death, fatal and nonfatal myocardial infarction, peripheral vascular disease leading to amputation, and fatal and nonfatal stroke.

主要终点是一个包括所有严重心血管事件的复合终点，包括突发和非突发的心脏死亡、致命和非致命性心肌梗死、导致截肢的外周血管疾病，以及致命和非致命性中风。

Secondary end points included extension of the primary end point to include noncardiac causes of death, the individual components of the primary end point, and a first cardiovascular event or death from any cause.

次要终点包括扩展主要终点以包括非心脏原因的死亡，主要终点的各个组成部分，以及首次心血管事件或任何原因的死亡。

Results

Between November 28, 2013, and July 22, 2019, a total of 1228 participants underwent randomization; 610 were assigned to the fish-oil group and 618 to the placebo group.

从2013年11月28日至2019年7月22日，共有1228名参与者进行了随机分组；610人被分配到鱼油组，618人被分配到安慰剂组。

During 3.5 years of follow-up, the rate of serious cardiovascular events was significantly lower in the fish-oil group than in the placebo group (0.31 vs. 0.61 per 1000 patient-days; hazard ratio, 0.57; 95% confidence interval[CI], 0.47 to 0.70; P<0.001).

在3.5年的随访期间，鱼油组严重心血管事件的发生率显著低于安慰剂组（每1000患者天0.31比0.61；风险比，0.57；95%置信区间[CI]，0.47至0.70；P<0.001）。

The rate of the extended primary end point that included noncardiac causes of death appeared to be lower in the fish-oil group than in the placebo group, with a hazard ratioof 0.77 (95% CI, 0.65 to 0.90).

包括非心脏原因死亡的扩展主要终点事件的发生率在鱼油组似乎低于安慰剂组，风险比为0.77（95%置信区间[CI]，0.65至0.90）。

The hazard ratiofor cardiac death was 0.55 (95% CI, 0.40 to 0.75); for fatal and nonfatal myocardial infarction, 0.56 (95% CI, 0.40 to 0.80); for peripheral vascular disease leading to amputation, 0.57 (95% CI, 0.38 to 0.86); for fatal and nonfatal stroke, 0.37 (95% CI, 0.18 to 0.76); and for a first cardiovascular event or death from any cause, 0.73 (95% CI, 0.61 to 0.87).

心源性死亡的风险比为0.55（95%置信区间，0.40至0.75）；致命和非致命性心肌梗死为0.56（95%置信区间，0.40至0.80）；导致截肢的周围血管疾病为0.57（95%置信区间，0.38至0.86）；致命和非致命性中风为0.37（95%置信区间，0.18至0.76）；首次心血管事件或任何原因导致的死亡为0.73（95%置信区间，0.61至0.87）。

Adherence to the trial regimen and the incidenceof adverse events did not differ meaningfully between the groups.

试验方案的依从性和不良事件的发生率在各组之间没有显著差异。

Conclusions

The rate of serious cardiovascular events among participants receiving maintenance hemodialysis was lower with daily supplementation with n-3 fatty acids than with placebo.

接受维持性血液透析的参与者中，每日补充 n-3 脂肪酸组发生严重心血管事件的比率低于安慰剂组。

(Supported by the Heart and Stroke Foundation of Canada and others; PISCES ClinicalTrials.gov number, ISRCTN00691795.).

(该研究由加拿大心脏和中风基金会等资助；PISCES 临床试验注册号，ISRCTN00691795。)