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补充辅酶Q10用于心血管疾病的一级预防。

Co-enzyme Q10 supplementation for the primary prevention of cardiovascular disease.

作者信息

Flowers Nadine, Hartley Louise, Todkill Daniel, Stranges Saverio, Rees Karen

机构信息

Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.

出版信息

Cochrane Database Syst Rev. 2014;2014(12):CD010405. doi: 10.1002/14651858.CD010405.pub2. Epub 2014 Dec 4.

Abstract

BACKGROUND

Cardiovascular disease (CVD) remains the number one cause of death and disability worldwide and public health interventions focus on modifiable risk factors, such as diet. Coenzyme Q10 (CoQ10) is an antioxidant that is naturally synthesised by the body and can also be taken as a dietary supplement. Studies have shown that a CoQ10 deficiency is associated with cardiovascular disease.

OBJECTIVES

To determine the effects of coenzyme Q10 supplementation as a single ingredient for the primary prevention of CVD.

SEARCH METHODS

We searched the Cochrane Central Register of Controlled Trials (CENTRAL 2013, Issue 11); MEDLINE (Ovid, 1946 to November week 3 2013); EMBASE (Ovid, 1947 to 27 November 2013) and other relevant resources on 2 December 2013. We applied no language restrictions.

SELECTION CRITERIA

Randomised controlled trials (RCTs) lasting at least three months involving healthy adults or those at high risk of CVD but without a diagnosis of CVD. Trials investigated the supplementation of CoQ10 alone as a single supplement. The comparison group was no intervention or placebo. The outcomes of interest were CVD clinical events and major CVD risk factors, adverse effects and costs. We excluded any trials involving multifactorial lifestyle interventions to avoid confounding.

DATA COLLECTION AND ANALYSIS

Two authors independently selected trials for inclusion, abstracted data and assessed the risk of bias.We contacted authors for additional information where necessary.

MAIN RESULTS

We identified six RCTs with a total of 218 participants randomised, one trial awaiting classification and five ongoing trials. All trials were conducted in participants at high risk of CVD, two trials examined CoQ10 supplementation alone and four examined CoQ10 supplementation in patients on statin therapy; we analysed these separately. All six trials were small-scale, recruiting between 20 and 52 participants; one trial was at high risk of bias for incomplete outcome data and one for selective reporting; all studies were unclear in the method of allocation and therefore for selection bias. The dose of CoQ10 varied between 100 mg/day and 200 mg/day and the duration of the interventions was similar at around three months.No studies reported mortality or non-fatal cardiovascular events. None of the included studies provided data on adverse events.Two trials examined the effect of CoQ10 on blood pressure. For systolic blood pressure we did not perform a meta-analysis due to significant heterogeneity. In one trial CoQ10 supplementation had no effect on systolic blood pressure (mean difference (MD) -1.90 mmHg, 95% confidence interval (CI) -13.17 to 9.37, 51 patients randomised). In the other trial there was a statistically significant reduction in systolic blood pressure (MD -15.00 mmHg, 95% CI -19.06 to -10.94, 20 patients randomised). For diastolic blood pressure we performed a random-effects meta-analysis, which showed no evidence of effect of CoQ10 supplementation when these two small trials were pooled (MD -1.62 mmHg, 95% CI -5.2 to 1.96).One trial (51 patients randomised) looked at the effect of CoQ10 on lipid levels. The trial showed no evidence of effect of CoQ10 supplementation on total cholesterol (MD 0.30 mmol/L, 95% CI -0.10 to 0.70), high-density lipoprotein (HDL)-cholesterol (MD 0.02 mmol/L, 95% CI -0.13 to 0.17) or triglycerides (MD 0.05 mmol/L, 95% CI -0.42 to 0.52).Of the four trials that investigated CoQ10 supplementation in patients on statin therapy, three of them showed that simultaneous administration of CoQ10 did not significantly influence lipid levels or systolic blood pressure levels between the two groups. The fourth trial showed a significant increase in the change in total and low-density lipoprotein (LDL)-cholesterol at three months across the four arms of the trial (α-tocopherol, CoQ10, CoQ10 + α-tocopherol and placebo), however the way in which the data were presented meant that we were unable to determine if there was any significant difference between the CoQ10 only and placebo arms. In contrast, there was no significant difference in the change in HDL-cholesterol and triglycerides after three months between the four arms of the trial.

AUTHORS' CONCLUSIONS: There are very few studies to date examining CoQ10 for the primary prevention of CVD. The results from the ongoing studies will add to the evidence base. Due to the small number of underpowered trials contributing to the analyses, the results presented should be treated with caution and further high quality trials with longer-term follow-up are needed to determine the effects on cardiovascular events.

摘要

背景

心血管疾病(CVD)仍是全球首要的死亡和致残原因,公共卫生干预措施主要聚焦于可改变的风险因素,如饮食。辅酶Q10(CoQ10)是一种抗氧化剂,人体可自然合成,也可作为膳食补充剂摄入。研究表明,CoQ10缺乏与心血管疾病有关。

目的

确定补充辅酶Q10作为单一成分用于心血管疾病一级预防的效果。

检索方法

我们于2013年12月2日检索了Cochrane对照试验中心注册库(CENTRAL 2013年第11期)、MEDLINE(Ovid,1946年至2013年11月第3周)、EMBASE(Ovid,1947年至2013年11月27日)及其他相关资源。我们未设语言限制。

入选标准

随机对照试验(RCT),持续时间至少三个月,涉及健康成年人或心血管疾病高危人群但未确诊心血管疾病者。试验仅研究单独补充CoQ10。对照组为无干预或安慰剂。感兴趣的结局为心血管疾病临床事件、主要心血管疾病危险因素、不良反应及成本。我们排除了任何涉及多因素生活方式干预的试验以避免混淆。

数据收集与分析

两位作者独立选择纳入试验、提取数据并评估偏倚风险。必要时我们与作者联系以获取更多信息。

主要结果

我们确定了六项RCT,共218名参与者被随机分组,一项试验等待分类,五项试验正在进行。所有试验均在心血管疾病高危参与者中进行,两项试验仅研究CoQ10补充,四项试验研究了他汀类药物治疗患者补充CoQ10的情况;我们分别对其进行分析。所有六项试验规模均较小,招募人数在二十至五十二人之间;一项试验因结局数据不完整存在高偏倚风险,一项试验因选择性报告存在高偏倚风险;所有研究在分配方法上均不明确,因此存在选择偏倚。CoQ10的剂量在每日100毫克至200毫克之间,干预持续时间相似,约为三个月。没有研究报告死亡率或非致命心血管事件。纳入的研究均未提供不良反应数据。两项试验研究了CoQ10对血压的影响。对于收缩压,由于存在显著异质性,我们未进行Meta分析。在一项试验中,补充CoQ10对收缩压无影响(平均差(MD)-1.90 mmHg,95%置信区间(CI)-13.17至9.37,51名患者被随机分组)。在另一项试验中,收缩压有统计学显著降低(MD -15.00 mmHg,95% CI -19.06至-10.94,20名患者被随机分组)。对于舒张压,我们进行了随机效应Meta分析,结果显示将这两项小试验合并后,没有证据表明补充CoQ10有效果(MD -1.62 mmHg,95% CI -5.2至1.96)。一项试验(51名患者被随机分组)研究了CoQ10对血脂水平的影响。该试验未发现补充CoQ10对总胆固醇(MD 0.30 mmol/L,95% CI -0.10至0.70)、高密度脂蛋白(HDL)胆固醇(MD 0.02 mmol/L,95% CI -0.13至0.17)或甘油三酯(MD 0.05 mmol/L,95% CI -0.42至0.52)有影响。在四项研究他汀类药物治疗患者补充CoQ10的试验中,三项试验表明同时补充CoQ10对两组间血脂水平或收缩压水平无显著影响。第四项试验显示,在试验的四个组(α-生育酚、CoQ10、CoQ10 + α-生育酚和安慰剂)中,三个月时总胆固醇和低密度脂蛋白(LDL)胆固醇的变化有显著增加,然而数据呈现方式意味着我们无法确定仅补充CoQ10组与安慰剂组之间是否存在任何显著差异。相比之下,试验四个组在三个月后HDL胆固醇和甘油三酯的变化无显著差异。

作者结论

迄今为止,很少有研究探讨CoQ10用于心血管疾病的一级预防。正在进行的研究结果将增加证据基础。由于纳入分析的试验数量少且效能不足,所呈现的结果应谨慎对待,需要进一步开展高质量、长期随访的试验以确定其对心血管事件的影响。

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