Effects of Homocysteine-Lowering With Folic Acid Plus Vitamin B12 vs Placebo on Mortality and Major Morbidity in Myocardial Infarction Survivors A Randomized Trial
Effects of Homocysteine-Lowering With Folic Acid Plus Vitamin B12 vs Placebo on Mortality and Major Morbidity in Myocardial Infarction Survivors A Randomized Trial
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DOI：
10.1001/jama.2010.840
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发表时间：
2010-06-23
影响因子：
120.7
通讯作者：
Collins, Rory
中科院分区：
文献类型：
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作者：
Armitage, Jane M.;Bowman, Louise;Collins, Rory
背景：血液同型半胱氨酸水平与心血管疾病呈正相关，但这种关联是否具有因果关系尚不确定。
目的：评估用叶酸和维生素B - 12降低同型半胱氨酸水平对血管和非血管结局的影响。
设计、地点和患者：1998年至2008年在英国二级护理医院对12064名心肌梗死幸存者进行的双盲随机对照试验。
干预措施：每日2毫克叶酸加1毫克维生素B12与匹配的安慰剂对比。
主要结局指标：首次主要血管事件，定义为主要冠状动脉事件（冠心病死亡、心肌梗死或冠状动脉血运重建）、致命或非致命性卒中，或非冠状动脉血运重建。
结果：分配到研究维生素组使同型半胱氨酸平均降低3.8 μmol/L（28%）。在6.7年的随访期间，分配到叶酸加维生素B12组的6033名参与者中有1537人（25.5%）发生主要血管事件，而分配到安慰剂组的6031名参与者中有1493人（24.8%）发生主要血管事件（风险比[RR]，1.04；95%置信区间[CI]，0.97 - 1.12；P = 0.28）。对主要冠状动脉事件（维生素组1229人[20.4%]，安慰剂组1185人[19.6%]；RR，1.05；95%CI，0.97 - 1.13）、卒中（维生素组269人[4.5%]，安慰剂组265人[4.4%]；RR，1.02；95%CI，0.86 - 1.21）或非冠状动脉血运重建（维生素组178人[3.0%]，安慰剂组152人[2.5%]；RR，1.18；95%CI，0.95 - 1.46）没有明显影响。在归因于血管原因（维生素组578人[9.6%]，安慰剂组559人[9.3%]）或非血管原因（维生素组405人[6.7%]，安慰剂组392人[6.5%]）的死亡人数，或任何癌症的发病率（维生素组678人[11.2%]，安慰剂组639人[10.6%]）方面也没有显著差异。
结论：通过补充叶酸和维生素B12大幅长期降低血液同型半胱氨酸水平对血管结局没有有益影响，但也与癌症发病率的不良影响无关。
Context Blood homocysteine levels are positively associated with cardiovascular disease, but it is uncertain whether the association is causal.Objective To assess the effects of reducing homocysteine levels with folic acid and vitamin B-12 on vascular and nonvascular outcomes.Design, Setting, and Patients Double-blind randomized controlled trial of 12 064 survivors of myocardial infarction in secondary care hospitals in the United Kingdom between 1998 and 2008.Interventions 2 mg folic acid plus 1 mg vitamin B12 daily vs matching placebo.Main Outcome Measures First major vascular event, defined as major coronary event (coronary death, myocardial infarction, or coronary revascularization), fatal or nonfatal stroke, or noncoronary revascularization.Results Allocation to the study vitamins reduced homocysteine by a mean of 3.8 mu mol/L (28%). During 6.7 years of follow-up, major vascular events occurred in 1537 of 6033 participants (25.5%) allocated folic acid plus vitamin B12 vs 1493 of 6031 participants (24.8%) allocated placebo (risk ratio [RR], 1.04; 95% confidence interval [CI], 0.97-1.12; P=.28). There were no apparent effects on major coronary events (vitamins, 1229 [20.4%], vs placebo, 1185 [19.6%]; RR, 1.05; 95% CI, 0.97-1.13), stroke (vitamins, 269 [4.5%], vs placebo, 265 [4.4%]; RR, 1.02; 95% CI, 0.86-1.21), or noncoronary revascularizations (vitamins, 178 [3.0%], vs placebo, 152 [2.5%]; RR, 1.18; 95% CI, 0.95-1.46). Nor were there significant differences in the numbers of deaths attributed to vascular causes (vitamins, 578 [9.6%], vs placebo, 559 [9.3%]) or nonvascular causes (vitamins, 405 [6.7%], vs placebo, 392 [6.5%]) or in the incidence of any cancer (vitamins, 678 [11.2%], vs placebo, 639 [10.6%]).Conclusion Substantial long-term reductions in blood homocysteine levels with folic acid and vitamin B12 supplementation did not have beneficial effects on vascular outcomes but were also not associated with adverse effects on cancer incidence.