Liu Xuedong, Shi Ming, Xia Feng, Han Junliang, Liu Zhirong, Wang Bo, Yang Fang, Li Li, Wu Songdi, Wang Ling, Liu Nan, Lv Yali, Zhao Gang
Department of Neurology, Xijing Hospital, the Fourth Military Medical University, Xi'an, Shaanxi, China.
Int J Stroke. 2015 Feb;10(2):264-8. doi: 10.1111/ijs.12017. Epub 2013 Mar 12.
Epidemiological studies suggest that elevated homocysteine is linked to stroke and heart disease. However, the results of lowering homocysteine levels in reducing the risk of stroke recurrence are controversial.
The study aims to evaluate whether homocysteine-lowering therapy with folic acid and vitamins B6 and B12 reduces recurrent stroke events and other combined incidence of recurrent vascular events and vascular death in ischemic stroke patients of low folate regions.
This is a multicenter, randomized, double-blinded, placebo-controlled trial. Patients (n = 8000, α = 0.05, β = 0.10) within one-month of ischemic stroke (large-artery atherosclerosis or small-vessel occlusion) or hypertensive intracerebral haemorrhage with plasma homocysteine level ≥ 15 μmol/l will be enrolled. Eligible patients will be randomized by a web-based, random allocation system to receive multivitamins (folic acid 0.8 mg, vitamin B6 10 mg, and vitamin B12 500 μg) or matching placebo daily with a median follow-up of three-years.
Patients will be evaluated at six monthly intervals. The primary outcome event is the composite event 'stroke, myocardial infarction, or death from any vascular cause', whichever occurs first. Secondary outcome measures include nonvascular death, transient ischemic attack, depression, dementia, unstable angina, revascularization procedures of the coronary, and cerebral and peripheral circulations.
This is the first multicenter randomized trial of secondary prevention for ischemic stroke in a Chinese population with a higher homocysteine level but without folate food fortification.
流行病学研究表明，同型半胱氨酸水平升高与中风和心脏病有关。然而，降低同型半胱氨酸水平以降低中风复发风险的结果存在争议。
本研究旨在评估在低叶酸地区的缺血性中风患者中，使用叶酸、维生素B6和B12降低同型半胱氨酸水平是否能减少复发性中风事件以及复发性血管事件和血管性死亡的其他合并发生率。
这是一项多中心、随机、双盲、安慰剂对照试验。将纳入缺血性中风（大动脉粥样硬化或小血管闭塞）或高血压性脑出血发生后1个月内、血浆同型半胱氨酸水平≥15μmol/l的患者（n = 8000，α = 0.05，β = 0.10）。符合条件的患者将通过基于网络的随机分配系统随机分组，每天接受多种维生素（叶酸0.8mg、维生素B6 10mg和维生素B12 500μg）或匹配的安慰剂，中位随访期为三年。
将每隔六个月对患者进行评估。主要结局事件是复合事件“中风、心肌梗死或任何血管原因导致的死亡”，以最先发生者为准。次要结局指标包括非血管性死亡、短暂性脑缺血发作、抑郁症、痴呆症、不稳定型心绞痛、冠状动脉以及脑和外周循环的血管重建手术。
这是第一项针对同型半胱氨酸水平较高但未进行叶酸食品强化的中国人群缺血性中风二级预防的多中心随机试验。
