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目的观察心血管病高危人群口服抗氧化剂α-硫辛酸(alpha-lipoic acid,ALA)前后臂踝脉搏波速度(baPWV)变化,探讨ALA能否降低心血管危险因素及动脉硬化程度,为心血管病人群提供一级预防理论依据。方法采用随机、双盲、对照、交叉试验设计,在克拉玛依市人民医院体检中心按照研究对象入选和排除条件筛选出健康的20～60岁的汉族研究对象104例,经签署知情同意书后,测量身高、体重、腰围、臀围、血脂4项、baPWV。采用区组设计随机化的方法随机分为2组,分别接受为期8周ALA(1200mg/d)干预和安慰剂对照,洗脱4周后,2组交换再进行8周的干预。整个研究过程中保持双盲的设计。比较2次观察终点时干预组和安慰剂对照组间空腹血糖、空腹胰岛素、甘油三酯、总胆固醇、高密度胆固醇、动脉硬化程度等心血管和2型糖尿病危险因素或者心血管疾病相关早期敏感指标等连续变量平均水平的差别。结果按照意向分析(ITT)策略,104例均进入结果分析。干预组左右两侧baPWV前后差值分别为-2.80±11.6和-3.01±12.7,均低于安慰剂组左右两侧baPWV前后差值(分别0.57±12.71和0.28±12.83),口服ALA左右两侧baPWV差异有统计学意义(P<0.05)。结论口服ALA可降低动脉硬化的程度,对氧化应激引起的心血管疾病有一定的预防作用。
Objective To observe the changes of ankle - brachial ankle pulse wave velocity (baPWV) before and after oral administration of anti - oxidant alpha - lipoic acid (ALA) in high risk population of cardiovascular disease and to explore whether ALA can reduce cardiovascular risk factors and atherosclerosis, The patient population provides a theoretical basis for prevention. Methods A randomized, double-blind, controlled and crossover design was conducted. In the physical examination center of Karamay People’s Hospital, 104 healthy Han Chinese subjects aged 20-60 years were screened according to the selection and exclusion conditions of the study subjects. After signing the informed consent, the height , Body weight, waist circumference, hip circumference, lipids 4, baPWV. Randomized block design randomized into two groups, respectively, for a period of 8 weeks of ALA (1200mg / d) intervention and placebo control, after four weeks of elution, two groups of exchange and then 8 weeks of intervention. Double-blind design was maintained throughout the study. The risk factors of cardiovascular disease and type 2 diabetes mellitus such as fasting blood glucose, fasting insulin, triglyceride, total cholesterol, high-density cholesterol and atherosclerosis were compared between the intervention group and the placebo control group at the end of the second visit. Indicators and other continuous variables, the average level of difference. Results In accordance with the intention to analyze (ITT) strategy, 104 cases were entered into the result analysis. The differences of baPWV between left and right sides of the intervention group were -2.80 ± 11.6 and -3.01 ± 12.7, respectively, which were lower than those of the placebo group (0.57 ± 12.71 and 0.28 ± 12.83, respectively), both sides of oral ALA baPWV difference was statistically significant (P <0.05). Conclusion Oral administration of ALA can reduce the degree of atherosclerosis and prevent cardiovascular diseases caused by oxidative stress.