口服α一硫辛酸对超重或肥胖患者脉搏波速度和卧位血压影响的随机、双盲、安慰剂对照、交叉试验研究

目的 探讨超重或肥胖患者口服抗氧化剂α-硫辛酸(ALA)对臂踝脉搏波速度(baPWV)、卧位收缩压(sSBP)和卧位舒张压(sDBP)的影响,为超重或肥胖相关心血管疾病的预防提供理论依据.方法 采用随机、双盲、安慰剂对照和交叉试验设计.按照入选标准(20～60岁汉族、BMI≥25 kg/m2和未服用任何抗氧化剂等)纳入研究对象103人(男性63人、女性40人).采用分层区组随机化设计方法将研究对象随机分到ALA组(52人)或安慰剂组(51人)进行为期8周的干预,剂量为1200mg/d.经过4周洗脱期后,两组干预措施交换再干预8周.基线测量包括问卷调查、人体测量、血压测量、脉搏波速度、卧位血压、血液生化指标的检测.两阶段起始和终末均采用统一的检测方法和同一批调查员.采用Stata 11.0软件进行混合效应模型分析.结果 ALA组和安慰剂组人体测量指标和生化指标的基线水平均衡可比(P＞0.05).经口服ALA 8周后,ALA组baPWV降低(-33.03±130.70)cm/s,安慰剂组升高(5.66±139.89)cm/s,两组差异无统计学意义(P=0.078).ALA组sSBP降低(-4.09±9.18)mm Hg,安慰剂组降低(-2.32±8.16)mm Hg,两组差异无统计学意义(P=0.067);ALA组sDBP降低(-1.29±6.55)mm Hg,安慰剂组降低(-0.48±6.63)mm Hg,但两组差异无统计学意义(P=0.595).混合效应模型分析结果显示,在控制了试验顺序、阶段等因素后,两组间baPWV、sSBP和sDBP的差异均无统计学意义.结论 ALA 1200mg/d口服8周,不能明显降低动脉硬度和卧位血压水平.

Abstract：

Objective To investigate the effect of oral alpha-lipoic acid (ALA) supplement on brachial-ankle pulse wave velocity (baPWV),supine systolic blood pressure (SBP) and diastolic blood pressure (DBP) in overweight/obese individuals.An 8-week double-blind,randomized,placebo-controlled and cross-over trial with a 4-week washout between cross-over periods.Methods Sixty-three males and 40 females aged 22-57 years old who met the inclusion criteria as (1) Han ethnicity;(2) 20-60 years old;(3) BMI≥25 kg/m2 and having at least one of the following risk factors:borderline hypertension (130 mm Hg≤SBP＜140 mm Hg and/or 85 mm Hg≤supine DBP＜90 mm Hg),dyslipidemia(fasting total cholesterol≥5.2 mmol/L or HDL-C＜1.04 mmol/L),or impaired fasting glucose (6.1 mmol/L≤fasting glucose＜7.0 mmol/L);(4)Not on any antioxidant gender.Group 1 received 8 weeks ALA (1200 mg/day) followed by 4-week washout period and followed by another 8 weeks placebo;while Group 2 received 8 weeks placebo (1200 mg/day)followed by 4-week washout period,and followed by ALA treatment for 8 weeks.BaPWV and supine blood pressure were measured at the beginning of 1st phase and 2nd phase and at the endpoint of the whole trial.Mixed effect linear regression model was performed to compare the change of baPWV and supine blood pressure between ALA group and placebo group.Results BaPWV decreased -33.03 cm/s ± 130.70 cm/s for ALA group and increased 5.66 cm/s ± 139.89 cm/s for placebo group,supine systolic blood pressure decreased -4.09 mm Hg±9.18 mm Hg for ALA group and -2.32 mm Hg±8.16 mm Hg for placebo group.Supine diastolic blood pressure decreased -1.29 mm Hg ± 6.55 mm Hg for ALA group and -0.48 mm Hg±6.63 mm Hg for placebo group.These three mix-effect models did not show significant effect of ALA treatment after adjustment on baseline values,sex,age,treatment sequence or period.Conclusion The current trial did not provide evidence that oral intake of ALA for 8 weeks had significant effects on lowering baPWV,supine systolic blood pressure or supine diastolic blood pressure.

The effect of oral alpha-lipoic acid in overweight/obese individuals on brachial-ankle pulse wave velocity and supine blood pressure: a randomized, crossover, double-blind, placebo-controlled trial

Objective To investigate the effect of oral alpha-lipoic acid (ALA) supplement on brachial-ankle pulse wave velocity (baPWV),supine systolic blood pressure (SBP) and diastolic blood pressure (DBP) in overweight/obese individuals.An 8-week double-blind,randomized,placebo-controlled and cross-over trial with a 4-week washout between cross-over periods.Methods Sixty-three males and 40 females aged 22-57 years old who met the inclusion criteria as (1) Han ethnicity;(2) 20-60 years old;(3) BMI≥25 kg/m2 and having at least one of the following risk factors:borderline hypertension (130 mm Hg≤SBP＜140 mm Hg and/or 85 mm Hg≤supine DBP＜90 mm Hg),dyslipidemia(fasting total cholesterol≥5.2 mmol/L or HDL-C＜1.04 mmol/L),or impaired fasting glucose (6.1 mmol/L≤fasting glucose＜7.0 mmol/L);(4)Not on any antioxidant gender.Group 1 received 8 weeks ALA (1200 mg/day) followed by 4-week washout period and followed by another 8 weeks placebo;while Group 2 received 8 weeks placebo (1200 mg/day)followed by 4-week washout period,and followed by ALA treatment for 8 weeks.BaPWV and supine blood pressure were measured at the beginning of 1st phase and 2nd phase and at the endpoint of the whole trial.Mixed effect linear regression model was performed to compare the change of baPWV and supine blood pressure between ALA group and placebo group.Results BaPWV decreased -33.03 cm/s ± 130.70 cm/s for ALA group and increased 5.66 cm/s ± 139.89 cm/s for placebo group,supine systolic blood pressure decreased -4.09 mm Hg±9.18 mm Hg for ALA group and -2.32 mm Hg±8.16 mm Hg for placebo group.Supine diastolic blood pressure decreased -1.29 mm Hg ± 6.55 mm Hg for ALA group and -0.48 mm Hg±6.63 mm Hg for placebo group.These three mix-effect models did not show significant effect of ALA treatment after adjustment on baseline values,sex,age,treatment sequence or period.Conclusion The current trial did not provide evidence that oral intake of ALA for 8 weeks had significant effects on lowering baPWV,supine systolic blood pressure or supine diastolic blood pressure.