CAJ | 학술논문

目的探讨在超重或肥胖人群中口服抗氧化剂α-硫辛酸对胰岛β细胞功能和氧化应激水平的影响.方法采用随机、双盲、安慰剂对照和交叉试验设计.选择2009年5月至10月在新疆克拉玛依市人民医院体检中心健康体检的汉族人群103名为研究对象,其中男63名,女40名,年龄20 ～ 60岁.采用分层区组随机设计方法将研究对象分配到d-硫辛酸组和安慰剂组[A组(52名)和B组(51名)]进行为期8周的口服α-硫辛酸干预和安慰剂交叉试验,α-硫辛酸为1200 mg/d,其间有4周的药物洗脱期.检测干预前后空腹及餐后2 h血糖、胰岛素水平、8-异前列腺素、氧化低密度脂蛋白(Ox-LDL)及其他血液生化指标.基线资料比较采用两独立样本t检验,统计分析采用ITT分析.结果与安慰剂组相比,除胰岛素分泌指数[3.96(-28.95～ 36.93)比0.03(-17.11 ～ 17.17),t=11.769,P ＜0.05]外,α-硫辛酸组胰岛素抵抗指数[0.27(-3.13 ～3.56)比0.23(-1.14 ～ 1.60)]、8-异前列腺素[36.91(-3.22 ～ 76.42)ng/L 比 32.15(-2.72 ～ 67.06)ng/L]、Ox-LDL[-3.52(-5.48 ～1.52)μg/L 比-6.49(-8.22 ～-4.78)μg/L]均无明显下降,差异无统计学意义(t=1.0443、0.848、1.247,均P＞0.05).混合效应模型分析结果显示,在调节了基线、年龄、性别、试验顺序、阶段等因素后,两组间胰岛素分泌指数、胰岛素抵抗指数、8-异前列腺素、Ox-LDL干预前后差异均无统计学意义(均P＞0.05).结论超重肥胖人群口服α-硫辛酸短期内可能不会降低氧化应激水平和减轻胰岛素抵抗,也不能改善胰岛B细胞的分泌功能.
목적 탐토재초중혹비반인군중구복항양화제α-류신산대이도β세포공능화양화응격수평적영향.방법 채용수궤、쌍맹、안위제대조화교차시험설계.선택2009년5월지10월재신강극랍마의시인민의원체검중심건강체검적한족인군103명위연구대상,기중남63명,녀40명,년령20 ～ 60세.채용분층구조수궤설계방법장연구대상분배도d-류신산조화안위제조[A조(52명)화B조(51명)]진행위기8주적구복α-류신산간예화안위제교차시험,α-류신산위1200 mg/d,기간유4주적약물세탈기.검측간예전후공복급찬후2 h혈당、이도소수평、8-이전렬선소、양화저밀도지단백(Ox-LDL)급기타혈액생화지표.기선자료비교채용량독립양본t검험,통계분석채용ITT분석.결과 여안위제조상비,제이도소분비지수[3.96(-28.95～ 36.93)비0.03(-17.11 ～ 17.17),t=11.769,P ＜0.05]외,α-류신산조이도소저항지수[0.27(-3.13 ～3.56)비0.23(-1.14 ～ 1.60)]、8-이전렬선소[36.91(-3.22 ～ 76.42)ng/L 비 32.15(-2.72 ～ 67.06)ng/L]、Ox-LDL[-3.52(-5.48 ～1.52)μg/L 비-6.49(-8.22 ～-4.78)μg/L]균무명현하강,차이무통계학의의(t=1.0443、0.848、1.247,균P＞0.05).혼합효응모형분석결과현시,재조절료기선、년령、성별、시험순서、계단등인소후,량조간이도소분비지수、이도소저항지수、8-이전렬선소、Ox-LDL간예전후차이균무통계학의의(균P＞0.05).결론 초중비반인군구복α-류신산단기내가능불회강저양화응격수평화감경이도소저항,야불능개선이도B세포적분비공능.
Objective To explore the effect of oral alpha-lipoic acid (ALA)supplement on the function of islet βcell and level of oxidative stress in overweight/obese subjects.Methods This was a clinical trial using the randomized,double blind,placebo controlled,cross-over design.In Physical Examine Department of People's Hospital of Kelamay City in Xinjiang between May 2009 and October 2009,103 overweight/obese Han subjects(63 males and 40 females) who met the inclusion and excluded criteria were randomly assigned to group A (n =52) or group B(n =51) using blocked randomization.Group A received 8-week ALA(1200 mg/d)followed by placebo for 8 weeks,while group B received 8-week placebo (1200 mg/d)followed by ALA for 8 weeks.A washout period of 4-week followed completion of the ALA/placebo study period.Questionare,plasma oxidized low density lipoprotein (Ox-LDL) and 8-iso-prostaglandin F (8-iso-PGF),fasting and postprandial 2-hour plasma glucose,fasting and postprandial 2-hour plasma insulin,blood pressure,anthropometrics and biochemical parameters were measured at baseline.The methods of examine and inspectors were same through the whole trial.Data were analyzed by mixed-effect statistical model using STATA 11.0.Results Compared with placebo group,except for HOMA-β(3.96(-28.95-36.93)vs 0.03(-17.11-17.17)),the value of HOMA-IR(0.27(-3.13-3.56) vs0.23(-1.14-1.60)),8-iso-PGF (36.91(-3.22-76.42) ng/L vs 32.15 (-2.72-67.06) ng/L),Ox-LDL(-3.52 (-5.48-1.52) μg/L vs-6.49 (-8.22-4.78) μg/L) was not reduced in the intervention group after 8 weeks.There was no significant difference between the two groups (t =1.0443,0.848,1.247,respectively,all P ＞ 0.05).But the mix-effect models showed ALA had no significant effect on HOMA-β,HOMA-IR,8-iso-PGF and Ox-LDL after adjusting for baseline values,sex,age,treatment order or period.Conclusions Oral ALA supplement,1200 mg/d for 8-week may not reduce the level of oxidative stress and insulin-resistant or improve the function of islet β cell for the short time in overweight/obese subjects.