1.Using magnetic resonance imaging to validate bioelectrical impedance analysis for measuring the area of visceral adipose tissue
Jiongxian YANG ; Jie YAN ; Yun PENG ; Changlu PAN ; Wenli YANG ; Yanqiu LYU
Chinese Journal of Health Management 2018;12(3):212-215
Objective To validate bioelectrical impedance analysis(BIA) for measuring the area of visceral fat of school-age populations using MRI as a reference method.Methods Sixty healthy children (30 boys and 30 girls) aged 7 to 18 years were enrolled in the study.Both MRI and BIA were completed in seven days.We obtained the indexes of the body composition from BIA and MRI in the morning before the participants had their breakfast.For reference,the navel plane image obtained with MRI was used to analyze the area of adipose tissue.With BIA,the area of visceral adipose tissue could be derived directly.Results Sixty healthy school-age children were enrolled in the study.The average age of the school children was (11.9±4.6) years,and their BMI was (22.8±7.3) kg/m2.The average area of visceral fat obtained with BIA was (85.4±64.2) cm2,which was higher than that obtained with MRI [(49.4±32.4) cm2](t=-6.524,P =0.000).The Pearson correlation coefficient was r=0.806 (P=0.000) and the simple linear regression equation for the areabetween the two was:y=0.41x + 14.78;β (95%CI) was 0.41(0.04-0.81).The Bland-Altman plot was (x-) ±1.96 s:(35.9± 83.7) cm2.Conclusion BIA is comparable to MRI for assessing the area of visceral fat and is a reliable and simple tool to evaluate the visceral fat area in school-age children.
2.Bioequivalence Study of Minocycline Hydrochloride Capsules in A Healthy Chinese Population
Xincheng FENG ; Jiongxian LYU ; Chang SU ; Chaochao HUANG ; Hong SUN ; Haijiao CHENG ; Minlu CHENG ; Juefang DING ; Li DING ; Yuwen SU
Herald of Medicine 2024;43(10):1545-1551
Objective To evaluate the bioequivalence of two formulations of minocycline hydrochloride capsules administered orally after fasting administration and fed administration.Methods An open-label,randomized,two-period,self-crossover design was employed to assess the bioequivalence study.Twenty-eight healthy subjects were enrolled in both fasting and fed groups,with each period involving a single administration of either the reference formulation or the test formulation of 50 mg,separated by a washout period of 7 days.The concentration of minocycline in human plasma was determined by HPLC-MS/MS and was used for calculating pharmacokinetic parameters and evaluating the bioequivalence of the test formulation and reference formulation.Results After oral administration of test and reference formulations of minocycline under fasting condition,the Cmax Values of minocycline were(541±137)ng·mL-1 for the test formulation and(558±140)ng·mL-1for the reference formulation.The AUC0-t values were(8 347±1 986)h·ng·mL-1 for the test and(8 205±1 790)h·ng·mL-1 for the reference.The t1/2 values were(18.2±2.84)h for the test and(18.0±3.05)h for the reference.After oral administration of the test and reference formulations of minocycline under fed condition,the Cmax values of minocycline were(349±72.1)ng·mL-1 for the test and(352±73.2)ng·mL-1for the reference.The AUC0-twere(6 428±1 077)h·ng·mL-1 for the test and(6 588±1 118)h·ng·mL-1 for the reference.The t1/2values were(18.5±3.10)h for the test and(18.4±3.21)h for the reference.Under fasting condition,the 90% confidence intervals for the geometric mean ratios of Cmax,AUC0-t,and AUC0-∞ between the test and reference formulations were(90.84%,101.46% ),(95.2%,102.8% ),and(95.31%,102.71% ),respectively.Under fed conditions,the 90% confidence intervals for the geometric mean ratios of Cmax,AUC0-t,and AUC0-∞ between the test formulation and the reference formulation were(94.71%,103.42% ),(95.40%,99.83% ),and(95.79%,100.02% ),respectively.Conclusions Bioequivalence of the two minocycline formulations was demonstrated after fasting administration and fed administration in a healthy Chinese population.