Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.
Estimation of Body Fat Percentage for Clinical Pharmacokinetic Studies in Children.
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DOI：
10.1111/cts.12896
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Cohen-Wolkowiez M
中科院分区：
文献类型：
--
作者：
Green TP;Binns HJ;Wu H;Ariza AJ;Perrin EM;Quadri M;Hornik CP;Cohen-Wolkowiez M
肥胖是一种常见的儿童疾病，肥胖程度似乎可能是许多药物药代动力学（PK）的重要协变量。我们开展这些研究是为了便于评价并在适当情况下量化体脂百分比（BF%）对儿童PK参数的协变量影响。我们检查了两个大型数据库，以确定健康体重儿童和肥胖儿童的BF%的值和变异性，比较了临床方法和人口统计学衍生技术估计BF%的准确性和精密度。此外，我们进行了模拟研究，以评估几种方法在临床试验中的应用。BF%与体重指数（BMI）相关，但在健康体重和肥胖儿童中差异很大。生物阻抗和几种人口统计学衍生技术产生的BF%平均估计值与双能X线吸收测定法的差异< 1%（准确度），SD为5%或更低（精确度）。模拟研究证实，当几种方法之间的精密度差异与PK参数的无法解释的受试者间变异性相比较小时，这些技术在评估BF%（如有）作为该PK参数的协变量的贡献方面具有相似的价值。性别和肥胖分期的组合可以解释BF%与BMI的68%的变异。根据性别和肥胖分期估计BF%可常规应用于PK临床试验，以评价BF%作为潜在协变量的贡献。
Obesity is a prevalent childhood condition and the degree of adiposity appears likely to be an important covariate in the pharmacokinetics (PKs) of many drugs. We undertook these studies to facilitate the evaluation and, where appropriate, quantification of the covariate effect of body fat percentage (BF%) on PK parameters in children. We examined two large databases to determine the values and variabilities of BF% in children with healthy body weights and in those with obesity, comparing the accuracy and precision of BF% estimation by both clinical methods and demographically derived techniques. Additionally, we conducted simulation studies to evaluate the utility of the several methods for application in clinical trials. BF% was correlated with body mass index (BMI), but was highly variable among both children with healthy body weights and those with obesity. Bio‐impedance and several demographically derived techniques produced mean estimates of BF% that differed from dual x‐ray absorptiometry by < 1% (accuracy) and a SD of 5% or less (precision). Simulation studies confirmed that when the differences in precision among the several methods were small compared with unexplained between‐subject variability of a PK parameter, the techniques were of similar value in assessing the contribution of BF%, if any, as a covariate for that PK parameter. The combination of sex and obesity stage explained 68% of the variance of BF% with BMI. The estimation of BF% from sex and obesity stage can routinely be applied to PK clinical trials to evaluate the contribution of BF% as a potential covariate.
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影响因子：
2.7
作者：
Cortés-Castell E;Juste M;Palazón-Bru A;Monge L;Sánchez-Ferrer F;Rizo-Baeza MM
通讯作者：
Rizo-Baeza MM
DOI：
10.1002/oby.21782
发表时间：
2017-04
期刊：
Obesity (Silver Spring, Md.)
影响因子：
--
作者：
Freedman DS;Butte NF;Taveras EM;Lundeen EA;Blanck HM;Goodman AB;Ogden CL
通讯作者：
Ogden CL
影响因子：
2.5
作者：
Holford, Nicholas H. G.;Buclin, Thierry
通讯作者：
Buclin, Thierry
影响因子：
8
作者：
Freedman, David S.;Berenson, Gerald S.
通讯作者：
Berenson, Gerald S.
影响因子：
4.9
作者：
Freedman, DS;Wang, J;Horlick, M
通讯作者：
Horlick, M