Background: Thyroid hormones are essential for early neurocognitive development and growth and development in childhood and adolescence. However, the reference intervals (RIs) for thyroid hormones in Chinese pediatric individuals remain unclear. This study aimed to establish thyroid hormone RIs for a Chinese pediatric population according to appropriate age-and sex-specific partitioning.
Methods:In this prospective observational study, a total of 1,279 healthy children (singletons, aged from 1 day to 12 years) were recruited, and serum samples were analyzed on a Mindray automated chemiluminescence immunoassay analyzer CL-6000i for thyroid hormone detection, including thyroidstimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), total triiodothyronine (T3), and total thyroxine (T4). Age and sex-specific RIs were established, and the corresponding 95% confidence intervals (CIs) were calculated in accordance with the Clinical Laboratory Standards Institute (CLSI) document C28-A3 guidelines.Results: Quantile testing revealed that the median (P50) and RIs [2.5 th percentile (P2.5)-97.5 th percentile (P97.5)] for TSH, FT3, T3, and T4 of males differed significantly from those of females (P<0.05), except for FT4 (P=0.483). For FT3 and T3, the RIs of males were higher than that of females, and the RI of T4 for males was narrower and higher than that of females [P2. 5-P97.5: 72.33-171.60 vs. 72.31-176.27 nmol/L; P50: 116.75 vs. 113.47 nmol/L, P=0.011]. RIs for TSH, FT3, FT4, T3, and T4 showed sex-and agespecific properties and displayed a wide variation during the first month of life but gradually narrowed and concentrated with increasing age.
Knowledge of pharmacokinetic (PK) behavior of norvancomycin (NVCM) in pediatric patients is lacking, which leads to empirical therapy in clinical practice. This study developed a population PK model of children aged 0‐15 years; 112 opportunistic samples in total from 90 children were analyzed. The stability and prediction of the final model were evaluated by goodness‐of‐fit plots, nonparametric bootstrap, visual predictive check, and normalized prediction distribution errors. The PKs of NVCM in children was described by a 2‐compartment model with first‐order elimination along with body weight and estimated glomerular filtration rate as significant covariates on clearance. The population typical values of the PK parameters were as follows: clearance 0.12 L/kg/h, central compartment distribution volume 0.17 L/kg, peripheral compartment distribution volume 0.38 L/kg, and intercompartmental clearance 0.35 L/kg/h. Logistic analysis showed that the ratio of area under the concentration‐time curve over 24 hours (AUC0‐24) to minimum inhibitory concentration (MIC) had the strongest correlation with clinical efficacy, and at least 80% clinical efficiency could be achieved when AUC0‐24/MIC ≥ 221.06 was defined as the target. Monte Carlo simulation results suggested that a higher dose was required for this pediatric population in order to reach the target. The dosing regimen was optimized based on the final model. A population PK model of NVCM was first characterized in children with hematologic malignancy, and an evidence‐based approach for NVCM dosage individualization was provided.
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