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Pharmacokinetic-Pharmacodynamic (PK-PD) Analysis of Second-Line Anti-Tubercular Drugs in Indian Children with Multi-Drug Resistance.

To conduct a thorough pharmacokinetic (PK)- pharmacodynamic (PD) analysis of second-line anti-tubercular therapy (ATT) in children diagnosed with multi-drug resistant tuberculosis (MDR-TB). Twenty-seven children undergoing second-line ATT, including kanamycin (KM, n = 13), fluoroquinolones (FQs, n = 26), ethionamide (ETH, n = 20), para amino salicylic acid (PASA, n = 4), and cycloserine (CS, n = 15), were sampled at 0 (pre-dose), 1, 2, 3, and 4 h post-drug administration. Plasma drug levels were determined using a mass spectrometer and the collected dataset underwent non-compartmental PK analysis using PK solver ver2.0. PK/PD assessments involved individual drug simulation studies on 1000 subjects using Modviz Pop ver 1.0 in R-software. A total of 22 and 5 children were considered as responders and non-responders, respectively. Non-compartmental PK analysis revealed mean plasma drug levels of this study cohort attained the targeted maximum drug plasma concentration (Cmax). The ratio of Cmax /minimum inhibitory concentration (MIC) or the area under the curve (AUC)/MIC of the studied drugs had not shown a significant difference between responders and non-responders. Non-responders of ETH and ofloxacin had shown deviation from the derived dose-response profile for the simulated population. The management of MDR-TB with second-line ATT following national guidelines had cured the majority of the children (> 80%) who participated in the study. Inter-individual variability in few children from the targeted Cmax range suggests the need for future investigations on pharmacogenomic aspects of drug metabolism.

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Does the 3C (Counselling, Checking and Certification) Initiative Prevent Hypoglycemia Among At-Risk Stable Late Preterm and Term Neonates? - A Randomized Controlled Trial.

To evaluate whether the 3C (Counselling, Checking, Certification) initiative helps in preventing hypoglycemia among at-risk neonates compared to standard care. This randomised controlled trial included 222 mother-newborn dyads with risk factors for neonatal hypoglycemia-Small for gestational age (SGA) babies, infants of diabetic mothers (IDM), large for gestational age (LGA) babies and late preterm infants (LPI). They were randomized to two groups. Group A received standard care while mothers in group B were administered 3C intervention. Early initiation of breastfeeding, incidence of neonatal hypoglycemia within 24h, and exclusive breastfeeding rate at 6 mo were evaluated. Early initiation of breastfeeding was higher in the 3C group compared to standard care group (94.6% vs. 55.9% p <0.001). The incidence of hypoglycemia within 24h was lower in the intervention group compared to standard care (3.6% vs. 15.3%, p <0.05). However, there was no significant difference in exclusive breastfeeding rates at 6 mo between the two groups (61% and 66% in group A and B respectively). The 3C intervention decreases the incidence of hypoglycemia among at-risk neonates. Early initiation of breast-feeding is higher among mothers who receive the 3C intervention.

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