Incidence and Predictors of Drug-Induced Liver Injury in Pediatric Tuberculosis Patients Under Anti-tubercular Therapy: A Prospective Observational Study.

BACKGROUND

Tuberculosis (TB) remains a significant global health challenge, particularly in pediatric populations, where effective treatment with anti-tubercular therapy (ATT) is often complicated by adverse drug reactions. Drug-induced liver injury (DILI) is among the most serious complications of ATT, and identifying risk factors for DILI in children is essential for improving treatment safety and outcomes.

OBJECTIVE

This study aimed to determine the incidence of DILI in pediatric TB patients undergoing ATT and identify demographic and clinical factors associated with its development.

METHODS

A prospective observational study was conducted over 18 months at a tertiary care center in South India. Fifty children aged 1-14 years diagnosed with TB and initiated on ATT were enrolled. Liver function tests (LFTs) were performed at baseline, one month, and six months, and clinical parameters were monitored to identify DILI cases. Nutritional status was assessed using WHO growth standards, and statistical analyses were conducted to identify significant risk factors.

RESULTS

DILI was observed in 16 of 50 patients (32%). Malnutrition was present in 70% of DILI cases compared to 48% of non-DILI cases (p < 0.05). Female patients showed a higher incidence of DILI (56%) than males (44%). Baseline liver enzyme levels, specifically serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT), were significantly higher in patients who developed DILI (p < 0.05). The most common clinical presentation of DILI was jaundice (50%), followed by anorexia and abdominal pain. Pulmonary TB accounted for 50% of DILI cases, while CNS TB represented 37.5%.

CONCLUSIONS

DILI is a common complication of ATT in pediatric TB patients, with malnutrition, female gender, and elevated baseline liver enzymes identified as significant risk factors. Routine liver function monitoring and nutritional interventions should be integral to TB management in children to mitigate the risk of DILI and improve treatment outcomes.