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Tolerance of pyrazinamide in short course chemotherapy for pulmonary tuberculosis in children
I Sánchez-Albisua1, M L Vidal, G Joya-Verde
1Department of Pediatrics, Hospital Infantil La Paz, Madrid, Spain.
Insights
Pyrazinamide is safe for pediatric tuberculosis treatment. While it may slightly increase uric acid levels, this had no adverse effects in children during short-course chemotherapy.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and therapeutics
- Tuberculosis research
Background:
- Short-course chemotherapy is standard for pediatric tuberculosis.
- Pyrazinamide is a key component, but its tolerance in children requires evaluation.
Purpose of the Study:
- To assess the safety and tolerance of pyrazinamide in children undergoing short-course tuberculosis chemotherapy.
- To monitor for clinical and laboratory adverse effects associated with pyrazinamide use.
Main Methods:
- Prospective study of 114 children (6 months to 15 years) with pulmonary tuberculosis.
- Administered a 6-month oral regimen including pyrazinamide for the first 2 months.
- Monitored clinical adverse events and laboratory parameters, including liver enzymes and uric acid.
Main Results:
- Clinical adverse effects were mild, with low incidence of fever and gastrointestinal disturbances.
- No hepatotoxicity observed; minor, transient elevations in alanine aminotransferase in some children.
- Significant, but generally manageable, increase in serum uric acid levels during pyrazinamide administration.
Conclusions:
- Pyrazinamide is safe and well-tolerated in short-course chemotherapy for pediatric tuberculosis.
- The observed increase in uric acid during pyrazinamide treatment did not lead to adverse clinical outcomes.
- Treatment interruption was not necessary in any patient due to adverse events.
Background:
This prospective study was performed to evaluate the tolerance of pyrazinamide in short course chemotherapy in children.
Methods:
A total of 114 children ages 6 months to 15 years (4.5 +/- 3.4 years) with diagnosed pulmonary tuberculosis from 1985 to 1995 entered the trial. A 2-month regimen of isoniazid, rifampin and pyrazinamide, followed by rifampin and isoniazid for the remaining 4 months, was administered orally to all children. Clinical adverse effects specifically investigated were gastrointestinal disturbances, rash, signs of hepatotoxicity and arthralgias. Laboratory toxicity data (number of leukocytes, erythrocyte sedimentation rate, aspartate aminotransferase, alanine aminotransferase and serum uric acid) were collected before treatment and 1, 3 and 5 months after the beginning of chemotherapy.
Results:
Clinical adverse effects were mild in all cases. Three children (2.6%) had fever and 5 (4.4%) had gastrointestinal disturbances. Aspartate aminotransferase and alanine aminotransferase mean values showed no differences along time and no patients had clinical signs of hepatotoxicity. Only 11 children (19.6%) showed a slight increase in alanine aminotransferase (< 194 units/l). Serum uric acid increased in 92.2% of the children compared with pretreatment values. This increase remained within the normal range in all but 9.8% of patients. There was a significant increase in uric acid mean concentrations after 1 month of therapy (from 3.7 +/- 0.7 mg/dl to 5.7 +/- 1.6 mg/dl, P < 0.05), which fell again (4.0 +/- 1.1) 1 month after pyrazinamide was stopped. There were no signs of gout or arthralgias. In no case was the treatment interrupted.
Conclusion:
The addition of pyrazinamide in chemotherapy for pulmonary tuberculosis in children was found to be safe. The slight increase in uric acid concentration during its administration had no recognized adverse consequences.