期刊
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
卷 62, 期 5, 页码 -出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/AAC.02410-17
关键词
MDR-TB; children; India; pharmacokinetics
We studied the pharmacokinetics of levofloxacin (LFX), pyrazinamide (PZA), ethionamide (ETH), and cycloserine (CS) in children with multidrug-resistant tuberculosis (MDR-TB) who were being treated according to the Revised National TB Control Programme (RNTCP) guidelines in India. This observational, pharmacokinetic study was conducted in 25 children with MDR-TB at the Sarojini Naidu Medical College, Agra, India, who were being treated with a 24-month daily regimen. Serial blood samples were collected after directly observed administration of drugs. Estimations of plasma LFX, PZA, ETH, and CS were undertaken according to validated methods by high-performance liquid chromatography. Adverse events were noted at 6 months of treatment. The peak concentration (C-max) of LFX was significantly higher in female than male children (11.5 mu g/ml versus 7.3 mu g/ml; P = 0.017). Children below 12 years of age had significantly higher ETH exposure (area under the concentration-time curve from 0 to 8 h [AUC(0-8)]) than those above 12 years of age (17.5 mu g/ml . h versus 9.4 mu g/ml; P = 0.030). Multiple linear regression analysis showed significant influence of gender on C-max of ETH and age on C-max and AUC(0-8) of CS. This is the first and only study from India reporting on the pharmacokinetics of LFX, ETH, PZA, and CS in children with MDR-TB treated in the Government of India program. More studies on the safety and pharmacokinetics of second-line anti-TB drugs in children with MDR-TB from different settings are required.
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