PURPOSE: To determine the safety and efficacy of linezolid (L), azithromycin (AZ), along with kanamycin, pyrazinamide, ethionamide and ethambutol in Indian patients having multi-drug resistant tuberculosis.
METHODS: Forty-six patients (study group), aged 18 years to 50 years having multi-drug resistant tuberculosis (MDR-TB) were given linezolid, azithromycin along with kanamycin, pyrazinamide, ethionamide and ethambutol under direct supervision. Forty-four patients (control group) were given kanamycin, pyrazinamide, ethionamide and ethambutol. All patients were HIV negative, smear-positive, non-pregnant and had been receiving anti-tuberculosis drugs for an average of 74 weeks (31 to 128 weeks). All patients had isolates resistant to both isoniazid and rifampicin. Linezolid was given for 6 months. Kanamycin was given in the dose of 25 mg/kg body weight on alternate days for 16 weeks. Pyrazinamide was stopped after 12 weeks of therapy. The course of treatment was 18 months. Sputum examination for acid-fast bacilli was done every 4 weeks.
RESULTS: Forty-two cases in the study group and 41 in the control group completed the treatment. The sputum negative conversion in the study group (82%) was significantly higher than in the control group (58%). The radiological improvement rate was 48% in the study group,which was significantly higher than that in the control group (29%) (P<0.01). The closure rate of the lung cavities in the study group (66%) was higher than in the control group (48%) (P<0.05). No significant difference was found in the side-effects between the two groups.
CONCLUSION: The regimen including linezolid, azithromycin, kanamycin and other second-line anti-TB drugs was effective and safe for the patients with MDR-TB.
CLINICAL IMPLICATIONS: Chemotherapy with linezolid, azithromycin, kanamycin, pyrazinamide, ethionamide and ethambutol seems to be promising for Indian patients having MDR-TB.
DISCLOSURE: Sudhir Agarwal, None.