To determine the safety and efficacy of sparfloxacin along with kanamycin, pyrazinamide, ethionamide and ethambutol in Indian patients having multi-drug resistant tuberculosis. Efficacy was assessed by sputum smear and culture negativity at the end of 20 weeks.
124 patients (aged 18 years to 50 years) of multi-drug resistant tuberculosis (MDR-TB) were given 400 mg of sparfloxacin along with kanamycin, pyrazinamide, ethionamide and ethambutol under direct supervision. All patients were HIV negative, smear-positive, non-pregnant and had been receiving anti-tuberculosis drugs for an average of 72 weeks (31 to 125 weeks). All patients had isolates resistant to both isoniazid and rifampicin. 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. Sputum examination for acid-fast bacilli was done every 4 weeks up to 20 weeks to know smear and culture negativity.
Three patients were withdrawn from the trial because of kanamycin induced ototoxicity. Sparfloxacin was stopped in three patients because of severe phototoxicity and in 2 patients because of prolongation of electrographic QTc interval. One hundred and sixteen out of 124 patients received sparfloxacin for 20 weeks. After 20 weeks smear conversion was in 99 (85%) and culture conversion in 86 (74%) patients.
Treatment with sparfloxacin along with kanamycin, ethionamide, pyrazinamide and ethambutol in patients with MDR-TB has favourable response with acceptable phototoxicity.
Chemotherapy with sparfloxacin, kanamycin, pyrazinamide, ethionamide and ethambutol seems to be promising for Indian patients MDR-TB.
S.K. Agarwal, None.