Efficacy and safety of sparfloxacin in combination with kanamycin and ethionamide in multidrug-resistant pulmonary tuberculosis patients: preliminaryresults

SETTING: Department of tuberculosis and chest diseases of a tertiary referr al tuberculosis institute in New Delhi, India. OBJECTIVE: To study the efficacy and safety of sparfloxacin, in combination with kanamycin (for the initial 3-4 months) and ethionamide, in multidrug- resistant (MDR) pulmonary tuberculosis patients. DESIGN: Prospective, uncontrolled study of nine patients with pulmonary tub erculosis who had received adequate anti-tuberculosis treatment with first- line drugs, including supervised category II treatment regimen as per World Health Organization guidelines for 5 months, and were still sputum smear a cid-fast bacilli positive. It was planned to give them kanamycin (initial 3 -4 months), ethionamide and sparfloxacin for 2 years. RESULTS: All nine patients achieved sputum conversion within G months. Seve n patients converted within 3.5 months, two of these within 1 month. All pa tients reported improvement in clinical symptoms, and chest X-ray improved in seven patients. Four patients developed mild to moderate phototoxicity. Eight patients have completed treatment for an average of 19 months (range 15-24 months), and are still under follow-up. One patient defaulted after 7 months of treatment. CONCLUSIONS: In MDR-TB patients, sparfloxacin, along with other anti-tuberc ulosis drugs, appears to be effective and safe. Mild to moderate phototoxic ity is common. However, the long-term results, including relapses, are stil l awaited.