Efficacy and safety of sparfloxacin in combination with kanamycin and ethionamide in multidrug-resistant pulmonary tuberculosis patients: preliminary results.
METHODS
Department of tuberculosis and chest diseases of a tertiary referral 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.


METHODS
Prospective, uncontrolled study of nine patients with pulmonary tuberculosis 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 acid-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 6 months. Seven patients converted within 3.5 months, two of these within 1 month. All patients 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-tuberculosis drugs, appears to be effective and safe. Mild to moderate phototoxicity is common. However, the long-term results, including relapses, are still awaited.
Singla
R
R
Department of Tuberculosis and Chest Diseases, LRS Institute of Tuberculosis and Allied Diseases, New Delhi, India. lrsinet@bol.net.in
Gupta
S
S
Gupta
R
R
Arora
V K
VK
D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D000995:Antitubercular Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D003470:Culture Media; D017484:Dermatitis, Phototoxic / Q000209:etiology; D004359:Drug Therapy, Combination; D005000:Ethionamide / Q000009:adverse effects* / Q000627:therapeutic use*; D024841:Fluoroquinolones; D006801:Humans; D007612:Kanamycin / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000187:drug effects; D011446:Prospective Studies; D013183:Sputum / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000188:drug therapy*; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
D000890:Anti-Infective Agents; D000995:Antitubercular Agents; D003470:Culture Media; D024841:Fluoroquinolones; D007612:Kanamycin; D005000:Ethionamide; C061363:sparfloxacin