Fixed-dose combination chemotherapy (Rifater/Rifinah) for active pulmonary tuberculosis in Taiwan: a two-year follow-up.
METHODS
Veterans General Hospital-Taipei, Taiwan.


OBJECTIVE
To assess the efficacy and safety of a fixed-dose combination (FDC) of Rifater (RFT)/Rifinah (RFN) in the treatment of newly diagnosed smear-positive pulmonary tuberculosis.


METHODS
Patients were randomly assigned to two 6-month short-course chemotherapy regimens. One group of patients was treated with FDCs and another was given the four component drugs (INH, RMP, EMB and PZA) as separate formulations.


RESULTS
The 105 patients enrolled in the study were divided into two treatment groups. Fifty-one patients who had completed treatment without interruption, 26 in the FDC group and 25 in the separate regimen, were eligible for analysis at the end of 2 years. Among the patients with a drug susceptibility test result available, four in the FDC group had bacilli resistant to pyrazinamide. In the separate regimen group, two patients had bacilli resistant to ethambutol and six had bacilli resistant to pyrazinamide. The two regimens were of similar effectiveness with regard to sputum conversion, compliance and radiological improvement. No patient with FDC treatment developed gastointestinal symptoms, visual disturbance or peripheral neuropathy (P < 0.05). However, FDC treatment resulted in drug-induced fever in one patient. One patient (3.8%) in the FDC group relapsed 5 months after completing treatment.


CONCLUSIONS
This study suggests that the two regimens had similar effectiveness in the treatment of smear-positive pulmonary tuberculosis. However, the fewer adverse drug events among those patients treated with the FDC regimen suggests that it has a better safety profile.
Su
W J
WJ
Division of Pulmonary Immunology and Infectious Diseases, Chest Department, Veterans General Hospital-Taipei, School of Medicine, National Yang-Ming University, Taiwan. wjsu@vghtpe.gov.tw
Perng
R P
RP
D000328:Adult; D000995:Antitubercular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000302:isolation & purification*; D010349:Patient Compliance; D011718:Pyrazinamide / Q000008:administration & dosage* / Q000009:adverse effects; D012293:Rifampin / Q000008:administration & dosage* / Q000009:adverse effects; D013183:Sputum / Q000382:microbiology; D013624:Taiwan; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy* / Q000382:microbiology
D000995:Antitubercular Agents; D004338:Drug Combinations; C087181:isoniazid, pyrazinamide, rifampin drug combination; D011718:Pyrazinamide; D007538:Isoniazid; D012293:Rifampin