Short course chemotherapy for pulmonary tuberculosis. A randomised controlled trial of a six month versus a nine month oral regimen.
We report on the first trial in the Republic of Ireland to look at chemotherapy for TB. This management trial, carried out in single unit, which treats a third of all TB cases in the Republic of Ireland compared to effectiveness of a three drug/nine month regimen (Rifampicin (R), Isoniazed (R), supplemented with Ethambutol (E) for the first two months = RHE9) with a four drug six months regimen (R, H supplemented with E and Pyrazinamide (Z) for the first two months = RHEZ6). Two hundred and eighty eight patients (288) were entered into the study. A total of 143, (76 were in the RHE9 group and 67 in the RHEZ6 group) completed the trial as planned. At the end of the third month, significantly more patients in the RHEZ6 regimen (98%) were culture negative compared to the RHE9 regimen (88%). All were culture negative at the end of chemotherapy. Drug intolerance was seen in 35 (12%) patients with no significant difference in hepatitis between the two regimens. Toxicity from Pyrazinamide was minimal. One hundred and forty five (145) patients were invalid for analysis for the following reason:- bacteriologically negative TB (41), drug intolerance (35), death (23), non-compliance (19), diagnosis not TB (10), drug resistance (7), extrapulmonary disease (4), consent withdrawn (3), Mycobacteria other than tuberculosis (3). All patients are being followed to monitor relapse rates.
Howell
F
F
O'Laoide
R
R
Kelly
P
P
Power
J
J
Clancy
L
L
D000284:Administration, Oral; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D007494:Ireland; D008297:Male; D008875:Middle Aged; D011897:Random Allocation; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*
D000995:Antitubercular Agents