6-MONTHS ISONIAZID-RIFAMPIN THERAPY FOR PULMONARY TUBERCULOSIS - REPORT OF A "UNITED-STATES-PUBLIC-HEALTH-SERVICE COOPERATIVE TRIAL

  • 1 January 1984
    • journal article
    • research article
    • Vol. 129  (4) , 573-579
Abstract
In a multicenter trial of 2 regimens for treatment of pulmonary tuberculosis, all patients received 300 mg of isoniazid (INH) and 600 mg of rifampin (RIF) daily for 6 mo. (the initial phase). During the next 9 mo. (the maintenance phase) patients received either daily INH (300 mg) and ethambutol (EMB) (15 mg/kg body wt) or matching placebos. Of the 672 patients who met the admission criteria, only 309 (46%) completed the initial and maintenance phases. Of the patients, .apprx. 20% failed to keep their appointments. Adverse drug reactions, most commonly hepatotoxicity, accounted for the withdrawal of 37 patients (5.5%). No visual toxicity caused by EMB was observed. During the maintenance phase, 3 patients who were taking INH and EMB, and 16 who were taking placebos, developed relapses, i.e., .gtoreq. 2 positive cultures. The significant difference in relapse rate between regimens (Fisher''s exact test, P < 0.001) demonstrates the inadequacy of INH-RIF given alone for only 6 mo.