A 62-Dose, 6-Month Therapy for Pulmonary and Extrapulmonary Tuberculosis

摘要: STUDY OBJECTIVE To evaluate the efficacy and toxicity of a 62-dose, four-drug, 6-month, directly observed regimen for treatment pulmonary extrapulmonary tuberculosis. DESIGN An open, nonblinded clinical trial, with intended follow-up patients 36 months after completion therapy. SETTING A metropolitan tuberculosis clinic in public health department. PATIENTS From March 1981 through April 1989, we enrolled 160 suspected or known tuberculosis; 35 these were excluded from analysis. INTERVENTIONS Isoniazid, rifampin, pyrazinamide, streptomycin administered daily 2 weeks; drugs then given higher doses twice weekly 6 weeks, followed by isoniazid rifampin 18 weeks. total 62 administered, all therapy was nurse an outreach worker. MEASUREMENTS AND MAIN RESULTS Of 125 evaluable patients, 101 (81%) had tuberculosis, 7 (6%) both involvement, 17 (13%) disease only. Seventy-one (57%) history recent alcoholism. There two relapses (1.6% +/- 2.2%), occurring 56 The time at which sputum samples became culture negative ranged 1 to 19 weeks (median, 4.6 weeks); 40% 9.6% culture-negative 4 therapy, 75% 8.5% 8 94% 4.7% 12 97% 3.3% 16 100% 20 Adverse drug reactions included hyperuricemia (greater than 178 mumol/L [3 mg/dL] above normal) secondary pyrazinamide 80 (64%), twofold greater elevations aspartate aminotransferase 21 (17%), 1.5-fold alkaline phosphatase 33 (27%), cutaneous abnormalities (6%), nausea five (4%), dizziness patient (1%). CONCLUSIONS This largely twice-weekly is efficacious relatively nontoxic especially useful whom indicated.