Efficacy of an unsupervised ambulatory treatment regimen for smear-negative pulmonary tuberculosis and tuberculous pleural effusion in Malawi

SETTING: Queen Elizabeth Central Hospital, Blantyre, and Zomba Central Hosp ital, Zomba, Malawi. OBJECTIVE: To evaluate treatment outcome of unsupervised ambulatory treatme nt (2R(3)H(3)Z(3)/2TH[EH]/4H) in Blantyre and 'standard' treatment (1STH [S EH]/11TH[EH]) in Zomba in human immunodeficiency virus (HIV) seropositive a nd seronegative patients with smear-negative pulmonary tuberculosis (PTB) a nd pleural TB. DESIGN: All patients with smear-negative and pleural TB registered between 1 April and 31 December 1995 were assessed for enrolment in the study. Stud y patients were followed up and 12-month treatment outcomes were recorded. RESULTS: A total of 434 patients, 296 with smear-negative PTB and 138 with pleural TB, were enrolled: 366 (84%) of patients were HIV-positive; 220 (51 %) completed treatment, and 144 (33%) died by 12 months. In patients from B lantyre and Zomba, baseline characteristics were similar, apart from older age in those from Zomba, and the proportion of patients who completed treat ment and who died were similar. In both sites, significantly higher case fa tality rates were found in older patients, HIV-positive patients and patien ts with pulmonary parenchymal lung disease. CONCLUSION: Unsupervised ambulatory treatment evaluated in this study had a n efficacy similar to that of 'standard' treatment. For operational reasons , however, it will not be recommended for widespread use in Malawi's Nation al Tuberculosis Control Programme.