Prednisolone: a beneficial and safe adjunct to antituberculosis treatment? A randomized controlled trial
OBJECTIVE: To appraise the adjunctive role of prednisolone (PN) in pulmonary tuberculosis (PTB) with toxic reactions.
DESIGN: After excluding other febrile causes, and 2 weeks of four/five-drug antituberculosis therapy insufficient to resolve toxic reactions, 178 human immunodeficiency virus (HIV) negative patients with advanced PTB causing persistent high-grade fever (≥38°C), weight loss (≥2 kg/week) and/or low serum albumin levels (<3 g/dL) were randomly allocated to receive either a 12-month course of antituberculosis treatment using four first-line drugs and PN (20 mg b.i.d. IV/IM initially, decreasing over 40 days) (91 patients–PN group), or 12 months of antituberculosis treatment only (87 patients–CO group). Twice-weekly sputum bacillary count, temperature recorded every 6 hours, weekly weight, serial albumin level and liver function measurements and chest roentgenograms were used to assess the effects of PN on PTB.
RESULTS: Temperature decreased from 39.1 ± 0.9 °C to 37.9 ± 0.7°8C (P = 0.0030) within the first 72 (±9) hours in those patients on PN treatment, whereas a gradual decline occurred over 22 (±3) days in the CO group. In the PN group, patients' weight increased from 49.7 ± 4.8 kg to 56.9 ± 8.3 kg, compared to 47.1 ± 6.4 kg to 51.3 ± 5.9 kg in the CO group (P = 0.0022). Increases in serum albumin levels in the PN and CO groups were from 2.26 ± 0.8 g/dL to 3.32 ± 0.6 g/dL and from 2.31 ± 0.5 g/dL to 2.90 ± 0.7 g/dL, respectively (P = 0.0035). The radiographic regression and drop in bacillary count were more rapid, and the hospital stay shorter (53.4 ± 3.1 days vs 71.3 ± 5.6 days) in the PN group, although there were no differences in the acid-fast bacilli conversion rates. There were no detrimental side effects and relapses attributable to PN during the 1–3 year follow-up, even in 18 cases with drug resistance.
CONCLUSION: Prednosolone is a beneficial and safe adjunct to 12-month antituberculosis treatment in advanced PTB causing toxic reactions, provided that close clinical, radiographic and bacillary monitoring is exercised.
Document Type: Regular Paper
Affiliations: Department of Thoracic Medicine, Izmir Chest Diseases and Surgery Training Hospital, Izmir, Turkey
Publication date: 1999-01-01
The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.
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