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Prednisolone: a beneficial and safe adjunct to antituberculosis treatment? A randomized controlled trial.

SETTING
A referral centre for thoracic diseases in Izmir, Turkey, 1992-1995.


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 (> or =38 degrees C), weight loss (> or =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 degrees C to 37.9+/-0.7 degrees C (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 51.31+/-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.