ABSTRACT
192 patients, most of them ambulatory, with acute exacerbation of chronic bronchitis were treated with 10- to 14-day courses of oral ofloxacin receiving 400 mg once daily or doxycycline first 200 mg and then 100 mg once daily in this randomized observer-blinded multicentre study. 98 patients were included in the ofloxacin group and 94 in the doxycycline group. The clinical efficacy was 86/87 (98.8%) in the ofloxacin group and 87/91 (91.2%) in the doxycycline group. The bacteriological efficacy was 31/34 (91.2%) in the ofloxacin group and 19/24 (79.2%) in the doxycycline group. Some patients had more than one pathogen. There was no statistically significant difference in efficacy between the two treatment groups; both treatments were highly effective and well tolerated. The adverse events showed an expected pattern. Ofloxacin treatment was discontinued in three patients. In conclusion, both treatments were found to have similar safety and efficacy and were well tolerated when used for treatment of acute exacerbations of chronic bronchitis.
Subject(s)
Bronchitis/drug therapy , Doxycycline/therapeutic use , Ofloxacin/administration & dosage , Administration, Oral , Chronic Disease , Doxycycline/administration & dosage , Doxycycline/pharmacology , Drug Administration Schedule , Female , Humans , Male , Ofloxacin/pharmacology , Ofloxacin/therapeutic use , Time FactorsABSTRACT
The effect of Biostim (RU 41.740), a new non-specific immune modulator, in reducing the number of acute exacerbations in patients with chronic bronchitis, was examined. One hundred and ninety-eight patients with chronic bronchitis stages 2 and 3 entered the study, which was conducted as a multicenter, double-blind, parallel three-group, placebo-controlled trial. The patients were randomised to placebo, Biostim 2 or 8 mg per day, and received treatment for 1 week every other week for 3 successive months during the winter 1983. A significant (p = 0.005) reduction in the number of acute exacerbations was observed in the patients treated with Biostim 2 mg/day, whereas no effect was observed in the placebo or 8 mg/day group. No serious side-effects were encountered.
