In a double-blind, double-placebo, randomized crossover study, we compared the effects of 6 wk of treatment with the anti-inflammatory drug nedocromil sodium (16 mg/day) with 6 wk of treatment with the bronchodilator drug albuterol (800 micrograms/day) in 29 adults with allergic asthma. After 3 and 6 wk of treatment with nedocromil sodium, patients were significantly less hyperresponsive to propranolol (p = 0.002 and p = 0.02) and almost significantly less hyperresponsive to histamine (p = 0.071 and p = 0.065). FEV1 and FVC percent predicted tended to be higher, morning PEF values increased significantly (p = 0.038 and p = 0.03), and diurnal and day-to-day PEF variation decreased (p = 0.03 and p = 0.093, p = 0.005 and p = 0.096, respectively) with nedocromil sodium treatment compared with albuterol treatment. Almost all symptoms (daytime and nighttime asthma, wheezing, shortness of breath) and the additional bronchodilator use were significantly reduced with nedocromil sodium treatment compared with albuterol treatment. Treatment with the anti-inflammatory drug nedocromil sodium was shown to be superior to treatment with the bronchodilator drug albuterol. The patient's clinical situation may deteriorate when beta 2-agonists are used continuously. Nedocromil sodium has good clinical effect, and it may serve as a first-line choice for antiinflammatory therapy in asthma.
Fifteen patients admitted to hospital with acute purulent exacerbations of chronic bronchitis were treated with enoxacin by mouth (three 200 mg capsules twice daily) for ten days. Sputum was cultured before, during and after the treatment course. Serum and sputum concentrations were measured microbiologically at intervals on the first treatment day. Blood was assayed before, and 1, 1 1/2, 2, 2 1/2, 3, 5 and 7 h after the first dose and purulent unhomogenized sputum was tested in samples collected 0-2, 2-4, 4-6 and 6-8 h after this dose. The highest concentrations in serum were usually noted 2 or 2 1/2 h after the medication and ranged from approximately 3 to 6 mg/l (average 4.08 mg/l). The highest sputum concentrations were generally found in the 2-4 or 4-6 h portions, and ranged from 2.2 to 6 mg/l (average 3.68 mg/l). The areas under the serum and sputum concentration-time curves were both calculated to be 17.03 mg/l.h (0-7 h values) whereas the projected 0-12 h values were 25.2 and 26.9 mg/l.h, respectively. The drug concentrations declined slowly in serum and sputum with half-lives of approximately 5 and 4 h. Penetration from blood to sputum as judged on peak to peak ratios was approximately 90%, whereas the AUC value ratios showed penetration ranging from 100 to 107.5%. Unfortunately, 9 of the 15 patients had to abandon the treatment (mostly on the third day) due to unwanted drug effects (principally nausea, but some patients had hallucinations, dizziness or epileptiform attacks) possibly related to interference with theophylline metabolism.
Results are presented from 186 hospitalized patients treated for acute purulent exacerbations of chronic bronchitis with orally administered ciprofloxacin (80 patients), enoxacin (26 patients), ofloxacin (30 patients) or pefloxacin (50 patients). In general, good clinical results were observed in 50-70% of the patients treated, most failures being due to relapses or reinfections with Streptococcus pneumoniae or Pseudomonas aeruginosa. Studies on blood and sputum concentration suggested that gastro-intestinal absorption was not always satisfactory. Unwanted drug effects were noted with all agents studied, generally presenting as stomach pain, nausea, hallucinations, or dizziness. Most adverse drug reactions were seen with enoxacin, often but not always during concomitant treatment with theophylline.
Forty-three patients admitted to hospital with acute purulent exacerbations of chronic bronchitis were treated with 400 mg pefloxacin twice daily for ten days. The first 20 patients were given the first dose of the drug as a 60 min intravenous infusion. Serum and sputum concentrations of pefloxacin were measured microbiologically at intervals on the first treatment day and the sputum was cultured before, during, and after the course of pefloxacin. Two patients died from unrelated causes during the follow-up and one refused to continue treatment. All strains of Haemophilus influenzae and Branhamella catarrhalis were eradicated at end-of-treatment but eight strains of Streptococcus pneumoniae and three of Pseudomonas aeruginosa were cultured and the sputum remained purulent despite the pefloxacin. Peak serum concentrations averaged approximately 4.5 mg/l after the infusion and 5 mg/l on oral administration, the corresponding sputum concentrations being 3.8 and 4.6 mg/l, respectively. MICs for H. influenzae were 0.06 mg/l, or less. Mode MICs for the pre- and post-treatment strains of Str. pneumoniae were 4 and 16 mg/l, and the corresponding values for Ps. aeruginosa were 2 and 16 mg/l. The poor results in pseudomonas and pneumococcal infections could largely be explained by the degree of resistance among these organisms.
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