Comparative study of cefaclor AF vs. cefuroxime axetil in acute exacerbations of chronic bronchitis.
Author(s): Haczynski J, Chyczewska E, Grzelewska-Rzymowska I, Malolepszy J, Marcinkowska-Suchowierska E, Milanowski J, Oklek K, Plusa T, Slominski J, Szmygin K, Rek M
Affiliation(s): Medical Department Eli Lilly Polska, Warsaw, Poland. Haczynski_jozef@lilly.com
Publication date & source: 2002-01, Med Sci Monit., 8(1):PI1-7.
Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial
BACKGROUND: Acute exacerbations of chronic bronchitis (AECB) are the most common complication of chronic bronchitis. The majority of AECB are caused by infection. The choice of appropriate antibacterial therapy for AECB is becoming more difficult and is usually empirically. Cefaclor and cefuroxime are used for ambulatory treatment of AECB. MATERIAL/METHODS: This multicenter, randomized, single blind study was undertaken in order to compare efficacy and safety of cefaclor AF (500 mg BID) and cefuroxime axetil (250 mg BID) in 10 days treatment of ambulatory patients with AECB. 170 adults were enrolled into the study. Clinical responses were assessed on 17th-24th day after randomization. RESULTS: Both antibiotics had high over 97% effectiveness in the treatment of AECB. There was statistically significant 1.7 times higher rate of patients with cough release after cefaclor treatment compared to cefuroxime (p<0.03). There was a significantly 2.25 higher rate of patients with AECB symptoms release like: increasing dyspnea, sputum volume and sputum purulence or cough in cefaclor group compared to cefuroxime (p<0.0187). Both treatments resulted in significant improvement of pulmonary peak expiratory flow (PEF). There were no differences between the rates of gastrointestinal and other side effects in both groups. CONCLUSIONS: 1. Cefaclor and cefuroxime have similar high efficacy and safety in 10 days treatment of patients with AECB. 2. Cefaclor treatment significantly higher 2.25 times reduces the rate of principle symptoms of AECB compared to cefuroxime. 3. Both antibiotics treatment significantly increase PEF, with higher tendency observed in after cefaclor treatment.