An open non-comparative trial of efficacy and safety of levofloxacin in acute exacerbation of COPD
https://doi.org/10.18093/0869-0189-2007-0-6-67-72
Abstract
The trial was aimed to evaluation of clinical and microbiological efficacy, safety and tolerability of levofloxacin in patients with moderate to severe acute exacerbation of COPD. There was an open, non-randomised prospective study involving 20 patients with acute exacerbation of COPD (16 males, 4 females, the average age, 63.1 ± 8.6 yrs; smoking history, 36.2 ± 14.3 pack/yrs). The drug was administered in the daily dose of 500 mg during 7 days (in 18 patients) or 1 000 mg during 14 days (in 2 patients with P.aeruginosa isolated from sputum). Clinical and microbiological efficacy and tolerability were evaluated in 3, 7 and 14 days of the antimicrobial therapy. Clinical improvement in 3 days of the therapy was noted in 15 patients (75 %) and in 7 days in 19 patients (95 %). Significant improvement was found in lung function parameters (FEV1 , from 40.5 ± 14.7 % pred. to 52.0 ± 18.6 %pred.; р = 0.0001; FVC, from 68.3 ± 21.3 %pred. to 77.6 ± 15.0%pred .; р = 0.005). During the therapy, blood hemoglobin level (р = 0.013) and leukocytes count (р = 0.001) have decreased. Eradication and supposed eradication of pathogens were obtained in 81.8 % of the cases. The drug tolerability was considered as excellent in 85 % of the patients and good in 15 % of the patients. Adverse events were rare, mold and transitional and did not require withdrawal of the drug. Therefore, levofloxacin is an effective antimicrobial drug for treatment of moderate to severe acute exacerbation of COPD; clinical efficacy was 95 % and microbiological efficacy was 82 %.The drug is well tolerated and has a convenient dosing regimen.
About the Authors
A. G. Chuchalin
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
S. N. Avdeev
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
G. E. Baymakanova
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
G. S. Nuralieva
ФГУ НИИ пульмонологии Росздрава
Russian Federation
Russian Federation
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Review
For citations:
Chuchalin A.G., Avdeev S.N., Baymakanova G.E., Nuralieva G.S. An open non-comparative trial of efficacy and safety of levofloxacin in acute exacerbation of COPD. PULMONOLOGIYA. 2007;(6):67-72. (In Russ.) https://doi.org/10.18093/0869-0189-2007-0-6-67-72
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