Abstract

Summary. This study was designed to evaluate clinical efficacy and safety of carbocysteine lysine salt in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD). This was a prospective randomized comparative controlled trial involving 50 hospitalized patients with acute exacerbation of COPD. The patients were divided in 2 groups: the 1st group patients (n = 25) were treated with syrop of carbocysteine lysine salt (Fluifort) 4 050 mg daily during 10 days, the 2nd control group patients (n = 25) did not receive any mucoactive drugs. Clinical and spirometric parameters and C-reactive protein (CRP) level were serially assessed. At the 5th and 10th days of the treatment, clinical symptoms (cough intensity and sputum expectoration) differed significantly between groups in favor of the carbocysteine group (p < 0.05). FEV1 and FVC improved in both the groups at the 10th day of therapy. Other lung function parameters and peripheral blood leukocyte number did not differ significantly between the groups to the 10th day. CRP decreased significantly to the 10th day in the carbocysteine group compared to the controls (6.8 ± 2.3 vs 9.5 ± 1.2 mg × L–1; p < 0.05). Carbocysteine was well-tolerated by all the patients, serious adverse events were not registered. Therefore, addition of carbocysteine lysine salt (Fluifort), a mucoactive drug with antioxidant and anti-inflammatory properties, to a standard therapy of acute exacerbation of COPD has led to improvement of symptoms and systemic inflammatory reaction.

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