RESUMO
BACKGROUND: Bacterial infections are involved in more than a half of the exacerbations of chronic obstructive pulmonary disease (COPD). AIM: To evaluate the efficacy and safety of moxifloxacin in the outpatient treatment of moderate exacerbations of bacterial origin in the COPD patients. METHODS: We performed a prospective, observational study including 64 COPD patients with moderate exacerbation of bacterial origin empirically treated with moxifloxacin. In 31 of them, moxifloxacin was used as an initial antibiotic (Group 1), whereas in 33 of them moxifloxacin was used after treatment failure with another antibiotic (Group 2). All patients have treated 7 days with moxifloxacin 400 mg once daily per os, and they were followed up for 20 days, with an intermediate visit at 3, 5 and 7 days at which the duration of symptoms and the side effects of the drug were evaluated. RESULTS: We registered high clinical success rate, i.e. the complete resolution of the symptoms or their return to the baseline severity, similar in both groups (84.3% in all study subjects, 83.9% in the Group 1 and 84.8% in the Group 2). The mean time to complete resolution of the cardinal symptoms or their return to the baseline severity was 5.2 ± 1.1 days. Also, the mean time to complete resolution of the certain cardinal symptoms (increased dyspnea, increased sputum volume and increased sputum purulence) or their return to the baseline severity is given 4.9, 4.7 and 4.2 days, respectively. The incidence of adverse effects during the treatment with moxifloxacin in all study subjects was 10.9%, 9.6% in Group 1 and 12.1% in Group 2. There was no serious adverse effect that required discontinuation of the treatment. Relapse during a 20 days follow-up period was registered in 7.4% of the all study subjects with complete resolution of the cardinal symptoms or their return to the baseline severity, i.e. in two patients from both Group 1 and Group 2 (7.6% and 7.1%, respectively). 4. CONCLUSION: Our findings suggest high efficacy and good tolerability of moxifloxacin in the treatment of moderate COPD exacerbations of bacterial origin.
RESUMO
BACKGROUND: 1,3/1,6-ß-glucans are recognised as immunomodulators in human and veterinary medicine for over 50 years. AIM: To assess the effects of pleuran (1,3/1,6-ß-glucan from Pleurotus ostreatus) on incidence and duration of bacterial exacerbations in patients with COPD. METHODS: We performed an observational, non-randomized, open-label study including 32 COPD patients (Group D) in whom besides the recommended chronic treatment for the stable disease were administered supplement combination containing pleuran 100 mg, vitamin C 60 mg and zinc 5 mg once daily over a three month-period (Group 1). Also, an equal number of Group D COPD patients who besides the recommended treatment for stable disease received the supplement combination containing vitamin C 60 mg and zinc 5 mg once daily, matched to the study subjects of the Group 1 by sex and age served as control (Group 2). RESULTS: Over the study period 57 exacerbations (24 in the Group 1 and 33 in the Group 2) were documented. A mean number of exacerbations over the study period was significantly lower in the Group1 (0.7 ± 0.4) as compared to their mean number in the Group 2 (1.0 ± 0.6) (P = 0.0218). Furthermore, a mean duration of exacerbations expressed in days needed for cure or clinical improvement (i.e. complete resolution of symptoms or return of the symptoms to their baseline severity) in the Group 1 (6.7 ± 0.8 days) was significantly shorter than the mean duration of exacerbations in the Group 2 (7.4 ± 1.3 days) (P = 0.0118). There was not reported any adverse effect during the study period by study subjects from both examined groups. CONCLUSION: Our findings indicated that pleuran might impact the incidence and duration of bacterial exacerbations in patients with COPD. There is a need for further studies for more precise determination of the influence of pleuran on the course of COPD.
