RESUMO
OBJECTIVE: The objective of this randomised, nonblind study was to assess the efficacy of fenspiride as complementary anti-inflammatory therapy in combination with ipratropium bromide in patients with chronic bronchitis (CB). A comparison was made with ipratropium bromide alone, the generally accepted standard therapy for CB. METHODS AND SUBJECTS: The study population comprised 20 patients with chronic obstructive bronchitis (COB) and 60 patients without signs of obstruction. Fifty-one males (64%) and 29 females (36%) aged from 25 to 65 years were studied over a 6-month treatment period. Combined therapy with fenspiride (160 mg/day) and ipratropium bromide (160 mug/day) was prescribed to 39 patients (28 with CB and 11 with COB) for 6 months, and monotherapy with ipratropium bromide (160 microg/day) was prescribed for 41 patients (32 with CB and nine with COB). RESULTS: The combined therapy group had a reduced intensity of dyspnoea, improvements in sputum nature and quantity of exudation, and a reduced intensity of coughing. The monotherapy group showed reductions in sputum exudation and cough intensity. Improvements in lung respiratory function were observed in both groups, but were greater in the combined therapy group of patients. Reduced cytosis, percentage and absolute content of neutrophils, and absolute content of lymphocytes and eosinophils in induced sputum were observed with CB patients in the combined therapy group. A reduced content of lymphocytes and an increase in macrophages were observed with CB patients in the monotherapy group. A significant decline in tumour necrosis factor (TNF)-alpha content in sputum was observed with both therapeutic regimens, although a statistically significant decline in serum TNFalpha (10.85 ng/L to 5.58 ng/L; p = 0.03) and reduced interleukin-8 in sputum (311.94 ng/L to 122.02 ng/L; p = 0.027) were observed with patients given combined therapy. CONCLUSION: The study showed greater efficacy of long-term treatment with fenspiride and ipratropium bromide compared with ipratropium bromide alone in patients with CB. This combination regimen can be recommended for the reduction of inflammation and prevention of disease progression in patients with CB and may also be useful in patients with COB.
RESUMO
AIM: To compare efficacy of atrovent alone and in combination with erespal in patients with chronic bronchitis (CB) and chronic obstructive pulmonary disease (COPD). MATERIAL AND METHODS: Of 80 participants of the trial (51 male and 29 female--63.75 and 36.25%, respectively) who had CB or COPD, 39 patients (28 with CB and 11 with COPD) received 6-month combined treatment with erespal (160 mg/day) and atrovent (160 mcg/day) and 41 patients (32 with CB and 9 with COPD) received atrovent monotherapy in the same dosage. RESULTS: Combined therapy produced positive changes in dyspnea, sputum characteristics and its discharge, cough, monotherapy improved sputum discharge and relieved cough; pulmonary ventilation improved in both groups especially in those on monotherapy. CB patients showed low cytosis, percentage and absolute count of neutrophils, absolute count of lymphocytes and eosinophils in induced sputum. In CB patients percentage of lymphocytes reduced while count of macrophages went up. Combined treatment including erespal also promoted a significant fall of serum and sputum TNFalpha and IL-8 reduction in the sputum. CONCLUSION: Erespal+atrovent treatment proved more effective than atrovent alone. It is recommended for both CB and COPD patients without marked disorders of external respiration function.
