In a 6-month, double-blind multicenter trial conducted over the winter, the effects of daily administration of ambroxol retard (75 mg) were compared with those of placebo in preventing exacerbations and improving symptoms and clinical signs in chronic bronchitis patients. The trial was completed by 110 patients in the ambroxol group and by 104 in the placebo group. Initially, there were no significant differences between the groups. By the end of the 2nd month of treatment, 67.2% of the ambroxol group had had no exacerbations compared to 50.4% in the placebo group. At the end of the 6-month trial, 45.5% of the treatment group had had no exacerbations, compared to only 14.4% of the control group. These differences were statistically significant. Patients in the treatment group lost significantly fewer days through illness (442) and had fewer days when they needed antibiotic therapy (371) compared to the placebo group patients (837 and 781). Ambroxol also produced statistically significant symptomatic improvement, measured as difficulty in expectoration, coughing, presence of dyspnea and the auscultatory signs as compared to controls. Since ambroxol was well tolerated and compliance was good, it appears like a drug of choice for pharmacological prophylaxis of chronic bronchitis.
In 10 patients who required extracorporeal circulation (ECC) during surgery, we studied the damage induced by surgery to the pulmonary surfactant and the effectiveness of ambroxol in preventing changes in the phospholipid pool. There were 5 control patients and 5 patients who were given 1 g/day of ambroxol on the 4 days prior to and the 4 days after surgery. To follow changes in phospholipid concentrations, bronchoalveolar lavage (BAL) was performed before surgery and 24 h and 8 days after ECC. Phospholipids were assayed in the BAL liquid by two-dimensional thin-layer chromatography. There were marked decreases in total phosphorus and quantitative alterations of individual phospholipid species in the surfactant of the control group, but not in the patients treated with ambroxol
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