2003, Number 4
Rev Inst Nal Enf Resp Mex 2003; 16 (4)
Efficacy and Tolerability Comparison of the Salbuterol-Ambroxol Combination or of Salbuterol in the Treatment of Bronchial Asthma in Pediatric Patients: Prospective, Double-Blind, Aleatory and Parallel Study.
Cortés BP, Maza GD, Velásquez SJR, Regalado PJ
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ABSTRACTIntroduction: The rise of the asthma at world level, particularly with symptoms in the pediatric age stimulates the study of associations of medications that can be complementary given the physiopathology of the illness. Material and methods: It was carried out a clinical study with the purpose of evaluating the security, tolerability and effectiveness of the combination albuterol-ambroxol, in patient in pediatric age of 6 to 14 years with a crisis of bronchial asthma classified as mild to moderate, with base in respiratory functional tests. The selected patients were assigned from an aleatory way to receive the combination albuterol-ambroxol or only albuterol during a period of 5 days and they were evaluated in the days 1, 3 and 5, through clinical study with base in a scale system and respiratory functional tests. Objective: To know if in this type of patient with exacerbation of their symptoms, some differences exist in relation to the clinical and functional response with the albuterol, medication of well-known efficacy in this pathology and the combination albuterol-ambroxol, agent used in many countries in the world due to its mucolytic effect. Results: A clinical evolution was observed with tendency to the improvement in those patient whom received the combination, the functional response was analyzed to the treatment of each group, being compared with the final measurement of FVC, FEV1 and FEF25-75% and it was found that the combination associated with an improvement statistically significant in the FEF25-75%: (p=0.01). When comparing the spirometric parameters between the first and the last day of the medication it was observed that the group that used the albuterol-ambroxol combination showed an increment respectively in the FVC and the FEF25-75% of the order of 16.8% and 20.6% in comparison with the group that only received albuterol whose increment in the mentioned parameters was of 1% (p< 0.05). Conclusions: This study suggests that the employment of the combination can improve the flow of air at level of peripheric airways in pediatric patient with mild to moderate exacerbations of asthma.