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The use of AMBOXOL in therapy of respiratory organs diseases in children

        Respiratory organs diseases take first place in the structure of children’s morbidity in Ukraine and constitute 598.1 per 1000 children. Taking into consideration a wide spread of respiratory pathology in children concomitant with in the majority of cases with failure of bronchial secretion and mucociliar transport processes, preparations having a bronchi-secretory effect are very important in the therapy of this pathology. AMBROXOL is an effective secretolytic and secretomotoric of benzyl amine group. This preparation has mucolytic and expectorating effects, stimulates serous cells of bronchial mucous coat by enlarging the content of mucous secret and changing damaged ratio of serous and mucous components of expectoration. Ambroxol syrup has been developed by Borschagovsky chemical and pharmaceutical plant jointly with the State scientific center of drugs. It is based on the substance produced by firm “Helm” (Germany). 5 ml syrup (1 teaspoonful) contains 15 mg active substance Ambroxol hydrochloride. As distinct from other mucolytics Ambroxol stimulates formation of surfactant of lipid-protein-mucopolysaccharide origin, maintaining a dynamic equilibrium between capillary tension in lungs and oncotic pressure of pulmonary tissues, thus preventing plasma outflow to alveolocytes (Н. Eckert et al, 1983, MJF. Heath, W. Jacobson, 1985). Normalization of the surfactant plays a barrier role, preventing infective agents invasion. Described also are the role of ambroxol in reducing hyper-reactivity of bronchi as well as a low antitussive effect of the preparation. The goal of this work is clinical study of therapeutic efficiency of ambroxol syrup in children with acute and chronic diseases of respiratory tracts concomitant with poor expectoration secretion. The preparation was prescribed under the following indications: acute bronchitis, chronic bronchitis at the stage of exacerbation, recurring bronchitis, obstructive bronchitis, asthmatic bronchitis, bronchial asthma (period of attacks) and pneumonia. The clinical studies did not include children with hypersensitivity to the preparation, with gastroduodenal ulcer and with combined therapy using preparations resulting in damage of gastrointestinal absorption of drugs. Ambroxol syrup was prescribed after meals in the following doses: infants before 2 years – 2.5 ml syrup (1/2 teaspoonful) twice a day; from 2 to 5 years -2.5 ml syrup (1/2 teaspoonful) 3 times a day, from 5 to 12 years – 5 ml 2 or 3 times a day and teenagers over 12 years – 10 ml (2 teaspoonfuls) 3 times a day. Treatment with the syrup was conducted on the background of a basic therapy, which included antibiotics, broncholytics, physio-therapeutic and non-medicinal therapy methods depending on clinical indications. Ambroxol syrup was not prescribed in combination with other sercretolytic, sercretomotor and antitussive drugs. 30 children aged from 2 months to 14 years were monitored. For every child a card was completed with records of demographic indicators, clinical symptoms of disease, data of objective, laboratory and instrumental examination as well as their dynamics with the use of the preparation under study. All children under examination entered the clinic with acute stage of disease. Coughing was a main clinical symptom in all examined children. In 7 children dry cough, in 23 – wet cough with scanty viscous sputum were noted. In auscultation of lungs in 22 children moist rale of different intensity and 8 children dry sibilant rale was heard. Tolerance of ambroxol syrup was assessed by the following clinical and biochemical indicators in therapy dynamics: heart rate, arterial tension, detailed blood count, general urinalysis, general blood protein count, alanine amino transferase and aspartate amino transferase, thymole test, creatinine, general bilirubin content, blood glucose. Monitoring of clinical and biochemical indicators in the process of therapy with the preparation had demonstrated no confidently significant side effects (vomiting, heartburn, rash, diarrhea), which fact proves good preparation tolerance. Clinical efficiency of ambroxol syrup in examined children was assessed with the use of a verbal scale: 0 – unchanged, 1 – easy rate, 2 – medium rate, 3 – expressed manifestation. From the above data we may derive that on the background of ambroxol syrup therapy an expressed positive dynamics of clinical symptoms of the disease is apparent. So, in 2-week therapy with the preparation coughing weakened and became more productive. Also, a visible reduction of sputum viscosity was noted. In all patients with acute bronchitis rale in therapy dynamics disappeared. The advisability of such analysis is explained by an ambiguous approach to prescription of mucolytics with bronchial asthma attacks. It is assumed that intensification of sputum secretion may aggravate asthma attacks. However, in case of post-attack bronchitis the use of mucolytics, especially of those having properties inherent to ambroxol, may occur very effective. In this context we have separately analyzed dynamics of clinical symptoms in children with bronchiobstructive syndrome Clinical assessment of efficiency of ambroxol syrup therapy in children with bronchial asthma and asthmatic bronchitis in 14 days after preparation application had ascertained coughing weakening and significant its reduction in 3 weeks after therapy commencement. Also, with ambroxol use an expressed positive effect on rheological properties of sputum in 14 and 21 days after therapy commencement was noted. The quantity of dry sibilant rale in dynamics of therapy with ambroxol apparently reduced after 14 days of therapy, however after 21 day of therapy with the preparation rale disappeared in 2/3 patients. At the same time no expressed positive dynamics of indicators of forced expiratory volume in the process of treatment was ascertained in examined children. Indicators of vital capacity of lungs before therapy did not exceed normal values and only insignificantly varied on 14th and 21st days of therapy. Conclusion. Clinical studies of ambroxol syrup (made by Borschagovsky CPP) demonstrate high therapeutic efficiency of this preparation in children with acute and chronic respiratory tract diseases. It was most efficient in patients with acute bronchitis. In children with bronchial asthma positive dynamics of clinical indicators after therapy commencement appeared somewhat later, which fact is conditioned by morphological and functional changes of bronchial tree with this pathology. Ambroxol does not significantly affect indicators of external respiration functions. No side effects in children with the use of ambroxol syrup were noted. Good preparation tolerance was demonstrated. Taking into consideration a wide spread of diseases of respiratory organs in children concomitant with damage of processes of bronchial secretion and mucociliary transport, ambroxol syrup may be recommended for a wide use in pediatric practice.

Published: 20.10.1998