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Systemic Oral Enzyme Therapy in the Complex Treatment of Recurrent Respiratory Inflammationsin Children - Post-registration Retrospective Multicentric Evaluation


Authors: E. Adámková 1;  J. Balcar 2;  E. Bartovičová 3;  Y. Fialová 4;  P. Gricová 5;  J. Hak 6;  B. Hubková 7;  M. Komárková 8;  D. Krbušek 9;  M. Kučerová 10;  D. Machoňová 11;  J. Slaninová 12;  I. Vokálová 13;  Vrajíková J. Statistické Zpracování Hačkajlo D. Koordinátor Honzíková M. 14 15 16
Authors‘ workplace: Pardubice1, Litoměřice2, Brno3, Soběslav4, Uherské Hradiště5, Liberec6, Kladno7, Kynšperk nad Ohří8, Mnichovo Hradiště9, Čkyně10, Tábor11, Kardašova Řečice12, Kralupy nad Vltavou13, Studénka14 Datové centrum IKEM, Praha15 MUCOS Pharma CZ - klinický výzkum 16
Published in: Čes-slov Pediat 2004; (10): 513-521.
Category:

Overview

The primary goal of systemic oral enzyme therapy (SET) administration is to influence the course ofinflammatory process. Its efficacy has been proven in a series of randomized double blind controlled clinical trials.Growing positive experience of paediatric practitioners regarding the effect of SET in the complex treatmentof children with recurrent respiratory inflammations (RZDC) was the main suggestion for performance ofretrospective multicentric evaluation of the preparationWobenzym, comparing its efficacy with that of bacterialimmunomodulators (BIM).Medical records of 468 children at the age of 3-18 years (SET: n=346 children; BIM: n=122 children) wereanalyzed at 14 workplaces of paediatric practitioners. Number of respiratory inflammations (inflammations of upper and lower respiratory tract including sinusitis and otitis media according to MKN-10) as well as number ofinterrelated antibiotic cures in the period of 12months before and after beginning of the therapy under investigationwere followed. Data obtained were processed by means of the PATS® system (Patient Analysis&Tracking System).In order to evaluate the decrease rate of number of diseases and number of interrelated antibiotic cures, the authorsused the ,,index of change" [I (%)]. The results were compared using Student's t-test.A statistically significant decrease of both investigated parameters was observed in both groups. In the SETgroup, there was a decrease in the average number of respiratory inflammations from 5.3 to 2.2 (IRZDC = _59%,p.001), while in the BIM group there was a decrease from 5.2 to 3.4 (IRZDC = _32%, p.001). The average numberof interrelated antibiotic cures decreased in the SET group from 2.7 to 0.8 (IATB = _68%, p.001) and from 2.7 to1.5 (IATB = _35%, p.001) in the BIM group. In the SET group there were no statistically significant differencesamong IRZDC and IATB for age subgroups (3-6 years, 7-10 years and 11-18 years, respectively).

Key words:
systemic oral enzyme therapy, recurrent respiratory inflammations, post-registration retrospectivemulti-centric evaluation, bacterial immnunomodulators

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Neonatology Paediatrics General practitioner for children and adolescents
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