Systemic Oral Enzyme Therapy in the Complex Treatment of Recurrent Respiratory Inflammations
in Children - Post-registration Retrospective Multicentric Evaluation
Adámková E.1, Balcar J.2, Bartovičová E.3, Fialová Y.4, Gricová P.5, Hak J.6, Hubková B.7, Komárková M.8, Krbušek D.9, Kučerová M.10, Machoňová D.11, Slaninová J.12, Vokálová I.13, Vrajíková J.14 Statistické zpracování: Hačkajlo D.15 Koordinátor: Honzíkov á M.16
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, Průhonice16 |
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Summary:
The primary goal of systemic oral enzyme therapy (SET) administration is to influence the course of
inflammatory 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 treatment
of children with recurrent respiratory inflammations (RZDC) was the main suggestion for performance of
retrospective multicentric evaluation of the preparationWobenzym, comparing its efficacy with that of bacterial
immunomodulators (BIM).
Medical records of 468 children at the age of 3-18 years (SET: n=346 children; BIM: n=122 children) were
analyzed 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 of
interrelated antibiotic cures in the period of 12months before and after beginning of the therapy under investigation
were 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 authors
used 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 SET
group, 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 number
of interrelated antibiotic cures decreased in the SET group from 2.7 to 0.8 (IATB = _68%, p.001) and from 2.7 to
1.5 (IATB = _35%, p.001) in the BIM group. In the SET group there were no statistically significant differences
among 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 retrospective
multi-centric evaluation, bacterial immnunomodulators
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