Usporedba kliničke djelotvornosti probiotika Lactobacillusa reuteri i enteroadsorbenta polimetilsiloksana u liječenju rotavirusnog gastroenteritisa u djece u dobi od 6 do 36 mjeseci [Comparison of clinical efficacy of probiotic Lactobacillus reuteri versus enteroadsorbent polymethylsiloxane (Enterosgel®) in the treatment of rotaviral gastroenteritis in children 6-36 months old]

Markovinović, Leo (2019) Usporedba kliničke djelotvornosti probiotika Lactobacillusa reuteri i enteroadsorbenta polimetilsiloksana u liječenju rotavirusnog gastroenteritisa u djece u dobi od 6 do 36 mjeseci [Comparison of clinical efficacy of probiotic Lactobacillus reuteri versus enteroadsorbent polymethylsiloxane (Enterosgel®) in the treatment of rotaviral gastroenteritis in children 6-36 months old]. PhD thesis, Sveučilište u Zagrebu.

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Abstract

Rotavirus gastroenteritis is the most common cause of acute infectious diarrhea in infants and young children. It is a very frequent cause of childhood hospitalisation due to its sudden onset of symptoms - vomiting, diarrhea and fever. There is still no causative therapy against rotavirus. However, there are many adjunctive therapies available to alleviate the symptoms of infection. Once very popular enterosorbent, medicinal activated charcoal, was replaced by some new agents, namely probiotics. Amongst many probiotic preparations only a few showed some advantages over placebo. In the last few years a new enterosorbent, polymethylsiloxane (Enterosgel) has emerged on the Croatian market and we wanted to compare it to the stardard therapy, probiotic L. reuteri (BioGaia). We chose L. reuteri because it was the first probiotic preparation registered for safe use in infants. We also wanted to compare two gastroenteritis clinical severity assessment scales and describe some clinical characteristics of rotavirus infection in our region. The efficacy of the investigated therapies was tested on three levels - duration of symptoms, duration of hospital stay and the total number of liquid stools. We have found no significant differences between the therapies according to any of the tested parameters. We have noticed no significant side-effects of the tested therapies. Probiotic preparation seemed to have better palatability, however this might be attributed to a smaller single dose volume (BioGaia cca 1 mL; Enterosgel cca 20-30 mL). Although very similar, the standard clinical severity scores for the evaluation of acute gastroenteritis, Vesikari's and Clark's, are not comparable. If there is a need for comparing different treatments or preventive measures (vaccinations) the same clinical score must be used. We also cannot use these scores for predicting the duration of symptoms of rotavirus disease. It would be beneficial if a single scale would be set as the standard on the international level, thus enabling easier comparison of future clinical trials. The clinical and epidemiological characteristics of the rotavirus infection in our examinees did not significantly differ to the ones described in the standard textbooks. However, the expected slightly higher number of cases in the late autumn was not recorded, due to the limited duration of the trial or it could be just a reflection of the usual seasonal variability. We did not find a significant number of rare manifestations of rotavirus infection such as urticaria, reactive arthritis, hepatitis, encephalitis, nor did we notice any complications such as severe dehydration, encephalopathy, etc. One of the reasons for that can be prompt admission of patients with more severe rotavirus infection to the intensive care unit. Due to the nature of the trial, these patients were not recruitable or suitable for inclusion as we could not obtain the parents' consent. Subsequently, the patients with the most severe and those with the most benign symptoms were not included in our trial. On the positive note, our study population was very homogeneous as all the patients had similar clinical characteristics thus making the comparison of treatment effectiveness more reliable. In conclusion, with the statistical power of 80 %, we can claim that there is no difference in the efficacy between the new enterosorbent polymethylsiloxane and probiotic L. reuteri in the treatment of rotavirus gastroenteritis in children.

Abstract in Croatian

Rotavirusni gastroenteritis je najčešći uzrok akutnog infektivnog proljeva u populaciji dojenčadi i predškolske djece. Zbog naglog nastupa simptoma, povraćanja, proljeva i vrućice, čest je razlog hospitalizacije u djece. Do danas nema uzročnog lijeka koji djeluje na rotavirus. Postoje mnoga pomoćna ljekovita sredstva koja služe ublažavanju simptoma. Nekada popularni enteroadsorbens medicinski ugljen zamijenila su neka novija sredstva, danas su to prije svih probiotici. Među brojnim preparatima samo neki imaju blagu prednost pred placebom. U zadnjih nekoliko godina na hrvatskom tržištu se pojavio novi enteroadsorbens polimetilsiloksan (Enterosgel) koji smo htjeli testirati uspoređujući ga sa standarnim sredstvom, probiotikom L. reuteri (BioGaia) koji je prvi probiotik licenciran u nas za upotrebu u dojenačkoj dobi. Osim toga, željeli smo ispitati dvije kliničke ljestvice za ocjenu težine rotavirusne infekcije i opisati neke kliničke osobitosti rotavirusne infekcije u našem podneblju. Djelotvornost ispitivanih lijekova ispitivali smo na tri razine - duljini trajanja bolesti, duljini bolničkog liječenja i ukupnom broju stolica u toku bolesti. Niti po jednom parametru nije bilo značajnih razlika između dva ispitivana lijeka. Nismo zamijetili niti jednu značajniju nuspojavu među našim ispitanicima. Dojam je nešto bolje palatabilnosti probiotika, ali to može biti i odraz manje količine pojedinačne doze (BioGaia oko 1 mL; Enterosgel 20-30 mL). Standardne kliničke ljestvice za ocjenu težine rotavirusne bolesti, Vesikarijeva i Clarkova, premda vrlo slične, nisu međusobno usporedive. U slučaju ispitivanja terapijskih tretmana ili preventivnih mjera (cijepljenje) potrebno je koristiti istu skalu. Ljestvice također ne možemo koristiti u svrhu predviđanja duljine bolesti. Bilo bi dobro da se na međunarodnoj razini odluči za jednu skalu radi lakše usporedbe kliničkih istraživanja u budućnosti. Kliničke i epidemiološke značajke rotavirusne infekcije u naših ispitanika ne razlikuju se značajno od onih opisanih u standardnim udžbenicima. Očekivali smo nešto veći broj oboljelih u kasnu jesen, ali izostanak većeg broja oboljelih u tom razdoblju može biti samo odraz sezonske varijabilnosti. Nismo našli značajniji udio rijetkih pojavnosti rotavirusne infekcije kao što su urtikarija, reaktivni artritis, hepatitis, encefalitis, niti komplikacija kao što su teška dehidracija, encefalopatija i sl. Jedan od razloga za to može biti prijem težih bolesnika u jedinicu intenzivnog liječenja. Teže oboljeloj djeci nismo bili u mogućnosti davati ispitivana ljekovita sredstva niti smo mogli pridobiti roditelje za sudjelovanje u našem istraživanju. Ipak, izostanak najtežih i najlakših bolesnika iz naše studije ima i nekih prednosti - čini skupinu ispitanika vrlo homogenom jer su sva djeca sličnih kliničkih karakteristika i prema tome usporedbu djelotvornosti čini točnijom. U zaključku možemo reći da sa statističkom snagom od 80 % možemo tvrditi da nema razlike u djelotvornosti između enteroadsorbensa polimetilsiloksana i probiotika L. reuteri u liječenju rotavirusnog gastroenteritisa.

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