Author/Editor		Košir, Primož
Title		Primerjalna raziskava terapevtske enakovrednosti med testnim in referenčnim zdravilom fiksne kombinacije 3 miligramov benzidaminijevega klorida in 1 miligrama cetilpiridinijevega klorida pri preiskovancih z vnetim žrelom, povezanim z okužbami zgornjih dihal
Translated title		A comparison of therapeutic equivalence between test and reference formulations of the fixed combination of 3 milligrams benzydamine hydrochloride and 1 milligram cetylpyridinium chloride in the treatment of sore throat associated with upper respiratory tract infections
Type		članek
Vol. and No.		Letnik 54, št. 3
Publication year		2015
Volume		str. 433-442
ISSN		0353-3484 - Medicinski razgledi
Language		slv
Abstract		Cetilpiridinijev klorid deluje kot antiseptik sirokega spektra. Njegovo antibakterijsko delovanje je znano že vrsto let. Benzidaminijev klorid je derivat indazola. Spada med nesteroidna protivnetna zdravila in deluje protibolečinsko, protivnetno, lokalno anestetično ter protivročinsko. V Evropi se uporablja že skoraj štiri desetletja. Kombinacija antiseptičnega delovanja cetilpiridinijevega klorida in protibolečinskega ter protivnetnega delovanja benzidaminijevega klorida je terapevtsko uporabna za zdravljenje okužb in vnetij zgornjih dihal. Cilj raziskave je bil potrditi učinkovitost in varnost kombinacije učinkovin pri zdravljenju vnetega žrela, povezanega z okužbami zgornjih dihal. Učinkovitost testnega zdravila (3 mg benzidaminijevega klorida in 1mg cetilpiridinijevega klorida; Septabene pastile, Krka, d.d) je bila v kliničnem preizkušanju bistveno boljša od placeba in primerljiva s primerjalnim zdravilom v kliničnem preizkušanju v vseh ocenjevanih točkah. Testno zdravilo je začelo delovati takoj, kar se je odražalo v manjši jakosti bolečine v žrelu in njenem olajšanju v 15-minutnem obdobju po vzetem odmerku. Jakost bolečine v žrelu se je v primerjavi s placebom statistično značilno zmanjšala za najmanj tri ure. Podobno kot jakost bolečine se je statistično značilno izboljšalo olajšanje bolečine znotraj treh ur. Po štiridnevnem zdravljenju se je jakost bolečine zmanjšala za več kot 85% od izhodisča Ob koncu zdravljenja je bolezen izzvenela pri 89 % bolnikov, ki so se zdravili s testnim zdravilom. Neželeni ucinki (suha usta in zgaga) so se pojavili pri 2,54 % preiskovancev v skupini, kije prejemala testno zdravilo. Neželeni učinki so bili blagi in so izzveneli v 24 urah. Obe aktivni zdravljenji sta imeli podoben varnostni profil, ki se klinično ni bistveno razlikoval od placeba. Raziskava je pokazala, da je testno zdravilo učinkovito, da ga bolniki dobro prenasajo in da je tak način zdravljenja primeren za bolnike z vnetjem žrela, povezanim z okužbami zgornjih dihal.Cetylpyridinium chloride acts as a broad-spectrum antiseptic. Its antibacterial effect has been recognized for many years. Benzydamine hydrochloride is an indazole, a non-steroidal anti-inflammatory drug that has analgesic, anti-inflammatory, local anesthetic and antipyretic properties and has been widely used across Europe for nearly four decades. The comŽ bination of antiseptic properties of cetylpyridinium chloride and anti-inflammatory and analgesic action of benzydamine hydrochloride is therapeutically useful in the treatment of upper respiratory tract infections and inflammations. The aim of our study was to conŽ firm efficacy and safety of the combination in the treatment of sore throat associated with upper respiratory tract infections. The formulation, 3 mg benzydamine hydrochloride and 1mg cetylpyridinium chloride (Septabene lozenges, Krka, d.d.), was significantly superior to the placebo and comparable to the reference investigational medicinal product in all efficacy endpoints. There was an immediate onset of action of the tested investigational medicinal product. This was shown by the reduction in throat pain intensity and improvement in throat pain relief over the initial 15-minute interval period after drug administration. Throat pain was statistically significantly reduced for at least three hours in comparison with the placebo. Similar improvement was observed in pain relief over three hours. After four days of treatment, pain intensity was reduced for more than 85% from baseline. At the end of the treatment , the clisease was resolved in 89% of patients treated with the tested investigational medicinal product. Adverse reactions (dry mouth and heartburn) were reported in 2.54% subjects treated with the tested investigational medicinal product. The reactions were evaluated as mild and were abated within 24 hours. Both active treatments had a similar safety profile, which was clinically not significantly different from the placebo. This study demonstrated that tested investigational mediciŽ nal product is effective and well tolerated and serves as an appropriate treatment option for patients with sore throat associated with upper respiratory tract infections.
Keywords		vnetje žrela cetilpiridinijev klorid benzidaminijev klorid protibolečinsko delovanje protivnetno delovanje antiseptično delovanje