SOVREMENNAYA PEDIATRIYA.2017.5(85):65-71

Kosir Primoz
Ljubljana, Slovenia
Published: Med Razgl. 2015. 54; Supl 3: 433-42. Translate: Zdorove rebenka. 2017. 12;2: 16-21.

Cetylpyridinium chloride is a broad-spectrum antiseptic. Its antibacterial effect has been recognized for many years. Benzydamine is a non-steroidal anti-inflammatory drug, an indazole that has analgesic, anti-inflammatory, local anesthetic and antipyretic properties and has been widely used across Europe for nearly 40 years. The objective of our study was to confirm the efficacy and safety of this combination in the treatment of sore throat associated with upper respiratory tract infections. The formulation of 3 mg benzydamine hydrochloride and 1 mg cetylpyridinium chloride (Septabene lozenges, Krka, d.d.) was significantly superior to the placebo and the reference drug in all efficacy criteria. There was an immediate onset of action of the tested investigational medicinal product that was shown by the reduction in throat pain intensity over the initial 15-minute interval period after drug administration. Throat pain was statistically significantly reduced for at least 3 hours in comparison with placebo. Similar improvement was also observed in pain relief over 3 hours. After 4 days of treatment start, pain intensity was reduced for more than 85% from baseline. The treatment was successful in 89% of patients, who received the tested drug. Adverse reactions (dry mouth and heartburn) were reported in 2.54% of subjects treated with the investigational medicinal product. The reactions were evaluated as mild and reduced 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 medicinal product is effective and well tolerated, as well as serves as an appropriate treatment option for patients with sore throat associated with upper respiratory tract infections.

Key words: sore throat; cetylpyridinium chloride; benzydamine hydrochloride; analgesic; anti-inflammatory; antiseptic

References

1. Bisino A. 2011. Acute pharyngitis. The New England Journal of Medicine. 344; 3: 205—11. https://doi.org/10.1056/NEJM200101183440308; PMid:11172144

2. Hannaford PC, Simpson JA, Bisset AF, Davis A, McKerrow W, Mills R. 2005. The prevalence of ear, nose and throat problems in the community: results from a national cross-sectional postal survey in Scotland. Fam Pract. 22: 227—33. https://doi.org/10.1093/fampra/cmi004; PMid:15772117

3. Addey D. 2012. Incidence, causes, severity and treatment of throat discomfort: a four-region online questionnaire survey. BMC Ear Nose Throat Disord. https://doi.org/10.1186/1472-6815-12-9; PMid:22883470 PMCid:PMC3489867

4. Wunderer H. 1986. Mund- und Rachentherapeutika. DAZ. 126(42): 2281—92.

5. Little PS, Wiliamson I. 1994. Contraversis in management: Are antibiotics appropriate for sore throats? Costs outweigh the benefits. BMJ. 309(6960): 1010—1. https://doi.org/10.1136/bmj.309.6960.1010

6. Little PS, Wiliamson I, Warner G et al. 1981. Open randomised trial of prescribing strategies in managing sore throat. Practitioner. 225(1352): 234—9.

7. Butler CC et al. 1998, Dec. Reducing antibiotics for respiratory tract symptoms in primary care: consolidating 'why' and considering 'how'. Br J Gen Pract. 48(437): 1865—1870. PMid:10198512 PMCid:PMC1313298

8. Strutz HJ, Dieterich HA. 1984. Behandlung infektios-entzundlicher Erkrankungen des Mund-, Hals- und Rachenraumes mit Cetylpyridiniumchlorid. Therapiewoche. 34: 565—9.

9. Meier E. 1990. Schluckbeschwerden, Halsschmerzen, Heiserkeit. Apotheker Journal. 12: 26—32.

10. Konschal U. 1977. Antiseptische Lokaltherapeutica als eigenstandige Therapie HNO-arzzlich gesehen. Therapiewoche. 27: 7732—9.

11. Merianos JJ. 1991. Quaternary ammonium antimicrobial compounds. In: Block SS: Disinfection, Sterilisation and Preservation. 4th ed. Philadelphia, London: Lea & Febiger. 225—55.

12. Anonymous: Mund- und Rachentherapeutika. Lutschen, Gurgeln, Pinseln, Spulen, Spruhen. 1983. DAZ. 123(50): 2465—9.

13. Pitten FA, Kramer A. 2001. Efficacy of Cetylpyridinium chloride used as oropharyngeal antiseptic. Arzneim-Forsch/Drug Res. 51: 588—95.

14. Quane PA, Graham GG, Ziegler JB. 1998. Pharmacology of benzydamine. Inflammopharmacology. 6 (2): 95—107. https://doi.org/10.1007/s10787-998-0026-0; PMid:17694367

15. Cioli V, Corradino C, Scorza Barcellona P. 1985. Review of Pharmacological Data of Benzydamine. Int J Tiss Reac; 7 (3): 205—13. PMid:3899969

16. Gordeev I: Final report. A comparison of therapeutic equivalence between the test and the reference formulation of fixed combination of cetylpyridinium chloride 1.0 mg/benzydamine hydrochloride 3 mg in subjects with sore throat associated with upper respiratory tract infections Phase III study. Data on file. Krka, d.d., Novo mesto, Slovenia, 2014.