Modern pharmacotherapy of acute bacterial sinusitis: results of an open randomized clinical trial of the therapeutic equivalence of Cefixime EXPRESS and Suprax Solutab

Kryukov A.I.; Gurov A.V.; Shadrin G.B.; Izotova G.N.; Yushkina M.A.; Muzhichkova A.V.; Zotova P.K.

doi:https://doi.org/10.17116/otorino20248903148

Kryukov A.I.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0002-0149-0676

Gurov A.V.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0001-9811-8397

Shadrin G.B.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology

ORCID: 0000-0002-3559-5302

Izotova G.N.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology

ORCID: 0000-0002-3134-3343

Yushkina M.A.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0002-9823-1047

Muzhichkova A.V.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0001-5940-9343

Zotova P.K.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology

ORCID: 0000-0001-9455-0705

Modern pharmacotherapy of acute bacterial sinusitis: results of an open randomized clinical trial of the therapeutic equivalence of Cefixime EXPRESS and Suprax Solutab

Authors:

Kryukov A.I., Gurov A.V., Shadrin G.B., Izotova G.N., Yushkina M.A., Muzhichkova A.V., Zotova P.K.

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Journal: Russian Bulletin of Otorhinolaryngology. 2024;89(3): 48‑56

DOI: 10.17116/otorino20248903148

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Kryukov AI, Gurov AV, Shadrin GB, Izotova GN, Yushkina MA, Muzhichkova AV, Zotova PK. Modern pharmacotherapy of acute bacterial sinusitis: results of an open randomized clinical trial of the therapeutic equivalence of Cefixime EXPRESS and Suprax Solutab. Russian Bulletin of Otorhinolaryngology. 2024;89(3):48‑56. (In Russ.)
https://doi.org/10.17116/otorino20248903148

Подписка 2026 Вестник оториноларингологии (Russian Bulletin of Otorhinolaryngology)

Использование инфографики авторами научных работ

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BACKGROUND

Acute bacterial sinusitis is one of the most common causes of prescribing systemic antibacterial drugs in otorhinolaryngology. With bacterial etiology of the disease, beta-lactam antibiotics are prescribed, in particular cefixim. Cefixim in the form of dispersible tablets has high clinical and bacteriological efficiency, as well as good tolerability in patients with acute sinusitis

OBJECTIVE

To study the therapeutic equivalence of two drugs of cefixim (reproduced drug Cefixim Express and reference drug Suprax Solutab) in patients with acute bacterial sinusitis.

MATERIAL AND METHODS

60 adult patients with a diagnosis of acute bacterial sinusitis took part in a randomized open comparative clinical study. Patients of group 1 (n=30) received the drug Cefixim Express in the form of dispersible tablets 400 mg once a day. Group 2 (n=30) received Suprax Solutab in the form of dispersible tablets 400 mg once a day. The duration of treatment course was 7 days. All patients conducted general clinical and otorhinolaryngological examinations, assessment of symptoms of acute sinusitis, assessment of the general clinical impression of the therapy, tolerance of treatment, analysis of the frequency of unwanted phenomena before treatment, 3 days after the beginning of therapy and after the course completion (7 days).

RESULTS

Recovery occurred in 63.3% of patients in group 1 according to the inspection on the 7^th day of treatment and in 66.67% of patients in group 2. The rate of clinical symptoms regression by the end of therapy was comparable in the comparison groups. Hyperemia of the nasal mucosa, purulent nasal discharge and difficulty in nasal breathing (p<0.01) regressed by the 7^th day in patients of both treatment groups. The incidence of adverse reactions on the 7^th day of treatment in group 1 was 10%, in group 2 — 6.7% (p>0.05).

CONCLUSION

The drug Cefixim Express has high therapeutic effectiveness in the treatment of acute bacterial sinusitis, comparable to Suprax Solutab. Cefixime EXPRESS has demonstrated a good tolerability and a favorable safety profile.

Keywords:

acute bacterial sinusitis

antibacterial therapy

cefixim

Cefixim Express

Suprax Solutab

Authors:

Kryukov A.I.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0002-0149-0676

Gurov A.V.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0001-9811-8397

Shadrin G.B.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology

ORCID: 0000-0002-3559-5302

Izotova G.N.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology

ORCID: 0000-0002-3134-3343

Yushkina M.A.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0002-9823-1047

Muzhichkova A.V.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology;
Pirogov Russian National Research Medical University

ORCID: 0000-0001-5940-9343

Zotova P.K.

Sverzhevsky Research Clinical Institute of Otorhinolaryngology

ORCID: 0000-0001-9455-0705

Received:

05.04.2024

Accepted:

10.04.2024

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References:

Kozlov SN, Strachunsky LS, Rachina SA, Tarasov AA, Alyonkina OA, Yemelyanova AA, Dmitrenok OV, Dobrovolskaya TO, Karamysheva AA, Kuzin VB, Ortenberg EA, Chemezov SA. Analysis of antibacterial therapy of acute sinusitis in outpatient practice: results multicenter research. Vestnik otorinolaringologii. 2004;6:4-8. (In Russ.).
Lopatin AS. Sovremennye metody endoskopicheskoj khirurgii neopukholevykh zabolevanij nosa i okolonosovykh pazukh. M.: Meditsina; 1998. (In Russ.).
Piskunov SZ, Tarasov IV, Medvedkova IG. Therapeutic tactics for rhinogenic orbital complications. Rossijskaya rinologiya. 1995; 2:48-49. (In Russ.).
Strachunsky LS, Kamanin EI. Antibacterial therapy of infections in otorhinolaryngology. RMZh. 1998;6(11):684-693. (In Russ.).
Antibakterial’naya terapiya. Prakticheskoe rukovodstvo. Strachunsky LS, Belousov YuB, Kozlov SN, eds. M.: Farmedinfo; 2000. (In Russ.).
Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O’Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(29 Suppl):1-464. PMID: 32077450. https://doi.org/10.4193/Rhin20.600
Ostryj sinusit. Klinicheskie rekomendatsii. 2021. Odobreno Nauchno-prakticheskim sovetom Ministerstva zdravookhraneniya Rossijskoj Federatsii. (In Russ.). Accessed April 22, 2024. https://cr.minzdrav.gov.ru/schema/313_
Chow AW, Benninger MS, Brook I, Brozek JL, Goldstein EJ, Hicks LA, Pankey GA, Seleznick M, Volturo G, Wald ER, File TM Jr; Infectious Diseases Society of America. IDSA clinical practice guideline for acute bacterial rhinosinusitis in children and adults. Clinical Infectious Diseases. 2012;54(8):e72-e112. Epub 2012 Mar 20. PMID: 22438350. https://doi.org/10.1093/cid/cir1043
Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngology — Head and Neck Surgery. 2015;152(2 Suppl):S1-S39. https://doi.org/10.1177/0194599815572097
Jaume F, Valls-Mateus M, Mullol J. Common Cold and Acute Rhinosinusitis: Up-to-Date Management in 2020. Current Allergy and Asthma Reports. 2020 June 03;20(7):28. PMID: 32495003; PMCID: PMC7266914. https://doi.org/10.1007/s11882-020-00917-5
Egorov AYu. The problem of bacterial complications in respiratory viral infections. Microbiology Independent Research Journal. 2018;5(1):1-11. (In Russ.). https://doi.org/10.18527/2500-2236-2018-5-1-1-11
Natsional’noe rukovodstvo. Otorinolaringologiya. Palchun VT, ed. 2-e izd., pererab. i dop. M.: GEOTAR-Media; 2022. (In Russ.).
Sidorenko SV, Yakovlev SV. Beta-lactam antibiotics. RMZh. 1997;21:2. (In Russ.).
Lukyanov SV. Rational choice of cephalosporins in the treatment of infectious and inflammatory diseases. Tikhookeanskij meditsinskij zhurnal. 2006;1:11-13. (In Russ.).
Egorova OA. The possibilities of cephalosporin of the third generation (cefixime) in the treatment of infections of the ENT organs in children. Pediatriya. Prilozhenie k zhurnalu Consilium Medicum. 2016;1:54-59. (In Russ.).
Safari D, Wahyono DJ, Tafroji W, Darmawan AB, Winarti Y, Kusdaryanto WD, Paramaiswari WT, Pramono H, Pratiwi M, Chamadi MR. Serotype Distribution and Antimicrobial Resistance Profile of Haemophilus influenza Isolated from School Children with Acute Otitis Media. International Journal of Microbiology. 2022:5391291. https://doi.org/10.1155/2022/5391291
Torumkuney D, Mayanskiy N, Edelstein M, Sidorenko S, Kozhevin R, Morrissey I. Results from the Survey of Antibiotic Resistance (SOAR) In Russia. Journal of Antimicrobial Chemotherapy. 2018;73(Suppl 5):14-21.
Zyryanov SK, Baybulatova EA. The use of new dosage forms of antibiotics as a way to increase the effectiveness and safety of antibacterial therapy. Antibiotiki i khimioterapiya. 2019;64:3-4. (In Russ.). https://doi.org/10.24411/0235-2990-2019-10020
Perechen’ vzaimozamenyaemykh lekarstvennykh preparatov. 2022. (In Russ.). Accessed April 22, 2024. https://www.pharmacokinetica.ru/jour/announcement/view/727
Sokolov AV, Kukes VG, Bunyatyan ND, Rodina TA, Prokofiev AB, Arkhipov VV, Krasnykh LM, Sokova EA. Therapeutic equivalence, bioequivalence and interchangeability of medicines. Vrach. 2015;10:32-35. (In Russ.).
Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry. 2007;4(7):28-37.
Knyazkina YuA. Assessment of the severity of the antiasthenic effect of the drug Metaprot in patients with chronic cerebral ischemia. RMZh. 2013;30:1577. (In Russ.).
Instruktsiya po meditsinskomu primeneniyu preparata Tsefiksim EKSPRESS. (In Russ.). Accessed April 22, 2024. https://grls.rosminzdrav.ru
Instruktsiya po meditsinskomu primeneniyu preparata Supraks Solyutab. (In Russ.). Accessed April 22, 2024. https://grls.rosminzdrav.ru
Zyryanov SK, Belousov YuB. Antibacterial therapy: original drugs or generics. Remedium. 2006;5:12-14. (In Russ.).