Results of the open-label randomized clinical trial on the study of therapeutic equivalence of the «Cefixime EXPRESS» and «Suprax Solutab» medications in the therapy of protracted bacterial sinusitis

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

Results of the open-label randomized clinical trial on the study of therapeutic equivalence of the «Cefixime EXPRESS» and «Suprax Solutab» medications in the therapy of protracted bacterial sinusitis

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 Rhinology. 2024;32(2): 117‑125

DOI: 10.17116/rosrino202432021117

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To cite this article:

Kryukov AI, Gurov AV, Shadrin GB, Izotova GN, Yushkina MA, Muzhichkova AV, Zotova PK. Results of the open-label randomized clinical trial on the study of therapeutic equivalence of the «Cefixime EXPRESS» and «Suprax Solutab» medications in the therapy of protracted bacterial sinusitis. Russian Rhinology. 2024;32(2):117‑125. (In Russ.)
https://doi.org/10.17116/rosrino202432021117

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OBJECTIVE

To study the therapeutic equivalence of two medications of cefixime («Cefixime EXPRESS» generic and «Suprax Solutab» reference medication) in patients with protracted bacterial sinusitis.

PATIENTS AND METHODS

The randomized open-label comparative clinical trial involved 60 adult patients with the «protracted bacterial sinusitis» diagnosis. The 1st group included 30 patients who received the «Cefixime EXPRESS» in the form of dispersible tablets, the 2nd group — 30 patients who took the «Suprax Solutab» in the form of dispersible tablets. Dosing regimen and duration of the course were identical (400 mg once a day for 7 days). All patients underwent general clinical and otorhinolaryngological examinations, assessment of symptoms of bacterial sinusitis, clinical global expression of the conducted therapy, tolerability of treatment, analysis of the incidence of adverse events before treatment, 3 days after the therapy initiation and after the end of treatment course (7th day).

RESULTS

According to the examination data on the 7th day, 70% of patients in the 1st group and 63.3% of patients in the 2nd group recovered. The rate of clinical symptoms regression was comparable in both groups. Hyperemia of the nasal mucous membrane, purulent discharge in the nasal cavity and nasal breathing difficulty regressed to the 7th day of treatment in patients of both groups. The incidence of adverse reactions was comparable and amounted to 3.33% in each group. Serious adverse events have not been registered.

CONCLUSIONS

The «Cefixime EXPRESS» has a high therapeutic effectiveness in the treatment of protracted bacterial sinusitis, comparable to the effectiveness of the «Suprax Solutab» medication. The «Cefixime EXPRESS» medication has demonstrated good tolerability and favorable safety profile.

Keywords:

protracted bacterial sinusitis

antibacterial therapy

cefixime

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:

09.04.2024

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