Opportunities for antimicrobial therapy of diseases accompanied by pathological discharge from the genital tract: results of the multicenter observational Prospectus program

DOI

https://dx.doi.org/10.18565/aig.2021.12.167-176

Apolikhina I.A., Guschin A.E., Efendieva Z.N., Tyulenev Yu.A.
1) Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, Moscow, Russia; 2) I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University), Moscow, Russia; 3) Moscow Scientific and Practical Center for Dermatovenerology and Cosmetology, Moscow Department of Health, Moscow, Russia

Objective: To study the etiological pattern of diseases accompanied by pathological discharge from the genital tract in reproductive-aged women and to evaluate the efficacy and tolerability of Macmiror Complex (nifuratel + nystatin) in the treatment of these diseases in in the context of modern clinical practice.
Materials and methods: The prospective multicenter observational Prospectus program was implemented in 11 centers of 10 cities of the Russian Federation (Moscow, Saint Petersburg, Nizhny Novgorod, Voronezh, Stavropol, Kazan, Ufa, Novosibirsk, Yekaterinburg, and Vladivostok). To establish the etiology of diseases accompanied by pathological discharge from the genital tract, such as bacterial vaginosis, aerobic vaginitis, and vulvovaginal candidiasis, a molecular biological study was conducted using a procedure based on real-time PCR AmpliPrime-Floroscreen (NextBio LLC). The combined drug nifuratel + nystatin (Macmiror Complex, Polichem, Italy) as vaginal capsules was used for etiotropic therapy and the patients were followed up at 10, 30 and 90 days after the therapy. At 10-day follow-up, the clinical efficiency was evaluated using the clinical data (namely, relief of the signs and symptoms of the disease). Molecular biological control of the treatment was carried out at 30-day follow-ups. The drug’s tolerability (frequency of adverse events) and the number of relapses after a therapy cycle in the next three months were also analyzed.
Results: The investigation enrolled 93 patients with the established etiology of diseases accompanied by pathological discharge from the genital tract by PCR using the AmpliPrime-Floroscreen tests. The patients’ mean age was 32.9±7.7 years. The etiological pattern included diseases, such as bacterial vaginosis (35/93 (38%)), vulvovaginal candidiasis (21/93 (22%)), aerobic vaginitis (9/93 (10%)), and mixed vaginitis (28/93 (30%)). The clinical efficiency of the therapy was achieved in 94.6% of cases. During 3 months of follow-up, clinical relapses occurred in no more than 8.3% of cases. The molecular biological evaluation of the efficiency of treatment showed a positive result in 87.5% of cases. Excellent and good tolerances of Macmiror Complex were noted in 85.3% of cases; no allergic reactions were seen in 100% of cases.
Conclusion: The pattern of diseases accompanied by pathological discharge from the genital tract exhibits a high proportion of mixed diseases. Macmiror Complex has demonstrated high efficiency and good tolerance and therefore can be recommended for active clinical application in patients with diseases accompanied by pathological discharge from the genital tract, including mixed vaginitis.

bacterial vaginosis

vulvovaginal candidiasis

aerobic vaginitis

mixed vaginal infections

empiric therapy

Macmiror Complex

nifuratel

nystatin

Full text (in Russian)

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Received 14.12.2021

Accepted 20.12.2021

Inna A. Apolikhina, MD, PhD, Head of the Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov NMRC for OG&P, Ministry of Health of Russia; Professor of the Department of Obstetrics, Gynecology, Perinatology, and Reproductology, Institute of Professional Education, I.M. Sechenov First MSMU,
Ministry of Health of Russia (Sechenov University), i_apolikhina@oparina4.ru, 117997, Russia, Moscow, Oparina str., 4.
Alexander E. Guschin, Ph.D. (Bio), Leading Researcher, Moscow Scientific and Practical Center for Dermatovenerology and Cosmetology, Moscow Department of Health, aguschin1965@mail.ru, 119071, Russia, Moscow, Leninsky Ave., 17.
Zulfia N. Efendieva, Ph.D., obstetrician-gynecologist at the Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov NMRC for OG&P,
Ministry of Health of Russia, efendievaz@yandex.ru, 117997, Russia, Moscow, Oparina str., 4.
Yuri A. Tyulenev, Ph.D. (Bio), Junior Researcher at the Department of Anogenital Dermatoses and Sexually Transmitted Infections, MNPCDK, Moscow Department of Health, tulenevsk@gmail.com, 119071, Russia, Moscow, Leninsky Ave., 17.

Authors’ contributions: Apolikhina I.A., Guschin A.E., Efendieva Z.N., Tyulenev Yu.A. – development of the concept and design of publications on the topic of the article, data analysis, writing the text of the manuscript, approval of the manuscript for publication.
Conflicts of interest: The authors declare that there are no conflicts of interest.
Funding: The article has been prepared without sponsorship.
Acknowledgment: The authors express their gratitude to Prof. Alevtina M. Savicheva, MD; Prof. Irina N. Korotkikh, MD;
Prof. Indira V. Sakhautdinova, MD; Prof. Vitaly M. Kuleshov, MD; Irina N. Kononova, MD; Tatiana I. Rumyantseva, PhD.;
Rusudan M. Ionova, PhD; Olga V. Danilova, PhD; Lyudmila S. Matyushkina, PhD; Olga A. Pauzina for participation
in the observational Prospectus program.
Patients’ Consent to Publication. All patients provided informed consent for the publication of their data.
Authors' Data Sharing Statement. The data supporting the findings of this study are available on request from the corresponding author after approval from the principal investigator.
For citation: Apolikhina I.A., Guschin A.E., Efendieva Z.N., Tyulenev Yu.A. Opportunities for antimicrobial therapy of diseases accompanied by pathological discharge from the genital tract: results of the multicenter observational Prospectus program.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2021; 12: 167-176 (in Russian)
https://dx.doi.org/10.18565/aig.2021.12.167-176

Opportunities for antimicrobial therapy of diseases accompanied by pathological discharge from the genital tract: results of the multicenter observational Prospectus program

Apolikhina I.A., Guschin A.E., Efendieva Z.N., Tyulenev Yu.A.

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