Experience of clinical application of the Vapigel prebiotic in combined two-stage therapy of bacterial vaginosis in reproductive-aged women
Belyakina I.V., Galkina I.S., Shobolov D.L., Shtykunova E.V., Arantseva D.A.
Objective: To evaluate the clinical and laboratory parameters of women with bacterial vaginosis before and after two-stage therapy with prebiotic vaginal gel.
Materials and methods: Twenty patients with bacterial vaginosis aged 28–46 years (median 37±9) were examined and treated in two stages. Vapigel was prescribed at the second stage of treatment for bacterial vaginosis (after antibiotic therapy) at a dose of one tube once a day (before bedtime) for seven days intravaginally. Clinical and laboratory parameters were evaluated before treatment (Visit 0), on days 8+2 from the beginning of the course of treatment with Vapigel (Visit 1) and on days 30+2 after the end of the second stage of treatment (Visit 2).
Results: There was a positive dynamics of clinical symptoms immediately after the end of therapy (Visit 1) and after 30 days (Visit 2). After the patients received the two-stage therapy with Vapigel prebiotic, the frequency of detection of Lactobacillus spp. in the concentration of 106 CFU/ml increased to 60% by Visit 1 and to 90% by Visit 2. The proportion of patients with clinically significant amounts of facultative and obligate anaerobic microorganisms tended to decrease immediately after the end of two-stage treatment and a month later. During the month after the end of the course of therapy, there were no clinical signs of a recurrence of bacterial vaginosis in 19/20 (95%) women; normal flora was confirmed 30 days after the end of treatment in 18/20 (90%) women.
Conclusion: The use of the Vapigel prebiotic intravaginally is beneficial for restoring the microbiocenosis of the vaginal microflora at the second stage of therapy of bacterial vaginosis. It is necessary to study the possibility of using Vapigel as a monotherapy for bacterial vaginosis as an important component in the system of measures aimed at reducing the use of antimicrobial drugs in routine clinical practice.
Authors’ contributions: Shobolov D.L., Shtykunova E.V., Galkina I.S. – developing the concept and design of the study;
Belyakina I.V., Shtykunova E.V. – collection and analysis of the data, statistical processing; Shtykunova E.V. – writing the article; Arantseva D.A. – editing the article; Shobolov D.L., Shtykunova E. V., Galkina I.S., Belyakina I.V., Arantseva D.A. – approval of the final version of the article.
Conflicts of interest: The authors declare no conflict of interest.
Funding: The clinical study was funded by Kinetic-Pharm LLC. Post-marketing clinical studies were conducted for the registered Vapigel drug.
Ethical Approval: The study was approved by the Ethical Review Board of the Kars Medical Center.
Patient Consent for Publication: The patients provided an 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: Belyakina I.V., Galkina I.S., Shobolov D.L., Shtykunova E.V., Arantseva D.A. Experience of clinical application of the Vapigel prebiotic in combined two-stage therapy of bacterial vaginosis in reproductive-aged women. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (11): 170-178 (in Russian)
https://dx.doi.org/10.18565/aig.2023.237
Keywords
bacterial vaginosis
two-stage therapy
prebiotic gel
vaginal microbiocenosis
lactobacilli
facultative anaerobic and obligate anaerobic microorganisms
References
- Меджидова М.К., Зайдиева З.С., Вересова А.А. Микробиоценоз влагалища и факторы, влияющие на его состояние. Медицинский Совет. 2013; (3): 118-25. [Medzhidova M.K., Zaydiyeva Z.S., Veresova A.A. Vaginal microbiocenosis and factors affecting its condition. Medical Council. 2013; (3): 118-25 (in Russian)].
- Коршунов В.М., Володин Н.Н., Ефимов Б.А. и др. Микроэкология влагалища. Коррекция микрофлоры при вагинальных дисбактериозах: Учебное пособие. М.: ВУНМЦ МЗ РФ; 1999. 80 с. [Korshunov V.M., Volodin N.N., Efimov B.A. et al. Vaginal microecology. Correction of microflora in vaginal dysbiosis: A textbook. Moscow; 1999. 80 p. (in Russian)].
- Мелкумян А.Р., Припутневич Т.В., Анкирская А.С., Трофимов Д.Ю., Муравьева В.В., Муллабаева С.М., Завьялова М.Г. Видовой состав лактобактерий при различном состоянии микробиоты влагалища у беременных. Клиническая микробиология, антимикробная химиотерапия. 2013; 15(1): 72-9. [Melkumyan A.R., Priputnevitch T.V., Ankirskaya A.S., Trofimov D.Yu., Muravyova V.V., Mullabaeva S.M., Zavyalov M.G. Lactobacilli species diversity in different states of vaginal microbiota in pregnant women. Clinical Microbiology and Antimicrobial Chemotherapy. 2013; 15(1): 72-9. (in Russian)].
- Титова С.И., Гончарова Н.Г. Оценка клинической эффективности, безопасности и переносимости комбинации пребиотика и энтеросорбента в терапии бактериального вагиноза. Лечащий врач. 2008; 10: 74-5. [Titova S.I., Goncharova N.G. Evaluation of the clinical efficacy, safety and tolerability of a combination of a prebiotic and an enterosorbent in the treatment of bacterial vaginosis. Lechaschi Vrach Journal. 2008; 10: 74-5. (in Russian)].
- Verstraelen H., Swidsinski A. The biofilm in bacterial vaginosis: implications for epidemiology, diagnosis and treatment. Curr. Opin. Infect. Dis. 2013;26(1): 86-9. https://dx.doi.org/10.1097/QCO.0b013e32835c20cd.
- Хрянин А.А., Решетников О.В. Бактериальный вагиноз. Новая парадигма. Акушерство и гинекология. 2016; 4: 133-9. [Khryanin A.A., Reshetnikov O.V. Bacterial vaginosis: а new paradigm. Obstetrics and Gynecology. 2016; (4): 133-9. (in Russian)]. http://dx.doi.org/10.18565/aig.2016.4.133-139.
- Кира Е.Ф., Душкина Е.А., Бадикова Н.С. Биологическая роль кислотности влагалища. Механизмы стабильности и методы коррекции. Акушерство и гинекология. 2013; 3: 102-6. [Kira E.F., Dushkina E.A., Badikova N.S. Biological role of vaginal acidity. stability mechanisms and correction methods. Obstetrics and Gynecology. 2013; (3): 102-6. (in Russian)].
- Taylor B.D., Darville T., Haggerty C.L. Does bacterial vaginosis cause pelvic inflammatory disease? Sex Transm. Dis. 2013; 40(2): 117-22. https://dx.doi.org/10.1097/OLQ.0b013e31827c5a5b.
- Кира Е.Ф. Бактериальный вагиноз. М.: ООО «Нева-Люкс»; 2001. 364 c. [Kira E.F. Bacterial vaginosis. Moscow: Neva-Lux LLC; 2001. 364p (in Russian)].
- Липова Е.В., Болдырева М.Н., Трофимов Д.Ю., Витвицкая Ю.Г. Чухриенко И.Ю., Мирзоянц М.А. Урогенитальные инфекции, обусловленные условно-патогенной биотой у женщин репродуктивного возраста. Клинико-лабораторная диагностика. Пособие для врачей. M.; 2009. 44c. [Lipova E.V., Boldyreva M.N., Trofimov D.Yu., Vitvitskaya Yu.G. Chukhrienko I.Yu., Mirzoyants M.A. Urogenital infections due to opportunistic pathogenic biota in women of reproductive age. Clinical and laboratory diagnostics. Manual for doctors. Moscow; 2009. 44p. (in Russian)].
- Ворошилина Е.С., Тумбинская Л.В., Донников А.Е., Плотко Е.Э., Хаютин Л.В. Биоценоз влагалища с точки зрения количественной полилимеразной цепной реакции: что есть норма? Акушерство и гинекология. 2011; 1: 57-65. [Voroshilina E.S., Tumbinskaya L.V., Donnikov A.E., Plotko E.A., Khayutin L.V.Vaginal biocenosis with a view to quantitative polymerase chain reaction: what is its norm? Obstetrics and Gynecology. 2011; (1): 57-65. (in Russian)].
- Gillet E., Meys J.F., Verstraelen H., Verhelst R., De Sutter P., Temmerman M., Vanden Broeck D. Association between bacterial vaginosis and cervical intraepithelial neoplasia: systematic review and meta-analysis. PLoS One. 2012; 7(10): e45201. https://dx.doi.org/10.1371/journal.pone.0045201.
- Боярский К.Ю., Кахиани Е.И. Микробиом репродуктивной системы человека. Проблемы репродукции. 2019; 25(4): 27‑34. [Boiarskiĭ K.Iu., Kachiani E.I. Microbiome of the human reproductive system. Russian Journal of Human Reproduction. 2019; 25(4): 27-34. (in Russian)]. https://dx.doi.org/10.17116/repro20192504127.
- Чаплин А.В., Ребриков Д.В., Болдырева М.Н. Микробиом человека. Вестник РГМУ. 2017; 2: 5-13. [Chaplin A.V., Rebrikov D.V., Boldyreva M.N. The human microbiome. Bulletin of RSMU. 2017; (2): 5-13. (in Russian)]. https://dx.doi.org/10.24075/brsmu.2017-02-01.
- Российское общество акушеров-гинекологов. Клинические рекомендации по диагностике и лечению заболеваний, сопровождающихся патологическими выделениями из половых путей женщин. М.; 2019. [Russian Society of Obstetrician Gynecologists. Clinical guidelines for the diagnosis and treatment of diseases accompanied by pathological discharge from the sexual routes of women. Moscow; 2019. (in Russian)].
- Linhares I.M., Giraldo P.C., Baracat E.C. New findings about vaginal bacterial flora. Rev. Assoc. Med. Bras. 2010; 56(3): 370-4. https://dx.doi.org/10.1590/s0104-42302010000300026.
- Nugent R.P., Krohn M.A., Hillier S.L. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J. Clin. Microbiol. 1991; 29(2): 297-301. https://dx.doi.org/10.1128/jcm.29.2.297-301.1991.
- Российское общество дермато-венерологов и косметологов. Федеральные клинические рекомендации. Дерматовенерология 2015. Болезни кожи. Инфекции, передаваемые половым путем. M.; 2016. [Russian Society of Dermatovenereologists and Cosmetologists. Federal clinical guidelines. Dermatovenerology 2015. Skin diseases. Sexually transmitted infections. Moscow; 2016. (in Russian)].
- Ефимов Б.А., Тютюнник В.Л. Бактериальный вагиноз: современный взгляд на проблему. РМЖ. 2008;16(1):18-22. [Efimov B.A., Tyutyunnik V.L. Bacterial vaginosis: a modern view of the problem. RMJ. 2008; 16(1): 18-22. (in Russian)].
- Гомберг М.А. Бактериальный вагиноз и новые инфекции, с ним ассоциированные. Российский вестник акушера-гинеколога. 2010; 10(2): 32-4. [Gomberg MA. Bacterial vaginosis and associated new infections. Russian Bulletin of Obstetrician-Gynecologist. 2010; 10(2): 32-4. (in Russian)].
Received 12.10.2023
Accepted 14.11.2023
About the Authors
Irina V. Belyakina, Ph.D., gynecologist, obstetrician, Associate Professor at the Department of Women's Diseases and Reproductive Health of the Institute for Advanced Medical Studies, N.I. Pirogov National Medical and Surgical Center, 105203, Russia, Moscow, Nizhnyaya Pervomaiskaya str., 70; Kars Medical Center,127434, Russia, Moscow, Dmitrovskoye shosse, 21A, +7(916)614-64-00, doctorbelyakina@mail.ru
Irina S. Galkina, Ph.D., Marketing Director, DNA-Technology LLC, 117587, Russia, Moscow, Varshavskoye sh., 125Zh, bldg. 6, +7(495)980-45-55, Galkina@dna-technology.ru
Dmitry L. Shobolov, Ph.D., General Director, Kinetiс-Pharm LLC, 141560, Russia, Moscow Region, Solnechnogorsk, md. Dedeshino (village Alabushevo), 7,
+7(903)721-56-70, shobolov@kineticpharm.ru, https://orcid.org/0000-0002-2522-0582
Elena V. Shtykunova, Ph.D., Medical Director, Kinetic-Pharm LLC, 141560, Russia, Moscow Region, Solnechnogorsk, md. Dedeshino (village Alabushevo), 7,
+7(916)086-17-48, keen_272001@mail.ru
Diana A. Arantseva, Head of the Laboratory of Parenteral Dosage Forms and Delivery Systems, Kinetic-Pharm LLC,
141560, Russia, Moscow Region, Solnechnogorsk, md. Dedeshino (village Alabushevo), 7, arantseva@kineticpharm.ru, https://orcid.org/0000-0003-0920-6921
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