Assessment of the lactobacillus profile after treatment of bacterial vaginosis using the combination of nifuratel+nystatin: A multicenter prospective observational controlled study
- Authors: Pustotina O.A.1, Demkin V.V.2,3, Terekhov M.A.1, Odinaeva F.M.4, Gus'kova O.S.5, Karaeva D.R.6, Kazakov A.A.2,3, Vershinina E.A.3, Koshechkin S.I.7
-
Affiliations:
- Inozemtsev Academy of Medical Education
- NanoDiagnostics LLC
- National Research Center “Kurchatov Institute”
- Moscow Multidisciplinary Clinical Center “Kommunarka”
- Odintsovo Regional Hospital
- Vorohobov's City Clinical Hospital No. 67
- Nobias Technologies LLC
- Issue: Vol 27, No 1 (2025)
- Pages: 27-36
- Section: ORIGINAL ARTICLE
- URL: https://journals.rcsi.science/2079-5831/article/view/290978
- DOI: https://doi.org/10.26442/20795696.2025.1.203151
- ID: 290978
Cite item
Full Text
Abstract
Aim. To evaluate the effectiveness of treatment of bacterial vaginosis (BV) with the nifuratel+nystatin complex and its effect on the lactobacillus profile (LBP) in the vagina.
Materials and methods. A multicenter, prospective, observational study included 41 patients diagnosed with BV (main group) who were treated with vaginal capsules containing 500 mg of nifuratel and 200,000 IU of nystatin (Macmiror® Complex). Efficacy was assessed at 2 weeks and 4–6 weeks after treatment based on clinical data (absence of pathological discharge). The control group for the comparative assessment of LBP included 25 healthy women. Lactobacillus index (LI, the proportion of lactobacilli in the total bacterial mass) and the abundance of Lactobacillus crispatus, L. gasseri, L. jensenii, and L. iners were assessed using a polymerase chain reaction before treatment with BV, at 2 weeks and 4–6 weeks after the end of therapy, as well as in the control group. Additionally, the vaginal pH level was measured.
Results. Clinical recovery was achieved in all main group patients and persisted throughout the observation. In all patients in this group, lactobacilli comprised 0.01–100% of the total bacterial mass. The frequency of lactobacilli species in the control group was relatively uniform, with a relatively uniform abundance of lactobacilli and a slight dominance of L. crispatus, with frequent isolation of two species in samples and high LI (>70%) in 80% of females. Before treatment in the main group, the majority of vaginal samples contained one species of lactobacilli; 40% had LI<70%, and in 62.5%, L. iners was isolated. LBP did not change significantly within 2 weeks after treatment, and after 4–6 weeks, it became comparable to that in the control group. A decrease in pH was associated with LBP recovery. However, there was no strong correlation between LI and individual species of lactobacilli in samples with or without BV.
Conclusion. Nifuratel+nystatin complex is highly effective in BV treatment. The treatment had no adverse effect on LBP, which did not differ significantly immediately after treatment compared to the baseline. However, 4–6 weeks after the treatment, LBP recovered spontaneously, reaching comparable indicators with a group of clinically healthy females regarding species composition and LI.
Full Text
##article.viewOnOriginalSite##About the authors
Olga A. Pustotina
Inozemtsev Academy of Medical Education
Author for correspondence.
Email: pustotina@gmail.com
ORCID iD: 0000-0001-6117-7270
D. Sci. (Med.)
Russian Federation, Saint PetersburgVladimir V. Demkin
NanoDiagnostics LLC; National Research Center “Kurchatov Institute”
Email: pustotina@gmail.com
ORCID iD: 0000-0002-3408-6100
Cand. Sci. (Med.)
Russian Federation, Moscow; MoscowMatvei A. Terekhov
Inozemtsev Academy of Medical Education
Email: pustotina@gmail.com
ORCID iD: 0000-0002-4259-7234
Applicant
Russian Federation, Saint PetersburgFarzona M. Odinaeva
Moscow Multidisciplinary Clinical Center “Kommunarka”
Email: pustotina@gmail.com
obstetrician-gynecologist
Russian Federation, MoscowOlga S. Gus'kova
Odintsovo Regional Hospital
Email: pustotina@gmail.com
obstetrician-gynecologist
Russian Federation, OdintsovoDiana R. Karaeva
Vorohobov's City Clinical Hospital No. 67
Email: pustotina@gmail.com
Cand. Sci. (Med.)
Russian Federation, MoscowAndrey A. Kazakov
NanoDiagnostics LLC; National Research Center “Kurchatov Institute”
Email: pustotina@gmail.com
ORCID iD: 0000-0002-5559-6003
Leading Engineer
Russian Federation, Moscow; MoscowElena A. Vershinina
National Research Center “Kurchatov Institute”
Email: pustotina@gmail.com
Student
Russian Federation, MoscowStanislav I. Koshechkin
Nobias Technologies LLC
Email: pustotina@gmail.com
ORCID iD: 0000-0002-7389-0476
Cand. Biol. (Sci.)
Russian Federation, MoscowReferences
- Tachedjian G, Aldunate M, Bradshaw CS, Cone RA. The role of lactic acid production by probiotic Lactobacillus species in vaginal health. Research in Microbiology. 2017;168(9-10):782-92. doi: 10.1016/j.resmic.2017.04.001
- Mancabelli L, Tarracchini C, Milani C, et al. Vaginotypes of the human vaginal microbiome. Environ Microbiol. 2021;23(3):1780-72. doi: 10.1111/1462-2920.15441
- Kwon MS, Lee HK. Host and Microbiome Interplay Shapes the Vaginal Microenvironment. Front Immunol. 2022;13:919728. doi: 10.3389/fimmu.2022.919728
- Chen X, Lu Y, Chen T, Li R. The Female Vaginal Microbiome in Health and Bacterial Vaginosis. Front Cell Infect Microbiol. 2021;11:631972. doi: 10.3389/fcimb.2021.631972
- Демкин В.В. Видовое разнообразие лактобактерий вагинального микробиома: как посмотреть. Молекулярная генетика, микробиология и вирусология. 2018;36(3):3-12 [Demkin VV. Species diversity of lactobacillus of vaginal microbiom: how to see. Molecular Genetics, Microbiology and Virology. 2018;36(3):3-12 (in Russian)]. doi: 10.17116/molgen2018360313
- Lamont RF, van den Munckhof EH, Luef BM, et al. Recent advances in cultivation-independent molecular-based techniques for the characterization of vaginal eubiosis and dysbiosis. Fac Rev. 2020;9:21. doi: 10.12703/r/9-21
- Bornstein J, Bradshaw C, Plummer E, et al. Bacterial vaginosis. In: Vieira-Baptista P, Stockdale CK, Sobel J. International Society for the Study of Vulvovaginal Disease recommendations for the diagnosis and treatment of vaginitis. Lisbon: Admedic, 2023. doi: 10.59153/adm.rdtv.001
- Amsel R, Totten PA, Spiegel CA, et al. Nonspecific vaginitis. Am J Med. 2004;74(1):14-22. doi: 10.1016/0002-9343(83)91112-9
- Серов В.Н., Аполихина И.А., Потекаев Н.Н., и др. Резолюция Совета экспертов в области акушерства-гинекологии, дерматовенерологии, гастроэнтерологии и микробиологии «Принципы интимной гигиены у здоровых женщин и при заболеваниях вульвы». Акушерство и Гинекология. 2023;8:229-34 [Serov VN, Apolikhina IA, Potekaev NN, et al. Resolution of the Council of Experts in the field of obstetrics-gynecology, dermatovenereology, gastroenterology and microbiology Principles of intimate hygiene in healthy women and diseases of the vulva. Obstetrics and Gynecology. 2023;8:229-34 (in Russian)]. doi: 10.18565/aig.2023.8.229-234
- Chen Y, Bruning E, Rubino J, Eder SE. Role of female intimate hygiene in vulvovaginal health: Global hygiene practices and product usage. Womens Health (Lond). 2017;13(3):58-67. doi: 10.1177/1745505717731011
- Patterson J, Millheiser L, Krychman ML. Moisturizers, Lubricants, and Vulvar Hygiene Products: Issues, Answers, and Clinical Implications. Curr Sex Health Rep. 2016;8(4):213-21. doi: 10.1007/s11930-016-0091-0
- Демкин В.В., Кошечкин С.И. Видовое разнообразие лактофлоры в вагинальном миикробиоме российских женщин. Молекулярная генетика, микробиология и вирусология. 2024;42(2):25-31 [Demkin VV. Species diversity of lactobacillus of vaginal microbiom: how to see. Molecular Genetics, Microbiology and Virology. 2024;42(2):25-31 (in Russian)]. doi: 10.17116/molgen20244202125
- Togni G, Battini V, Bulgheroni A, et al. In Vitro Activity of Nifuratel on Vaginal Bacteria: Could It Be a Good Candidate for the Treatment of Bacterial Vaginosis? Antimicrob Agents Chemother. 2011;55(5):2490-42. doi: 10.1128/aac.01623-10
- De La Hoz FJE. Efficacy and safety of the combination nifuratel-nystatin and clindamycin-clotrimazole, in the treatment of bacterial vaginosis. Randomized controlled clinical trial. Int J Reprod Med Sex Health. 2021;3:01-10.
- De La Hoz FJE. Efficacy And Safety of Nifuratel-Nystatin in The Treatment of Mixed Vaginitis, in Pregnant Women From Quindío, 2013–2017. Randomized Clinical Trial Pregn Womens Health Care Int J. 2022;2(1):1-7.
- Аполихина И.А., Гущин А.Е., Эфендиева З.Н., Тюленев Ю.А. Возможности антимикробной терапии заболеваний, сопровождающихся патологическими выделениями из половых путей: результаты многоцентровой наблюдательной программы «Проспект». Акушерство и Гинекология. 2021;12:167-76 [Apolikhina A, Guschin AE, Efendieva ZN, Tyulenev YuA. Opportunities for antimicrobial therapy of diseases accompanied by pathological discharge from the genital tract: results of the multicenter observational Prospectus program. Obstetrics and Gynecology. 2021;12:167-76 (in Russian)]. doi: 10.18565/aig.2021.12.167-176
- Аполихина И.А., Рахматулина М.Р., Припутневич Т.В., и др. Систематический обзор эффективности и безопасности применения нифуратела у женщин с заболеваниями, сопровождающимися патологическими выделениями из половых путей. Акушерство и Гинекология. 2023;11:48-58 [Apolikhina IA, Rakhmatulina МR, Priputnevich ТV, et al. Systematic review of the efficacy and safety of nifuratel for women with diseases accompanied by pathological discharge from the genital tract. Obstetrics and Gynecology. 2023;11:48-58 (in Russian)]. doi: 10.18565/aig.2023.248
- Доброхотова Ю.Э., Казанцева В.Д., Озолиня Л.А., Савченко Т.Н. Терапевтические стратегии при различных фенотипических вариантах бактериального вагиноза. Архив акушерства и гинекологии им. В.Ф. Снегирева. 2024;11(4):440-8 [Dobrokhotova YuE, Kazantseva VD, Ozolinya LA, Savchenko TN. Treatment strategies in different phenotypic forms of bacterial vaginosis. V.F. Snegirev Archives of Obstetrics and Gynecology. 2024;11(4):440-8 (in Russian)]. doi: 10.17816/aog630065
- Костюк С.А., Шиманская И.Г., Полуян О.С., Руденкова Т.В. Особенности видового разнообразия Lactobacillus spp. при нормоценозе, мезоценозе и дисбиозе влагалища. Медицинские новости. 2015;10:63-6 [Kostiuk SA, Shimanskaya IG, Poluyan OS, Rudenkova TV. The lactobacillus spp. diversity species features at vagina normotsenoze, mezotsenoze and dysbiosis. Meditsinskie novosti. 2015;10:63-6 (in Russian)].
- Демкин В.В., Пустотина О.А., Казаков А.А., и др. Лактобактерии и бактериальный вагиноз: типирование видов и анализ уровней содержания в микробиоме. Молекулярная генетика, микробиология и вирусология. 2025 [Demkin VV, Pustotina OA, Kazakov AA, et al. Laktobakterii i bakterial'nyi vaginoz: tipirovanie vidov i analiz urovnei soderzhaniia v mikrobiome. Molekuliarnaia genetika, mikrobiologiia i virusologiia. 2025 (in Russian)].
- Будиловская О.В., Шипицына Е.В., Герасимова Е.Н., и др. Видовое разнообразие вагинальных лактобацилл в норме и при дисбиотических состояниях. Журнал акушерства и женских болезней. 2017;66(2):24-32 [Budilovskaya OV, Shipitsyna EV, Gerasimova EN, et al. Species diversity of vaginal lactobacilli in norm and in dysbiotic states. Journal of Obstetrics and Women’s Diseases. 2017;66(2):24-32 (in Russian)]. doi: 10.17816/jowd66224-32
- Khedkar R, Pajai S. Bacterial Vaginosis: A Comprehensive Narrative on the Etiology, Clinical Features, and Management Approach. Cureus. 2022;14(11):e31314. doi: 10.7759/cureus.31314
- Holdcroft AM, Ireland DJ, Payne MS. The Vaginal Microbiome in Health and Disease – What Role Do Common Intimate Hygiene Practices Play? Microorganisms. 2023;11(2):298. doi: 10.3390/microorganisms11020298
Supplementary files
