Possibilities of antibacterial therapy in patients with mixed infections of the vagina and cervix: the results of the Flora Centrum study
Apolikhina I.A., Boris D.A., Iurova M.V., Gorbunova Е.А., Teterina Т.А.
Objective: To evaluate the efficacy and safety of the use of the Symprazole combined drug (ornidazole 500 mg + ciprofloxacin 500 mg) in women with mixed bacterial infections of the vagina and cervix which are caused by sensitive Gram+ and Gram- microorganisms in combination with anaerobic microorganisms in real clinical practice.
Materials and methods: The study included 40 women aged 18 to 50 years with mixed bacterial infections of the vagina and cervix confirmed by laboratory tests. The study consisted of three periods: selection of patients (initial assessment and analysis), inclusion in the study and initiation of therapy, evaluation of the effectiveness of therapy and control analyses. The schedule of patients’ visits was determined based on actual clinical practice. The participation of each patient in the study did not exceed 49 days. The total duration of the course of treatment with the Symprazole drug was determined by the researcher and ranged from 5 to 7 days: one tablet was taken twice a day.
Results: The clinical efficacy of the therapy of the above drug was 97.5%, and the microbiological efficacy was 95%. During the course of treatment, there was an improvement in clinical symptoms: the absence of discomfort, itching, burning, mucosal hyperemia, and a decrease in symptoms of dyspareunia. A fast clinical effect (complete absence of complaints after 36–72 hours) was observed in 92.7% of patients. Microbiological picture improved when laboratory parameters of vaginal microbiocenosis were normalized. After the end of the course of therapy (after 35–37 days), there was a significant decrease in the intensity of colonization by opportunistic microorganisms in the vaginal biotope of patients and there were representatives of normal biocenosis. The Symprazole drug has shown its high safety, no adverse events have been detected during its use.
Conclusion: The original combination Symprazole drug has shown its high effectiveness and rapid onset of clinical effect in the treatment of mixed bacterial infections of the vagina and cervix caused by Gram+ and Gram- microorganisms in combination with anaerobic flora.
Authors' contributions: Apolikhina I.A. – developing the concept and design of the study; Boris D.A. – collecting and processing material, statistical analysis of data, review of publications on the topic of the article, writing the text of the manuscript, editing; Iurova M.V., Gorbunova E.A., Teterina T.A. – collecting material.
Conflicts of interest: The authors declare no possible conflicts of interest.
Funding: The study was conducted without sponsorship.
Ethical Approval: The study was approved by the Ethical Review Board of the Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia.
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: Apolikhina I.A., Boris D.A., Iurova M.V., Gorbunova Е.А., Teterina Т.А. Possibilities of antibacterial therapy in patients with mixed infections of the vagina and cervix: the results of the Flora Centrum study.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2024; (5): 134-142 (in Russian)
https://dx.doi.org/10.18565/aig.2024.118
Keywords
vaginitis
cervicitis
bacterial vaginosis
bacterial infections
vaginal infections
relapses
treatment
combination drug
ornidazole
ciprofloxacin
Symprazole
References
- McClelland R.S., Balkus J.E., Lee J., Anzala O., Kimani J., Schwebke J. et al. Randomized trial of periodic presumptive treatment with high-dose intravaginal metronidazole and miconazole to prevent vaginal infections in HIV-negative women. J. Infect. Dis. 2015; 211(12): 1875-82. https://dx.doi.org/10.1093/infdis/jiu818.
- Peixoto F., Camargos A., Duarte G., Linhares I., Bahamondes L., Petracco A. Efficacy and tolerance of metronidazole and miconazole nitrate in treatment of vaginitis. Int. J. Gynaecol. Obstet. 2008; 102(3): 287-92. https://dx.doi.org/10.1016/j.ijgo.2008.04.014.
- Kenyon C., Colebunders R., Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am. J. Obstet. Gynecol. 2013; 209(6): 505-23. https://dx.doi.org/10.1016/j.ajog.2013.05.006.
- Sobel J.D. Recurrent vulvovaginal candidiasis. Am. J. Obstet. Gynecol. 2016; 214(1): 15-21. https://dx.doi.org/10.1016/j.ajog.2015.06.067.
- Liang Q., Li N., Song S., Zhang A., Li N., Duan Y. High-dose nifuratel for simple and mixed aerobic vaginitis: A single-center prospective open-label cohort study. J. Obstet. Gynaecol. Res. 2016; 42(10): 1354-60. https://dx.doi.org/10.1111/jog.13052.
- Sobel J.D., Subramanian C., Foxman B., Fairfax M., Gygax S.E. Mixed vaginitis-more than coinfection and with therapeutic implications. Curr. Infect. Dis. Rep. 2013; 15(2): 104-8. https://dx.doi.org/10.1007/s11908-013-0325-5.
- Бондаренко К.Р. Цервико-вагинальные микст-инфекции в гинекологии: нерешенные вопросы терапии. РМЖ. Мать и дитя. 2019; 2(3): 194-9. [Bondarenko K.R. Cervical vaginal mixed infections in gynecology: unresolved therapeutic issues. Russian Journal of Woman and Child Health. 2019; 2(3): 194-9. (in Russian)]. https://dx.doi.org/10.32364/2618-8430-2019-2-3-194-199.
- Беженарь В.Ф., Молчанов О.Л., Кукес И.В., Мезников А.А., Галиуллина Л.А., Зосимовский А.Ю., Позняк А.Л. Эффективность монопрепарата, содержащего комбинацию ципрофлоксацина – орнидазола в лечении инфекционно-воспалительных и дисбиотических заболеваний влагалища. Медицинский совет. 2021; 13: 207-15. [Bezhenar V.F., Molchanov O.L., Kukes I.V., Meznikov A.A., Galiullina L.A., Zosimovskiy A.Y., Poznyak A.L. The effectiveness of a monopreparation containing a combination of ciprofloxacin – ornidazole in the treatment of infectious-inflammatory and dysbiotic vagina diseases. Medical Council. 2021; (13): 207-15. (in Russian)]. https://dx.doi.org/10.21518/2079-701X-2021-13-207-215.
- Деговцов Е.Н., Трухан Д.И., Сулимов А.Ф. Комбинированный антибактериальный препарат в амбулаторной хирургической практике с позиций клинической эффективности и лекарственной безопасности. Стационарозамещающие технологии. Амбулаторная хирургия. 2019; (3-4): 74-82. [Degovtsov E.N., Trukhan D.I., Sulimov A.F. Combined antibacterial drug in ambulatory surgical practice with a position of clinical efficiency and drug safety. Hospital-replacing technologies: Ambulatory Surgery. 2019; (3-4): 74-82. (in Russian)]. https://dx.doi.org/10.21518/1995-1477-2019-3-4-74-82.
- Перепанова Т.С., Мартов А.Г., Хазан П.Л. Антимикробная профилактика инфекционно-воспалительных осложнений после урологических вмешательств. Эффективная фармакотерапия. 2007; 17: 6-10. [Perepanova T.S., Martov A.G., Khazan P.L. Antimicrobial prophylaxis of infectious-inflammatory complications after urological interventions. Effective Pharmacotherapy. 2007; (17): 6-10. (in Russian)].
- Пестрикова Т.Ю., Юрасов И.В., Юрасова Е.А. Воспалительные заболевания органов малого таза: современные тренды диагностики и терапии (обзор литературы). Гинекология. 2018; 20(6): 35-41. [Pestrikova T.Yu., Yurasov I.V., Yurasova E.A. Inflammatory disease of the womans reproductive system: modern trends in diagnosis and therapy (literature review). Gynecology. 2018; 20(6): 35-41. (in Russian)]. https://dx.doi.org/10.26442/20795696.2018.6.180072.
- Workowski K.A., Bolan G.A.; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm. Rep. 2015; 64(RR-03): 1-137.
- Амирханян А.С., Прилепская В.Н., Байрамова Г.Р., Бурменская О.В., Костава М.Н., Асатурова А.В. Хронический цервицит: современные возможности диагностики и лечения. Акушерство и гинекология. 2018; 4: 22-7. [Amirkhanyan A.S., Prilepskaya V.N., Bairamova G.R., Burmenskaya O.V., Kostava M.N., Asaturova A.V. Chronic cervicitis: current opportunities for diagnosis and treatment. Obstetrics and Gynecology. 2018; (4): 22-7. (in Russian)]. https://dx.doi.org/10.18565/aig.2018.4.22-27.
- Denning D.W., Kneale M., Sobel J.D., Rautemaa-Richardson R. Global burden of recurrent vulvovaginal candidiasis: a systematic review. Lancet Infect. Dis. 2018; 18(11): e339-e347. https://dx.doi.org/10.1016/S1473-3099(18)30103-8.
- Sherrard J., Wilson J., Donders G., Mendling W., Jensen J.S. 2018 European (IUSTI/WHO) International Union against sexually transmitted infections (IUSTI) World Health Organisation (WHO) guideline on the management of vaginal discharge. Int. J. STD AIDS. 2018; 29(13): 1258-72. https://dx.doi.org/10.1177/0956462418785451.
- Mason M.J., Winter A.J. How to diagnose and treat aerobic and desquamative inflammatory vaginitis. Sex Transm. Infect. 2017; 93(1): 8-10. https://dx.doi.org/10.1136/sextrans-2015-052406.
- Paavonen J.A., Brunham R.C. Vaginitis in Nonpregnant Patients: ACOG Practice Bulletin Number 215. Obstet. Gynecol. 2020; 135(5): 1229-30. https://dx.doi.org/10.1097/AOG.0000000000003857.
- Hillier S.L., Austin M., Macio I., Meyn L.A., Badway D., Beigi R. Diagnosis and treatment of vaginal discharge syndromes in community practice settings. Clin. Infect. Dis. 2021; 72(9): 1538-43. https://dx.doi.org/10.1093/cid/ciaa260.
Received 15.05.2024
Accepted 22.05.2024
About the Authors
Inna A. Apolikhina, Dr. Med. Sci., Professor, Head of the Department of Aesthetic Gynecology and Rehabilitation, V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4; Professor at the Department of Obstetrics, Gynecology, Perinatology, and Reproductology, Institute of Professional Education, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University), 119991, Russia, Moscow, Trubetskaya str., 8-2, i_apolikhina@oparina4.ru, https://orcid.org/0000-0002-4581-6295Dayana A. Boris, PhD, obstetrician-gynecologist, doctor of ultrasound diagnostics, Researcher at the Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4, +7(915)081-89-97, dayana_boris@mail.ru, https://orcid.org/0000-0002-0387-4040
Mariia V. Iurova, obstetrician-gynecologist, oncologist, Researcher at the Scientific and Polyclinic Department, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4: Teaching Assistant, I.M. Sechenov First Moscow State Medical University, Ministry of Health of Russia (Sechenov University), 119991, Russia, Moscow, Trubetskaya str., 8-2, m_yurova@oparina4.ru,
https://orcid.org/0000-0002-0179-7635
Tatiana A. Teterina, PhD, obstetrician-gynecologist, Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4, t_teterina@oparina4.ru,
https://orcid.org/0000-0003-0990-2302
Elena A. Gorbunova, obstetrician-gynecologist, Researcher at the Department of Aesthetic Gynecology and Rehabilitation, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, 117997, Russia, Moscow, Ac. Oparina str., 4, el_gorbunova@oparina4.ru,
https://orcid.org/0000-0002-4723-4299
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