Optimization of combination therapy for bacterial vaginosis in reproductive-aged women
Objective. To evaluate the efficacy and tolerability of Multi-Gyn ActiGel used in the combination treatment of recurrent bacterial vaginosis (BV) in reproductive-aged women.Abashova E.I., Shalina M.A., Yarmolinskaya M.I., Misharina E.V.
Subjects and methods. Fifty reproductive-aged women with recurrent BV were randomized equally into 2 groups: 1) those who received a standard two-stage treatment regimen with clindamycin phosphate vaginal cream 2% for 7 days, followed by intravaginal application of Multi-Gyn ActiGel for 5 days; 2) those who used long-term treatment: after the standard regimen they continued to have Multi-Gyn ActiGel twice weekly for 3 months. BV was diagnosed using the clinical data, Amsel’s criteria, and microscopic and molecular techniques. The effectiveness of treatment for BV was evaluated 1 and 3 months after start of therapy.
Results. The effectiveness of therapy at 1 month after start of two-stage treatment in patients with recurrent BV in both groups was high and amounted to 88% and 84%, respectively. Following 3 months, the recurrent BV rate was significantly lower among the women receiving the long-term treatment regimen (p < 0.05) and was confirmed by clinical and laboratory data than that in patients with the standard regimen using intravaginal Multi-Gyn ActiGel.
Conclusion. Multi-Gyn ActiGel is well-tolerated, convenient, and easy-to-use, has no side effects, thus shows high compliance, including that during its long-term use. The long-term use of intravaginal Multi-Gyn ActiGel in the two-stage treatment of bacterial vaginosis significantly (p < 0.01) increases the number of lactobacilli in the vaginal biotope, reduces vaginal pH values, and restores normal microflora, which allows a relapse of the disease to be prevented in 80% of patients with bacterial vaginosis.
Keywords
Supplementary Materials
References
1. Кира Е.Ф. Бактериальный вагиноз. М.: МИА; 2012. 472с. [Kira E.F. Bacterial vaginosis. Moscow: MIA; 2012. 472p. (in Russian)]
2. Kenyon C., Colebunders R., Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am. J. Obstet. Gynecol. 2013; 209(6): 505-23. doi: 10.1016/j.ajog.2013.05.006.
3. Балан В.Е., Тихомирова Е.В., Овчинникова В.В. Рецидивирующий бактериальный вагиноз – возможность увеличения продолжительности ремиссии. Акушерство и гинекология. 2017; 1: 83-8. http://dx.doi.org/10.18565/aig.2017.1.83-88 [Balan V.E., Tikhomirova E.V., Ovchinnikova V.V. Recurrent bacterial vaginosis: Possibility of increasing the duration of remission. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2017; (1): 83-8. (in Russian) http://dx.doi.org/10.18565/aig.2017.1.83-8]
4. Bradshaw C.S., Morton A.N., Hocking J., Garland S.M., Morris M.B., Moss L.M. et al. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J. Infect. Dis. 2006; 193(11): 1478-86.
5. Анкирская А.С. Неспецифические вагиниты. Клиническая микробиология и антимикробная терапия. 2000; 2: 23-8. [Ankirskaya A.S. Nonspecific vaginitis. Clinical microbiology and antimicrobial therapy. 2000; 2: 23-8. (in Russian)]
6. Allsworth J.E., Peipert J.F. Severity of bacterial vaginosis and the risk of sexually transmitted infection. Am. J. Obstet. Gynecol. 2011; 205(2): 113. e1-6.
7. Donati L., Di Vico A., Nucci M., Quagliozzi L., Spagnuolo T., Labianca A. et al. Vaginal microbial flora and outcome of pregnancy. Arch. Gynecol. Obstet. 2010; 281(4): 589-600. doi: 10.1007/s00404-009-1318-3.
8. Haggerty C.L., Totten P.A., Tang G., Astete S.G., Ferris M.J., Norori J. et al. Identification of novel microbes associated with pelvic inflammatory disease and infertility. Sex. Transm. Infect. 2016; 92(6): 441-6. doi: 10.1136/sextrans-2015-052285.
9. Taylor B.D., Darville T., Haggerty C.L. Does bacterial vaginosis cause pelvic inflammatory disease? Sex. Transm. Dis. 2013; 40(2): 117-22. doi: 10.1097/OLQ.0b013e31827c5a5b.
10. Абашова Е.И., Боровик Н.В., Мартикайнен З.М., Савичева А.М., Тарасова М.А. Эффективность клиндамицина фосфата при лечении бактериального вагиноза у больных сахарным диабетом 1-го типа. Акушерство и гинекология. 2006; 6: 46-9. [Abashova E.I., Borovik N.V., Martikainen Z.M., Savicheva A.M., Tarasova M.A. Efficacy of clindamycin phosphate in the treatment of bacterial vaginosis in patients with type 1 diabetes mellitus. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2006; 6: 46-9. (in Russian)]
11. Гомберг М.А. Бактериальный вагиноз и новые инфекции, с ним ассоциированные. Российский вестник акушера-гинеколога. 2010; 10(2): 32-4. [Gomberg M.A. Bacterial vaginosis and new infections associated with it. Rossiyskiy vestnik akushera-ginekologa. 2010; 10(2): 32-4. (in Russian)]
12. Foxman B., Wen A., Srinivasan U., Goldberg D., Marrs C.F., Owen J. et al. Mycoplasma, bacterial vaginosis-associated bacteria BVAB3, race, and risk of preterm birth in a high-risk cohort. Am. J. Obstet. Gynecol. 2014; 210(3): 226. e1-7.
13. Amsel R., Totten P., Spiegel C., Chen K., Eschenbach D., Holmes K. Nonspecific vaginitis. Diagnostic criteria and microbial and epidemiologic associations. Am. J. Med. 1983; 74(1): 14-22.
14. Прилепская В.Н., Мирзабалаева А.К., Кира Е.Ф., Гомберг М.А., Аполихина И.А., Байрамова Г.Р. Федеральные клинические рекомендации. Диагностика и лечение заболеваний, сопровождающихся патологическими выделениями из половых путей женщин. М.: Российское общество акушеров-гинекологов; 2013. [Prilepskaya V.N., Mirzabalaeva A.K., Kira E.F., Gomberg M.A., Apolikhina I.A., Bayramova G.R. Federal clinical guidelines. Diagnosis and treatment of diseases accompanied by pathological secretions from the genital tract of women. Moscow: Russian Society of Obstetricians and Gynecologists; 2013. (in Russian)]
15. Савичева А.М., Шипицына Е.В. Микробиота влагалища при бактериальном вагинозе. Аспекты диагностики и терапии. Медицинский cовет. 2014; 9: 90-5. [Savicheva A.M., Shipitsyna E.V. Vaginal microbiota in bacterial vaginosis. Aspects of diagnosis and therapy. Meditsinskiy sovet. 2014; 9: 90-5. (in Russian)]
16. Шипицына Е.В., Хуснутдинова Т.А., Рыжкова О.С., Крысанова А.А., Будиловская О.В., Рыбина Е.В., Воробьева Н.Е., Савичева А.М., Гущин А.Е. Сравнение эффективности диагностики бактериального вагиноза по клиническим признакам с результатами лабораторных исследований. Журнал акушерства и женских болезней. 2016; 65(4): 76-82. [Shipitsyna E.V., Khusnutdinova T.A., Ryzhkova O.S., Krysanova A.A., Budilovskaya O.V., Rybina E.V., Vorobyova N.E., Savicheva A.M., Gushchin A.E. Comparison of the effectiveness of diagnosis of bacterial vaginosis by clinical signs with the results of laboratory studies. Zhurnal akusherstva i zhenskih bolezney. 2016; 65 (4): 76-82. (in Russian)]
17. Березовская Е.С., Макаров О.И., Гомберг М.А., Боровкова Е.И., Чулкова Е.А., Аракелян Л.А. Биопленки при бактериальном вагинозе. Акушерство, гинекология, репродукция. 2013; 2: 34-6. [Berezovskaya E.S., Makarov O.I., Gomberg M.A., Borovkova E.I., Chulkova E.A., Arakelyan L.A. Biofilms with bacterial vaginosis. Akusherstvo, ginekologiya, reproduktsiya. 2013; 2: 34-6. (in Russian)]
18. Swidsinski A., Loening-Baucke V., Swidsinski S., Verstraelen H. Polymicrobial Gardnerella biofilm resists repeated intravaginal antiseptic treatment in a subset of women with bacterial vaginosis: a preliminary report. Arch. Gynecol. Obstet. 2015; 291(3): 605-9.
19. Рахматулина М.Р., Плахова К.И. Бактериальный вагиноз, ассоциированный с Atopobium. vaginae: современные принципы диагностики и терапии. Акушерство и гинекология. 2012; 3: 62-6. [Rakhmatulina M.R., Plakhova K.I. Bacterial vaginosis associated with Atopobium. vaginae: the current principles of diagnosis and therapy. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2012; 3: 62-6. (in Russian)]
20. Machado A., Jefferson K.K., Cerca N. Interactions between Lactobacillus crispatus and bacterial vaginosis (bv)-associated bacterial species in initial attachment and biofilm formation. Int. J. Mol. Sci. 2013; 14(6): 12004-12. doi: 10.3390/ijms140612004.
21. Verstraelen H., Swidsinski A. The biofilm in bacterial vaginosis: implications for epidemiology, diagnosis and treatment. Curr. Opin. Infect. Dis. 2013; 26(1): 86-9. doi: 10.1097/QCO.0b013e32835c20cd.
22. Ventolini G., Mitchell E., Salazar M. Biofilm formation by vaginal Lactobacillus in vivo. Med. Hypothesis. 2015; 84(5): 417-20. doi: 10.1016/j.mehy.2014.12.020.
23. Савичева А.М., Шалепо К.В., Назарова В.В. Полнота восстановления вагинальной микроэкологии как критерий эффективности двухэтапной терапии бактериального вагиноза. Status Praesesns. 2014; 3: 33-7. [Savicheva A.M., Shalepo K.V., Nazarova V.V. Completeness of restoration of vaginal microecology as a criterion of the effectiveness of two-stage therapy of bacterial vaginosis. Status Praesesns. 2014; 3: 33-7. (in Russian)]
24. Macklaim J.M., Clemente J.C., Knight R., Gloor G.B., Reid G. Changes in vaginal microbiota following antimicrobial and probiotic therapy. Microb. Ecol. Health Dis. 2015; 26: 27799. doi: 10.3402/mehd.v26.27799.
25. Workowski K.A., Berman S. Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm. Rep. 2010; 59(RR-12): 1-110.
26. Мазуркевич М.В., Фирсова Т.А., Духанина М.В. Патогенетическая коррекция дисбиоза влагалища. Гинекология. 2014; 16(4): 14-7. [Mazurkevich M.V., Firsova T.A., Dukhanina M.V. Pathogenetic correction of vaginal dysbiosis. Ginekologiya. 2014; 16 (4): 14-7. (in Russian)]
27. Ferris M.J., Masztal A., Aldridge K.E., Fortenberry J.D., Fidel P.L. Jr., Martin D.H. Association of Atopobium vaginae, a recently described metronidazole resistant anaerobe, with bacterial vaginosis. (2004). BMC Infect. Dis. 2004; 4: 5. doi: 10.1186/1471-2334-4-5
28. Пустотина О.А. Современный подход к этиологии, патогенезу и профилактике бактериального вагиноза и вагинального кандидоза. Гинекология. 2015; 17(3): 79 - 82. [Pustotina O.A. A modern approach to the etiology, pathogenesis and prevention of bacterial vaginosis and vaginal candidiasis. Ginekologiya. 2015; 17 (3): 79-82. (in Russian)]
29. Духанина М.В., Мазуркевич М.В., Фирсова Т.А. Пути решения проблемы бактериального вагиноза в практике врача акушера- гинеколога. Акушерство и гинекология. 2016; 1: 101-8. https://dx.doi.org/10.18565/aig.2016.1.101-108. [Dukhanina M.V., Mazurkevich M.V., Firsova T.A., Kokaya I.Yu., Davtyan A.O. Ways to solve the problems of bacterial vaginosis in practice of an obstetrician/gynecologist’s practice. Akusherstvo i ginekologiya/Obstetrics and Gynecology. 2016; (1): 101-108. (in Russian) https://dx.doi.org/10.18565/aig.2016.1.101-108]
30. Радзинский В.Е., Тигиева А.В. Вульвовагинальные болезни: возможности патогенетической терапии. Эффективная фармакотерапия. 2014; 4: 38-42. [Radzinsky V.E., Tigieva A.V. Vulvovaginal diseases: the possibilities of pathogenetic therapy. Effektivnaya farmakoterapiya. 2014; 4: 38-42. (in Russian)]
31. Yarbrough V.L., Winkle S., Herbst-Kralovetz M.M. Antimicrobial peptides in the female reproductive tract: a critical component of the mucosal immune barrier with physiological and clinical implications. Hum. Reprod. Update. 2015; 21(3): 353-77. doi: 10.1093/humupd/dmu065.
32. Логутова Л.С., Новикова С.В., Цивцивадзе Е.Б., Федотова А.В. Клиническая оценка эффективности и безопасности местного лечения бактериального вагиноза у беременных женщин. Акушерство и гинекология. 2015; 10: 91-6. [Logutova L.S., Novikova S.V., Tsivtsivadze E.B., Fedotova A.V. Clinical evaluation of the efficiency and safety of topical treatment for bacterial vaginosis in pregnant women. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2015; 10: 91-6. (in Russian)]
33. Савичева А.М., Менухова Ю.Н., Воробъева Н.Е., Назарова В.В., Шалепо В.В., Ширшова Н.Ю., Башмакова М.А. Опыт комбинированной терапии у больных с бактериальным вагинозом. Российский вестник акушера-гинеколога. 2011; 11(3): 69-73. [Savicheva A.M., Menukhova Yu.N., Vorobyeva N.E., Nazarova V.V., Shalepo V.V., Shirshova N.Yu., Bashmakova M.A. Experience of combined therapy in patients with bacterial vaginosis. Rossiyskiy vestnik akushera-ginekologa. 2011; 11 (3): 69-73. (in Russian)]
34. Межевитинова Е.А., Бровкина Т.В., Довлетханова Э.Р. Бактериальный вагиноз: как снизить число рецидивов? Гинекология. 2012; 14(4): 53-7. [Mezhevitinova E.A., Brovkina T.V., Dovletkhanova E.R. Bacterial vaginosis: how to reduce the number of relapses? Ginekologiya. 2012; 14(4): 53-7. (in Russian)]
35. Подзолкова Н.М. Результаты российского многоцентрового исследования эффективности различных терапевтических схем при рецидивирующих вульвовагинальных инфекциях (БИОС-2). Status Praesens. 2014; 3: 38-46. [Podzolkova N.M. Results of a Russian multicentre study of the effectiveness of various therapeutic regimens for recurrent vulvovaginal infections (BIOS-2). Status Praesens. 2014; 3: 38-46. (in Russian)]
Received 08.09.2017
Accepted 22.09.2017
About the Authors
Abashova Elena Ivanovna, Candidate of Medical Science, Senior Researcher, Department of Endocrinology Reproduction, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction. 199034, Russia, St. Petersburg, Mendeleevskaya line, 3. Tel.: +78123289820, +79219459090. E-mail: abashova@yandex.ruShalina Maria Aleksandrovna, MD, doctor obstetrician-gynecologist of the department of gynecological endocrinology, D.O. Ott Research Institute of Obstetrics,
Gynecology and Reproduction. 199034, Russia, St. Petersburg, Mendeleevskaya line, 3. Tel.: +78123289820, +79219348777. E-mail: amarus@inbox.ru
Yarmolinskaya Maria Igorevna, Professor of the Russian Academy of Sciences, Head of the Department of Endocrinology of Reproduction, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction. 199034, Russia, St. Petersburg, Mendeleevskaya line, 3. Tel.: +78123289820, +79219166903. E-mail: m.yarmolinskaya@gmail.com
Misharina Elena Vladimirovna, Candidate of Medical Science, senior researcher of the Department of Endocrinology Reproduction, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction. 199034, Russia, St. Petersburg, Mendeleevskaya line, 3. Tel.: +78123289820, +79219558524. E-mail: mishellena@gmail.com
For citations: Abashova E.I., Shalina M.A., Yarmolinskaya M.I., Misharina E.V. Optimization of combination therapy for bacterial vaginosis in reproductive-aged women. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2017; (11): 134-40. (in Russian)
https://dx.doi.org/10.18565/aig.2017.11.134-140