Lactobacteria LCR35 for prevention of relapse of vulvovaginal candidiasis: results of the multicenter open non-interventional study
Objective. To evaluate the efficacy and safety of the preparation containing the culture of lactobacilli LCR35 (vaginal capsules) in preventing recurrence of vulvovaginal candidiasis after local and/or systemic treatment with antifungal drugs.Manukhin I.B., Abashova E.I., Bazina M.I., Gerasimov A.M., Katkova N.Yu., Maltseva L.I., Olina A.A., Tkachenko L.V.
Subjects and methods. A total of 800 patients diagnosed with acute vulvovaginal candidiasis (VVC) participated in the study. Depending on the therapy the patients were divided into two groups. Patients in group 1 (n = 200) received a course of VVC therapy with local and/or systemic antifungal drugs. Patients of group 2 (n = 600) received a course of VVC therapy with local and/or systemic antifungal drugs, and then a preparation containing a culture of lactobacilli LCR35 (lactogynal) in one capsule vaginally at night for 21 days. The period of dynamic observation of patients after the end of the therapy was five months, during which the recurrence of VVC was recorded. The study also assessed the level of patients’ adherence to the therapy using a multifactorial questionnaire. Statistical data analysis was performed using IBM SPSS 23.
Results. The period of time before the relapse of VVC was significantly longer in group 2 than in group 1, it was 98.08 ± 7.66 days and 86.19 ± 3.91 days, respectively, p = 0.037. The incidence of relapses of VVC was significantly lower in group 2 (4.7%) compared to group 1 (34.9%), p < 0.001. Evaluation of patients’ adherence to the treatment with the investigational drug lactogynal showed a high level (178.16 ± 1.16 points). The treatment groups analyzed were comparable in the number and severity of adverse events.
Conclusion. The presented results demonstrate the efficacy and safety of the preparation containing the culture of lactobacilli LCR35 (lactogynal) in the complex therapy of VVC.
Keywords
probiotic
relapse
vulvovaginal candidiasis
lactogynal
LCR35
References
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Received 30.11.2018
Accepted 07.12.2018
About the Authors
Manukhin, Igor B., MD, Honored Doctor of Russia, professor, Department of Obstetrics and Gynecology, Medical Faculty, Moscow State University of Medicine and Dentistry, Ministry of Health of Russia.127473, Russia, Moscow, Delegatskaya str. 20, bldg. 1. Tel.: +74991782831. E-mail: mgmsugyn@mail.ru
Abashova, Elena I., PhD, senior researcher, Department of Endocrinology Reproduction, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproduction.
199034, Russia, St. Petersburg, Mendeleevskaya line str. 3. Tel.: +78123289820, +79219459090. E-mail: abashova@yandex.ru
Bazina, Marina I., MD, professor, Department of Obstetrics and Gynecology, Krasnoyarsk State Medical University named after prof. V.F. Voyno-Yasenetskii.
660034, Russia, Krasnoyarsk, Krasnoyarskiy rabochiy pr. 170
Maltseva, Larisa I., MD, professor, Department of obstetrics and gynecology № 1, Kazan State Medical Academy.
420012, Russia, Kazan, Mushtari str.1. Tel: +7 (843)233-34-87. E-mail:laramalc@mail.ru
Olina, Anna A., MD, professor of Department of obstetrics and gynecology, Academician E.A. Vagner Perm State Medical University, Ministry of Health of Russia.
614990, Russia, Perm, Petropavlovskaya str. 26. Tel.: +73422172020. E-mail: olina29@mail.ru
Tkachenko, Ludmila V., MD, professor, head of Department of Obstetrics and Gynecology, Faculty of advanced training of doctors, Volgograd State Medical University.
400131, Russia, Volgograd, Pavshikh Bortsov Sq. str. 1. Tel.: +78442385005. E-mail: tkachenko.fuv@mail.ru
Katkova, Nadezhda Yu., MD, associate professor of the Department of Obstetrics and Gynecology, Postgraduate Education Faculty, Nizhny Novgorod State Medical Academy. 603005, Russia, Nizhny Novgorod, Minin and Pozharsky sq. str. 10/1. Tel.: +78314657575. E-mail: rector@gma.nnov.ru
Alexey, Gerasimov M., MD, Ivanovo State Medical Academy. 153462, Russia, Ivanovo, F. Engels Ave. str. 8. Tel.: +74932301766
For citations: Manukhin I.B., Abashova E.I., Bazina M.I., Gerasimov A.M., Katkova N.Yu., Maltseva L.I., Olina A.A., Tkachenko L.V. Lactobacteria LCR35 for prevention of relapse of vulvovaginal candidiasis: results of the multicenter open non-interventional study. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (12): 132-40. (in Russian)
http://dx.doi.org/10.18565/aig.2018.12.132-140
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