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Opportunities of combination therapy in reproductive age patients with bacterial vaginosis combined with vulvovaginal candidiasis

https://doi.org/10.17749/2313-7347/ob.gyn.rep.2024.572

Abstract

Aim: to assess the effectiveness of combination therapy in reproductive age patients with mixed vaginitis.

Materials and Methods. A retrospective analysis of the therapeutic effectiveness for mixed vaginitis in 158 patients aged 18 to 45 years was carried out. For treatment, the drugs Gainomax (standard dose – thioconazole 100 mg, tinidazole 150 mg in the form of a suppository) and Gainomax plus (standard dose – thioconazole 200 mg, tinidazole 300 mg, lidocaine 100 mg in the form of a suppository) were used for 3 days. The criteria for treatment effectiveness were disappearance of clinical symptoms and normalization of laboratory parameters.

Results. Clinical and laboratory efficacy of therapy reached 95.6 %. Lack of therapeutic effectiveness presented as persistent complaints from patients was recorded in 7 out of 158 (4.4 %) of patients, at the same time, the normalization of vaginal pH was established (pH = 4.1 ± 0.4), the Lactobacilli count increased up to 107 ± 2.8 CFU/cm3, eradication of other opportunistic bacteria and fungi Candida occurred. No side effects were reported while assessing drug safety and tolerability.

Conclusion. Therapy combining thioconazole and tinidazole in treatment of patients with mixed vaginitis demonstrated high effectiveness.

About the Authors

I. V. Savelieva
Omsk State Medical University, Health Ministry of Russian Federation
Russian Federation

Irina V. Savelieva, MD, Dr Sci Med. 

Scopus Author ID: 57200599659. WoS ResearcherID: АВА-3474-2021

12 Lenin Str., Omsk 644099



E. A. Bukharova
Omsk State Medical University, Health Ministry of Russian Federation
Russian Federation

Elena A. Bukharova, MD, PhD. 

 Scopus Author ID: 57205684835. WoS ResearcherID: ABA-3642-2021

12 Lenin Str., Omsk 644099



E. G. Galyanskaya
Omsk State Medical University, Health Ministry of Russian Federation
Russian Federation

Elena G. Galyanskaya, MD, PhD.

Scopus Author ID: 57205684257. WoS ResearcherID: АВА-3717-2021

12 Lenin Str., Omsk 644099



N. V. Nosova
Omsk State Medical University, Health Ministry of Russian Federation
Russian Federation

Natalia V. Nosova, MD.

Scopus Author ID: 57205683143. WoS ResearcherID: ABA-2619-2021

12 Lenin Str., Omsk 644099



P. V. Davydov
Omsk State Medical University, Health Ministry of Russian Federation
Russian Federation

Pavel V. Davydov, MD. 

Scopus Author ID: 57205680365. WoS ResearcherID: ABA-3707-2021

12 Lenin Str., Omsk 644099



References

1. Cervix, vagina, vulva. Physiology, pathology, colposcopy, aesthetic correction. Guide for practitioners. Eds. S.I. Rogovskaya, E.V. Lipova. [Shejka matki, vlagalishche, vul'va. Fiziologiya, patologiya, kol'poskopiya, esteticheskaya korrekciya. Rukovodstvo dlya prakticheskih vrachej. Pod red. S.I. Rogovskoj, E.V. Lipovoj]. Moscow: Izd-vo zhurnala Status Praesens, 2016. 829 p. (In Russ.).

2. Firichenko S.V., Popova E.O., Smirnova S.O. Chronic nonspecific cervicitis. [Hronicheskij nespecificheskij cervicit]. Akusherstvo i ginekologiya. 2023;(7):135–46. (In Russ.). https://doi.org/10.18565/aig.2022.233. 

3. Abu-Rustum N.R., Yashar C.M., Bean S. at al. NCCN Guidelines Insights: Cervical Cancer, Version 1.2020. J Natl Compr Canc Netw. 2020;18(6):660–6. https://doi.org/10.6004/jnccn.2020.0027. 

4. Volkov V.G., Zakharova T.V. Improving preoperative management of women with high-grade cervical intraepithelial neoplasia. [Optimizaciya predoperacionnoj podgotovki zhenshchin s cervikal'nymi neoplaziyami vysokoj stepeni]. RMZh. Mat' i ditya. 2019;2(3):243–6. (In Russ.).  https://doi.org/10.32364/2618-8430-2019-2-3-243-246. 

5. Sung H., Ferlay J., Siegel R.L. et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. https://doi.org/10.3322/caac.21660.

6. Workowski K.A., Bachmann L.H., Chan P.A. et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1–187. https://doi.org/10.15585/mmwr.rr7004a1. 

7. Bitew A., Abebaw Y. Vulvovaginal candidiasis: species distribution of  Candida and their antifungal susceptibility pattern. BMC Womens Health.  2018;18(1):94. https://doi.org/10.1186/s12905-018-0607-z.  

8. Cyr S.S., Barbee L., Workowski K.A. et al. Update to CDC's Treatment  Guidelines for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1911–6. https://doi.org/10.15585/mmwr.mm6950a6. 

9. Torshin I.Yu., Apolikhina I.A., Baranov I.I. et al. The efficacy and safety  of a combination of tinidazole and thioconazole in the treatment of vaginal infections. [Effektivnost' i bezopasnost' kombinacii tinidazola i tiokonazola v lechenii vaginal'nyh infekcij]. Akusherstvo i ginekologiya. 2020;(4):214–22. (In Russ.). https://doi.org/10.18565/aig.2020.4.214222.

10. Silverberg B., Moyers A., Hinkle T. et al. 2021 CDC Update: treatment and complications of sexually transmitted infections (STIs). Venereology. 2022;1(1):23–46. https://doi.org/10.3390/venereology1010004. 

11. Preti M., Joura E., Vieira-Baptista P. et al. The European Society of Gynaecological Oncology (ESGO), the International Society for the Study of Vulvovaginal Disease (ISSVD), the European College for the Study of Vulval Disease (ECSVD) and the European Federation for Colposcopy  (EFC) consensus statements on pre-invasive vulvar lesions. Int J Gynecol Cancer. 2022;32(7):830–45. https://doi.org/10.1136/ijgc-2021-003262. 

12. Clinical guidelines – Bacterial vaginosis – 2022-2023-2024 (04.05.2022).  [Klinicheskie rekomendacii – Bakterial'nyj vaginoz – 2022-2023-2024  (04.05.2022)]. Moscow: Ministerstvo zdravoohraneniya Rossijskoj Federacii, 2022. 16 p. Available at: http://disuria.ru/_ld/11/1191_kr22N89MZ.pdf. [Accessed: 23.05.2024].

13. Instruction for medical use of the drug Gainomax, ЛП-000007.  [Instrukciya k medicinskomu primeneniyu lekarstvennogo preparata Gajnomaks, ЛП-000007]. (In Russ.). Available at: https://www.rlsnet.ru/drugs/gainomaks-40214. [Accessed: 23.05.2024].

14. Treatment Guidelines. International Union against Sexually Transmitted Infections, 2023. Available at: https://iusti.org/treatment-guidelines.  [Accessed: 23.05.2024]. 

15. Workowski K.A., Bachmann L.H., Chan P.A. et al. Sexually Transmitted Infections Treatment Guidelines. Recommendations and Reports. MMWR. 2021;70(4):1–192. Available at: https://www.cdc.gov/std/treatmentguidelines/STI-Guidelines-2021.pdf. [Accessed: 23.05.2024]. 

16. International Society for the Study of Vulvovaginal Disease recommendations for the diagnosis and treatment of vaginitis. Eds. P. Vieira-Baptista, C.K. Stockdale, J. Sobel. Lisbon: Admedic, 2023.  198 p. https://doi.org/10.59153/adm.rdtv.001. 

17. Instruction for medical use of the drug Gainomax Plus, LP-007796. [Instrukciya k medicinskomu primeneniyu lekarstvennogo preparata Gajnomaks Plyus, ЛП-007796]. (In Russ.). Available at: https://www.rlsnet.ru/drugs/gainomaks-40214. [Accessed: 23.05.2024].

18. Savicheva A.M., Moskvicheva V.S., Martynova M.A. A global view of the microworld. ISSVD recommendations on vulvovaginitis (2023): Information bulletin. Ed. V.E. Radzinsky. [Global'nyj vzglyad na mikromir. Rekomendacii ISSVD po vul'vovaginitam (2023): Informacionnyj byulleten'. Pod red. V.E. Radzinskogo]. Moscow: Redakciya zhurnala Status Praesens, 2024. 20 p. (In Russ.).

19. Savicheva A.M. Modern ideas about the laboratory diagnosis of reproductively significant infections in women of reproductive age.  Еxpert opinion. [Sovremennye predstavleniya o laboratornoj diagnostike reproduktivno znachimyh infekcij u zhenshchin reproduktivnogo  vozrasta. Mnenie eksperta]. Voprosy prakticheskoj kol'poskopii. Genital'nye infekcii. 2022;(3):34–9. (In Russ.). https://doi.org/10.46393/27826392_2022_3_34. 

20. Regidor P.A., Sailer M. Open prospective study to evaluate the efficacy of a new vaginal pessary containing 300 mg Tinidazole, 200 mg Tioconazole and 100 mg Lidocaine with a 3-day regime (GynomaxXL®) in the treatment of vaginal infections due to bacterial vaginosis, candidiasis and  mixed infections. Biomed J Sci Tech Res. 2019;12(5):9617–27. https://doi.org/10.26717/bjstr.2019.12.002327. 

21. Lefler E., Stevens D.A. Inhibition and killing of Candida albicans in vitro by five imidazoles in clinical use. Antimicrob Agents Chemother. 1984;25(4):450–4. https://doi.org/10.1128/AAC.25.4.450.  

22. American College of Obstetricians and Gynecologists. Vaginitis in nonpregnant patients: ACOG Practice Bulletin, Number 215. Obstet Gynecol. 2020;135(1):e1–e17. https://doi.org/10.1097/AOG.0000000000003604. 

23. Farah C.H., D’Elia E., Trabulsi L.R. Use of tinidazole/tioconazole combination in the treatment of vaginal infections caused by Trichomonas,  Gardnerella vaginalis or Candida albicans. J Bras Ginecol. 1987;97(1–2):43–7.  

24. Katkova N.Yu., Guseva O.I., Kachalina O.V., et al. Treatment for vaginitis in pregnancy. [Lechenie vaginitov pri beremennosti]. Akusherstvo i ginekologiya. 2020;(4):190–4. (In Russ.). https://doi.org/10.18565/aig.2020.4.190-194. 

25. Shikh E.V., Lazareva N.B., Ponomarenko T.M. Short courses of antimicrobial therapy for bacterial vaginosis: possibilities of modern pharmacology: A review. [Korotkie kursy antimikrobnoj terapii pri bakterial'nom vaginoze: vozmozhnosti sovremennoj farmakologii]. Ginekologiya. 2022;24(4):271–6. (In Russ.). https://doi.org/10.26442/20795696.2022.4.201826.


What is already known about this subject?

► Рathological whites remain one of the most common pathologies with which patients turn to gynecologists during outpatient consultations comprising more than 50 % in pattern of all infectious and inflammatory diseases.

► Researchers recognize the existence of microbial combinations as the main predisposing factors in development of mixed vaginitis.

► Currently, mixed vaginitis frequently adopts a recurrent course, which turns into a chronic inflammatory process. The presence of several microorganisms negatively affects the immune system compared to exposure to a single microorganism, which complicates disease diagnostics and treatment.

What are the new findings?

► The clinical and laboratory parameters assessing effectiveness of mixed vaginitis during combination therapy by Gainomax and Gainomax plus reached 95.6 %. Insufficient therapeutic effectiveness was recorded in 7/158 (4.4 %) women, while normalization of vaginal contents pH value reached 4.1 ± 0.4, Lactobacilli count increased up to 107 ± 2.8 CFU/cm3, eradication of opportunistic bacteria and genus Candida fungi occurred.

► Disease-related symptoms completely regressed in 151/158 (95.6 %) of patients, which significantly increases the odds of clinical recovery.

How might it impact on clinical practice in the foreseeable future?

► A drug course according to the instructions for use is associated with a minimal risk of disease resistance and helps to prevent recurrence of the pathological process.

► Positive aspects such as the lack of any-reason drug withdrawal specified in the informed consent evidence about a high patients’ adherence to therapy and allows the drug to be used in treatment of mixed vaginitis beginning from the first day at the outpatient stage.

Review

For citations:


Savelieva I.V., Bukharova E.A., Galyanskaya E.G., Nosova N.V., Davydov P.V. Opportunities of combination therapy in reproductive age patients with bacterial vaginosis combined with vulvovaginal candidiasis. Obstetrics, Gynecology and Reproduction. 2024;18(6):800-808. (In Russ.) https://doi.org/10.17749/2313-7347/ob.gyn.rep.2024.572

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ISSN 2313-7347 (Print)
ISSN 2500-3194 (Online)