Open prospective study to evaluate the efficacy of a new vaginal pessary containing 300mg tinidazole, 200mg tioconazole and 100mg lidocaine with a 3-day regime (Gynomax XL®) in the treatment of vaginal infections due to bacterial vaginosis, candidiasis an
DOI:
https://doi.org/10.18370/2309-4117.2024.71.117-126Keywords:
candidiasis, bacterial vaginosis, mixed vaginal infections, tinidazole, tioconazolAbstract
Introduction. The management of infections of the vulva and vagina depend on the selection and administration of effective specific therapies that allow a fast treatment, enhancing the compliance of the patients.
Objective of the study: the efficacy and safety of a new medicinal product containing 300mg tinidazole/200mg tioconazole/100mg lidocaine for the treatment against vaginal candida albicans, bacterial vaginosis and combined infections was evaluated upon 69 patients.
Materials and methods. Clinical controls, pH, 10% KOH probe, microscopical and microbiological analysis were performed at day 1, day 4, day 10 and at day 30 of the study. Success was defined as follows: 0 points = no symptoms, 1 point = mild symptoms, 2 points = moderate symptoms, 3 points = severe symptoms.
Results. A complete clinical recovery at day 10 was observed in 54 (80.6%) patients. A clinical improvement in 12 (17.9%) and a failure in 1 patient (1,5%). At day 30 a clinical complete recovery was observed in 58 (86.6%) patients, a clinical improvement in 7 (10.4%) and a failure in 2 patients (3%).
Conclusions. This formulation (GynomaxXL), a vaginal suppository given at 3 consecutive days, is a highly effective and safe combination in the therapy of vulvovaginal candidiasis and bacterial vaginosis.
References
- Brocklehurst P, Mindel A. Recurrent genital infections. Br J Sex Med. 1991 18: 54–7.
- Landers DV. The treatment of vaginitis: Trichomonas, yeast, and bacterial vaginosis. Clin Obstet Gynecol. 1988 Jun;31(2):473–9. DOI: 10.1097/00003081-198806000-00021.
- Mardh PA, Tchoudomirova K, Elshibly S, Hellberg D. Symptoms and sings in single and mixed genital infections. Int J Gynecol Obstet. 1998 Nov;63(2):145–52. DOI: 10.1016/s0020-7292(98)00140-4.
- Govender L, Hoosen AA, Moodley J, et al. Bacterial vaginosis and associated infections in pregnancy. Int J Gynecol Obstet. 1996. Oct;55(1): 23–28. DOI: 10.1016/0020-7292(96)02744-0
- Redondo Lopez V, Meriwether C, Schmitt C, et al. Vulvovaginal candidiais complicating recurrent bacterial vaginosis. Sex Transm Dis. 1990 Jan-Mar;17(1): 51–3.
- Blackwell A. Infectious causes of abnormal vaginal discharge – part two. Matern Child Health 1987 12: 368–375. https://doi.org/10.1177/030006059302100104
- Ferris DG, Hendrich J, Payne PM, et al. Office laboratory diagnosis of vaginitis. Clinicianperformed tests compared with a rapid nucleic acid hybridization test. J Fam Pract 1995. Dec;41(6): 575–81.
- Morton O. Neotran – new double-active pessary for the treatment of vaginitis. J Int Med Res 1993;21:36–46. https://doi.org/10.1177/03000605930210010
- Kukner S, Ergin T, Cicek N, et al. Treatment of vaginitis. Int J Gynecol Obstet 1996;52(1): 43–47. DOI: 10.1016/0020-7292(95)02531-6.
- Altıntaş A, Embil K. A new pessary for the treatment of vaginitis – clinical trial report (abstract 93.004). 8th Edn. International Congress of Infectious Diseases, Boston, USA. 1998.
- Taner C, Yucel ES, İnce M, et al. Vaginitis and treatment (abstract 93.005). 8th Edn. International Congress of Infectious Diseases, Boston, USA. 1998.
- Ozyurt E, Toykuliyeva MB, Danilyans IL, et al. Efficacy of 7-day treatment with metronidazole + miconazole (Neo-Penotran) – a triple-active pessary for the treatment of single and mixed vaginal infections. Int J Gynecol Obstet 2001;74(1): 35–43. DOI: 10.1016/s0020-7292(01)00388-5
- Huseyinova L, Toykuliyeva MB, Ozyurt E, Danilyans IL, Baktır G. Tolerance, acceptability and absorption study with Neo-Penotran→ Forte-L and Neo-Penotran→ Forte in healthy volunteers (abstract 0158). 10th Edn. International Congress of Infectious Diseases, Singapore. 2002
- Regidor PA, Ozyurt E, Toykuliyeva MB, et al. Treatment and prevention of trichomoniasis, bacterial vaginosis and candidiasis with a new 7-day regime containing metronidazole and meiconazole in a single vaginal pessary. IJMDAT 2018;1(1):e118.
- Duarte G, Baracat EC, Wehba S. Efficacy and tolerability of tioconazole/tinidazole combination in the treatment of vulovovaginitis. Femina 2016;96(24):895–904.
- Tinidazole, Micromedex. Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Reuters (Healthcare). Updated periodically. 2010.
- Mattila J, Mannisto PT, Mantyla R, et al. Comparative pharmacokinetics of metrinidazole and tinidazole as influenced by administration route. Antimicrobial agents and chemotherapy. 1993. May;23: 721–5. DOI: 10.1128/AAC.23.5.721.
- Jevons S, Gymer, GE, Brammer KW, et al. Antifungal activity of tioconazole (UK-20,349), a new imidazole derivate. Antimicrobial agents Chemotherapy 1979 Apr;15(4):597–602. DOI: 10.1128/AAC.15.4.597.
- Morton O. Neotran – new double-active pessary for the treatment of vaginitis. J Int Med Res 1993;21:36–46. https://doi.org/10.1177/03000605930210010
- Houang ET, Lawrence A. Systemic absorption and persistence of tioconazole in vaginal fluid after insertion of a single 300- mg tioconazole ovule. Antimicrobila Agents and Chemotherapy 1995;27: 964–5.
- Borchardt, Kenneth A. Sexually transmitted diseases: epidemiology, pathology, diagnosis, and treatment. CRC Press, Boca Raton, Florida, 1997:p. 4.
- Donders GG, Zodzika J, Rezeberga D. Treatment of bacterial vaginosis: what we have and what we miss. Expert opinion on pharmacotherapy 2014 Apr;15(5):645–57. DOI: 10.1517/14656566.2014.881800.
- Sharma H, Tal R, Clark NA, Segars JH. Microbiota and Pelvic Inflammatory Disease. Seminars in Reproductive Medicine 2014 Jan;32(01):43–9.
- What are the symptoms of bacterial vaginosis? National Institute of Child Health and Human Development. 2013 May 21. [Retrieved 3 March 2015].
- Kenyon C, Colebunders R, Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol. 2013 Dec;209(6):505–23. DOI: 10.1016/j.ajog.2013.05.006
- Bradshaw CS, Brotman RM. Making inroads into improving treatment of bacterial vaginosis – striving for long-term cure. BMC Infect Dis. 2015 Jul 29;15:292. DOI: 10.1186/s12879-015-1027-4
- Queenan JT, Spong CY, Lockwood CJ. Queenan’s management of high-risk pregnancy: an evidence-based approach [6th ed.]. Chichester, West Sussex: Wiley-Blackwell, 2012:p.262.
- What are the treatments for bacterial vaginosis (BV)? National Institute of Child Health and Human Development. 2015. [Last Reviewed Date5/5/2021].
- Bennett J. Mandell, Dolin R. Douglas, and Bennett’s principles and practice of infectious diseases. Philadelphia, PA: Elsevier/Saunders, 2015:p.4028.
- Bacterial Vaginosis (BV): Condition Information. National Institute of Child Health and Human Development. 2015
- Nardis C, Mastromarino P, Mosca L. Vaginal microbiota and viral sexually transmitted diseases. Annali di Igiene. 2013 Sep-Oct;25 (5):443–56. DOI: 10.7416/ai.2013.1946.
- Bacterial Vaginosis – CDC Fact Sheet. Centers for Disease Control and Prevention. 2014
- Mashburn J. Etiology, diagnosis, and management of vaginitis. Journal of midwifery & women’s health 2006 Nov- Dec;51(6):423–30. DOI: 10.1016/j.jmwh.2006.07.005.
- Mulley AG, Goroll AH. Primary Care Medicine: office evaluation and management of the adult patient. Philadelphia: Wolters Kluwer Health. 2006: p.802–3.
- Goehring RV. Mims’ medical microbiology. [4th Edn.]. Mosby Elsevier, Philadelphia, USA, 2008:p.656.
- Nwokolo NC, Boag FC. Chronic vaginal candidiasis. Management in the postmenopausal patient. Drugs Aging. 2000 16(5): 335–339.
- Bassetti M, Mikulska M, Viscoli C. Bench-to-bedside review: therapeutic management of invasive candidiasis in the intensive care unit. Critical Care. 2010 14(6):244. DOI: 10.1186/cc9239
- Odds FC. Candida infections: an overview. Crit Rev Microbiol. 1987 15(1):1–5.
- Choo ZW, Chakravarthi S, Wong SF, et al. A comparative histopathological study of systemic candidiasis in association with experimentally induced breast cancer. Oncology Letters 2010 Jan 1(1): 215–222. DOI: 10.3892/ol_00000039
- Akpan A, Morgan R. Oral candidiasis. Postgraduate Medical Journal 2002 Aug;78(922): 455–459. DOI: 10.1136/pmj.78.922.455.
- AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD, 2010:p.3522.
- Dunne RL, Dunn LA, Upcroft P, et al. Drug resistence in the sexually transmitted protozoan Trichonomas vaginalis. Cell res 2003 Aug;13(4):239–49. DOI: 10.1038/sj.cr.7290169.
- Sobel JD, Nyirjesy P, Brown W. Tinidazole therapy for metronidazole-resistant vaginal trichomoniasis. Clin Infect Dis. 2001 Oct;33(8): 1341–6. DOI: 10.1086/323034.
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