RANDOMIZED MULTICENTER TRIAL OF THE EFFICACY OF LOMEXIN 600 AND 1200 MG USED IN THE TREATMENT OF CANDIDA VULVOVAGINITIS IN REPRODUCTIVE-AGED WOMEN


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Abstract

To evaluate the efficiency of using fenticonazole (Lomexin) in doses of 1200 mg (600 mg twice at a 3-day interval) and 600 mg once in reproductive-aged women with Candida vulvovaginitis. Subject and methods. The randomized multicenter open-labeled trial enrolled 66 patients with Candida vulvovaginitis. The patients were divided in 2 groups of 33 women in each, by applying the envelop method. Group 1 patients were given lomexin 1200 mg (600 mg intravaginally twice at a 3-day interval) and group 2 patients received the drug in a single dose of 600 mg. Results. In groups 1 and 2, the microbiological efficacy of lomexin was 91.9 and 60.6%, respectively; the clinical subjective (rated by the patients) and objective (assessed by the physician) efficacies were 97.0% и 84.8% and 93.9 and 87.9%, respectively. Conclusion. The trial results showed the high efficiency of both fenticonazole (Lomexin) dosage regimens for the treatment of Candida vulvovaginitis; however, the microbiological treatment eficiency, patients’ subjective efficiency, and full cure with the physichian’s objective assessment were significantly more frequently recorded in the use of Lomexin 1200 mg (600 mg twice at a 3-day interval) versus 600 mg intravaginally.

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About the authors

V. E RADZINSKY

Peoples' Friendship University of Russia

N. V ARTYMUK

Kemerovo State Medical Academy

Email: artymuk@gmail.com

I. V BERLEV

S.M. Kirov Military Medical Academy

V. G VOLKOV

Tula State University

I. D EVTUSHENKO

Siberian State Medical University

L. Yu KARAKHALIS

Kuban State Medical University

I. I KUKARSKAYA

Perinatal Center, Tyumen Region

M. M SAFRONOVA

I.I. Mechnikov North-Western State Medical University

G. P ZUYEVA

Kemerovo State Medical Academy

M. S PETROVA

Siberian State Medical University

References

  1. Тихомиров А.Л., Олейник Ч.Г. Кандидозный вульвовагинит: патогенез, клиника, диагностика, современные принципы терапии. Лечащий врач. 2002; 11: 26-32.
  2. Veronese M., Salvaterra M., Barzaghi D. Fenticonazole, a new imidazole derivative with antibacterial and antifungal activity. In vitro study. Arzneimittelforschung. 1981; 31(12): 2133-7.
  3. Palacín C., Tarragó C., Agut J., Guglietta A. In vitro activity of sertaconazole, fluconazole, ketoconazole, fenticonazole, clotrimazole and itraconazole against pathogenic vaginal yeast isolates. Methods Find. Exp. Clin. Pharmacol. 2001; 23(2): 61-4.
  4. Hernández Molina J.M., Llosá J., Martinez Brocal A., Ventosa A. In vitro activity of cloconazole, sulconazole, butoconazole, isoconazole, fenticonazole, and five other antifungal agents against clinical isolates of Candida albicans and Candida spp. Mycopathologia. 1992; 118(1): 15-21.
  5. Van Cutsem J. The in vitro activity ofterconazole against yeasts: its topical long-acting therapeutic efficacy in experimental vaginal candidiasis in rats. Am. J. Obstet. Gynecol. 1991; 165(4, Pt 2): 1200-6.
  6. Feng Z., Zou Q., Tan X., Che W., Zhang Z. Determination of fenticonazole enantiomers by LC-ESI-MS/MS and its application to pharmacokinetic studies in female rats. Arzneimittelforschung. 2011; 61(10): 587-93.
  7. Lawrence A.G., Houang E.T., Hiscock E., Wells M.B., Colli E., Scatigna M. Single dose therapy of vaginal candidiasis: a comparative trial of fenticonazole vaginal ovules versus clotrimazole vaginal tablets. Curr. Med. Res. Opin. 1990; 12(2): 114-20.
  8. Studd J.W., Dooley M.M., Welch C.C., Vijayakanthan K., Mowat J.M., Wade A., Newell M. Comparative clinical trial of fenticonazole ovule (600 mg) versus clotrimazole vaginal tablet (500 mg) in the treatment of symptomatic vaginal candidiasis. Curr. Med. Res. Opin. 1989; 11(8): 477-84.
  9. Munoz Reyes J.R., Villanueva Reynoso C., Ramos C.J., Menendez Vazquez J., Bailon Uriza R., Vargas A.J. Efficacy and tolerance of 200 mg fenticonazole versus 400 mg of miconazole in the intravaginal treatment of mycotic vulvovaginitis. Ginecol. Obstet. Mex. 2002; 70: 59-65.
  10. Fernandez-Alba J., Valle-Gay A., Dibildox M., Vargas J.A., Gonzalez J., Garcia M., L. H. Lopez L.H. and the Fentimex Mexican Study Group. Fenticonazole nitrate for treatment of vulvovaginitis: efficacy, safety, and tolerability of 1-gram ovules, administered as ultra-short 2-day regimen. J. Chemother. 2004; 16: 179-86.
  11. Kovachev S., Nacheva A., Vacheva-Dobrevska R., Vasilev N. Combined single-day treatment in acute vulvovaginal candidosis. Akush. Ginekol. (Sofiia). 2009; 48(6): 18-23.
  12. Gorlero F., Sartani A., Cordaro C.I., Bertin D., Reschiotto C., De Cecco L. Fenticonazole tissue levels after the application of 3 different dosage forms of vaginal ovules. Int. J. Clin. Pharmacol. Ther. Toxicol. 1988; 26(10): 479-81.
  13. Wiest W., Ruffmann R. Short-term treatment of vaginal candidiasis with fenticonazole ovules: a three-dose schedule comparative trial. J. Int. Med. Res. 1987; 15(5): 319-25.

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