Casanova-Román G, Madrid H, Ramírez-Palacios CD, Sánchez-Contreras J

Language: Spanish
References: 10
Page: 28-35
PDF size: 283.84 Kb.

ABSTRACT

Objective: To compare effectivity of an ovule with three components (clindamycin, terconazole and fluocinolone) in a three days treatment, versus an ovule with three components (nistatin, metronidazole and fluocinolone) in a ten days treatment, for bacterial vaginitis/vaginosis. Patients and methods: It is a prospective, open, comparative, with two parallel arms, multicentric clinical trial, which evaluates 160 patients from 18 to 45 years old, with sexual activity and microbiological confirmed diagnosis of vaginal candidiasis or bacterial vaginosis, and every patient was random assigned to a treatment “A” with terconazole 80 mg, clindamycin 100 mg and fluocinolone acetonide 0.5 mg for three days; group 2 receives an ovule “B” with nistatin 100,000 IU, metronidazole 500 mg and fluocinolone acetonide 0.5 mg for ten days. Patients were evaluated clinically and microbiologically at the end of treatment (day 7 and 13), and evaluated clinically in a following visit (days 12 and 18). Absence of symptoms was evaluated and microbiological and clinical cure were defined. It was recorded any concomitant medication and the presence of adverse events and deviations for physical exploration of patient. Results: For per protocol population, there were 73 and 75 patients for treatment “A” and treatment “B”, respectively. Broadly, for baseline visit, all variables were homogeneous. There was a significant symptoms decrease in patients for both treatments. Treatment “A” presents a higher rate for symptom decrease for pruritus and burning. Investigator global evaluation reports values as 98.70 and 98.20%, qualified as excellent and good for treatment “A” and treatment “B”, respectively, with no significant differences. Clinical cure is 77.30% for treatment “A” and 63% for treatment “B” with no significant differences (P = 0.06). Predominant microorganisms at baseline culture were Candida albicans and Candida spp and Gardnerella vaginalis increasing improvement for both groups. Only one adverse event was reported for every treatment. Adverse events were not related to medical study drug. Conclusion: It is shown that the effectivity of three days of treatment is equal to 10 days, meaning that although the There are significant differences in the time of vulvar pain reduction with treatment “A” in comparison to treatment with the ovule “B”. A three-day treatment, poses convenience and adherence to treatment for the patient.

REFERENCES

1. Casanova RG. Cervicovaginitis. En: Arredondo GJL. Ed. Temas actuales de Infectología .1ª ed. Mex, D.F.: Ed. Intersistemas; 2000. p. 453-71.

2. Casanova RG. Vaginosis bacteriana. En: Casanova RG, Ortiz IFJ, Reyna FJ. Infecciones de transmisión sexual. 1a ed. Mex. D. F: Alfil; 2004. p.163-80.

3. Casanova RG. Vaginosis bacteriana: Conceptos actuales. Temas actuales en Ginecología. Libro 1. Programa de Actualización Continua en Ginecología.1° Ed. Mex D.F.: Ed. Intersistemas, S.A. de C.V; 2002.p. 1-45.

4. Reyna FJ, Morales RV, Ortiz IFJ, Casanova RG, Beltrán ZM. Eficacia de un instrumento clinimétrico en el diagnóstico de candidiasis vulvovaginal. Ginecol Obstet Mex 2004; 72 :219-26.

5. Flores RE, Casanova RG, Beltrán ZM. Vaginosis bacteriana. Relación de la flora vaginal con las células epiteliales de vagina con diferente tratamiento. Estudio ultraestructural. Ginecol Obstet Mex 1997; 65: 182-90.

6. Montes de Oca-Acosta E, García-Escamilla RM, Bernal-Gutiérrez MDJ, Pérez-Rostro C. Sondas de AND versus examen en fresco, en pacientes con patología vaginal. Rev Mex Patol Clin 2002; 49: 100-7.

7. Clarke RM. Bacterial vaginosis: Common, Subtle, and More Serious Than Ever. Clinician Reviews 2001; 11 (11): 59-68.

8. Sood GN, Weitz P, Chatwani MVA. Terconazole cream for non-Candida albicans fungal vaginitis: Results of a retrospective analysis. Infect Dis Obstet Gynecol 2000; (8): 240-3.

9. Barclay L. Clindamycin reduces pregnancy complications linked to bacterial vaginosis. Lancet 2003; 361: 983-8.

10. Cosima De Punzio, Fluconazole 150 mg single dose versus itraconazole 200 mg per day for 3 days in the treatment of acute vaginal candidiasis; a double randomized study. Eur J Obst And Gyn 2003; (106): 193-7.