Dosis alternativas del tinidazol en el tratamiento de la vaginosis bacteriana: Reporte preliminar. /
Abstract
Resumen:
Los derivados imidazólicos como el metronidazol y el secnidazol han demostrado funcionar en la curación de la vaginosis bacteriana (VB), pero sus efectos secundarios y modo de administración son de gran interés. El objetivo del presente estudio fue determinar si el tinidazol en diferentes dosis también es un medicamento eficaz para la curación de la VB. Se distribuyeron al azar 45 pacientes con diagnóstico de VB en tres grupos, a los cuales se les administró tinidazol por vía oral (VO) en diferentes dosis: grupo A (n=9): 1 g por un día; grupo B (n=17): 2g por un día; grupo C (n=19): 2g por dos días. El grupo B mostró curación clínica del 82,4% (p<0,0001 y la citológica fue de 94,1% (p=0,0001). En el grupo C se encontró que la curación clínica fue del 84,2% (p<0,0001) y la citológica fue de 89,5% (p<0,0001). El uso único de 1 g no fue suficiente para lograr la curación clínica (55,6%) y/o citológica (66,7%). En relación a los efectos secundarios, no se encontró ninguna ventaja con el uso de dosis más bajas y por menor tiempo. La conclusión de los resultados preliminares del presente trabajo fue que el uso de 2 g VO de tinidazol por un día fue tan eficaz para la curación de la VB como el uso de 2 g por dos días.
Abstract.
Imidazole derivatives such metronidazole and secnidazole have shown to work in treating bacterial vaginosis (BV) but their side effects and mode of administration are of concern. The aim of the present study was to determine whether tinidazole in different doses was also an effective therapy for BV. Forty-five patients with diagnosis of BV were randomized in three groups who received tinidazol orally in different dosages: group A (n=9): 1 g for one day; group B (n=17): 2 g for one day; group C (n=19): 2 g for two days. The group B showed an 82.4% clinical cure (p<0.0001) and the cytological was 94.1% (p=0.0001). We found a clinical cure of 84.2% (p<0.0001) and the cytological cure was 85.5% (p<0.0001) in the group C. One gram (Group A) was not enough to achieve the clinical and cytological cure. There were no dif-ferences in side effects using lower doses and less time of treatment. The pre-liminary conclusion was that 2 g of tinidazol for one day had the same efficacy to cure BV that 2 g for two days.
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References
Rekha S, Jyothi S. Comparison of visual, clinical and microbiological diagnosisof symptomatic vaginal discharge in the re- productive age group. Int J Pharm Biomed Res 2010; 1(4): 144-148.
Kenyon C, Colebunders R, Crucitti T. The global epidemiology of bacterial vaginosis: a systematic review. Am J Obstet Gynecol 2013; 209(6): 505-523.
Ma L, Su J, Su Y, Sun W, Zeng Z. Pro- biotics administered intravaginally as a complementary therapy combined with antibiotics for the treatment of bacterial vaginosis: a systematic review protocol. BMJ 2017; 7(10): e019301. doi: 10.1136/bmjopen-2017-019301.
Paladine HL, Desai UA. Vaginitis: diagno- sis and treatment. Am Fam Physician 2018; 97(5): 321-329.
Verstraden H, Verhelst R, Vaneechoutte M, Temmerman M. The epidemiology of bacte- rial vaginosis in relation to sexual behavior. BMC Infect Dis 2010; 81:10.
Walker J, Hocking JS, Fairly CK, Tabrizi S, Chen M, Bowden F, Gunn J, Donovan B, Kaldor J, Bradshaw C. The prevalence and incidence of bacterial vaginosis in a cohort of young Australian women. In: Conferen- ce Proceedings of the International Society for Sexually Transmitted Research. Quebec, Canada. 2011; 87(S1): A110-A111.
Eschenbach DA, Hillier S, Critchlow C, Stevens C, DeRouen T, Holmes KK. Diag- nosis and clinical manifestations of bacte- rial vaginosis. Am J Obstet Gynecol 1988; 158(4): 819-828.
Armstrong N, Wilson JD. Tinidazole in the treatment of bacterial vaginosis. Int J Wo- men Health 2009; 1: 59-65.
Schwebke J. Bacterial Vaginosis. Curr In- fect Dis Rep 2000; 2(1): 14-17.
Lewis PM, Bernstein KT, Aral SD. Vaginal microbiome and its relationship to beha- vior, sexual health, and sexual transmitted diseases. Obstet Gynecol 2010; 129(4):643-654.
Reiter S, Kellog SS. Bacterial vaginosis: a primer for clinicians. Postgrad Med 2019; 131(1): 8-18.
Center for Disease Control and Prevention. 2015 STD Treatment Guidelines – Bacterial Vaginosis – Updated diagnostic, treatment, and screening recommendations for STDs. Disponible en: https://www.cdc.gov/std/ bv/default.htm. Revisado:14/06/2018.
Amsel R, Totten PA, Spiegel CA, Chen KCS, Eschenbach DA, Holmes KK. Non- specific vaginitis: diagnostic and microbial and epidemiological associations. Am J Med 1983; 74(1): 14-22.
Livengood CH. Bacterial vaginosis: an over- view for 2009. Rev Obstet Gynecol 2009; 2(1): 28-37.
Hillier SL, Nyirjesy P, Waldbaum AS, Schwebke JR, Morgan FG, Adetoro NA, Braum CJ. Secnidazole treatment of bacte- rial vaginosis: A trial. Obstet Gynecol 2017; 130(2): 379-386.
Núñez JT, Gómez G. Low-dose secnidazole in the treatment of bacterial vaginosis. Int J Gynaecol Obstet 2005; 88(3): 281-285.
Raja IM, Basavareddy A, Mukherjee D, Me- her BR. Randomized, double-blind, compa- rative study of oral metronidazole and tini- dazole in treatment of bacterial vaginosis. Ind J Pharmacol 2016; 48(6): 654-658.
Bohbot JM, Vicaut E, Fagnen D, Brau- man M. Treatment of bacterial vaginosis: a multicenter double-blind, double-dummy, randomized phase III study comparing sec- nidazole and metronidazole. Inf Dis Obstet Gynecol 2010.Epub 2010 Sep 15. http:// dx.doi.org/10.1155/2010/705692.
Verstraelen H, Verhelst R, Roelens K, Tem- meramn M. Antiseptics and disinfectants for the treatment of bacterial vaginosis: A systematic review. BMC Infect Dis 2012; 12: 148.
Petrina MAB, Consentino LA, Rabe LK, Hillier SL. Susceptibility of bacterial vagino- sis (BV)-associated bacteria to secnidazole compared to metronidazole, tinidazole and clindamycin. Anaerobe 2017; 47: 115-119.
Thellin O, Zorzi W, Zorzi D, Delvenne P, Heinen E, Elmoualij B, Quatresooz P. Lysozyme as cotreatment during antibiotic use against vaginal infections: a in vitro stu- dy on Gardnerella vaginalis biofilm models. Int Microbiol 2016; 19(2): 101-107.
Nord CE, Kager L. Tinidazole-microbiolo- gy, pharmacology and efficacy in anaerobic infections. Infection 1983; 11(1); 54-60.
Mohanty KC, Deighton R. Comparison of 2 g single dose of metronidazole, nimorazole and tinidazole in the treatment of vaginitis associated with Gardnerella vaginalis. J An-
timicrob Chemother 1987; 19(3): 393-399.
Schwebke JR, Desmond RN. Tinidazole versus metronidazole for the treatment of bacterial vaginosis. Am J Obstet Gynecol 2011; 204(3): 211.e1-211.e6.
Sanz-Sanz F, Hernandez AD, Sanchez EA, Alvarez CG, Muelas M, Rodriguez-Noriega Controlled comparative study of metro- nidazole (Flagyl) versus tinidazole (Trico- lan) in the treatment of nonspecific vagini- tis (vaginitis due to Gardnerella vaginalis). Rev Gynaecol Obstet 1985; 44 (2): 717-720.
Buranawarodomkul P, Chandeying V, Sutthijumroon S. Seven day metronidazo- le versus single dose tinidazole as therapy for nonspecific vaginitis. J Med Assoc Thai 1990; 73 (3): 283-287.
Sanz-Sanz F, Arreaza L, Vidriales I, Miran- da P, Grande J, Valle R. Concerning the different therapeutic options for bacterial vaginosis. Progress Obstet Ginecol 1996; 39(5): 669-674.
Milani M, Barcellona E, Agnello A. Effica- cy of the combination of 2 g oral tinidazo- le and acidic buffering vaginal gel in com- parison with vaginal clindamycin alone in bacterial vaginosis: a randomized, investi- gator-blinded controlled trial. Eur J Obstet Gynaecol Reprod Biol 2003; 109(1): 67-71.
Milani M, Baldoni A, Guerro B, Spinillo The “talent” multicenter trial: efficacy of tinidazole, metronidazole, and tinidazole + acidic gel in the treatment of B. vaginosis. Abstracts of the 86th World Congress for Infectious and Immunological Diseases in Obstetrics and Gynaecology, 2003. Venice, Italy; 39: 669-674.
Schindler EM, Thamm H, Ansmann EB, Sarnow E, Schindler AE. Treatment of bac- terial vaginitis. Multicenter, randomized, open study with tinidazole in comparison with metronidazole. Fortschr Med 1991; 109(5): 138-140.
Ambika B, Mamatha KR, Shivamurthy G. Single dose metronidazole, tinidazole and ornidazole in the treatment of bacterial vaginosis - a comparative study. Int J Basic Clin Pharmacol 2016; 5(5): 1966-1971.
Livengood CH, Ferris DG, Wiesenfeld HC, Hillier SL, Soper DE, Nyirjesy P, Marrazzo J, Chatwani A, Fine P, Sobel J, Taylor SN, Wood L, Kanalas JJ. Effectiveness of two ti- nidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynaecol 2007;110 (2): 302-309.
Paavonen J, Vesterinen E, Purola E, Joki- pii AM, Jokipii L, Holttinen K, Vartiainen E. Single dose of tinidazole in the treatment of vaginal discharge. Scand J Urol Nephrol Suppl 1984; 86: 237-240.
Piot P, Van Dyck E, Godts P, Vanderheyden J. A placebo-controlled, double-blind com- parison of tinidazole and triple sulfonamide cream for the treatment of nonspecific va- ginitis. Am J Obstet Gynecol 1983; 147(1): 85-89.
Van Der Meijden WI. Treatment of nons- pecific vaginitis with a single dose of tini- dazole. Scand J Infect Dis Suppl 1983; 40: 85-89.
Ekgren J, Norling B, Degre M, Midret T. Comparison of tinidazole given as a sin- gle dose and on 2 consecutive days for the treatment of nonspecific bacterial vagino- sis. Gynecol Obstet Invest 1988; 26(4):313-317.
Joesoef MR, Schmid GP. Bacterial vagi- nosis: review of treatment options and po- tential clinical indications for therapy. Clin Infect Diseases 1995, 20(Supl 1): s72-s79.
Nailor MD, Sobel JD. Tinidazole for bacte- rial vaginosis. Expert Opin Investig Drugs 2007; 16(5):743-751.
British Association for Sexual Health and HIV. United Kingdom National Guideline for the management of bacterial vaginosis 2012. Disponible from: https:// www.bashh-guidelines.org/current-guide- lines/vaginal-discharge/bacterial-vaginosis- 2012/. Revisado: 15/05/2019.
Australasian College of Sexual Health Physi- cians. Clinical Guidelines for the management of sexually transmissible infections among priority populations 2018. Disponible from: http://www.sti.guidelines.org.au/sexually- transmissible-infections/infections-associated-with-sex/bacterial-vaginosis#management. Revisado:15/05/2019.
