학술논문

Seguridad y actividad de la solucion de bardana como coadyuvante en el manejo del prurito vulvovaginal en Colombia. Ensayo clinico fase II
Document Type
Clinical report
Source
Revista Colombiana de Obstetricia y Ginecologia. Jan, 2010, Vol. 61 Issue 1, p42, 7 p.
Subject
Pruritus
Language
Spanish
ISSN
0034-7434
Abstract
El prurito genital puede ser la manifestacion de problemas alergicos, infecciones genitales, entidades sistemicas o una reaccion primaria. El manejo de este sindrome es un reto para ginecologos y medicos generales. Objetivo: evaluar la seguridad y actividad de la solucion de bardana al 1,2% en aplicaciones externas diarias por 5 dias, como coadyuvante en el manejo de las vulvovaginitis para generar alivio del prurito. Metodologia: el presente es un ensayo clinico de fase II, multicentrico, abierto, no comparativo, realizado en pacientes con prurito genital, quienes fueron evaluadas en 14 ciudades colombianas. En el estudio se incluyeron a todas aquellas mujeres mayores de 18 anos con prurito genital sin importar su etiologia, quienes no hubiesen recibido tratamiento alguno para la vulvovaginitis o la vulvovaginosis en los 30 dias previos a su inclusion en el estudio y quienes, ademas, no hubiesen utilizado ningun producto farmaceutico de manera topica en los 8 dias anteriores al inicio del tratamiento. Asimismo, se excluyeron todas las pacientes en estado de embarazo, con trastornos psiquicos o mentales de dificil control y con antecedentes de alergias a medicamentos. Se evaluo la edad de la paciente, la intensidad del prurito, la presencia de irritacion vulvar, leucorrea, los agentes infecciosos asociados con esta y la tolerancia. Resultados: se incluyeron 154 pacientes de las cuales se excluyeron 2 por no asistir al ultimo control. Al final de los tratamientos, 83,6% de ellas manifestaban no tener prurito o solo en una intensidad minima y 11,8% lo referian como leve. El prurito clasificado inicialmente en 30,5% de las mujeres como severo se encontro solo en 2,6% al segundo dia y tan solo en 1,3% persistia al final de la terapia. Similares resultados se obtuvieron en los subgrupos con infeccion demostrada por solo candida o solo bacterias. Conclusion: la utilizacion local complementaria de una solucion topica de bardana en mujeres con prurito genital podria ser una alternativa eficaz de manejo. Palabras clave: prurito, solucion, candidiasis, vulvovaginal, eczema, eritema, leucorrea, vulvar. Genital itching is associated with allergic and infectious aetiologies, systemic causes or a primary reaction. Managing this syndrome is a challenge for gynaecologists and general practitioners. Objective: evaluating the safety and activity of a 1.2% burdock solution in external applications per day, for 5 days, as an adjuvant in managing vulvovaginitis to relieve itching. Methodology: this was an open, non-comparative, multicentre, phase II clinical trial involving patients suffering from genital pruritus. The evaluation was made in 14 Colombian cities; it included women aged over 18 suffering from genital itching (regardless of aetiology) who had been not been treated for vulvovaginitis or vulvovaginosis during the 30 days prior to their inclusion in the study and had not used any topical pharmaceutical product during the 8 days before beginning treatment recommended by the study. Patients were excluded who were suffering from psychiatric or mental disorders, difficult to control, pregnant or had a history of drug allergy. The patients' ages, itching intensity, presence of leukorrhoea (vulvar irritation) and associated infectious agents were classified. Results: 152 patients were included in the study after fulfilling the inclusion criteria; 2 of them were excluded for not attending the last control at the end of the treatment. 83.6% reported no itching by this time, or only minimum intensity, and 11.8% regarded it as just being slight. Itching initially classified by 30.5% of the patients as being severe at the start was only rated so by 2.6% on the second day; 1.3% still rated it as being severe at the end of therapy. Similar results were obtained in the subgroups suffering from single candida infection or single bacteria. Conclusion: the supplementary local use of a 2% topical burdock solution in women suffering from genital itching could be an effective management alternative. Key words: pruritus, burdock solution, candidiasis, vulvovaginal, eczema, erythema, vaginal discharge, vulvar.
A phase II clinical trial of burdock solution as an adjuvant in managing vulvovaginal pruritus in Colombia. INTRODUCCION El prurito es una sensacion cutanea que genera un deseo de rascarse [...]