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Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a Coriolus-versicolor-based vaginal gel (Papilocare®) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women ≥ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study's duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild-moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare® vaginal gel than spontaneous regression rates reported in the literature.
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In the PALOMA trial, Papilocare® demonstrated efficacy in repairing low-grade cervical lesions related to human papillomavirus (HPV). This sub-analysis aimed to evaluate its efficacy in repairing these cervical lesions and clearing HPV in women aged older than 40 years. This was a multicenter, randomized, open-label, parallel-group, controlled clinical trial. Patients with low-degree HPV-dependent cervical lesions receiving 6-month treatment with the vaginal gel were compared to those with a watchful waiting approach. Among the 41 women analyzed (aged 47.7 years), 31 presented high-risk (HR) oncogenic HPV subtypes, and 14 had 16-18-31 HPV genotypes. After 6 months, normalized cytology and concordant colposcopy were achieved by a greater percentage of treated women. The difference was significant in the total population (92.3% vs. 50.0%, p = 0.007), and HR-HPV subpopulation (90.5% vs. 33.3%, p = 0.003). In the HR HPVs-16-18-31 subpopulation, the values were 75.0% and 40.0% (p = 0.293). In the total population, 61.5% of treated patients obtained HPV clearance, compared to 50.0% in the control group. Regarding the HR-HPV subpopulation, these values were 66.7% and 44.4%, respectively. Papilocare® demonstrated significant efficacy in repairing low-degree HPV-related cervical lesions and a positive trend to clear HPV in women older than 40 years old in comparison to the watchful waiting approach.
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No disponible
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Humanos , Femenino , Tamizaje Masivo/métodos , Neoplasias del Cuello Uterino/patología , Infecciones por Papillomavirus/patología , Neoplasias del Cuello Uterino/prevención & control , Detección Precoz del Cáncer/métodos , Manejo de Especímenes/normas , Factores de EdadRESUMEN
No disponible
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Detección Precoz del Cáncer/métodos , Neoplasias del Cuello Uterino/diagnóstico , Infecciones por Papillomavirus/diagnóstico , Tamizaje Masivo/métodos , Exámenes Obligatorios , Frotis Vaginal/métodos , Prueba de Papanicolaou/métodos , Factores de Edad , Papillomaviridae/patogenicidad , Análisis Costo-BeneficioRESUMEN
No disponible
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Humanos , Infecciones del Sistema Genital , Neoplasias de los Genitales Femeninos , VacunaciónRESUMEN
OBJECTIVES: To assess and analyze the information and recommendations provided by Google Web Search™ (Google) in relation to web searches on the HPV vaccine, indications for females and males and possible adverse effects. RESULTS: In the comprehensive analysis of results, 72.2% of websites offer information favorable to HPV vaccination, with varying degrees of content detail, vs. 27.8% with highly dissuasive content in relation to HPV vaccination. The most frequent type of site is the blog or forum. The information found is frequently incomplete, poorly structured, and often lacking in updates, bibliography and adequate citations, as well as sound credibility criteria (scientific association accreditation and/or trust mark system). MATERIALS AND METHODS: Descriptive cross-sectional study of the results of 14 web searches. Comprehensive analysis of results based on general recommendation given (favorable/dissuasive), as well as compliance with pre-established criteria, namely design, content and credibility. Sub-analysis of results according to site category: general information, blog / forum and press. CONCLUSIONS: Google, as a tool which users employ to locate medical information and advice, is not specialized in providing information that is necessarily rigorous or valid from a scientific perspective. Search results and ranking based on Google's generalized algorithms can lead users to poorly grounded opinions and statements, which may impact HPV vaccination perception and subsequent decision making.
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Difusión de la Información/métodos , Internet , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/inmunología , Neoplasias del Cuello Uterino/prevención & control , Estudios Transversales , Femenino , Educación en Salud/métodos , Humanos , Masculino , Infecciones por Papillomavirus/complicaciones , Infecciones por Papillomavirus/epidemiología , Neoplasias del Cuello Uterino/etiologíaRESUMEN
No disponible
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Humanos , Masculino , Femenino , Vacunación/métodos , Vacunación , Papiloma/epidemiología , Papiloma/inmunología , Sociedades Científicas/ética , Neoplasias del Pene/epidemiología , Displasia del Cuello del Útero/epidemiología , Factores de Riesgo , Sociedades Científicas/normas , Sociedades Científicas , Medicina Basada en la Evidencia/métodos , Medicina Basada en la Evidencia/tendencias , Neoplasias del Cuello Uterino/epidemiología , Neoplasias de la Vulva/inmunologíaRESUMEN
Objetivo. Valorar el grado de conocimiento y la aplicación en la práctica clínica de las nuevas recomendaciones auspiciadas por la Sociedad Española de Ginecología y Obstetricia (SEGO), para la prevención del cáncer de cuello de útero y la vacunación frente al virus del papiloma humano (VPH), por parte de los ginecólogos españoles. Métodos. Estudio transversal (desde noviembre de 2010 a marzo de 2011) en el que a través de una plataforma on line los participantes cumplimentaron una encuesta de conocimientos y de práctica clínica real sobre la epidemiología de la infección por el VPH, cribado del cáncer de cuello uterino y la vacuna frente al VPH, desarrollada previamente por el Comité Científico Nacional. Resultados. Un total de 454 ginecólogos participaron en el estudio. Se observó un buen conocimiento sobre la transmisibilidad del VPH, volumen de enfermedad relacionado con VPH, mortalidad por cáncer de cuello de útero, demostración de memoria inmune, seguridad y eficiencia de las vacunas frente a VPH y espectro de protección de la vacuna tetravalente. Los conocimientos sobre la tasa de mujeres sexualmente activas positivas al VPH a los 5 años, diferencia entre eficacia y eficiencia del cribado citológico e intervalos de control seguros en mujeres con doble test negativo (citología y VPH) fueron deficientes. Asimismo, la actitud proactiva de la vacunación frente al VPH en el segmento de edad prioritario (<27 años) fue pobre, con una tasa de encuestados del 63% recomendando la vacunación. Sorprendentemente, un 4% recomendaba la vacuna en mujeres mayores de 45 años. El 15% manifestaba no disponer de tiempo para explicar que el control trienal citológico es seguro y el 27% lo consideraba inseguro. El 35% declaró no tener disponible el test de VPH en su medio. En un 12% de los casos, la colposcopia se usaba como complemento de la citología en la revisión inicial. Conclusiones. Aunque los conocimientos de la epidemiología y vacunas frente al VPH eran adecuados, la actitud proactiva de vacunación en el grupo etario preferente fue pobre. Solo un 38% de los participantes demostró un seguimiento completo de las recomendaciones de la SEGO. Es indispensable diseñar e implementar estrategias a nivel nacional para difundir y mejorar la aplicación clínica de dichas recomendaciones (AU)
Objective. To assess the degree of knowledge of the new recommendations of the Spanish Society of Obstetrics and Gynecology (Sociedad Española de Ginecología y Obstetricia [SEGO]) for the prevention of cervical cancer and vaccination against human papilloma virus (HPV) among Spanish gynecologists and implementation of these recommendations in daily clinical practice. Methods. A cross-sectional survey (from November 2010 to March 2011) was carried out, in which participants used an online platform to complete a questionnaire previously developed by the National Scientific Committee on knowledge of the epidemiology of HPV infection, cervical cancer screening and HPV vaccines, and activities related to these issues in daily clinical practice. Results. A total of 454 gynecologists participated in the study. The gynecologists showed good knowledge of HPV transmission, HPV disease load, mortality due to cervical cancer, demonstration of immune memory, safety and efficiency of HPV vaccines, and the spectrum of protection by the tetravalent vaccine. Knowledge of the rate of sexually-active HPV-positive women at 5 years, differences between the efficacy and efficiency of cytological screening, and safe screening intervals in women with a double negative test (cytology and HPV) was deficient. Proactive attitudes to HPV vaccination in the priority age group (<27 years) was poor, with 63% of the surveyed physicians recommending vaccination. Surprisingly, 4% recommended vaccination in women older than 45 years. Fifteen percent reported they lacked time to explain that cytological testing every 3 years was safe, and 27% considered this practice unsafe. Thirty-five percent reported that the HPV test was unavailable in his/her environment. In 12% of cases, colposcopy was used to complement cytology at the initial visit. Conclusions. Although knowledge of HPV epidemiology and vaccines was adequate, proactive attitudes to HPV vaccination in the preferential age group were scarce. Complete adherence to SEGO recommendations was found in only 38% of participants. Nationwide strategies should be designed and introduced to spread and improve the implementation of these recommendations in daily clinical practice (AU)
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Conocimientos, Actitudes y Práctica en Salud , Neoplasias del Cuello Uterino/epidemiología , Neoplasias del Cuello Uterino/prevención & control , Práctica Profesional/ética , Pautas de la Práctica en Medicina , Infecciones Tumorales por Virus/epidemiología , Sociedades Médicas/ética , Sociedades Médicas/normas , Sociedades Médicas , Administración de la Práctica Médica/ética , Administración de la Práctica Médica/tendenciasRESUMEN
An important percentage of vulvar and vaginal cancers may be attributed to infections by the human papillomavirus. Although the incidence of invasive vulvar and vaginal cancers is low, it has remained stable over the past years. Hospital discharges related to malignant neoplasias and in situ carcinomas of the vulva and vagina from 1997 to 2008 were selected from the Minimum Data Set of the Ministry of Health in Spain. 17,883 hospital admissions related to vulvar and vaginal malignant neoplasias and 2,185 admissions related to in situ carcinomas of the vulva and vagina were gathered, with a hospitalization rate of 7,054 and 0.862 discharges per 100,000 women/year, respectively. The mean age of patients was 57 (SD:18) years, and the mean length of hospital stay was 8 (SD:10) days. There was a statistically significant increase in the hospitalization rate for malignant neoplasias and in situ carcinomas with increasing patient age. This increase was significant for all locations. Overall, there was a case fatality rate of 9.34% for vulvar and vaginal malignant neoplasias and 0.46% for in situ carcinomas of an external genital organ. Mortality and case fatality rates increased significantly throughout the length of the study. 92% of all deaths occurred in those older than 55 years of age. Mortality and case fatality rates also increased significantly with age. The hospitalization rate follows a north-south pattern. These data of the pre-anti-HPV vaccine era may be useful to develop cost-effectiveness models and strategies and evaluate the impact of HPV vaccination in Spain.
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Infecciones por Papillomavirus/epidemiología , Neoplasias Vaginales/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Hospitalización , Humanos , Lactante , Persona de Mediana Edad , Papillomaviridae/patogenicidad , Infecciones por Papillomavirus/patología , Infecciones por Papillomavirus/virología , España/epidemiología , Vagina/patología , Neoplasias Vaginales/mortalidad , Neoplasias Vaginales/virología , Vulva/patología , Neoplasias de la Vulva/epidemiología , Neoplasias de la Vulva/mortalidad , Neoplasias de la Vulva/virologíaRESUMEN
No disponible
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Femenino , Humanos , Papiloma/patología , Papiloma/virología , Prevención Primaria/métodos , Prevención Secundaria/métodos , Neoplasias del Cuello Uterino/tratamiento farmacológico , Neoplasias de la Vulva/terapia , Papiloma/genética , Papiloma/metabolismo , Prevención Primaria , Neoplasias del Cuello Uterino/terapia , Neoplasias de la Vulva/tratamiento farmacológicoRESUMEN
Successful implementation of Human Papillomavirus (HPV) vaccine in each country can only be achieved from a complementary and synergistic perspective, integrating all the different points of view of the diverse related professionals. It is this context where the Spanish HPV Vaccine Consensus Group (Grupo Español de Consenso sobre la Vacuna VPH, GEC-VPH) was created. GEC-VPH philosophy, objectives and experience are reported in this article, with particular attention to the management of negative publicity and anti-vaccine groups. Initiatives as GEC-VPH--adapted to each country's particular idiosyncrasies--might help to overcome the existing barriers and to achieve wide and early implementation of HPV vaccination.
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Esquemas de Inmunización , Papillomaviridae/inmunología , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/administración & dosificación , Neoplasias del Cuello Uterino/prevención & control , Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , Infecciones por Papillomavirus/virología , Vacunas contra Papillomavirus/efectos adversos , Vacunas contra Papillomavirus/inmunología , España , Neoplasias del Cuello Uterino/virología , Vacunación , Adulto JovenRESUMEN
We aimed to assess the effectiveness of an educational leaflet to modify sexual risk behaviour in women with external genital warts. Women with genital warts who attended in daily gynecological practice participated in a 12-month prospective randomised observational study. Randomisation was carried out by centres. At the initial visit, patients underwent complete gynecological examination, including an acetic acid test. Those assigned to the intervention group received an educational leaflet to improve patient's knowledge about warts (counselled group). Only patients with complete clearance after 6 months of initial therapy continued the study. The counselled group included 114 women and the non-counselled group 97. A significant increase in the use of condoms at visit 3 as compared with baseline (83.2% vs 66.1%, P < 0.05) was observed in the counselled group. The mean number of sexual partners was also significantly lower in the counselled group at each follow-up visit. Recurrences were documented in 9 of the 145 patients who completed the study (recurrence rate 6.2%). Recurrences occurred in 7 patients in the counselled group and in 2 in the non-counselled group (8.6% vs 3.1%, P = 0.299), and in all cases occurred at 9 months after initiation of treatment. In conclusion, the educational leaflet, which is simple and easy to implement in routine daily practice, proved to be effective in modifying sexual risk behaviour in women with external genital warts. This educational strategy did not seem to affect recurrence if an acetic acid test is routinely performed during the initial work-up studies.