Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: Retrospective pooled analysis of trial data

Objectives To determine the effect of human papillomavirus (HPV) quadrivalent vaccine on the risk of developing subsequent disease after an excisional procedure for cervical intraepithelial neoplasia or diagnosis of genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia. Design Retrospective analysis of data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)). Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world. Participants Among 17 622 women aged 15–26 years who underwent 1:1 randomisation to vaccine or placebo, 2054 received cervical surgery or were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia. Intervention Three doses of quadrivalent HPV vaccine or placebo at day 1, month 2, and month 6. Main outcome measures Incidence of HPV related disease from 60 days after treatment or diagnosis, expressed as the number of women with an end point per 100 person years at risk. Results A total of 587 vaccine and 763 placebo recipients underwent cervical surgery. The incidence of any subsequent HPV related disease was 6.6 and 12.2 in vaccine and placebo recipients respectively (46.2% reduction (95% confidence interval 22.5% to 63.2%) with vaccination). Vaccination was associated with a significant reduction in risk of any subsequent high grade disease of the cervix by 64.9% (20.1% to 86.3%). A total of 229 vaccine recipients and 475 placebo recipients were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia, and the incidence of any subsequent HPV related disease was 20.1 and 31.0 in vaccine and placebo recipients respectively (35.2% reduction (13.8% to 51.8%)). Conclusions Previous vaccination with quadrivalent HPV vaccine among women who had surgical treatment for HPV related disease significantly reduced the incidence of subsequent HPV related disease, including high grade disease.

Impacto de la vacuna del virus del papiloma humano en mujeres en edad fértil: revisión sistemática de literatura

Introducción. Con la creación de la vacuna contra el virus de papiloma humano en los años ochentas, se ha promovido su aplicación de manera sistemática para evitar el cáncer cervical, que es la segunda causa de mortalidad por cáncer en mujeres en edad fértil. Actualmente se desconoce el impacto de los resultados de su aplicación. Se pretendió evaluar la mejor evidencia relacionada con los resultados de la vacuna contra VPH en mujeres en edad fértil. Metodología Se realizó una revisión sistemática de literatura incluyendo los artículos con mejor evidencia en los últimos cinco años. Los términos mesH incluyeron HPV vaccine, women, efficacy entre otros. Todos los artículos fueron clasificados por evidencia antes de ser analizados. Resultados Se encontraron un total de 557 artículos relacionados con el tema de los cuales 21 cumplieron criterios para su selección. La mayoría de artículos fueron clasificados como evidencia II. Las causas más frecuentes de exclusión fueron por tema no acorde y título. Discusión Los resultados de la revisión sistemática permiten definir que la eficacia de la vacuna contra VPH, tanto y la vacuna bivalente como y la cuadrivalente supera el 97% cuando se completan tres dosis. No hay reportes de eventos adversos graves, la edad de aplicación ideal es entre 9-14 años de edad.

Eficacia de la limpieza corporal con clorhexidina en prevenir la sepsis neonatal en cuidado intensivo revisión sistemática

ANTECEDENTES. La mortalidad neonatal se debe principalmente a procesos infecciosos y a prematurez. Se ha sugerido que el lavado corporal total con clorhexidina podría reducir la mortalidad neonatal relacionada con infección. No existen revisiones sistemáticas que exploren la eficacia de esta intervención. Objetivo. Evaluar la eficacia y seguridad de la limpieza corporal total con clorhexidina en la prevención de las infecciones asociadas al cuidado de la salud en neonatos de alto riesgo hospitalizados en cuidado intensivo neonatal. Metodología. Se realizó una revisión sistemática de la literatura. La búsqueda se hizo a través de las bases de datos Medline, Embase, LilaCS, Cochrane library y el registro de ensayos clínicos del Instituto Nacional de Salud de Estados Unidos. Se incluyeron ensayos clínicos publicados en los últimos 15 años hasta el 30 de enero del 2015. Las variables cualitativas se estimaron mediante OR o RR con sus IC95%. Las variables cuantitativas mediante diferencias de promedios o diferencias estandarizadas de promedios con sus IC95%. Resultados: Se incluyeron 3 estudios en el análisis cualitativo y cuantitativo. No se encontró evidencia concluyente que permita recomendar el uso de la limpieza corporal total con clorhexidina en los recién nacidos hospitalizados en cuidado intensivo neonatal. Conclusión: No existe evidencia que permita concluir que la limpieza corporal total con clorhexidina al 0.25% es mejor respecto a otras intervenciones en la prevención de sepsis neonatal asociada al cuidado de la salud . Es una intervención segura sin efectos adversos significativos.

Evaluación de la disfunción sexual en mujeres con incontinencia urinaria antes y después de la cinta suburetral

Objetivo: Evaluar prospectivamente el grado de disfunción sexual en pacientes con incontinencia urinaria de esfuerzo antes y después de la cinta suburetral libre de tensión mediante el cuestionario PISQ-12 validado en español. Materiales y Métodos: Estudio observacional longitudinal de antes y después. Se seleccionaron 60 mujeres sexualmente activas con algún grado de disfunción sexual, entre abril del 2014 hasta marzo del 2015, diagnosticadas con incontinencia urinaria, programadas para colocación de cinta suburetral transobturadora en el Hospital Universitario Mayor Méderi. La mayoría de las pacientes presentaron algún grado de prolapso genital y requirieron corrección quirúrgica asociada a la cinta. Todas las pacientes respondieron el cuestionario PISQ-12 antes y 6 meses después del procedimiento. Resultados: La edad promedio fue 48 ± 4.58 años. El grado de prolapso con mayor frecuencia fue el estadío II del POP-Q 55% (n=33). El 96.7% (n=50) de las pacientes requirieron además de la colocación de la cinta suburetral corrección quirúrgica del prolapso genital. En la evaluación preoperatoria la disfunción sexual se distribuyó así: Severa: 70%, Moderada 18.3% y Leve 11.7%, después de 6 meses postoperatorios se encontró una diferencia estadísticamente significativa del cambio en el grado de disfunción sexual así: Moderada 41.5% y Leve 58.2% donde ninguna paciente quedó clasificada con disfunción severa. Discusión y Conclusión: Las pacientes que presentaron disfunción sexual severa obtuvieron mayor cambio en el grado de disfunción, luego de la colocación de la cinta suburetral.

Small-area variation in health care affecting the choice of cesarean delivery: the case of a Colombian health insurer

In the midst of health care reform, Colombia has succeeded in increasing health insurance coverage and the quality of health care. In spite of this, efficiency continues to be a matter of concern, and small-area variations in health care are one of the plausible causes of such inefficiencies. In order to understand this issue, we use individual data of all births from a Contributory-Regimen insurer in Colombia. We perform two different specifications of a multilevel logistic regression model. Our results reveal that hospitals account for 20% of variation on the probability of performing cesarean sections. Geographic area only explains 1/3 of the variance attributable to the hospital. Furthermore, some variables from both demand and supply sides are found to be also relevant on the probability of undergoing cesarean sections. This paper contributes to previous research by using a hierarchical model and by defining hospitals as cluster. Moreover, we also include clinical and supply induced demand variables.

Es divertido pero no es un juego : campa??a de prevenci??n de embarazos en adolescentes

Copia tambi??n en catal??n

Caracterización de la femineidad.

Estudiar los caracteres que han sido considerados femeninos y comprobar en qué medida son ciertos. Explica los caracteres corporales y la inestabilidad neurovegetativa de las mujeres, analiza los caracteres psicológicos que han sido atribuidos a las mismas, éstos son: pasividad, masoquismo, instinto maternal, emotividad, erotismo, sensibilidad, infantilismo, complejo de inferioridad, ansiedad, envidia, inmoralidad, rivalidad, pudor, narcisismo, hipocresía, hostilidad, espíritu de contradicción, derrotismo, resignación, mediocridad, fanatismo, utilitarismo, materialismo, avaricia. Y finalmente estudia las facultades intelectuales de las mujeres. 1) Los caracteres que la mujer posee independientemente de su puesto social y cultural son los corporales, la inestabilidad neurovegetativa, un especial erotismo, la sensibilidad, el infantilismo físico y el pudor. 2) Los caracteres corporales de la mujer europea presentan una diferencia clara con respecto a los del hombre. Las hormonas masculinas producen mayor musculatura mientras que las femeninas mayor adiposidad. Las diferencias funcionales no pueden suprimirse por completo, aunque sí reducirse por efecto de la educación. En resistencia vital, tradicionalmente la mujer ha superado al hombre, aunque actualmente esta diferencia se va suprimiendo, por efecto de la vida activa. 3) El organismo femenino es inestable por naturaleza. Periódicamente tiene lugar en él, una serie de trastornos relacionados con la función reproductora. Todos los meses se realiza la maduración de un óvulo acompañado de una serie de reacciones. Sube la tensión arterial antes del flujo sanguíneo y baja enseguida, aumenta la velocidad del pulso y a veces la temperatura llegando en casos hasta la fiebre. Aumenta el metabolismo basal y disminuye el número de glóbulos rojos. Las sales que transporta la sangre actúan sobre el ovario, la tiroides y la hipófisis cuya actividad ha aumentado. Esa inestabilidad de las glándulas provoca una gran fragilidad nerviosa que alcanza el sistema central. La mujer en esos días es emotiva, nerviosa e irritable. Con la fecundación esta enajenación es más profunda. Pero los desequilibrios de la mujer no desencadenan en ineptitud. 4) El papel erótico de la mujer es pasivo por naturaleza y costumbre. Tiene una doble sensualidad, la clitoriana, agresiva y la vaginal, pasiva. La madurez de la mujer lleva consigo el desarrollo del erotismo vaginal, pero sin que desaparezca del todo el clitoridiano. Quiere ser acariciada y abrazada por unos brazos fuertes y al mismo tiempo necesita acariciar algo suave y delicado. Su excitación erótica es de una intensidad y profundiad mayor que la del hombre. Pero sus resistencias morales pueden impedir la aparición del placer. El ritmo de su sexualidad no coincide con el de la masculina, tarda más en gozar y su voluptuosidad es de distinta forma. 5) Todos los autores coinciden en aplicar a la mujer una mayor sensibilidad. Se interesa más por las personas que por los hechos objetivos. Gracias a esta cualidad desarrolla gran tacto, comprensión, empatía e identificación. 6) Las demás características de la mujer no hacen más que reflejar la situación dependiente de la mujer con respecto al hombre. Alguna, como el amor maternal, no es exclusiva de la mujer, pues es una característica humana no ligada a la maternidad. En los últimos años, la mujer ha visto abierto el camino hacia nuevas funciones, aunque no ha perdido las que tenía anteriormente. Con este cambio ha desarrollado una serie de rasgos nuevos, en mayor número de los que ha perdido en esta ampliación de su campo de actividad. Entre ellos podemos contar las capacidades prácticas, confianza en sí misma y eficiencia. Además, sus intereses son más objetivos e impersonales que los de sus antepasados, acepta y actúa conforme a la moral contractual del mundo en el que se ha introducido. Confía más en su propio juicio, por lo que depende menos de la opinión ajena.

Estudo da metrite puerperal numa exploração leiteira da região de Idanha-a-Nova

Com o presente trabalho, pretendeu realizar-se um resumo bibliográfico, seguido de um estudo de campo, contribuindo para uma melhor identificação da metrite puerperal, dos factores responsáveis pelo seu desenvolvimento, bem como das consequências que diariamente provoca nas explorações de bovinos leiteiros em Portugal. O estudo foi realizado numa exploração leiteira de grande dimensão, e contou com uma amostragem de 202 animais que completaram a gestação entre final de Outubro e fim de Fevereiro e que foram sujeitos a um exame de monitorização das vacas recém-paridas. Durante o exame, foi possível observar a metrite puerperal em 37,8% das vacas. Constatou-se também que a palpação vaginal é um método extremamente eficaz, prático e útil na detecção da metrite puerperal em explorações de grandes dimensões. Na análise dos factores de risco, constatou-se que a incidência da metrite não se encontrou significativamente correlacionada com o número de lactações, com o período do ano em que se diagnosticou a metrite, com os partos distócicos ou com a retenção placentária. Ao dia 30-37 pp., os animais com metrite puerperal tiveram maior probabilidade de desenvolver endometrite clínica. As vacas com metrite puerperal também apresentaram menor quantidade de leite produzido, e afectaram a performance reprodutiva com um aumento do intervalo parto-concepção, do número serviços até concepção e com diminuição da taxa de animais gestantes ao 1º serviço.

A practical approach to a multi-level analysis with a sparse binary outcome within a large surgical trial

Objectives: To assess the potential source of variation that surgeon may add to patient outcome in a clinical trial of surgical procedures. Methods: Two large (n = 1380) parallel multicentre randomized surgical trials were undertaken to compare laparoscopically assisted hysterectomy with conventional methods of abdominal and vaginal hysterectomy; involving 43 surgeons. The primary end point of the trial was the occurrence of at least one major complication. Patients were nested within surgeons giving the data set a hierarchical structure. A total of 10% of patients had at least one major complication, that is, a sparse binary outcome variable. A linear mixed logistic regression model (with logit link function) was used to model the probability of a major complication, with surgeon fitted as a random effect. Models were fitted using the method of maximum likelihood in SAS((R)). Results: There were many convergence problems. These were resolved using a variety of approaches including; treating all effects as fixed for the initial model building; modelling the variance of a parameter on a logarithmic scale and centring of continuous covariates. The initial model building process indicated no significant 'type of operation' across surgeon interaction effect in either trial, the 'type of operation' term was highly significant in the abdominal trial, and the 'surgeon' term was not significant in either trial. Conclusions: The analysis did not find a surgeon effect but it is difficult to conclude that there was not a difference between surgeons. The statistical test may have lacked sufficient power, the variance estimates were small with large standard errors, indicating that the precision of the variance estimates may be questionable.

Selected topics in probiotics and prebiotics: meeting report for the 2004 international scientific association for probiotics and prebiotics

On August 2931, 2004, 84 academic and industry scientists from 16 countries gathered in Copper Mountain, Colorado USA to discuss certain issues at the forefront of the science of probiotics and prebiotics. The format for this invitation only meeting included six featured lectures: engineering human vaginal lactobacilli to express HIV inhibitory molecules (Peter Lee, Stanford University), programming the gut for health (Thaddeus Stappenbeck, Washington University School of Medicine), immune modulation by intestinal helminthes (Joel Weinstock, University of Iowa Hospitals and Clinics), hygiene as a cause of autoimmune disorders (G. A. Rook, University College London), prebiotics and bone health (Connie Weaver, Purdue University) and prebiotics and colorectal cancer risk (Ian Rowland, Northern Ireland Centre for Food and Health). In addition, all participants were included in one of eight discussion groups on the topics of engineered probiotics, host-commensal bacteria communication, 'omics' technologies, hygiene and immune regulation, biomarkers for healthy people, prebiotic and probiotic applications to companion animals, development of a probiotic dossier, and physiological relevance of prebiotic activity. Brief conclusions from these discussion groups are summarized in this paper.

New scientific paradigms for probiotics and prebiotics

The inaugural meeting of the International Scientific Association for Probiotics and Prebiotics (ISAPP) was held May 3 to May 5 2002 in London, Ontario, Canada. A group of 63 academic and industrial scientists from around the world convened to discuss current issues in the science of probiotics and prebiotics. ISAPP is a non-profit organization comprised of international scientists whose intent is to strongly support and improve the levels of scientific integrity and due diligence associated with the study, use, and application of probiotics and prebiotics. In addition, ISAPP values its role in facilitating communication with the public and healthcare providers and among scientists in related fields on all topics pertinent to probiotics and prebiotics. It is anticipated that such efforts will lead to development of approaches and products that are optimally designed for the improvement of human and animal health and well being. This article is a summary of the discussions, conclusions, and recommendations made by 8 working groups convened during the first ISAPP workshop focusing on the topics of: definitions, intestinal flora, extra-intestinal sites, immune function, intestinal disease, cancer, genetics and genomics, and second generation prebiotics. Humans have evolved in symbiosis with an estimated 1014 resident microorganisms. However, as medicine has widely defined and explored the perpetrators of disease, including those of microbial origin, it has paid relatively little attention to the microbial cells that constitute the most abundant life forms associated with our body. Microbial metabolism in humans and animals constitutes an intense biochemical activity in the body, with profound repercussions for health and disease. As understanding of the human genome constantly expands, an important opportunity will arise to better determine the relationship between microbial populations within the body and host factors (including gender, genetic background, and nutrition) and the concomitant implications for health and improved quality of life. Combined human and microbial genetic studies will determine how such interactions can affect human health and longevity, which communication systems are used, and how they can be influenced to benefit the host. Probiotics are defined as live microorganisms which, when administered in adequate amounts confer a health benefit on the host.1 The probiotic concept dates back over 100 years, but only in recent times have the scientific knowledge and tools become available to properly evaluate their effects on normal health and well being, and their potential in preventing and treating disease. A similar situation exists for prebiotics, defined by this group as non-digestible substances that provide a beneficial physiological effect on the host by selectively stimulating the favorable growth or activity of a limited number of indigenous bacteria. Prebiotics function complementary to, and possibly synergistically with, probiotics. Numerous studies are providing insights into the growth and metabolic influence of these microbial nutrients on health. Today, the science behind the function of probiotics and prebiotics still requires more stringent deciphering both scientifically and mechanistically. The explosion of publications and interest in probiotics and prebiotics has resulted in a body of collective research that points toward great promise. However, this research is spread among such a diversity of organisms, delivery vehicles (foods, pills, and supplements), and potential health targets such that general conclusions cannot easily be made. Nevertheless, this situation is rapidly changing on a number of important fronts. With progress over the past decade on the genetics of lactic acid bacteria and the recent, 2,3 and pending, 4 release of complete genome sequences for major probiotic species, the field is now armed with detailed information and sophisticated microbiological and bioinformatic tools. Similarly, advances in biotechnology could yield new probiotics and prebiotics designed for enhanced or expanded functionality. The incorporation of genetic tools within a multidisciplinary scientific platform is expected to reveal the contributions of commensals, probiotics, and prebiotics to general health and well being and explicitly identify the mechanisms and corresponding host responses that provide the basis for their positive roles and associated claims. In terms of human suffering, the need for effective new approaches to prevent and treat disease is paramount. The need exists not only to alleviate the significant mortality and morbidity caused by intestinal diseases worldwide (especially diarrheal diseases in children), but also for infections at non-intestinal sites. This is especially worthy of pursuit in developing nations where mortality is too often the outcome of food and water borne infection. Inasmuch as probiotics and prebiotics are able to influence the populations or activities of commensal microflora, there is evidence that they can also play a role in mitigating some diseases. 5,6 Preliminary support that probiotics and prebiotics may be useful as intervention in conditions including inflammatory bowel disease, irritable bowel syndrome, allergy, cancer (especially colorectal cancer of which 75% are associated with diet), vaginal and urinary tract infections in women, kidney stone disease, mineral absorption, and infections caused by Helicobacter pylori is emerging. Some metabolites of microbes in the gut may also impact systemic conditions ranging from coronary heart disease to cognitive function, suggesting the possibility that exogenously applied microbes in the form of probiotics, or alteration of gut microecology with prebiotics, may be useful interventions even in these apparently disparate conditions. Beyond these direct intervention targets, probiotic cultures can also serve in expanded roles as live vehicles to deliver biologic agents (vaccines, enzymes, and proteins) to targeted locations within the body. The economic impact of these disease conditions in terms of diagnosis, treatment, doctor and hospital visits, and time off work exceeds several hundred billion dollars. The quality of life impact is also of major concern. Probiotics and prebiotics offer plausible opportunities to reduce the morbidity associated with these conditions. The following addresses issues that emerged from 8 workshops (Definitions, Intestinal Flora, Extra-Intestinal Sites, Immune Function, Intestinal Disease, Cancer, Genomics, and Second Generation Prebiotics), reflecting the current scientific state of probiotics and prebiotics. This is not a comprehensive review, however the study emphasizes pivotal knowledge gaps, and recommendations are made as to the underlying scientific and multidisciplinary studies that will be required to advance our understanding of the roles and impact of prebiotics, probiotics, and the commensal microflora upon health and disease management.

Arcanobacterium hippocoleae sp. nov., from the vagina of a horse

A polyphasic taxonomic study was performed on a previously unidentified gram-positive, facultatively anaerobic, diphtheroid-shaped organism isolated from a vaginal discharge of a horse. Comparative 16S rRNA gene sequencing demonstrated that the strain was a member of the genus Arcanobacterium, but sequence divergence values of >4% with described species of this genus (viz: Arcanobacterium haemolyticum, Arcanobacterium bernardiae, Arcanobacterium phocae, Arcanobacterium pluranimalium and Arcanobacterium pyogenes) demonstrated that the isolate represented a novel species. The unknown bacterium was readily distinguished from other Arcanobacterium species by biochemical tests. Based on phylogenetic and phenotypic evidence, it is proposed that the unknown bacterium be classified as Arcanobacterium hippocoleae sp. nov. The type strain of A. hippocoleae is CCUG 44697T (= CIP 106850T).

Characterization of Actinomyces isolates from samples from the human urogenital tract: description of Actinomyces urogenitalis sp. nov.

Three strains of a previously undescribed Actinomyces-like bacterium were isolated from human clinical sources (urine, urethra and vaginal secretion). Biochemical testing and PAGE analysis of whole-cell proteins indicated that the strains were phenotypically homogeneous and distinct from previously described Actinomyces and Arcanobacterium species. Comparative 16S rRNA gene sequencing studies showed the bacterium to be a hitherto unknown subline within a group of Actinomyces species which includes Actinomyces bovis, the type species of the genus. Based on phylogenetic and phenotypic evidence it is proposed that the unknown bacterium from humans be classified as Actinomyces urogenitalis sp. nov. The type strain of Actinomyces urogenitalis is CCUG 38702T (= CIP 106421T).

Carnauba wax nanoparticles enhance strong systemic and mucosal cellular and humoral immune responses to HIV-gp140 antigen

Induction of humoral responses to HIV at mucosal compartments without inflammation is important for vaccine design. We developed charged wax nanoparticles that efficiently adsorb protein antigens and are internalized by DC in the absence of inflammation. HIV-gp140-adsorbed nanoparticles induced stronger in vitro T-cell proliferation responses than antigen alone. Such responses were greatly enhanced when antigen was co-adsorbed with TLR ligands. Immunogenicity studies in mice showed that intradermal vaccination with HIV-gp140 antigen-adsorbed nanoparticles induced high levels of specific IgG. Importantly, intranasal immunization with HIV-gp140-adsorbed nanoparticles greatly enhanced serum and vaginal IgG and IgA responses. Our results show that HIV-gp140-carrying wax nanoparticles can induce strong cellular/humoral immune responses without inflammation and may be of potential use as effective mucosal adjuvants for HIV vaccine candidates.

Advances in mucoadhesion and mucoadhesive polymers

Mucoadhesion is the ability of materials to adhere to mucosal membranes in the human body and provide a temporary retention. This property has been widely used to develop polymeric dosage forms for buccal, oral, nasal, ocular and vaginal drug delivery. Excellent mucoadhesive properties are typical for hydrophilic polymers possessing charged groups and/or non-ionic functional groups capable of forming hydrogen bonds with mucosal surfaces. This feature article considers recent advances in the study of mucoadhesion and mucoadhesive polymers. It provides an overview on the structure of mucosal membranes, properties of mucus gels and the nature of mucoadhesion. It describes the most common methods to evaluate mucoadhesive properties of various dosage forms and discusses the main classes of mucoadhesives.