RESUMO
La actualización de la presente política reafirma el compromiso del Organismo Andino de Salud Convenio Hipólito Unanue con la toma de decisiones en salud, basadas en la mejor evidencia científica mediante la evaluación de tecnologías sanitarias. Para lograr este objetivo general en nuestra región, se han trazado 4 ejes estratégicos para su implementación: políticas públicas basadas en evidencia, fortalecimiento de las evaluaciones de tecnologías sanitarias en la región andina, establecer un marco de calidad y fomentar el uso racional de las tecnologías. Los indicadores propuestos en esta política monitorearán la implementación de las evaluaciones de tecnologías sanitarias en la región Andina y en un futuro próximo, pueden ser el punto de partida de una lista de chequeo para acreditar agencias de evaluación de tecnologías sanitarias en la región
Assuntos
Avaliação da Tecnologia Biomédica , Acesso a Medicamentos Essenciais e Tecnologias em SaúdeRESUMO
PURPOSE: To perform a systematic review and individual- and aggregate-data meta-analysis of observational studies to determine the success rate of the lateral sinus floor elevation with simultaneous implant placement and without grafting materials. MATERIAL AND METHODS: We included prospective and retrospective observational studies analyzing survival rate of implants in patients who underwent graftless lateral sinus floor elevation. Secondary outcomes included increase of bone height, marginal bone loss (MBL), implant stability, and adverse events such as sinus membrane perforation and signs of infection in the maxillary sinuses. Survival rate and proportion of adverse outcomes were calculated using the variance-stabilizing Freeman-Tukey double-arcsine transformation. Meta-analyses of bone gain and MBL were performed based on changes from baseline and sampling variance. Implant stability was analyzed at follow-up. Individual participant data were modeled using a one-step approach. The survival probability was determined using the Kaplan-Meier method, and the Cox proportional-hazards regression was applied to investigate the association between survival time of implants and covariates. RESULTS: 11 observational studies were included in the study. The meta-analysis based on 660 implants and 17 failures showed a pooled survival rate of 97.5% (CI 95% 95.8 to 98.9). Pooled analysis also showed an increase in mean bone height of 5.7 mm (CI 95% 4.78 to 6.56), MBL of 1.2 mm (CI 95% 0.84 to 1.51), and implant stability quotient of 70.5 (CI 95% 64.2 to 76.9). A pooled rate of 20.0% (CI 95% 10.9 to 30.6) and 3.0% (CI 95% 0.5 to 6.8), respectively, for membrane perforations and sinus infection was found. Individual-data meta-analysis showed an overall 5-year survival of 93.1% (SE 2.67%) with a mean survival time of 6.7 years (SE 0.08). Longer implants were associated with a decreased hazard ratio (0.64; CI 95% 0.41 to 0.99). CONCLUSIONS: Current available evidence based on aggregate and individual patient data meta-analysis suggests that lateral maxillary sinus floor elevation without grafting, and simultaneous implant placement, is a safe and effective technique with high survival rates, especially for implants with more than 13 mm in length.
Assuntos
Implantação Dentária Endóssea , Implantes Dentários , Falha de Restauração Dentária , Levantamento do Assoalho do Seio Maxilar/métodos , Humanos , Complicações Pós-OperatóriasRESUMO
Objetivos. Describir el proceso de priorización para el desarrollo de guías de práctica clínica (GPC) en el Seguro Social de Salud del Perú (EsSalud). Métodos. El proceso de priorización se realizó mediante un análisis multicriterio en tres pasos: identificar las variables, obtener información de las mismas y asignarles una ponderación. Finalmente, se obtuvo una lista ordenada que fue puesta a consideración de los decisores de política. Resultados. Las cinco enfermedades con mayor número de AVISA (años de vida saludable perdidos) fueron: artrosis, glaucoma, esquizofrenia, osteoporosis y fracturas patológicas, y diabetes mellitus. Las de mayor gasto en medicamentos fueron: hemofilia, el grupo de nefritis, nefrosis (principalmente insuficiencia renal crónica), artritis reumatoide, cáncer de mama y SIDA. Las enfermedades prioritarias desde el punto de vista de la oferta de servicios fueron aquellas con alta mortalidad y alta discapacidad. Conclusiones. Se realizó el primer proceso de priorización de GPC en el Perú. Las 5 primeras enfermedades priorizadas fueron: artrosis, diabetes mellitus, glaucoma, enfermedad renal crónica y lumbago.
Objectives. To describe the prioritization process for developing the clinical practice guidelines (GPC) in the Seguro Social del Peru (EsSalud). Methods. The prioritization process was carried out through a multicriteria analysis in three steps: identify the variables, obtain information from them and assign them a weighting. Finally, an ordered list was obtained that was put to the consideration of the policy makers. Results. The five diseases with the highest number of DALY (disability adjusted life year) were osteoarthritis, glaucoma, schizophrenia, osteoporosis and pathological fractures, and diabetes mellitus. The most spending for drugs were hemophilia, the nephritis group, nephrosis (mainly chronic renal failure), rheumatoid arthritis, breast cancer and AIDS. Priority diseases from the point of view of the services offered were those with high mortality and high disability. Conclusions. This is the first process of guidelines prioritizing in Peru. The first 5 diseases prioritized were: osteoarthritis, diabetes mellitus, glaucoma, chronic kidney disease and lumbago.
RESUMO
La Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios N.° 29459, publicada ennoviembre de 2009, orienta la regulación de estos productos sustituyendo al Capítulo III de la Ley General de Salud N.º 26842. A través de esta Ley se ha modificado los aspectos más cuestionados en la Ley N.° 26842, al establecer requisitos para solicitar el registro sanitario de productos farmacéuticos que son necesarios para garantizar su eficacia,seguridad y calidad, incluyendo también los plazos necesarios para su evaluación y que el costo de la tasa por registrosanitario sea en función de lo que implique otorgar dicho registro, lo cual incluye también las actividades de control y vigilancia sanitaria. Así mismo, restablece la exigencia de la autorización sanitaria de funcionamiento, previa al inicio delas actividades, previa inspección para verificar el cumplimiento de los dispositivos legales vigentes. La Ley incorpora también tres capítulos específicos sobre acceso, uso racional de productos farmacéuticos, dispositivos médicos y productos sanitarios, así como un capítulo de investigación.
The Law of Pharmaceutical Products, Medical devices and Sanitary products N°. 29459, published in November, 2009, guides the regulations of these products, substituting Chapter III of the General Law of Health N°. 26842. Through this law, the most questioned aspects of the Law N°. 26842 have been modified, establishing requisites to apply for the sanitary registry of pharmaceutical products that are necessary to guarantee their efficacy, security and quality, also including the required terms for their evaluation and the cost of the health registration fee must be according to all what implies to give the registry, including control activities and health surveillance. It also resets the requirement of the operating health approval, prior to the initiation of the activities, and having had a previous inspection to verify the accomplishment of the actual legal devices. The law also incorporates three specific chapters about access, rational use of pharmaceutical products, medical devices and health products, as well as a chapter on research.
