ABSTRACT
Objetivo: Apresentar o mapeamento entre vocabulários controlados da Agência Nacional de Vigilância Sanitária (ANVISA) para listas do European Directorate for the Quality of Medicines and Healthcare (EDQM). Método: O mapeamento obedeceu aos princípios da ABNT NBR ISO 12300. Resultados: Foram mapeadas as listas: Via de Administração, Forma Farmacêutica e Embalagem. 47% dos mapeamentos foram classificados com grau de equivalência 4, onde o conceito fonte foi mais restrito com mais significado específico que o conceito/termo alvo. Conclusão: Entende-se que este estudo fornece subsídios para a ANVISA prosseguir no trabalho de harmonização das listas locais com o padrão IDMP.
Objective: To present the mapping between controlled Brazilian Health Regulatory Agency (ANVISA) vocabularies for European Directorate for the Quality of Medicines and Healthcare (EDQM) lists. Method: The mapping followed the principles described in the ABNT NBR ISO 12300. Results: Terms of three lists were mapped: Routes of Administration, Pharmaceutical Dose Forms and Packaging. Almost half of the mappings were classified with equivalence grade 4 meaning that the source concept was more restricted with more specific meaning than the target concept / term. Conclusion: This work provides the necessary subsidies for ANVISA to proceed with the work of harmonizing local lists with the IDMP standard.
Objetivo: Presentar el mapeo entre vocabularios controlados de Agencia Nacional de Vigilancia Sanitaria (ANVISA) para listas European Directorate for the Quality of Medicines and Healthcare (EDQM). Método: El mapeo siguió los principios descritos en lo estándar ABNT NBR ISO 12300. Resultados: Se mapearon los términos de las listas: Vía de administración, Forma farmacéutica y Embalajes. La mayoría se clasificaron como grado de equivalencia 4, donde el concepto fuente era más restringido con un significado más específico que el concepto/término objetivo. Conclusión: Se entiende que este estudio proporciona subsidios para ANVISA continúe el trabajo de armonizar las listas locales con el estándar IDMP.
Subject(s)
Quality of Health Care , Pharmaceutical Preparations , Vocabulary, Controlled , Brazilian Health Surveillance Agency , Terminology as Topic , Equivalence Trials as TopicSubject(s)
Humans , Female , Pregnancy , Adolescent , Adult , Young Adult , Levonorgestrel/administration & dosage , Contraception, Postcoital/methods , Intrauterine Devices, Medicated , Intrauterine Devices, Copper , Pregnancy Tests , Randomized Controlled Trials as Topic , Multicenter Studies as Topic , Pregnancy Rate , Unsafe Sex , Intention to Treat Analysis , Equivalence Trials as TopicABSTRACT
BACKGROUND@#Neck pain caused by cervical spondylosis (CS) is a chronic pain condition, with an increasingly high incidence in the general population. Electroacupuncture is a common analgesic modality that has been widely applied in neck pain treatment. However, current electroacupuncture instruments used in the clinic have low intelligence levels and obscure parameter standards. We here designed this study for assessing the effect and safety of a new, intelligent electroacupuncture instrument, the CX-DZ-II, in treating neck pain.@*METHODS@#The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial for CX-DZ-II on treating neck pain caused by CS. Totally 160 eligible patients will be included in this trial and randomly assigned to an experimental group and a control group in a 1:1 ratio. A semi-standard acupoint selection strategy will be employed. In the experimental group, selected acupoints will be stimulated by CX-DZ-II. Electroacupuncture treatment will be accomplished by a pre-existing electroacupuncture instrument in the control group. The duration of treatment will be 2 weeks. The primary outcome is the change of Visual Analog Scale (VAS) score after one course of treatment. The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument.@*DISCUSSION@#This study will evaluate the effect and safety of the CX-DZ-II intelligent electroacupuncture therapeutic instrument in comparison with a pre-existing non-intelligent instrument in the treatment of neck pain caused by CS. The results will hopefully demonstrate a more optimal electroacupuncture instrument for the treatment of neck pain. (Trial registration No. gov NCT03005301).
Subject(s)
Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Electroacupuncture , Methods , Equivalence Trials as Topic , Multicenter Studies as Topic , Neck Pain , Therapeutics , Pain Measurement , Prospective Studies , Spondylosis , TherapeuticsABSTRACT
Abstract: In 2008, the first HPV vaccination program in Latin America started in Panama, targeting girls aged 10-11 years with a 3-dose vaccine schedule, an initiative that was to be followed by other Latin American countries after local feasibility and population acceptability evaluations were completed. A 3-dose vaccine regimen over six months was originally chosen for HPV vaccines, copying the Hepatitis B vaccine schedule (0, 1-2, 6 months). Alternative vaccine schedules have been proposed afterwards based on: i) noninferior immunogenicity or immune response levels compared to those at which clinical efficacy has been proven (i.e., those observed in a 3-dose HPV vaccine schedule in women aged 15-26), and, ii) proven efficacy in clinical trials and/or effectiveness among women who were provided less than three doses due to a lack of adherence to a 3-dose vaccine schedule. In 2014, based on the available evidence and the potential increase in coverage by expansion of vaccination target groups, particularly in low and middle income countries (LMIC), the World Health Organization recommended a 2-dose schedule with at least a 6-month interval between doses for females up to 15 years of age and a 3-dose schedule for older women. More recently, it has been suggested that 1-dose HPV vaccination schemes may provide enough protection against HPV infection and may speed up the introduction of HPV vaccination in LMIC, where most needed.
Resumen: En 2008, se inició en Panamá el primer programa de vacunación contra el virus del papiloma humano (VPH), dirigido a niñas de 10 a 11 años, utilizando un esquema de tres dosis en seis meses, iniciativa que fue adoptada por otros países de la región tras evaluar la aceptabilidad en la población y la viabilidad de llevar a cabo el programa. Inicialmente, el esquema de tres dosis para las vacunas contra el VPH se basó en el utilizado en la vacunación contra la hepatitis B (0, 1-2, 6 meses). Posteriormente, se han propuesto esquemas de vacunación alternativos, utilizando evidencia sobre: i) la inmunogenicidad o niveles de respuesta inmune no inferiores a aquéllos con los cuales la eficacia clínica de la vacuna fue probada (es decir, aquéllos observados con tres dosis en mujeres de 15 a 26 años); y ii) la eficacia demostrada en ensayos clínicos y efectividad demostrada en mujeres a quienes se vacunó con menos de tres dosis debido a falta de adherencia al esquema completo de tres dosis. En 2014, la Organización Mundial de la Salud recomendó un esquema de dos dosis con al menos seis meses de intervalo entre dosis para mujeres de hasta 15 años de edad y uno de tres dosis para mujeres mayores. La recomendación se basó en la evidencia disponible hasta entonces y a un posible aumento en cobertura mediante la ampliación de los grupos etarios a vacunarse, particularmente en países de ingresos bajos y medios (PIBMs). Más recientemente, se ha sugerido un esquema de vacunación contra el VPH de una sola dosis, el cual podría proporcionar suficiente protección contra la infección por VPH y así acelerar la introducción de la vacunación contra el VPH en PIBMs donde más se necesita.