ABSTRACT
De acordo com a definição de uso off label (ou seja, quando um medicamento é indicado ao paciente de maneira diferente daquela que foi autorizada pelo órgão regulatório em um país), o objetivo deste estudo foi identificar a presença desse tipo de prescrição, diferente da recomendação aprovada pela FDA e ANVISA, para crianças e adolescentes do nascimento até 18 anos. Para isso, foram analisadas as solicitações de medicamentos feitas por ordem judicial ao CEMEPAR/ SESA-PR (Centro de Medicamentos do Paraná / Secretaria de Saúde do Paraná) no ano de 2008. Foram impetradas 934 solicitações, sendo que, destas, 142 (15,20%) tinham indicação diferente da recomendada quando comparadas com informações da FDA, além de outras 112 (12%) quando comparadas com informações da ANVISA. Das prescrições analisadas, 22,54% estavam relacionadas à faixa etária diferente da recomendada de acordo com a FDA e 26,79% de acordo com a ANVISA. Considerando-se a importância do tema para a saúde pública, ressalta-se a necessidade da divulgação de informações e regulamentações sobre o assunto no Brasil.
Noting the definition of off-label use (ie, when a drug is indicated for a patient with a condition for which it has not been authorized by the regulatory agency of the country), the aim of this study was to identify the presence of this type of prescription, at variance with the recommendations of the FDA and (in Brazil) ANVISA, for children and adolescents from birth up to 18 years of age. To this end, the requests for drugs made by court order to CEMEPAR / SESA-PR (Paraná State Medicine Center) in 2008 have been analyzed. A total of 934 requests were filed, out of which 142 (15.20%) contained indications other than the recommended ones, according to information from FDA, and another 112 (12%) indicated a use conflicting with information from ANVISA. Out of the prescriptions analyzed, 22.54% were for patients whose age differed from the range recommended by FDA and 26.79% from the ANVISA range. Considering the importance of the issue to public health, the study highlights the need to spread information on the regulations on these practices in Brazil.
Subject(s)
Adolescent , Child , Drug PrescriptionsABSTRACT
Enfuvirtida é um inibidor de fusão que interfere nascélulas com a penetração do vírus HIV. Sua aplicaçãoé feita por via subcutânea, o que provoca efeitos nocivos no local da aplicação. Os pacientes em uso deenfuvirtida deixam de usá-la constantemente, sugerindo uma baixa adesão devido às diferentes reações quepodem ocorrer com a administração subcutânea do medicamento. O objetivo da pesquisa, portanto, foi avaliar a relação entre a adesão e o acompanhamento farmacoterapêutico a pacientes usuários de enfuvirtida. A pesquisa foi realizada com pacientes com AIDS emuso de enfuvirtida, no CRE Metropolitano. Dados do perfil clínico e sócio-econômico foram coletados por meio de entrevistas. As entrevistas foram agendadas, mensalmente, para verificar a adesão do paciente ao uso de enfuvirtida durante os meses de setembro de 2008 a junho de 2009. Algumas peculiaridades do uso da forma farmacêutica injetável e a posologia de duas vezes por dia são identificadas como fatores limitantes para o tratamento. A maioria dos pacientes reconhece a importância do tratamento. Porém, cerca de 40%relatam dificuldades na aplicação e são intolerantes às reações adversas causadas pela aplicação subcutânea. Cerca de 33% deles, devido à assistência que estão recebendo, ainda esperam a liberação de novos medicamentos para a troca de esquema sem interrompero uso de enfuvirtida.
Enfuvirtide is a fusion inhibitor that interferes with the penetration of HIV into cells. It is injected subcutaneously, causing adverse side effects at the application site. Patients using enfuvirtide often discontinue the treatment, suggesting low compliance due to the various reactions provoked by the subcutaneous administration of the drug. The objective of this research was thus to assess the connection between pharmacotherapeutic follow-up and adherence of patients to the enfuvirtide regimen. The survey was conducted on AIDS patients prescribed enfuvirtide at a Metropolitan CRE (Brazilian Specialty Public Health Center). Data on the clinical profile and socioeconomic conditions were collected by interview. The interviews were scheduled monthly, to monitor patient adherence to the enfuvirtide treatment over the period from September 2008 to June 2009. Some peculiarities of the use of the injectable pharmaceutical form and the twice-daily injections are identified as limiting factors for the treatment. Most patients recognized its importance, but about 40% reported difficulties in injecting the drug and were intolerant of the adverse reactions caused by subcutaneous administration. About 33% of them, due to the accompaniment they are receiving, are still awaiting the release of new medicines so as to change their treatment plan without interrupting the use of enfuvirtide.
Subject(s)
Humans , Male , Female , Adult , Acquired Immunodeficiency Syndrome/drug therapy , ZidovudineABSTRACT
O controle da AIDS no Brasil apresenta resultados favoráveis devido à política seguida pelo Ministério da Saúde que dá ênfase conjunta, na prevenção e atenção à doença com o fornecimento gratuito dos medicamentos. O Ministério da Saúde através do Programa Nacional de DST/AIDS (PN-DST/AIDS) seleciona e compra os medicamentos antirretrovirais (ARVs) e os distribui aos estados. O PN-DST/AIDS distribui 17 medicamentos ARV, em 29 formas farmacêuticas a todos os estados do Brasil. No Paraná, o Centro de Medicamentos do Paraná (CEMEPAR) é o responsável pelo recebimento desses e pela distribuição às 36 Unidades Dispensadoras de Medicamentos (UDMs). Foi realizado um levantamento no estado do Paraná/CEMEPAR no período de janeiro a dezembro/2008 sobre as solicitações enviadas para cadastro de início de tratamento e/ou troca de esquema ARV onde foi observado que 70,56% referiu-se à troca de esquema e, também, que das 5.992 solicitações enviadas, 8,34% (500) apresentavam algum tipo de erro. A pesquisa demonstrou a importância da análise das solicitações, que é um serviço diferenciado realizado pelo estado do Paraná onde foi possível verificar a alta ocorrência de troca de esquemas e a necessidade de um acompanhamento farmacoterapêutico para melhorar a adesão ao tratamento.
The Aids control program in Brazil has been achieving favorable results, owing to the policy adopted by the Ministry of Health, which gives emphasizes both prevention and care for the disease, with the free distribution of medications. The Ministry of Health selects and buys all antiretroviral medications through the National Program DST/AIDS (PN-DST/AIDS) and distributes 17 ARV medications in 29 pharmaceutical forms to all states of Brazil. In Parana State, CEMEPAR (Medicine Center of Parana), is responsible for receiving these medications and redistributing them to the 36 Medicine Distribution Units (UDMs). All requests to change ARV regimen or to start ARV treatment are sent to CEMEPAR for analysis and authorization. An analysis was made of the requests sent to CEMEPAR from January to December 2008 by all of the UDMs where the patients received their medications and it was found that 70.56% were for changes of ARV regimen and that, in 8.34% of all requests, there was some kind of mistake. The survey demonstrated the importance of analyzing the requests, which is a specific service provided by the state of Parana, in which it was possible to observe the high frequency of changes of treatment schemes and a need for pharmacotherapeutic guidance, to improve patient adherence to the treatment.
Subject(s)
Humans , Antiretroviral Therapy, Highly Active , Drug Administration Schedule , Acquired Immunodeficiency Syndrome/therapyABSTRACT
The assessment of fluid volume in neonates by a noninvasive, inexpensive, and fast method can contribute significantly to increase the quality of neonatal care. The objective of the present study was to calibrate an acquisition system and software to estimate the bioelectrical impedance parameters obtained by a method of bioelectrical impedance spectroscopy based on step response and to develop specific equations for the neonatal population to determine body fluid compartments. Bioelectric impedance measurements were performed by a laboratory homemade instrument. The volumes were estimated in a clinical study on 30 full-term neonates at four different times during the first month of life. During the first 24 hours of life the total body water, extracellular water and intracellular water were 2.09 ± 0.25, 1.20 ± 0.19, and 0.90 ± 0.25 liters, respectively. By the 48th hour they were 1.87 ± 0.27, 1.08 ± 0.17, and 0.79 ± 0.21 liters, respectively. On the 10th day they were 2.02 ± 0.25, 1.29 ± 0.21, and 0.72 ± 0.14 liters, respectively, and after 1 month they were 2.34 ± 0.27, 1.62 ± 0.20, and 0.72 ± 0.13 liters, respectively. The behavior of the estimated volume was correlated with neonatal body weight changes, leading to a better interpretation of such changes. In conclusion, this study indicates the feasibility of bioelectrical impedance spectroscopy as a method to help fluid administration in intensive care neonatal units, and also contribute to the development of new equations to estimate neonatal body fluid contents.
Subject(s)
Humans , Male , Female , Body Composition , Body Fluid Compartments , Electric Impedance , Infant, Newborn , Calibration , Spectrum Analysis , Time FactorsABSTRACT
The detection of muscular activity by surface electromyografhic (SEMG) signals has been used in different clinical applications and continues to present a research chaalenge, especially in weak muscular contraction condition with low signal to noise ratio. This work shows a comparison among three single-threshold methods and a double-threshold (DT) method for automatic muscle activity detection using a simulated SEMG signals. Latency and a contraction index were used to compare the results. Despite of some authors have reported good results with the DT method, in our results it was not observed...
Subject(s)
Electromyography , Motor Activity , Muscle ContractionABSTRACT
Electrical impedance is one of the methods that have recently been applied to study the response of skin to an irritant stimulus...
Subject(s)
Electric Impedance , Skin Irritancy Tests , Spectrum AnalysisABSTRACT
O offset dos eletrodos de captação de biopotenciais normalmente impede a utilização de ganhos elevados dos pré-amplificadores associados, devido a saturação dos mesmos. Neste trabalho será apresentada uma nova topologia que resolve o problema mencionado, possibilitando ganhos e CMRR elevados.
The electrode offset effect forbídes hígh gains in bioelectric preamplifíers. due the saturation of the formers. ln this work present a new that solves the mencioned problem, resulting in high...
Subject(s)
Electrodes , Amplifiers, Electronic , Reaction Time , Signal Processing, Computer-Assisted , Electromyography , Electric ImpedanceABSTRACT
Este trabalho faz parte da investigação da aplicação de algumas técnicas de processamento de sinais, quais sejam análise "wavelet", escalogramas e redes neurais, aos sinais fonocardiográficos, visando à classificação automática de patologias cardiovasculares. Obtivemos resultados preliminares que sugerem investigação mais minuciosa do uso da "wavelet auditiva" na análise desses sinais.