The data used to build the models: Pertussis morbidity and mortality burden considering various Brazilian data sources.

BACKGROUND: Pertussis is associated with significant disease burden in children worldwide. In addition to its cyclical nature, resurgences of pertussis cases, hospitalizations and deaths have been reported by many countries. We describe the dynamics of pertussis in Brazil, a middle-income country that has experienced a resurgence and that provides good quality data to allow building a dynamic transmission disease model. METHODS: We conducted a descriptive analysis of pertussis burden considering data from the national disease surveillance system, national hospitalization information system and national mortality registry. Study period was 2000-2016. Absolute numbers and rates per 100,000 inhabitants over time, by age sub-groups and geographical regions are presented. RESULTS: From 2000 to 2016, a total of 37,299 reported pertussis cases, 25,240 hospitalizations, and 601 deaths due to pertussis were reported. Although the outcomes - pertussis cases, hospitalizations, and deaths - come from independent information systems, our results document low disease burden with periodic increases every 3-4 years during the years 2000-2010, followed by a sharp increase which peaked in 2014. In both periods, disease burden is concentrated in young children, while its more serious outcomes - hospitalizations and deaths, are concentrated in infants. Pre-outbreak and outbreak disease burden as well as timing of peak during the outbreak period vary by states and within geographical regions, representing valuable resources of data for modelling purposes. CONCLUSION: Consistent disease burden patterns were observed over time in Brazil using a variety of data sources. Given the scarcity of good epidemiological data on pertussis available from low- and middle-income countries, our reported data provide valuable information for the assessment of the public health impact and cost-effectiveness modelling studies of newer strategies to prevent and control pertussis. These data were used to build and calibrate a national dynamic transmission model, which was used to evaluate the cost-effectiveness of maternal immunization. Clinical Trial registry name and registration number: Not applicable.

Traumatismo cranioencefálico e sua associação com uso de canabinoides e cocaína: experiência de hospital universitário brasileiro / Traumatic brain injury and its association to marijuana and cocaine use: a Brazilian university hospital experience

Objetivo: Este estudo objetivou identificar aspectos da epidemiologia dos traumatismos cranioencefálicos (TCEs) moderados e graves dos pacientes admitidos no Hospital de Clínicas da Universidade Federal de Uberlândia, bem como sua associação com consumo de cocaína e canabinoides. Métodos: Para isso, foram coletados dados prospectivos sobre 139 vítimas assistidas nesse hospital, todas com idade igual ou superior a 18 anos. Os acidentes de transporte responderam pelo maior número de vítimas, seguidos daquelas pessoas que sofreram quedas acidentais. Resultados: Do total de pacientes avaliados, 84 (com casos de TCE moderado, grave e mesmo leve) tiveram amostra de urina coletada para detecção de maconha e cocaína. Os exames foram positivos para maconha em 8,2% dos pacientes e em 13,9% para cocaína. Conclusão: Não foram vistas diferenças significativas no tocante ao sexo e à idade, bem como à atividade realizada no momento do trauma. A maioria dos atendimentos desses pacientes, no entanto, se deu no período noturno. A alta frequência de consumo de substâncias ilícitas associada aos TCEs evidencia a importância de se incluírem esses dados quando da realização de estudos acerca desse tipo de traumatismo, bem como aponta para um problema de saúde pública.

Objective: This study aimed at identifying epidemiological aspects of moderate and severe traumatic brain injury (TBI) of patients who were admitted at the Clinics Hospital of the Federal University of Uberlândia, as well as its association with marijuana and cocaine intake. Methods: Prospective data were collected from 139 assisted patients, all of them aged 18 or more years. Traffic accidents were responsible for the greatest number of victims, followed by accidental drops. Results: Eighty-four patients (including moderate, severe and even light TBI) had a urine sample evaluated for the presence of marijuana and cocaine. Marijuana positive tests were found in 8.2% of patients, and there were 13.9% for cocaine. Conclusion: No significant differences were seen concerning age and sex, neither for the activity performed at the trauma time. However more patients were admitted at the hospital at night time. The high frequency of consumption of these illegal stuff associated with TBI shows the importance of having this information while performing trials about this kind of trauma. It also indicates this is public health problem.

Occurrence of severe and moderate traumatic brain injury in patients attended in a Brazilian Teaching Hospital: epidemiology and dosage of alcoholemy.

This study aimed at observing aspects of epidemiology in order to investigate the use of alcohol in patients older than 18 with severe and moderate traumatic brain injury, which were attended in the Clinics Hospital of the University of Uberlândia. Positive alcoholemy was found in 39.3% of the patients. Of the 33 positive exams alcoholemy was found higher than 60 mg/dL in 28 (84.6%). There was not significant relation between alcoholemy levels and trauma severity. The major prevalence occurred on Saturdays nights. The most frequent types of external causes were transportation accidents (64.74) followed by accidental falls (17.27%) and physical aggression (16.55%). 93.9% of the patients with positive alcoholemy were men aged 20-29. 24.2% of the ones with positive alcoholemy died yet no significant difference was found in the study of the ones with negative alcoholemy (n=51) (p=0.93); RR= 0.9; IC95%=0.40-2.08.

Occurrence of severe and moderate traumatic brain injury in patients attended in a Brazilian Teaching Hospital: epidemiology and dosage of alcoholemy

This study aimed at observing aspects of epidemiology in order to investigate the use of alcohol in patients older than 18 with severe and moderate traumatic brain injury, which were attended in the Clinics Hospital of the University of Uberlândia. Positive alcoholemy was found in 39.3 percent of the patients. Of the 33 positive exams alcoholemy was found higher than 60 mg/dL in 28 (84.6 percent). There was not significant relation between alcoholemy levels and trauma severity. The major prevalence occurred on Saturdays nights. The most frequent types of external causes were transportation accidents (64.74) followed by accidental falls (17.27 percent) and physical aggression (16.55 percent). 93.9 percent of the patients with positive alcoholemy were men aged 20-29. 24.2 percent of the ones with positive alcoholemy died yet no significant difference was found in the study of the ones with negative alcoholemy (n=51) (p=0.93); RR= 0.9; IC95 percent=0.40-2.08.

Os objetivos deste estudo são investigar aspectos da epidemiologia e identificar o uso de álcool em pacientes com traumatismo craniencefálico grave e moderado em maiores de 18 anos atendidos no Hospital de Clínicas da Universidade Federal de Uberlândia. Encontrou-se alcoolemia positiva em 39,3 por cento dos pacientes. Nos 33 exames positivos, foram observadas alcoolemias superiores a 60 mg/dL em 28 (84,6 por cento). Não houve relação significativa entre os níveis de alcoolemia e a gravidade do trauma. Maior prevalência ocorreu aos sábados, no período noturno. Os tipos de causa externa mais frequentes foram os acidentes de transporte (64,74 por cento), seguidos de quedas acidentais (17,27 por cento) e de agressões (16,55 por cento). Dos pacientes com alcoolemia positiva, 93,9 por cento eram do sexo masculino, com maior prevalência dos 20 aos 29 anos. Dentre aqueles com alcoolemia positiva, 24,2 por cento vieram a falecer, não havendo diferença significante com os pacientes com alcoolemia negativa (n=51) (p=0,93); RR= 0,9; IC95 por cento=0,40-2,08.

Intercambialidade de medicamentos: abordagem clínica e o ponto de vista do consumidor / Drug interchangeability: clinical approach and consumer's point of view

A construção racional do arsenal terapêutico, considerando a necessidade do paciente, a segurança e a disponibilidade do medicamento, e o melhor custo-benefício pressupõem embasamento na tríade: segurança, eficácia e qualidade. Mas na prática diária, a efetividade do medicamento é o que mais influencia a decisão do prescritor, que considera critérios que aumentem a adesão ao tratamento, tais como toxicidade relativa, conveniência de administração, custo e experiência de emprego. A entrada no mercado de novas moléculas para mesmos fins terapêuticos, acompanhada de grande publicidade, interfere no processo decisório do prescritor, assim como práticas de bonificações da indústria para venda nos balcões das farmácias repercutem na decisão de compra do paciente. O confronto entre a conhecida variabilidade biológica dos seres humanos e a não similaridade absoluta entre medicamentos da mesma classe terapêutica ou mesmo medicamentos genéricos, tem impacto na lista individualizada de medicamentos, que deve englobar os conceitos de droga de primeira escolha e segunda escolha. O desconhecimento desta discussão por parte dos prescritores é determinante do uso irracional de medicamentos, um problema de saúde publica. Assim, o objetivo do trabalho foi apresentar aos prescritores de medicamentos informações que possam auxiliar na construção mais racional do arsenal terapêutico utilizado para seus pacientes, com base em experiência na regulação de medicamentos da Agência Nacional de Vigilância Sanitária.

The rational construction of an essential drug list, considering the patient's need, drug safety, availability and the best cost-benefit ratio, is based on drug safety, efficacy and quality. However, in daily practice, the prescriber's decision is mostly influenced by drug effectiveness, following criteria that increase adherence to the treatment, such as relative drug toxicity, convenience, cost and prescriber's experience. In addition, frequent launching of new molecules for the same therapeutic indication, together with wide publicity targeting prescribers, interferes with the decision-making process. Similarly, the bonuses offered by the industry for over-the-counter drug sales interfere with the consumer's choice. The confrontation between known human biological variability and the knowledge that there is no absolute similarity between drugs of the same therapeutic class, or even generic drugs, has an impact on the prescriber's drug list, which should include the concept of first and second choice drugs. Prescribers' unfamiliarity with these subjects is a determinant factor for irrational drug use: a public health issue. The objective of this study was to introduce to drug prescribers information that can help them building up a rational drug list for their patients, based on the National Health Surveillance Agency (Anvisa) experience of drug regulation.

[The National Health Surveillance Agency, ANVISA, and clinical research in Brazil]. / A Agência Nacional de Vigilância Sanitária e a pesquisa clínica no Brasil.

Conduction of clinical trials with drugs in Brazil requires prior approval by Committees for Ethics in Research (CEPs) and, in certain cases, by the National Commission for Ethics in Research (CONEP). Approval by the National Health Surveillance Agency (ANVISA), through its Office for New Drugs, Research and Clinical Trials (GEPEC), is currently required only for drugs and medical devices manufactured in other countries and therefore need permission to be imported. This article briefly reviews the history of clinical research regulation in Brazil, then presents an overview of the current regulatory role of ANVISA and its future prospective. Major points discussed are the new forthcoming ANVISA regulations, with emphasis on adverse event notifications and inspections/audits on clinical trials and their impact on clinical research in Brazil, from the standpoint of the industry, university, contract research organizations, physicians and other health professionals. It should be stressed that to decide upon the licensing of new drugs ANVISA must obtain information from clinical trials.

A Agência Nacional de Vigilância Sanitária e a pesquisa clínica no Brasil / ANVISA and clinical research in Brazil

A realização de ensaios clínicos com medicamentos no Brasil requer aprovação prévia pelos Comitês de Ética em Pesquisa (CEPs) e, em certos casos, pela Comissão Nacional de Ética em Pesquisa (CONEP). Aprovação pela Agência Nacional de Vigilância Sanitária (ANVISA), através de sua Gerência de Medicamentos Novos, Pesquisa e Ensaios Clínicos (GEPEC) é também necessária para ensaios clínicos com medicamentos e produtos para a saúde (correlatos) que são fabricados em outros países e, portanto, necessitam autorização para serem importados. Este artigo revê brevemente a história da legislação sobre pesquisa clínica no Brasil, e apresenta um panorama do papel regulador da ANVISA no presente e suas perspectivas futuras. Pontos importantes discutidos são as legislações novas e futuras da ANVISA, com ênfase nas notificações de eventos adversos e inspeções/auditorias em ensaios clínicos, e seu impacto na pesquisa clínica no Brasil sob o ponto de vista da indústria, da universidade, organizações representativas de pesquisa clínica, médicos e outros profissionais de saúde. A importância para a ANVISA da obtenção de informações a partir de ensaios clínicos para a avaliação do registro de novos medicamentos também é ressaltada.

[Drug interchangeability: clinical approach and consumer's point of view]. / Intercambialidade de medicamentos: abordagem clínica e o ponto de vista do consumidor.

The rational construction of an essential drug list, considering the patient's need, drug safety, availability and the best cost-benefit ratio, is based on drug safety, efficacy and quality. However, in daily practice, the prescriber's decision is mostly influenced by drug effectiveness, following criteria that increase adherence to the treatment, such as relative drug toxicity, convenience, cost and prescriber's experience. In addition, frequent launching of new molecules for the same therapeutic indication, together with wide publicity targeting prescribers, interferes with the decision-making process. Similarly, the bonuses offered by the industry for over-the-counter drug sales interfere with the consumer's choice. The confrontation between known human biological variability and the knowledge that there is no absolute similarity between drugs of the same therapeutic class, or even generic drugs, has an impact on the prescriber's drug list, which should include the concept of first and second choice drugs. Prescribers' unfamiliarity with these subjects is a determinant factor for irrational drug use: a public health issue. The objective of this study was to introduce to drug prescribers information that can help them building up a rational drug list for their patients, based on the National Health Surveillance Agency (Anvisa) experience of drug regulation.

Adverse reactions associated with a Fuenzalida-Palacios rabies vaccine: a quasi-experimental study.

The Fuenzalida-Palacios rabies vaccine has been used in South America for rabies post-exposure prophylaxis. To determine the frequency of adverse reactions associated with this vaccine compared to a control group a quasi-experimental study was carried out in Uberlândia, Brazil, from May 1997 to April 1998. Victims of bites or other injuries by dogs or other mammals and who received or not post-exposure prophylaxis with Fuenzalida-Palacios rabies vaccine were compared as to the occurrence of a list of signs and symptoms. Out of 2,440 victims of bites and other injuries from dogs and other mammals 2,114 participated in the study; 1,004 of them provided follow-up information within 10 to 15 days. Headache and pain at the injection sites were the most commonly found symptoms (125/1,000). No neuroparalytic event was detected. Patients who were given Fuenzalida-Palacios rabies vaccine and those who were not had similar incidences of symptoms (risk ratios close to 1). Regarding the occurrence of adverse reactions, Fuenzalida-Palacios rabies vaccine is a valid alternative for rabies post-exposure prophylaxis.

Adverse reactions associated with a Fuenzalida-Palacios rabies vaccine: a quasi-experimental study

A vacina anti-rábica tipo Fuenzalida-Palacios é utilizada na América do Sul para a profilaxia anti-rábica pós-exposiçäo. Um estudo quase-experimental foi realizado em Uberlândia, Brasil, de maio de 1997 a abril de 1998, para determinar a freqüência de reações adversas associadas a esta vacina. Vítimas de mordeduras e outras lesöes causadas por cäes ou outros mamíferos que receberam ou näo vacina anti-rábica tipo Fuenzalida-Palacios como profilaxia pós-exposiçäo foram comparados quanto à ocorrência de uma série de sinais e sintomas. As informações sobre esses eventos foram obtidas por entrevistas pessoais ou por telefone. De 2.440 vítimas de mordeduras e outros traumatismos por cäes ou outros mamíferos 2.114 participaram do estudo; 1004 forneceram informações sobre ocorrência de sintomas dentro de 10 a 15 dias. Cefaléia e dor nos locais das injeções foram os sintomas mais freqüentes (125/1.000). Nenhum evento neuroparalítico foi detectado. Pacientes que receberam ou näo a vacina anti-rábica tiveram incidências semelhantes de reações adversas (razöes de risco próximas a 1). No que diz respeito à ocorrência de reações adversas, a vacina anti-rábica tipo Fuenzalida-Palacios é uma alternativa válida para a profilaxia anti-rábica pós-exposiçäo.

Validade da amilasemia e da lipasemia no diagnóstico diferencial entre pancreatite aguda/crônica agudizada e outras causas de dor abdominal aguda / Validity of serum amylase and lipase for the differential diagnosis between acute/acutized chronic pancreatitis and other causes of acute abdominal pain

RACIONAL: Várias doenças abdominais podem cursar com aumento de amilasemia e lipasemia. OBJETIVO: Avaliar a validade da amilasemia e lipasemia para os diagnósticos diferenciais entre pancreatite aguda/pancreatite crônica agudizada, doenças das vias biliares, úlcera gastroduodenal perfurada e apendicite aguda. PACIENTES E MÉTODOS: Foram avaliados, prospectivamente, 38 pacientes com pancreatite aguda/pancreatite crônica agudizada, 35 com doenças das vias biliares, 17 com úlcera gastroduodenal perfurada e 44 com apendicite aguda, com idade média (desvio padrão) de 42,4 ± 17,7, 46,7 ± 18,3, 47,8 ± 12 e 33,7 ± 17,8 anos, respectivamente. A amilasemia e a lipasemia foram determinadas à admissão no pronto-socorro. RESULTADOS: Para o diagnóstico de pancreatite aguda/pancreatite crônica agudizada, quando o nível de corte da amilasemia variou entre o limite superior de referência e 5 vezes este limite, a sensibilidade diminuiu de 92 por cento para 74 por cento, a especificidade aumentou de 85 por cento para 99 por cento, o valor preditivo positivo aumentou de 71 por cento para 97 por cento e o valor preditivo negativo diminuiu de 96 por cento para 91 por cento. Para a lipasemia valores semelhantes foram obtidos para sensibilidade e valor preditivo negativo, mas a especificidade e o valor preditivo positivo foram mais baixos. Quando se considerou amilasemia ou lipasemia elevadas, houve pequeno aumento na sensibilidade e no valor preditivo negativo. CONCLUSÕES: Para o diagnóstico de pancreatite aguda/pancreatite crônica agudizada, 1) o melhor nível de corte para ambos os testes foi o de duas vezes o limite superior de referência; 2) as sensibilidades da amilasemia e da lipasemia foram semelhantes; 3) a especificidade e o valor preditivo positivo da amilasemia foram ligeiramente maiores do que as da lipasemia; 4) a sensibilidade, mas não a especificidade, aumentou quando pelo menos uma das enzimas estava elevada.