ABSTRACT
Resumo OBJETIVO: descrever o perfil de segurança dos soros heterólogos produzidos pelo Instituto Butantan (IB) de São Paulo-SP, Brasil. MÉTODOS: estudo descritivo dos relatos de eventos adversos (EA) pós-exposição aos soros produzidos pelo IB, codificados pela terminologia do Dicionário Médico para Atividades Regulatórias (MedDRA), notificados espontaneamente ao IB entre 2012 e 2015. RESULTADOS: foram notificados 52 usuários com algum evento adverso relacionado, principalmente, aos soros antibotrópico (n=11), antidiftérico (n=9) e antiofídico não especificado (n=9); observaram-se, em média, 3,2 EA por indivíduo; dos 173 EA notificados, 63,0% eram esperados por serem eventos descritos em bula; os EA mais notificados foram categorizados como afecções dos tecidos cutâneos e subcutâneos (30,6%); houve seis óbitos temporalmente relacionados ao uso de soros, porém essa associação foi descartada. CONCLUSÃO: no período estudado, os soros produzidos pelo IB não apresentaram alteração em seu perfil de segurança, já que os EA relatados eram esperados conforme informação descrita em bula.
Abstract OBJECTIVE: to describe the safety profile of the heterologous serum produced by the Butantan Institute (BI) of São Paulo-SP, Brazil. METHODS: a descriptive study of adverse events (AEs) post-exposure to serum produced by the BI, encoded in the medical terminology of the Medical Dictionary for Regulatory Activities (MedDRA), and spontaneously reported to BI from 2012 to 2015. RESULTS: 52 individuals reported AEs, mainly related to Bothrops antivenom (n=11), diphtheria antitoxin (n=9) and unspecified snakebite serum (n=9); a mean of 3.2 AEs per individual was observed; among the total of 173 AEs, 63.0% were expected considering that they were described in the package insert; most of them were classified as skin and subcutaneous tissue disorders (30.6%); there were six deaths temporally related to the use of serum, but this association was discarded. CONCLUSION: in the studied period, the serum produced by the BI had no changes in their safety profiles, considering that the AEs were expected, according to the information previously described in the package insert.
Resumen OBJETIVO: describir el perfil de seguridad de los sueros heterólogos producidos por el Instituto Butantan (IB) de São Paulo-SP, Brasil. MÉTODOS: estudio descriptivo de los informes de eventos adversos (EAs) post-exposición a los sueros del IB y codificados según el Diccionario Médico para Actividades Regulatorias (MedDRA). RESULTADOS: 52 usuarios presentaron EAs relacionados con los sueros antibotrópico (n=11), antidiftérico (n=9) y antiofídico no especificado (n=9); se observó, en los EAs, 3,2 de media por persona; de los 173 EAs reportados, 63,0% fueron "esperados", ya que figuran descritos en la bula farmacológica; los EAs más reportados fueron los trastornos de piel y tejido subcutáneo (30,6%); hubo seis muertes, pero se descartó la asociación con el uso de suero. CONCLUSIÓN: durante el período de estudio, los sueros del IB no mostraron ningún cambio en su perfil de seguridad, ya que los EAs reportados eran esperados conforme información descrita en la bula.
Subject(s)
Adolescent , Adult , Child , Child, Preschool , Female , Humans , Male , Middle Aged , Young Adult , Antitoxins/adverse effects , Immune Sera/adverse effects , Brazil , Antitoxins/administration & dosage , Immunization, Passive/adverse effects , Immune Sera/administration & dosageABSTRACT
Soroterapia antiveneno consiste na utilização de soro para neutralizar venenos inoculados após acidente por animal peçonhento. Dados epidemiológicos de 2010 do Hospital João XXIII revelaram que 20% dos atendimentos no Serviço de Toxicologia no hospital foram de- correntes de acidentes com animais peçonhentos. O soro deve ser administrado o mais pre- cocemente possível sendo que a dose administrada em adultos e crianças é igual, uma vez que a função do soro é neutralizar a maior quantidade de veneno circulante, independente do peso do paciente. A aplicação deve ser feita entre 20 e 60 minutos, sob estrita vigilãncia médica e da enfermagem, em sala de emergência. Complicações da soroterapia incluem reações anafilßticas, anafilactoides e a doença do soro. As medicações utilizadas no trata- mento das reações adversas incluem epinefrina, anti-histamínicos (antagonistas H 1 c H2) e corticosteroides. Teste de sensibilidade ao soro e pré-medicação são contraindicados...
Serotherapy antivenom is the use of serum to neutralize poisons inoculated atter an accident by venomous animal. Epidemiological data from the João XXIII Hospital in 2010 revealed that 20% of attendances at the Service of Toxicology ai lhe hospital were due to accidents ioith venomous animals. The serum should be administered as early as possible and lhe dose administered is equal to adults and children, since lhe function of the serum to neutralize the greater amount of venom currenl, independent of patient weight. The application must be made between 20 and 60 minutes under strict medica! supervision anel nursing in lhe emergency room. Complications of antivenom therapy include anaphylactic reactions, anaphylactoid anel serum sickness. Medications used to treat adverse reactions incluede epinephrine. antihistamines (H1and H2 antagonists) and corticosteroids. Sensitioity test to serum and premedication are contraindicated...
Subject(s)
Humans , Drug Hypersensitivity , Immunization, Passive/adverse effects , Bites and Stings/drug therapyABSTRACT
The immunogenicity and safety of a purified Vero-cell rabies vaccine (PVRV, VERORAB; Aventis Pasteur, France) were evaluated in 171 patients treated for severe exposure to rabies (WHO category III contacts) at the Shandong Provincial Antiepidemic Station in Jinan and an EPI center in Ping Yin, China. Post-exposure treatment consisted of a single dose of equine rabies immunoglobulin (ERIG, 40 IU/kg body weight) on Day (D) 0, and intra-muscular administration of PVRV on D 0, 3, 7, 14 and 28. Antirabies antibody levels were evaluated on D 0, 7, 14, 28, 90 and 180 using the rapid fluorescent focus inhibition test. By D 14 all subjects had seroconverted (> or = 0.5 IU/ml), with a geometric mean titer of 50.3 IU/ml. Antibody titers remained above the seroprotection threshold in all patients for 3 months, and in 98.2% of subjects for 6 months. All patients were still alive 6 months after the start of treatment. PVRV and ERIG were shown to be well tolerated and no serious adverse events were observed. Following PVRV administration, 12 patients (7.0%) had at least one local reaction (mostly pruritus, erythematous rash and pain). Fourteen patients (8.2%) developed local reactions at the site of ERIG administration. Twelve patients (7.0%) developed systemic reactions following post-exposure treatment, the most frequent of which were pruritus, rash and vertigo. This study demonstrates that PVRV is immunogenic and safe in Chinese patients treated according to WHO recommendations for severe rabies exposure.
Subject(s)
Animals , Antibodies, Viral/blood , Chlorocebus aethiops , China , Erythema/etiology , Female , Humans , Immunization, Passive/adverse effects , Male , Pruritus/etiology , Rabies/prevention & control , Rabies Vaccines/adverse effects , Rabies virus/immunology , Vero CellsSubject(s)
Bee Venoms/enzymology , Bites and Stings/classification , Bites and Stings/diagnosis , Spider Bites/diagnosis , Spider Bites/drug therapy , Spider Bites/epidemiology , Spider Bites/prevention & control , Spider Venoms/pharmacology , Scorpion Venoms/pharmacology , Wasp Venoms/enzymology , Antivenins/administration & dosage , Antivenins/adverse effects , Antivenins/therapeutic use , Immunization, Passive/adverse effects , Immunization, PassiveABSTRACT
En este estudio se incluyeron veintisiete pacientes con diagnóstico de anemia de múltiples causas, quienes recibieron transfusiones de concentrado globular para evaluar la influencia que ejerce la transfusión sanguínea sobre los niveles séricos de ferritina, capacidad total de fijación del hierro, hierro sérico; los cuales fueron determinados entes y 2-14 días posterior a la transfusión sanguínea. No se lograron determinar cambios significativos en estos niveles en las muestras después de la transfusión a los 2 y 14 días. Sin embargo la transfusión sanguínea ejerció efectos sobre los niveles de hierro sérico cuando éste se encontró por debajo de 35 mcg/dl en el valor pretransfusional