RESUMO
BACKGROUND: Fomepizole is a competitive alcohol dehydrogenase inhibitor used for the treatment of ethylene glycol and methanol poisoning. We evaluated the safety and effectiveness of fomepizole in patients with ethylene glycol or methanol poisoning in Japan. RESEARCH DESIGN AND METHODS: This retrospective post-marketing surveillance study conducted in Japan registered patients who received fomepizole intravenous infusion per the package insert (January 2015-June 2022). Endpoints included adverse drug reactions/infections (ADRs), arterial blood pH, and treatment outcomes. RESULTS: Of 147 patients registered (91 institutions), 131 and 126 were included in the safety and effectiveness analysis sets, respectively. Mean age was 43.6 years, and 66.4% were male. Mean time from poison ingestion to treatment was 15.1 hours; 66.4% received concomitant hemodialysis. No serious ADRs were reported. ADRs were reported in seven patients; the most-reported ADR was vomiting (2.3%). Seven patients died, 105 survived without sequelae, and 19 survived with sequelae. Most common sequelae were renal failure or renal dysfunction. Mean arterial blood pH increased to 7.4 by 4 hours of treatment, remaining stable for 24 hours post-treatment. CONCLUSIONS: Fomepizole is well tolerated and helps improve clinical outcomes in patients with ethylene glycol or methanol poisoning in Japan. TRIAL REGISTRATION: Japanese Pharmaceutical Information Center (JapicCTI-152817).
RESUMO
The efficiency and speed with which first responders, paramedics, and emergency physicians respond to an event caused by the release of a chemical is an important concern in all modern cities worldwide. A system for the initial triage and decontamination of victims of a chemical release was developed using colored clothes pegs of the following seven colors: red, yellow, green, black, white, and blue. Red indicates the need for emergency care, yellow for semi-emergency care, green for non-emergency care, black for expectant, white for dry decontamination, and blue for wet decontamination. The system can be employed as one of the techniques directed at improving the efficiency of decontamination in countries where there is a risk of chemical releases. It is recommended that this system should be adopted internationally and used for both drills and actual events.
Assuntos
Terrorismo Químico , Serviços Médicos de Emergência/organização & administração , Exposição Ambiental , Triagem/métodos , Cor , Descontaminação/métodos , Etiquetas de Emergência Médica , Substâncias Perigosas , Humanos , Sistemas de Identificação de PacientesRESUMO
BACKGROUND: There is no standard triage method for earthquake victims with crush injuries because of a scarcity of epidemiologic and quantitative data. We conducted a retrospective cohort study to develop predictive models based on clinical data for crush injury in the Kobe earthquake. METHODS: The medical records of 372 patients with crush injuries from the Kobe earthquake were retrospectively analyzed. Twenty-one risk factors were assessed with logistic regression analysis for three outcomes relating to crush syndrome. Two types of predictive triage models--initial evaluation in the field and secondary assessment at the hospital--were developed using logistic regression analysis. Classification accuracy, Brier score and area under the receiver operating characteristic curve (AUC) were used to evaluate the model. RESULTS: The initial triage model, which includes pulse rate, delayed rescue, and abnormal urine color, has an AUC of 0.73. The secondary model, which includes WBC, tachycardia, abnormal urine color, and hyperkalemia, shows an AUC of 0.76. CONCLUSIONS: These triage models may be especially useful to nondisaster experts for distinguishing earthquake victims at high risk of severe crush syndrome from those at lower risk. Application of the model may allow relief workers to better utilize limited medical and transportation resources in the aftermath of a disaster.
Assuntos
Síndrome de Esmagamento/diagnóstico , Desastres , Trabalho de Resgate/métodos , Medição de Risco/métodos , Triagem/métodos , Análise de Variância , Estudos de Coortes , Feminino , Humanos , Hiperpotassemia , Japão , Contagem de Leucócitos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Pulso Arterial , Estudos Retrospectivos , Taquicardia , UrinaAssuntos
Arritmias Cardíacas/terapia , Hipertensão/terapia , Hipotensão/terapia , Intoxicação/terapia , Guias de Prática Clínica como Assunto , Doença Aguda , Ansiolíticos/uso terapêutico , Antiarrítmicos/administração & dosagem , Arritmias Cardíacas/etiologia , Atropina/administração & dosagem , Estimulação Cardíaca Artificial , Dopamina/administração & dosagem , Overdose de Drogas , Hidratação , Humanos , Hipertensão/etiologia , Hipotensão/etiologia , Isoproterenol/administração & dosagem , Nitroglicerina/uso terapêutico , Intoxicação/complicações , Propranolol/administração & dosagem , Vasopressinas/administração & dosagemRESUMO
Use-result surveillance was conducted to investigate the safety and efficacy of Acetylcysteine Oral Solution 17.6 % "SENJU" having the indication for the antidote to acetaminophen (Paracetamol) overdose. Ninety six cases (patients) were collected for the safety evaluation, and 13 cases (incidence was 13.5 %) showed 29 adverse drug reactions as follows: 4 cases of nausea; 3 cases of vomiting; 2 cases each of liver dysfunction, headache, abdominal pain, diarrhea, blood bilirubin increased; and one case each of CK increased, anaemia, prothrombin time prolonged, gamma-glutamyltransferase increased, LDH increased, body temperature increased, proteinuria, blood potassium decreased, thrombocytopenia, platelet count increased, white blood cell decreased, and blood amylase increased. One case of severe liver dysfunction which was ameliorated later was found. Neither case showing transitional chronic liver dysfunction, nor case of death was observed. Patient background analysis showed that 79.2% of the total patients was female, and that 28.1% was patients with mental disease. Gastrolavage, active charcoal administration, and extracorporeal removal of toxins were performed in cases of 71.9%, 50.0% and 7.3%, respectively. Those concomitant treatments, however, showed no influence for the incidence of adverse drug reaction or the drug effectiveness. Blood acetaminophen assay was performed in only 43.8% of the total cases. This rate indicates that the medical treatment procedure needs more consideration on the clinical standard for the antidote to acetaminophen overdose and on its practical application.
Assuntos
Acetaminofen/intoxicação , Acetilcisteína/administração & dosagem , Antídotos/administração & dosagem , Vigilância de Produtos Comercializados , Acetilcisteína/efeitos adversos , Administração Oral , Adolescente , Adulto , Antídotos/efeitos adversos , Carvão Vegetal/administração & dosagem , Criança , Pré-Escolar , Overdose de Drogas/terapia , Feminino , Lavagem Gástrica , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Gravidez , Soluções , Resultado do TratamentoRESUMO
We investigated a method for the simultaneous screening, identification, and quantitative determination of salicylic acid, acetaminophen, theophylline, barbiturates, and bromvalerylurea, drugs that frequently cause acute poisoning in Japan and therefore require rapid analysis for effective treatment in the clinical setting. The method employs liquid chromatography/electrospray mass spectrometry (LC/MS) of solid-phase extracted serum samples. For LC/MS ionization, the electrospray-ionization method was used, with acetaminophen in the positive-ion mode, and salicylic acid, theophylline, phenobarbital, bromvalerylurea, pentobarbital, amobarbital, and o-acetamidophenol (internal standard) in the negative-ion mode, the base ions were used in each case for quantitative analysis. Quantitation was possible for the following sample concentration ranges: salicylic acid and acetaminophen, 100 to 5 microg/ml; theophylline, 100 to 0.5 microg/ml; and phenobarbital, bromvalerylurea, pentobarbital, and amobarbital, 100 to 1 microg/ml. Using full-scan mass spectrometry, the lower detection limits of 1 microg/ml for salicylic acid and acetaminophen, 0.1 microg/ml for theophylline, and 0.5 microg/ml for phenobarbital, bromvalerylurea, pentobarbital, and amobarbital were adequate for identifying acute poisoning. When each compound was added to serum to a final concentration of 5 microg/ml and solid-phase extraction was performed using Oasis HLB 1-cc (30-mg), the mean recovery rate of each compound was 89.2 to 96.1% (n=5), and the coefficients of variation of the intraday and interday assays were 3.55 to 6.05% (n=5) and 3.68 to 6.38% (n=5), respectively, which are acceptable. When this method of analysis was applied in testing the sera of a female patient who had consumed a large amount of an unknown commercial drug, salicylic acid and bromvalerylurea were identified, and the treatment strategy could be determined in accordance with the serum concentration of those drugs.
Assuntos
Acetaminofen/sangue , Amobarbital/sangue , Analgésicos não Narcóticos/sangue , Bromisoval/metabolismo , Hipnóticos e Sedativos/sangue , Pentobarbital/sangue , Fenobarbital/sangue , Ácido Salicílico/sangue , Teofilina/sangue , Vasodilatadores/sangue , Acidose/induzido quimicamente , Adulto , Bromisoval/intoxicação , Calibragem , Cromatografia Líquida , Feminino , Humanos , Indicadores e Reagentes , Reprodutibilidade dos Testes , Espectrometria de Massas por Ionização por ElectrosprayAssuntos
Anticonvulsivantes/administração & dosagem , Antídotos/administração & dosagem , Intoxicação/complicações , Intoxicação/terapia , Convulsões/etiologia , Convulsões/terapia , Doença Aguda , Diagnóstico Diferencial , Discinesias/etiologia , Discinesias/terapia , Humanos , Monitorização Fisiológica , Oxigenoterapia , Preparações Farmacêuticas , Intoxicação/diagnóstico , Convulsões/diagnósticoAssuntos
Febre/terapia , Hipotermia/terapia , Intoxicação/terapia , Doença Aguda , Gasometria , Pressão Venosa Central , Eletrocardiografia , Febre/diagnóstico , Febre/etiologia , Humanos , Hipertermia Induzida/métodos , Hipotermia/diagnóstico , Hipotermia/etiologia , Hipotermia Induzida/métodos , Monitorização Fisiológica , Intoxicação/complicações , MicçãoRESUMO
In the present study, by using IPCC-MS3 (GL Sciences Inc. Tokyo, Japan) as the counter-ion in the mobile phase, we established a simple, quick method of analysis that separated and quantified paraquat and diquat on an ODS column by introducing the deproteinized serum sample directly into HPLC. The calibration curve of paraquat and diquat detected at UV 290 nm showed good linearity when the concentration of the injected sample was in the range 0.1-10.0 microg/ml. The detection limit was 0.05 microg/ml, and the mean recoveries (n=5) added 1.0 microg/ml each of paraquat and diquat to standard serum were 87.5% and 89.1%, respectively, while the RSD were 4.52% and 3.85%. All of these were good results, and the time taken for one analysis was less than 30 min. As a result of employing this analytical method for the analyses in four cases of acute poisoning, it was possible to decide promptly on treatment approaches for all of the present cases.