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1.
Med. clín (Ed. impr.) ; 154(5): 178-184, mar. 2020. tab
Artigo em Espanhol | IBECS | ID: ibc-186631

RESUMO

Se define como reacción adversa a medicamentos (RAM) cualquier respuesta nociva y no intencionada a un medicamento. Las RAM constituyen una importante causa de morbimortalidad y de aumento de los costes sanitarios. Los sistemas de farmacovigilancia permiten la identificación y prevención de los riesgos asociados al uso de medicamentos, sobre todo de los fármacos de reciente comercialización; detectan señales a partir de datos del registro mundial de RAM y, además, dan soporte a las decisiones adoptadas por las agencias reguladoras de los diferentes países. Solo una minoría de los medicamentos comercializados se retiran del mercado: la hepatotoxicidad es la causa más frecuente. La notificación espontánea de RAM es el método más utilizado, barato y sencillo para reconocer nuevos problemas de seguridad, si bien su principal limitación es la infranotificación. El futuro de la farmacovigilancia y de las RAM pasará por una mayor implicación de los pacientes, médicos, autoridades sanitarias y empresas farmacéuticas y por el uso de las nuevas tecnologías


An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. ADRs are an important cause of morbidity and mortality and increase health costs. The pharmacovigilance systems allow the identification and prevention of the risks associated with use of a drug, especially of recently marketed drugs; they detect signals from data of the global ADR register and also support decisions taken by regulatory agencies in different countries. Only a few drugs are withdrawn from the market, mainly due to hepatotoxicity. Spontaneous notification of ADR is the cheapest, simplest and most used method to recognize new safety drug problems, under-reporting being its main limitation. The future of pharmacovigilance and ADRs will include a higher involvement of patients, doctors, health authorities and pharmaceutical companies, and the use of new technologies


Assuntos
Humanos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Farmacovigilância , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Indicadores de Morbimortalidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação
4.
Cancer Invest ; 38(2): 130-138, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31985314

RESUMO

Background: Pembrolizumab as an immune checkpoint inhibitor (ICI) has emerged as an effective treatment for many cancers. It has unique immune-related adverse events (irAE) and little is known about its risk of fatal adverse events (FAEs). We conducted a meta-analysis of clinical trials to determine the incidence and risk of FAEs with pembrolizumab.Methods: A systematic search for phase I-III clinical trials of pembrolizumab was conducted using databases including PUBMED and abstracts presented at the American Society of Clinical Oncology (ASCO) conferences until October 2018. Eligible studies included prospective clinical trials of pembrolizumab with available data on FAE. Data on FAE was extracted from each study and pooled for calculations. Incidence, relative risk (RR) and 95% confidence intervals (CI) were calculated by employing fixed or random-effects models.Results: A total of 11 clinical trials with 3713 patients were included for analysis. The overall incidence of FAE with pembrolizumab was 1.2% (95% CI: 0.5-2.8%). The incidence of FAE significantly varied among different tumor types (p = .02), ranging from 0.2% in melanoma to 3.1% in breast cancer, and with its combination with chemotherapy (0.7%, 95% CI: 0.4-1.2% versus 7.0%, 95% CI: 4.9-10%; p<.01). Chemotherapy plus pembrolizumab 7.0% (95%CI: 4.9-10) as compared to pembrolizumab alone 0.7%, (95% CI: 0.4-1.2; p < .001). There was no significant difference in the risk of FAEs when pembrolizumab was compared with chemotherapy with RR = 1.24 (95% CI: 0.8-1.89; p = .31). The most common FAEs were due to infectious complication (26.5%), cardiac toxicity (14.7%) and pneumonitis (13.2%).Conclusions: The risk of FAEs with pembrolizumab may be similar to chemotherapy in cancer patients and may vary with tumor types and its combination with chemotherapy.


Assuntos
Anticorpos Monoclonais Humanizados/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Ensaios Clínicos como Assunto/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Neoplasias/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Incidência , Medição de Risco/métodos , Medição de Risco/estatística & dados numéricos , Fatores de Risco
5.
Toxicol Lett ; 322: 104-110, 2020 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-31981687

RESUMO

Isoniazid and rifampicin are well-known anti-mycobacterial agents and are widely used to treat pulmonary tuberculosis (TB) as part of the combined therapy approach, recommended by the World Health Organization. The ingestion of these first-line TB drugs are, however, not free of side effects, and are toxic to the liver, kidney, and central nervous system. These side effects are associated with poor treatment compliance, resulting in TB treatment failure, relapse and drug resistant TB. This occurrence has subsequently led to the recent application of novel research technologies, towards a better understanding of the underlying toxicity mechanisms of TB drugs in humans, mostly focussing on the 2 most important TB drugs: isoniazid and rifampicin. In this review, we discuss the contribution that one such an approach, termed metabolomics has made toward this field, and also highlight the impact that this might have towards the development of improved TB treatment regimens.


Assuntos
Antituberculosos/toxicidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Isoniazida/toxicidade , Metabolômica/métodos , Rifampina/toxicidade , Testes de Toxicidade/métodos , Animais , Antituberculosos/metabolismo , Biomarcadores/metabolismo , Biotransformação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/metabolismo , Humanos , Isoniazida/metabolismo , Rifampina/metabolismo , Medição de Risco
6.
J Oncol Pharm Pract ; 26(1): 13-22, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30832554

RESUMO

PURPOSE: To describe the outcomes of a pharmacist-led multi-center, collaborative patient education and proactive adverse event management program in a community-based oncology setting. METHODS: Patients with EGFR mutation-positive (EGFRm+) non-small cell lung cancer, newly prescribed with oral afatinib, and monitored as part of the Florida Cancer Specialists patient management program, were included in a retrospective, observational analysis. During follow-up, data were collected on adverse event frequency, and changes in afatinib dosing. Data analyses were descriptive and exploratory in nature. RESULTS: The mean age of the 123 patients included in the analysis was 69 years, and 78% were female. At the time of the analysis, 3 patients had discontinued before receiving treatment, 89 patients had discontinued afatinib treatment, and 31 patients were continuing to receive afatinib treatment. The most common afatinib-related adverse events were diarrhea (85%), rash/skin reactions (58%), stomatitis/mucositis (19%), and paronychia (16%). Overall, 13% of patients discontinued due to afatinib-related adverse events. The median duration of treatment was 4 months in patients who discontinued due to adverse events, 6 months in those who discontinued for other reasons, and 18 months in those who were continuing to receive therapy. Afatinib dose-reductions were more frequent in patients continuing treatment versus those who discontinued due to adverse events (77% vs. 42%, respectively). CONCLUSIONS: Findings suggest that adverse events in patients with EGFRm + non-small cell lung cancer receiving afatinib can be successfully managed in a community-based, real-world setting with the help of collaborative pharmacist-led patient education, adverse event monitoring, and continuous support.


Assuntos
Afatinib/efeitos adversos , Antineoplásicos/efeitos adversos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Educação de Pacientes como Assunto/tendências , Farmacêuticos/tendências , Adulto , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Carcinoma Pulmonar de Células não Pequenas/genética , Serviços Comunitários de Farmácia/tendências , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Receptores ErbB/genética , Feminino , Humanos , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/genética , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto/métodos , Relações Profissional-Paciente , Estudos Retrospectivos
7.
J Oncol Pharm Pract ; 26(1): 60-66, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30924739

RESUMO

PURPOSE: As immune checkpoint inhibitors continue to acquire new indications, it is important to understand the impact their use has on patients. This study adds to current literature by presenting an analysis of hospitalizations in this population. The primary objective was to assess the reasons for an emergency department visit or hospital admission in patients who receive immune checkpoint inhibitors. Secondary objectives included identifying the frequency of suspected or confirmed immune related adverse events, types of immune related adverse events, number of preventable admissions, duration of immunotherapy, and length of stay. METHODS: This study was a retrospective, multi-center, chart review of patients hospitalized after receiving an immune checkpoint inhibitor. The population included patients aged 18 and above who received at least one dose of an immune checkpoint inhibitor at a network facility and had a documented admission within one year following the initiation of immunotherapy. Descriptive statistics were performed along with inferential comparisons and a Poisson regression to determine if the immune checkpoint blocker or cancer type predicted admission or reason for admission. RESULTS: The 99 patients who met inclusion criteria had a total of 202 admissions. Of these patients, 56 (56.6%) had multiple admissions within the year following initiation of immunotherapy. The most common diagnoses on initial admissions were shortness of breath, pain, and pneumonia. A total of 104 admissions (51.5%) were considered potentially preventable. Suspected or confirmed immune related adverse events were identified in 15.6% of all admissions. There were no significant predictors of admissions or reason for admission. CONCLUSION: Reasons for admission in the study population were comparable to those identified in the general cancer population, with immune related adverse events being associated with a minority of both total and potentially preventable admissions.


Assuntos
Hospitalização/tendências , Hospitais Comunitários/tendências , Hospitais de Ensino/tendências , Fatores Imunológicos/efeitos adversos , Imunoterapia/efeitos adversos , Imunoterapia/tendências , Adulto , Idoso , Idoso de 80 Anos ou mais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/imunologia , Feminino , Humanos , Fatores Imunológicos/administração & dosagem , Masculino , Pessoa de Meia-Idade , Neoplasias/imunologia , Neoplasias/terapia , Estudos Retrospectivos
8.
Semin Oncol ; 46(4-5): 362-371, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31727344

RESUMO

The correlation between clinical outcomes and treatment-related adverse events (AEs) has always been a debated topic in clinical oncology. Despite toxicities pharmacodynamics effects, the misunderstanding has always been around the corner: AEs themselves could lead to morbidity and mortality; on the other hand, the choice of the clinical outcomes to measure is not univocal. After the advent of immune checkpoint inhibitors (ICIs), such as anti-cytotoxic T-lymphocyte-associated protein 4 and anti-programmed death-1/programmed death ligand-1, new class-specific AEs have emerged, called immune-related AEs (irAEs). With irAEs, the correlation between toxicity and clinical outcomes has suddenly been suggested, but it is still to be proven. We conducted a systematic literature review regarding this emerging association, pointing out all the available data and speculating on the possible underlying mechanisms. Thirty-six studies were included in the analysis, involving different malignancies (mostly melanoma and lung cancer), with different measured clinical outcomes. The most of them were retrospective. Despite the high heterogeneity, and the enormous biases of the revised studies, we can assume that irAEs occurrence is linked to the therapeutic activity of immune checkpoint inhibitors, with a (certain) direct proportionality, maybe subtending the likelihood of an immunogenic phenotype. This phenomenon seems to occur with both anti-cytotoxic T-lymphocyte-associated protein 4 and anti-programmed death-1/programmed death ligand-1, and across different solid malignancies.


Assuntos
Antineoplásicos Imunológicos/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Neoplasias/complicações , Neoplasias/epidemiologia , Antineoplásicos Imunológicos/uso terapêutico , Biomarcadores Tumorais/antagonistas & inibidores , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos , Terapia de Alvo Molecular/efeitos adversos , Metástase Neoplásica , Estadiamento de Neoplasias , Neoplasias/diagnóstico , Neoplasias/tratamento farmacológico , Avaliação de Resultados da Assistência ao Paciente , Vigilância em Saúde Pública
9.
Zhongguo Fei Ai Za Zhi ; 22(10): 605-614, 2019 Oct 20.
Artigo em Chinês | MEDLINE | ID: mdl-31650941

RESUMO

The application of immunological checkpoint inhibitors (ICIs) has modified many treatment strategies of malignant tumors, which has become a milestone in cancer therapy. The principle of action can be explained as "brake theory". After releasing the brakes by ICIs, unprecedented systemic toxicities, even some refractory and fatal immune-related adverse effects (irAEs) may develop. In this article, we summarized the recommended treatments of grade 3-4 severe irAEs in the latest European Society for Medical Oncology (ESMO), National Comprehensive Cancer Network (NCCN)/American Society of Clinical Oncology (ASCO), Society for Immunotherapy of Cancer (SITC) and Chinese Society of Clinical Oncology (CSCO) guidelines and consensus. We also performed a systemic review of case reports and reviews of irAEs up to May 20, 2019 in PubMed and Chinese journals. Successful applications of specific immunosuppressive drugs and stimulating factors beyond the above guidelines and consensus were supplemented and highlighted, including agents blocking interleukin 6 (IL-6), rituximab, anti-tumor necrosis factor-α (TNFα) monoclonal antibody (mAb), anti-integrin 4 mAb, Janus kinase inhibitors, thrombopoietin receptor agonists and antithymocyte globulin (ATG) etc. We put some concerns of using high-dose steroids for long-term, and emphasize the secondary infections, tumor progression, and unavailability of ICI re-challenge during steroid treatment. We propose the "De-escalation Therapy" principle for severe and refractory irAEs, and suggest that immunosuppressive drugs specifically targeting cytokines should be used as early as possible. Many irAEs in the era of immunotherapy are unprecedented compared with traditional chemotherapy and small-molecule targeted therapy, which is a big challenge to oncologists. Therefore, the establishment of multidisciplinary system is very important for the management of cancer patients.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Imunoterapia/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/imunologia
10.
Int J Med Inform ; 132: 103971, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31630063

RESUMO

CONTEXT: Adverse events in healthcare are often collated in incident reports which contain unstructured free text. Learning from these events may improve patient safety. Natural language processing (NLP) uses computational techniques to interrogate free text, reducing the human workload associated with its analysis. There is growing interest in applying NLP to patient safety, but the evidence in the field has not been summarised and evaluated to date. OBJECTIVE: To perform a systematic literature review and narrative synthesis to describe and evaluate NLP methods for classification of incident reports and adverse events in healthcare. METHODS: Data sources included Medline, Embase, The Cochrane Library, CINAHL, MIDIRS, ISI Web of Science, SciELO, Google Scholar, PROSPERO, hand searching of key articles, and OpenGrey. Data items were manually abstracted to a standardised extraction form. RESULTS: From 428 articles screened for eligibility, 35 met the inclusion criteria of using NLP to perform a classification task on incident reports, or with the aim of detecting adverse events. The majority of studies used free text from incident reporting systems or electronic health records. Models were typically designed to classify by type of incident, type of medication error, or harm severity. A broad range of NLP techniques are demonstrated to perform these classification tasks with favourable performance outcomes. There are methodological challenges in how these results can be interpreted in a broader context. CONCLUSION: NLP can generate meaningful information from unstructured data in the specific domain of the classification of incident reports and adverse events. Understanding what or why incidents are occurring is important in adverse event analysis. If NLP enables these insights to be drawn from larger datasets it may improve the learning from adverse events in healthcare.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/classificação , Registros Eletrônicos de Saúde/tendências , Processamento de Linguagem Natural , Gestão de Riscos/classificação , Gestão de Riscos/normas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Registros Eletrônicos de Saúde/normas , Humanos
11.
Aerosp Med Hum Perform ; 90(10): 896-900, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31558199

RESUMO

BACKGROUND: A fundamental responsibility of aerospace medicine is the analysis and mitigation of the human component's risk to the aviation system. Medications are part of this risk mitigation process and are present within a multitude of work environments, including aviation. For example, during fiscal year (FY) 2013-2015, the Army Aeromedical Activity (AAMA) received 8596 medication waiver requests. During this same time period the U.S. Army Medical Department's Patient Administration Systems and Biostatistics Activity reported the organization prescribed over 187,668 prescriptions for opioids, 133,475 prescriptions for SSRIs, 116,649 prescriptions for muscle relaxants, and 71,723 prescriptions for hypnotics to its active duty soldiers in the outpatient setting.METHODS: A conceptual model to mitigate the risk of adverse reactions to medications by severity score was developed based off the methodology published by Prudhomme et al.RESULTS: The mean severity score of the 50 historically safe medications in the Army aviation community is 7346. The standard deviation of the population is 7300. The difference between safe and unsafe drugs determined by subject matter experts (SME) is highly significant when tested with the nonparametric Wilcoxon rank sum test.CONCLUSION: The visual representation of the data from this conceptual model clearly demonstrates room for improvement from current methods. Historically, utilizing SME opinion has created a system with deficiencies related to high variance, inconsistencies, and perceived ambiguity. There is need for a model addressing adverse drug reactions that has concrete strengths of transparency, simplicity, and speed of use.Cronrath CM, Klick MP, Merfeld CM, Gaydos SJ. Medication Adverse Reaction, Risk Stratification (MAR2S) model. Aerosp Med Hum Perform. 2019; 90(10):896-900.


Assuntos
Medicina Aeroespacial , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Militares/estatística & dados numéricos , Modelos Biológicos , Medicina do Trabalho/métodos , Aviação , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Humanos , Medição de Risco/métodos , Índice de Gravidade de Doença , Estados Unidos
12.
Pediatr Cardiol ; 40(8): 1638-1644, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31485699

RESUMO

Troponin is a marker that displays cardiac injury quickly and accurately. In adults, troponin elevation is usually associated with coronary artery disease and requires urgent cardiac catheterization. In healthy children, myocardial injury is rare and may develop due to many different causes. Therefore, troponin elevation in children and adolescents does not usually require emergency cardiac catheterization. The aim of this study is to assess the most common causes of troponin elevation in children and adolescents and to show which diagnostic tests are helpful in assessing pediatric patients with elevated troponin. Patients who had been diagnosed with troponin I elevation (> 0.06 ng/ml) at Dr. Sami Ulus Maternity, Children's Health and Disease Training and Research Hospital between 2007 and 2018 were retrospectively evaluated. Patients undergoing cardiac surgery and those with severe congenital heart disease were excluded from the study. The medical records of the patients were examined and age, gender, diagnostic tests, and diagnosis were evaluated. During the study period, the records of 972 patients were obtained. 213 patients were excluded from the study because of heart surgery, congenital heart disease, and neonatal asphyxia or sepsis. Of the remaining 759 patients, 58% were male, 42% were female, and the median age was 4 years (3 days to 17 years). The most frequent causes are myopericarditis (n: 164), drug intoxications (n: 85), carbon monoxide poisoning (n: 74), perimyocarditis (n: 65), and intensive inhalation ß agonist use in acute asthma and lower respiratory tract infections (n: 70). Patients diagnosed with myocarditis and myopericarditis were admitted with a complaint of chest pain, and the diagnosis was made by history, physical examination, ECG, and echocardiographic findings. Unlike adults, troponin I elevation may be associated with many cardiac and non-cardiac pathologies in children. The most common pathologies in cardiac etiology are myopericarditis and perimyocarditis and can be diagnosed by history, physical examination, ECG, and echocardiography. Cardiac catheterization is not necessary except for rare cardiac pathologies and does not alter the prognosis.


Assuntos
Miocardite/sangue , Troponina I/sangue , Adolescente , Biomarcadores/sangue , Intoxicação por Monóxido de Carbono/sangue , Intoxicação por Monóxido de Carbono/diagnóstico , Estudos de Casos e Controles , Criança , Pré-Escolar , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/sangue , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Ecocardiografia , Eletrocardiografia , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Miocardite/diagnóstico , Estudos Retrospectivos
13.
Indian J Cancer ; 56(3): 207-210, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31389382

RESUMO

PURPOSE: There is no study till date determining the spectrum of adverse events of pazopanib in Indian patients with advanced sarcoma. MATERIALS AND METHODS: We conducted a retrospective study by analyzing the case records of metastatic sarcoma patients treated with pazopanib from January 2016 to July 2017 in sarcoma medical oncology clinic. Toxicity was assessed according to CTCAE v.4.03 criteria. SPSS version 23 was used for statistical evaluation. RESULTS: A total of 33 patients received pazopanib. The median age was 41 years (range, 19-75 years), with a male predominance (54.5%). Twenty-six patients (78.8%) had ECOG performance status 1 at the time of pazopanib initiation. The most common type of sarcoma was synovial sarcoma, and the mean duration of pazopanib intake in patients was 4.12 months. The median follow-up was 13 months. Median progression-free survival was 5 months, and median overall survival was 18 months. Overall response rate was 6.0%. Out of the 33 patients, 42.4% (n = 14) received it after first line of therapy. Six patients (18.2%) required dose reductions due to toxicity. Thirteen (39.4%) patients experienced CTCAE grade 3 or 4 toxicities. Most common grade 3 and 4 toxicities experienced among patients were hand-foot skin reaction (18.2%) and proteinuria (9.1%). No significant difference was seen when analyzed for variables such as age, sex, ECOG performance status, comorbidities, and number of previous lines received in patients experiencing grade 3 and 4 toxicities. CONCLUSIONS: The spectrum of adverse events in Indian patients at doses lower than the recommended dose is distinctly different from the western population. However, this unique toxicity profile needs to be validated in prospective studies.


Assuntos
Inibidores da Angiogênese/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Pirimidinas/efeitos adversos , Sarcoma/tratamento farmacológico , Neoplasias de Tecidos Moles/tratamento farmacológico , Sulfonamidas/efeitos adversos , Adulto , Idoso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Retrospectivos , Sarcoma/secundário , Neoplasias de Tecidos Moles/patologia , Taxa de Sobrevida , Adulto Jovem
14.
BMJ Case Rep ; 12(8)2019 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-31451475

RESUMO

A 62-year-old previously healthy male was admitted with new onset generalised tonic-clonic seizures. Treatment was initiated with the antiepileptic levetiracetam and he had no further episodes of seizures. Creatine kinase (CPK) level was 1812 IU/L 12-hour postadmission. Despite good hydration, his CPK levels continued to rise dramatically and reached a level of 19 000 IU/L on day 5. This rise was unexplained as he did not have any further seizures and had a normal renal function. In the absence of other risk factors, the rare possibility of levetiracetam being responsible for the disproportionately high CPK was considered. Within 12 hours of withdrawal of levetiracetam, there was a downward trend in the CPK levels, with a 10-fold decrease in CPK levels over the next 4 days. This is only the ninth case reported in literature regarding this rare and potentially serious adverse effect of levetiracetam.


Assuntos
Creatina Quinase/sangue , Substituição de Medicamentos/métodos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Levetiracetam , Rabdomiólise , Convulsões/tratamento farmacológico , Anticonvulsivantes/administração & dosagem , Anticonvulsivantes/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/sangue , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Humanos , Levetiracetam/administração & dosagem , Levetiracetam/efeitos adversos , Masculino , Pessoa de Meia-Idade , Exame Neurológico , Fenitoína/administração & dosagem , Rabdomiólise/sangue , Rabdomiólise/induzido quimicamente , Rabdomiólise/diagnóstico , Rabdomiólise/terapia , Convulsões/diagnóstico , Resultado do Tratamento
15.
Plast Reconstr Surg ; 144(3): 783-795, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31461049

RESUMO

BACKGROUND: The objective of this narrative review of local anesthetic systemic toxicity is to provide an update on its prevention, diagnosis, and management. METHODS: The authors used a MEDLINE search of human studies, animal studies, and case reports and summarize findings following the American Society of Regional Anesthesia and Pain Medicine practice advisories on local anesthetic systemic toxicity. RESULTS: Between March of 2014 and November of 2016, there were 47 cases of systemic toxicity described. Twenty-two patients (47 percent) were treated with intravenous lipid emulsion and two patients (4.3 percent) died. Seizures were the most common presentation. The spectrum of presenting neurologic and cardiovascular symptoms and signs are broad and can be obscured by perioperative processes. Local anesthetic type, dosage, and volume; site of injection; and patient comorbidities influence the rate of absorption from the site of injection and biodegradation of local anesthetics. Consider discussing appropriate dosages as a component of the surgical "time-out." A large-volume depot of dilute local anesthetic can take hours before reaching peak plasma levels. Oxygenation, ventilation, and advanced cardiac life support are the first priorities in treatment. Lipid emulsion therapy should be given at the first sign of serious systemic toxicity with an initial bolus dose of 100 ml for adults weighing greater than 70 kg and 1.5 ml/kg for adults weighing less than 70 kg or for children. CONCLUSION: All physicians who administer local anesthetics should be educated regarding the nature of systemic toxicity and contemporary management algorithms that include lipid emulsion therapy.


Assuntos
Anestesia Local/efeitos adversos , Anestésicos Locais/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Emulsões Gordurosas Intravenosas/uso terapêutico , Animais , Modelos Animais de Doenças , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Humanos
16.
Int Immunopharmacol ; 74: 105728, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31288153

RESUMO

BACKGROUND: Rechallenge with oxaliplatin is common in the treatment of colorectal cancer and increases the risk of a detrimental oxaliplatin-induced immune reaction. Allergic reactions to oxaliplatin may be partially avoided by desensitization protocols involving immune suppressive drugs, slow administration and gradually increasing chemotherapeutic doses. However, non-IgE-mediated immunopathologic reactions to oxaliplatin remain challenging and may be potentially life-threatening. CASE PRESENTATION: Here we report two potentially fatal cases of type II hypersensitivity to oxaliplatin in metastatic colorectal cancer patients. Both patients manifested with severe thrombocytopenia, intravascular haemolysis, and acute kidney injury 4-6 h after oxaliplatin administration in a rechallenge setting. Serology revealed that the reactive entity for immune haemolysis was an IgG oxaliplatin-induced antibody. The course of anti-cancer treatment and severe adverse event after oxaliplatin rechallenge including diagnostic dilemma and the results of detailed routine clinical chemistry and hematology testing are described. Extended immunohaematology/serology testing revealed that the oxaliplatin-induced IgG antibody was present in the circulation prior to the onset of hypersensitivity, persisted for months and elicited cross-reactivity with other platinum agents. CONCLUSION: Development of type II hypersensitivity reaction manifesting as a sudden onset of severe thrombocytopenia and immune haemolysis must be considered in patients treated with oxaliplatin, especially those on long-term therapy or when rechallenged. Step-wise diagnosis involves clinical presentation, detection of haemolysis in patient's blood and/or urine, evaluation of platelet count, and direct anti-globulin Coombs test.


Assuntos
Adenocarcinoma/diagnóstico , Antineoplásicos/efeitos adversos , Hipersensibilidade a Drogas/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Oxaliplatina/efeitos adversos , Neoplasias Retais/diagnóstico , Lesão Renal Aguda , Adenocarcinoma/complicações , Adenocarcinoma/tratamento farmacológico , Corticosteroides/uso terapêutico , Idoso , Antineoplásicos/uso terapêutico , Dessensibilização Imunológica , Hipersensibilidade a Drogas/tratamento farmacológico , Hipersensibilidade a Drogas/etiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Hemólise , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Oxaliplatina/uso terapêutico , Neoplasias Retais/complicações , Neoplasias Retais/tratamento farmacológico , Trombocitopenia
17.
J Vet Emerg Crit Care (San Antonio) ; 29(5): 573-577, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31342645

RESUMO

OBJECTIVE: To report the use of gas chromatography-mass spectrometry to confirm a diagnosis of synthetic cannabis toxicosis in a dog and to describe the clinical course of the intoxication. CASE SUMMARY: An 11-year-old neutered female Boxer dog was referred due to acute onset of vomiting, ataxia, dull mentation, and delirium that progressed to generalized seizures, unresponsive to diazepam. Prior to presentation, the dog was found lying down, minimally responsive with vomitus around it. A chewed bag containing dried plant material was found next to the dog. The dog was anesthetized and ventilated with positive pressure for 16 hours, and eventually made a full recovery. Gas chromatography-mass spectrometry analysis of the plant material and a plasma sample from the dog revealed presence of the synthetic cannabinoid N-[(1S)-1-(aminocarbonyl)-2-methylpropyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide, also known as AB-CHMINACA, a relatively new illegal synthetic cannabinoid, known by the local forensic police department as a drug of recreational abuse. NEW OR UNIQUE INFORMATION PROVIDED: Reports of synthetic cannabinoid toxicosis in dogs are scarce and are based on urine test kits for tetrahydrocannabinol that have not been validated in the veterinary literature. This is the first report to describe utilization of gas chromatography-mass spectrometry on canine plasma to reach a definitive diagnosis.


Assuntos
Canabinoides/toxicidade , Doenças do Cão/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/veterinária , Animais , Canabinoides/sangue , Diagnóstico Diferencial , Doenças do Cão/sangue , Cães , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Feminino , Cromatografia Gasosa-Espectrometria de Massas/veterinária
18.
In Vivo ; 33(4): 1333-1339, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31280227

RESUMO

BACKGROUND/AIM: The risk factors, clinical features and non-hematological toxicity profiles during chemotherapy in acute lymphoblastic leukemia (ALL) patients treated in pediatric hematology centres were analysed. MATERIALS AND METHODS: A total of 902/1872 children were reported as having grade 3 or 4 toxicity. RESULTS: Among the analysed toxicities, infection and gastrointestinal and liver toxicities were the most common. The median follow-up was 6.8 years. Overall survival and event-free survival rates for the analysed group were lower than those reported for the group without grade ≥3 toxicity. In univariate analysis, we identified the number of toxic episodes, the risk group and remission status that had a significant impact on the outcome. Multivariate analysis demonstrated the risk group and the number of toxic episodes ≥3 to be statistically significant for the results. CONCLUSION: The toxic profiles investigated in our report should be used in future efforts to decrease the burden of side effects during chemotherapy.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Leucemia-Linfoma Linfoblástico de Células Precursoras/complicações , Leucemia-Linfoma Linfoblástico de Células Precursoras/tratamento farmacológico , Adolescente , Fatores Etários , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Biomarcadores Tumorais , Biópsia , Criança , Pré-Escolar , Feminino , Testes Genéticos , Humanos , Imunofenotipagem , Lactente , Masculino , Leucemia-Linfoma Linfoblástico de Células Precursoras/diagnóstico , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Prognóstico , Índice de Gravidade de Doença
19.
BMC Res Notes ; 12(1): 421, 2019 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-31311587

RESUMO

OBJECTIVE: Incidence and clinical outcomes of medication prescribing errors are common and potentially more harmful in the pediatric population than in the adult population. Hence, this study was aimed to assess the prevalence and types of medication prescribing errors in the pediatric wards of Nekemte Referral Hospital (NRH). RESULTS: Of 384 pediatric patients included in the study, 241 (63%) were males and 116 (30.21%) of them were aged between 1-3 years. About 241 (62.76%) of the patients were treated based on empirical diagnosis and only 10 (2.60%) pediatrics had co-morbid disease. The most category of medication prescribing error was dosing error 251 (48.6%) followed by incorrect drug selection 98 (19.0%). Being critically ill (AOR = 5.31, 95% CI = 1.80-12.31, p = 0.003), route of administration via IV (AOR = 3.98, 95% CI = 1.85-11.15, p = 0.011) and via IV + IM route (AOR = 2.22, 95% CI = 1.05-9.25, p = 0.045) as well as 4-6 medications per patient (AOR = 3.10, 95% CI = 3.43-12.42, p = 0.012) and > 6 medications per patient (AOR = 7.23, 95% CI = 3.91-21.45, p < 0.001) were independent predictors of medication prescribing errors. Antibiotics were the most common classes of drugs responsible for prescribing errors.


Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Hospitalização/estatística & dados numéricos , Erros de Medicação/estatística & dados numéricos , Encaminhamento e Consulta/estatística & dados numéricos , Criança , Pré-Escolar , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Etiópia/epidemiologia , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Erros de Medicação/efeitos adversos , Prevalência
20.
Int J Rheum Dis ; 22(8): 1572-1577, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31245906

RESUMO

AIM: Methotrexate (MTX) is the anchor drug for the treatment of rheumatoid arthritis (RA). MTX is associated with adverse events that limit its use. The MTX intolerance severity score (MISS) was developed to identify symptoms related to MTX use in juvenile idiopathic arthritis and RA patients. The aim of this study is to translate and validate the MISS in the Arabic language. METHODS: Forward and backward translation of the MISS were performed by two fluent Arabic translators and reviewed by three rheumatologists. Consecutive patients with RA who used MTX for ≥3 months were recruited from two tertiary care centers in Riyadh, Saudi Arabia. A test was considered positive if the patient scored ≥6 points. The internal consistency and stability of the items were evaluated using Cronbach's alpha and the test-retest method. RESULTS: A total of 185 patients were recruited. Of those patients, 158 (85.4%) were female. The mean (±SD) age and disease duration were 49.7 (±12.67) and 8.67 (±7.1) years, respectively. The mean Disease Activity Score of 28 joints was 3.2 (±1.3). Fifty-five (30%) patients were illiterate. Seventy-three (39.5%) patients had a positive MISS. Of those patients, 55 (75.3%) and 18 (24.7%) were using the oral and subcutaneous forms of MTX, respectively. The Arabic MISS had good internal consistency (Cronbach's alpha = 0.792) and a factorable study size for test-retest and factor analysis (Kaiser-Meyer-Olkin = 0.745). CONCLUSION: The Arabic MISS showed validity and good reliability in detecting MTX intolerance in RA patients. MTX intolerance is prevalent among RA patients. Larger studies are needed to confirm these findings.


Assuntos
Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Metotrexato/efeitos adversos , Inquéritos e Questionários , Tradução , Adulto , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/epidemiologia , Estudos Transversais , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prevalência , Reprodutibilidade dos Testes , Arábia Saudita/epidemiologia
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