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1.
BMC Ophthalmol ; 21(1): 243, 2021 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-34058994

RESUMO

BACKGROUND: To evaluate alterations in the serum concentrations of vascular endothelial growth factor (VEGF) and netrin-1 after intravitreal bevacizumab (BCZ) injection for the treatment of diabetic macular edema (DME). METHODS: This prospective case-control study included a total of 50 participants assigned to one of three groups, including 10 individuals with DME and non-proliferative diabetic retinopathy (NPDR), 13 with DME, and proliferative diabetic retinopathy (PDR), and 27 healthy individuals as a control group. Serum VEGF and netrin-1 concentrations were measured by enzyme-linked immunosorbent assays (ELISAs) immediately before, as well as 1 week and 1 month after, intravitreal BCZ injection. RESULTS: The mean VEGF serum concentrations in the PDR and NPDR groups were 388.4 and 196.9 pg/mL at baseline, respectively. After 1 week, these concentrations changed to 193.41 and 150.23 pg/mL, respectively (P = 0.001 and P = 0.005, respectively); after 1 month, the concentrations were 97.89 and 76.46 pg/mL, respectively (P = 0.001 and P = 0.009, respectively). The mean netrin-1 serum concentrations in the PDR patients and NPDR groups were 318.2 and 252.7 pg/mL at baseline, respectively. After 1 week, these concentrations increased to 476.6 and 416.3 pg/mL, respectively (P = 0.033 and P = 0.005, respectively), and after 1 month, they were 676.6 and 747.5 pg/mL, respectively (P = 0.001 and P = 0.005, respectively). The correlation analysis revealed a significant inverse relationship between changes in serum VEGF and netrin-1 concentrations in both the PDR and NPDR groups (r = - 0.685, P = 0.029). CONCLUSIONS: Intravitreal BCZ injections work systemically to significantly decrease serum VEGF levels, leading to a significant upregulation in the concentration of another angiogenic mediator, netrin-1.


Assuntos
Retinopatia Diabética , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Edema Macular , Inibidores da Angiogênese/uso terapêutico , Anticorpos Monoclonais Humanizados , Bevacizumab/uso terapêutico , Estudos de Casos e Controles , Retinopatia Diabética/tratamento farmacológico , Humanos , Edema Macular/tratamento farmacológico , Netrina-1/uso terapêutico , Estudos Prospectivos , Fator A de Crescimento do Endotélio Vascular
2.
Rev Med Liege ; 76(5-6): 380-386, 2021 May.
Artigo em Francês | MEDLINE | ID: mdl-34080367

RESUMO

The «one size fits all¼ approach is seriously challenged by rapid progression of medical knowledge, especially in the field of individual genome expression. It is currently known that the anti-tumour effect of a given treatment and possible side effects at the level of healthy tissues, can at least partly be predicted and explained by individual variations of gene expression. However, most of us realize that these differences in response are also linked to a variety of other individual characteristics, such as for example the environment and socio-economic factors. Without any possible doubt, there are multiple problems (technical, administrative, financial, cultural and ethical) to be solved, before we witness the real irruption of precision medicine and its holistic individualized approach in our daily oncological practice. It has to start with an international effort, disregarding borders of individual countries, in order to obtain very large amounts of data (with a high degree of variability to avoid bias). This holistic approach, at both societal and individual levels, is the entrance door for a personalized approach in care, whether this is curative, predictive or preventive.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias , Humanos , Neoplasias/terapia , Medicina de Precisão
3.
Rev Med Liege ; 76(5-6): 403-407, 2021 May.
Artigo em Francês | MEDLINE | ID: mdl-34080371

RESUMO

Immunotherapy has revolutionized cancer management in recent years and is affecting more and more patients. Immunotherapy side effects are specific, immune-related, and their early recognition and management are essential. Here we describe the main adverse effects of immunotherapy and their general principles of management.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias , Humanos , Fatores Imunológicos , Imunoterapia/efeitos adversos , Neoplasias/terapia
4.
Rev Med Liege ; 76(5-6): 408-412, 2021 May.
Artigo em Francês | MEDLINE | ID: mdl-34080372

RESUMO

Cardio-oncology is a new interdisciplinary specialty that has emerged over the past ten years. With the development of increasingly potent cancer therapies which improve cancer survival, but at the cost of cardiovascular toxicity, the demand for specialized cardio-oncology services has emerged. Also, cardiovascular diseases are more common and more serious in cancer patients than in the general population. Cardio-oncology focuses on the prevention, detection, monitoring, and treatment of cardiovascular diseases in cancer patients, mostly those occurring as a side effect of chemo- and radiotherapy.


Assuntos
Doenças Cardiovasculares , Sistema Cardiovascular , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias , Doenças Cardiovasculares/terapia , Humanos , Oncologia , Neoplasias/terapia
5.
Med Clin North Am ; 105(4): 577-597, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34059239

RESUMO

Severe cutaneous adverse reactions to medications (SCARs) include drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. They are all non-immunoglobulin E mediated hypersensitivity reaction patterns, distinguished from simple cutaneous drug eruptions by immunologic pathogenesis and internal organ involvement. Herein the clinical features, diagnostic workup, and management considerations are presented for each of these major SCARs.


Assuntos
Pustulose Exantematosa Aguda Generalizada/patologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Eosinofilia/diagnóstico , Síndrome de Stevens-Johnson/etiologia , Síndrome de Stevens-Johnson/patologia , Pustulose Exantematosa Aguda Generalizada/diagnóstico , Pustulose Exantematosa Aguda Generalizada/etiologia , Corticosteroides/administração & dosagem , Corticosteroides/uso terapêutico , Adulto , Idoso , Diagnóstico Diferencial , 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/terapia , Eosinofilia/induzido quimicamente , Feminino , Humanos , Hipersensibilidade/imunologia , Masculino , Pessoa de Meia-Idade , Farmacogenética , Prognóstico , Fatores de Risco , Índice de Gravidade de Doença , Síndrome de Stevens-Johnson/diagnóstico , Síndrome de Stevens-Johnson/mortalidade
6.
Med Clin North Am ; 105(4): 757-782, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34059249

RESUMO

Connective tissue diseases (CTDs) encompass a broad spectrum of clinical presentations that involve multidisciplinary management. Cutaneous findings are common in CTD and careful examination of these features aids in appropriate diagnosis and subsequent evaluation. Thorough work-up of CTD is crucial to properly identify disease subtypes and systemic involvement. Management plans can be developed based on diagnosis and systemic manifestations of disease. Disease management often requires treatment with pharmacotherapies with potential for toxicities, further underscoring the importance of diagnostic accuracy in this patient population. Evolving research strives to better elucidate the pathogenic mechanisms of CTDs allowing for more targeted treatment modalities.


Assuntos
Doenças do Tecido Conjuntivo/complicações , Doenças do Tecido Conjuntivo/tratamento farmacológico , Doenças do Tecido Conjuntivo/patologia , Tratamento Farmacológico/métodos , Adulto , Comorbidade , Doenças do Tecido Conjuntivo/diagnóstico , Dermatomiosite/diagnóstico , Dermatomiosite/etiologia , Dermatomiosite/patologia , Diagnóstico Diferencial , Tratamento Farmacológico/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Diagnóstico Precoce , Feminino , Humanos , Comunicação Interdisciplinar , Lúpus Eritematoso Cutâneo/diagnóstico , Lúpus Eritematoso Cutâneo/etiologia , Lúpus Eritematoso Cutâneo/patologia , Lúpus Eritematoso Discoide/diagnóstico , Lúpus Eritematoso Discoide/etiologia , Lúpus Eritematoso Discoide/patologia , Lúpus Eritematoso Sistêmico/diagnóstico , Lúpus Eritematoso Sistêmico/etiologia , Lúpus Eritematoso Sistêmico/patologia , Masculino , Administração dos Cuidados ao Paciente/métodos , Escleroderma Sistêmico/diagnóstico , Escleroderma Sistêmico/etiologia , Escleroderma Sistêmico/patologia , Vasculite/diagnóstico , Vasculite/etiologia , Vasculite/patologia
7.
J Int Med Res ; 49(5): 3000605211010734, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33947260

RESUMO

Secondary organizing pneumonia (SOP) is a nonspecific inflammatory response towards acute lung injuries caused by various diseases. However, organizing pneumonia (OP) secondary to occupational acute nitrogen oxide poisoning has been reported rarely. We report a 49-year-old man who suffered from nitrogen oxide poisoning after inhaling mixed gas at work. After pathological examination, he was diagnosed with OP. In the absence of other underlying factors causing OP, he was diagnosed with SOP owing to acute nitrogen oxide poisoning. After systematic treatment, the patient recovered and was discharged in better health. In patients with lung injury caused by acute nitrogen oxide poisoning, physicians should be alert to the risk of patients subsequently developing SOP, and timely diagnosis and treatment are essential for complete recovery.


Assuntos
Pneumonia em Organização Criptogênica , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Pneumonia , Humanos , Masculino , Pessoa de Meia-Idade , Óxidos de Nitrogênio , Pneumonia/induzido quimicamente , Pneumonia/tratamento farmacológico
8.
Lakartidningen ; 1182021 05 11.
Artigo em Sueco | MEDLINE | ID: mdl-33973222

RESUMO

Serious adverse drug reactions, drug intolerance, and lack of effect are major problems in healthcare. Pharmacogenomics is the part of precision medicine that aims to develop predictive risk markers in this respect and establish such testing in clinical practice. The nation-wide project Genomic Medicine Sweden (GMS) is undertaking large-scale sequencing to predict risk of drug toxicity and lack of efficacy in malignant diseases. The aim is to facilitate an improved, individualized treatment with increased patient safety. In addition to accurate genotyping, other technical or infrastructure-related aspects need to be considered for a successful implementation in healthcare, for example electronic accessibility and visibility of pharmacogenomic data of long-standing relevance for an individual's ongoing and future drug treatment.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacogenética , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/genética , Genômica , Genótipo , Humanos , Medicina de Precisão , Suécia
9.
Stud Health Technol Inform ; 281: 1089-1090, 2021 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-34042851

RESUMO

Clinical Decision Support Systems (CDSS) could play a prominent role in preventing Adverse Drug Reactions (ADRs) especially when integrated in larger healthcare systems (e.g. Electronic Health Record - EHR systems, Hospital Management Systems - HMS, e-Prescription systems etc.). This poster presents an approach to model Therapeutic Prescription Protocols (TPPs) via the Business Process Management Notation (BPMN), as part of the e-Prescription CDSS developed in the context of the PrescIT project.


Assuntos
Sistemas de Apoio a Decisões Clínicas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Sistemas Computacionais , Assistência à Saúde , Humanos , Prescrições
10.
Stud Health Technol Inform ; 281: 1110-1111, 2021 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-34042861

RESUMO

As social media are an interesting source of information for pharmacovigilance, we implemented a novel visualisation method for pharmacovigilance specialists applied to French discussion forums. A word embedding model was trained on posts to facilitate the identification of patterns associated with adverse drug reactions.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Mídias Sociais , Sistemas de Notificação de Reações Adversas a Medicamentos , Humanos , Farmacovigilância
11.
J Chromatogr A ; 1647: 462147, 2021 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-33957347

RESUMO

Drug-induced phospholipidosis (DIPLD) represents a big concern for both regulatory authorities and pharmaceutical companies in drug discovery. Many researches pointed out that the negatively charged intralysosomal lipids play an important role in the formation of DIPLD. To better mimic this negatively charged lipid surface, a novel immobilized artificial membrane (IAM) column was prepared via in situ copolymerization of 12-methacryloyl n-dodecylphosphocholine (MDPC) and 12-methacryloyl n-dodecylphosphoric acid (MDPA). By introducing MDPA, the surface of the resulting monolithic column can be maintained negatively charged over a broad pH range. Scanning electron microscopy, elemental analysis and nano-HPLC experiments were carried out to characterize the physicochemical properties and chromatographic performance of the obtained monolithic IAM column. The results of ζ-potential and retention mechanism studies indicate that both hydrophobic and electrostatic interactions contribute greatly to the retention of cation analytes owing to the existence of the negatively charged MDPA under acidic conditions. To better assess the DIPLD potency of drug, the molar ratio between MDPC and MDPA in the monolithic column was carefully optimized. The results show that the poly(MDPC70PA30-co-EDMA) column has the best predictability with only two false-positives (donepezil, flecainide) in qualitative analysis of 61 drugs.


Assuntos
Doenças por Armazenamento dos Lisossomos/induzido quimicamente , Membranas Artificiais , Preparações Farmacêuticas , Fosfolipídeos , Química Farmacêutica , Cromatografia Líquida de Alta Pressão , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos , Interações Hidrofóbicas e Hidrofílicas , Microscopia Eletrônica de Varredura , Preparações Farmacêuticas/análise , Preparações Farmacêuticas/química , Preparações Farmacêuticas/metabolismo , Ácidos Fosfatídicos , Fosfolipídeos/química , Fosfolipídeos/metabolismo , Eletricidade Estática
12.
Nihon Yakurigaku Zasshi ; 156(3): 171-177, 2021.
Artigo em Japonês | MEDLINE | ID: mdl-33952847

RESUMO

The modified Irwin's method and functional observational battery (FOB)used in non-clinical studies for predicting side effects that may appear in the central nervous system (CNS)in clinical studies consist of mainly macroscopic observation and largely depend on the observer's ability. Therefore, appropriate training for the observer and consistency of findings are extremely important, making it necessary for methods and judgment criteria to be standardized. In addition, because of concern for animal welfare as well as an increase in biopharmaceutical and anticancer drug development, there is increasing opportunity to incorporate safety pharmacological evaluation into general toxicity studies. While CNS evaluation can be incorporated into general toxicity studies relatively easily, studies need to be designed in such a way that reliable data can be obtained without reducing the ability to detect neurobehavioral abnormalities. It is therefore important to improve CNS evaluation techniques and to share these techniques with new observers in order to reliably detect the effects on the CNS during drug development.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacologia , Animais , Sistema Nervoso Central , Desenvolvimento de Medicamentos , Avaliação Pré-Clínica de Medicamentos , Japão
13.
Zhong Nan Da Xue Xue Bao Yi Xue Ban ; 46(4): 404-413, 2021 Apr 28.
Artigo em Inglês, Chinês | MEDLINE | ID: mdl-33967088

RESUMO

The human leukocyte antigen (HLA) molecules encoded within the human major histocompatibility complex are a group of highly conserved cell surface proteins, which are related to antigen recognition. HLA genes display a high degree of genetic polymorphism, which is the basis of individual differences in immunity. Specific HLA genotypes have been highly associated with typical adverse drug reactions. HLA-A*31:01 and HLA-B*15:02 are associated with carbamazepine-induced severe cutaneous adverse reactions, HLA-B*57:01 is related to abacavir-induced drug-induced hypersensitivity syndrome and flucloxacillin/pazopanib-induced drug-induced liver injury, while HLA-B*35:01 is a potential biomarker for predicting polygonum multiflorum-induced liver injury. It is not clear how small drug molecules to interact with HLA molecules and T cell receptors (TCR). There are four mechanistic hypotheses, including the hapten/prohapten theory, the pharmacological interaction concept, the altered peptide repertoire model, and the altered TCR repertoire model.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/genética , Genótipo , Antígenos HLA/genética , Humanos , Polimorfismo Genético
14.
Anticancer Res ; 41(5): 2563-2568, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33952484

RESUMO

BACKGROUND/AIM: The aim of this study was to evaluate the effect of drug-induced interstitial lung disease (DILD) on treatment outcomes by comparing the mortality of patients with DILD induced by different pharmacological types of anticancer drugs. PATIENTS AND METHODS: Japanese patients with lung cancer who had received chemotherapy at Fujita Health University Hospital were enrolled. The primary outcome was the short-term mortality rate from the administration of chemotherapy that might have caused DILD. RESULTS: Eleven, 16, and 20 patients with DILD were assigned to the kinase inhibitor (KI), immune-checkpoint inhibitor (ICI), and cytotoxic anticancer drug groups, respectively. The 90-day mortality rate after the DILD event in the group treated with cytotoxic anticancer drugs was significantly higher than in the KI and ICI groups. CONCLUSION: Patients with DILD induced by cytotoxic anticancer drugs have poorer prognoses than those with DILD induced by KIs or ICIs.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Doenças Pulmonares Intersticiais/mortalidade , Neoplasias/mortalidade , Idoso , Idoso de 80 Anos ou mais , Citotoxinas/administração & dosagem , Citotoxinas/efeitos adversos , Tratamento Farmacológico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Feminino , Humanos , /efeitos adversos , Doenças Pulmonares Intersticiais/induzido quimicamente , Doenças Pulmonares Intersticiais/tratamento farmacológico , Doenças Pulmonares Intersticiais/patologia , Masculino , Pessoa de Meia-Idade , Neoplasias/classificação , Neoplasias/complicações , Neoplasias/tratamento farmacológico , Prognóstico , Inibidores de Proteínas Quinases/administração & dosagem , Inibidores de Proteínas Quinases/efeitos adversos
15.
Anticancer Res ; 41(5): 2637-2645, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33952494

RESUMO

BACKGROUND/AIM: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common chemotoxicities. However, no effective clinical CIPN screening methods have been reported. This study aimed to investigate whether changes in heart rate variability (HRV) could predict the development of CIPN for early symptom control in chemotherapy-prescribed patients with gastrointestinal (GI) cancer. PATIENTS AND METHODS: Fifty-five GI cancer outpatients undergoing palliative chemotherapy including taxanes and/or platinum compounds were enrolled. CIPN was diagnosed using National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI-CTCAE). HRV measures were derived from electrocardiogram signals. RESULTS: Twelve weeks after starting chemotherapy, 39 (70.9%) patients who complained of NCI-CTCAE grade 1-3 sensory changes were diagnosed with CIPN. Standard deviation of normal-to-normal R-R intervals (SDNN), high frequency (HF), low frequency (LF), and LF/HF ratio changed significantly during 3 assessment periods. Percentage changes in SDNN and HF were related to the occurrence of CIPN symptoms. A decision tree model indicated that patients with a rapid percentage change decrease in SDNN and HF were CIPN-positive. CONCLUSION: Using SDNN and HF, our decision tree predicted CIPN occurrence. The changes in HRV may occur earlier than sensory CIPN symptoms.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/fisiopatologia , Neoplasias Gastrointestinais/tratamento farmacológico , Frequência Cardíaca/efeitos dos fármacos , Doenças do Sistema Nervoso Periférico/fisiopatologia , Sistema Nervoso Autônomo/efeitos dos fármacos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Neoplasias Gastrointestinais/complicações , Neoplasias Gastrointestinais/epidemiologia , Neoplasias Gastrointestinais/fisiopatologia , Frequência Cardíaca/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Doenças do Sistema Nervoso Periférico/induzido quimicamente , Doenças do Sistema Nervoso Periférico/epidemiologia
16.
Washington, D.C.; OPS; 2021-05-14. (OPS/HSS/MT/COVID-19/21-0008).
Não convencional em Espanhol | PAHO-IRIS | ID: phr-53949

RESUMO

Esta publicación tiene como objetivo proporcionar recomendaciones sobre la notificación y evaluación de eventos adversos graves, sospechas de reacciones adversas graves inesperadas y eventos adversos de especial interés detectados durante la realización de ensayos clínicos con vacunas contra la COVID-19, así como sobre su integración con la información de seguridad proveniente de la vigilancia posautorización. Está dirigido a las autoridades regulatorias nacionales y a todos los actores que toman parte en el monitoreo de la seguridad de las vacunas contra la COVID-19, incluidos los programas nacionales de inmunización y los departamentos y oficinas de vigilancia epidemiológica.


Assuntos
Farmacovigilância , Vacinas , Vacinação , Ensaios Clínicos como Assunto , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Infecções por Coronavirus , Infecções por Coronavirus , Betacoronavirus , Pandemias
17.
MMWR Morb Mortal Wkly Rep ; 70(18): 680-684, 2021 May 07.
Artigo em Inglês | MEDLINE | ID: mdl-33956784

RESUMO

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Janssen (Ad.26.COV2.S) COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson) (1). The Janssen COVID-19 vaccine, the third COVID-19 vaccine authorized for use in the United States, uses a replication-incompetent human adenoviral type 26 vector platform* (2) and is administered as a single intramuscular dose, whereas the first two authorized vaccines use an mRNA platform and require 2 doses. On February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for use of Janssen COVID-19 vaccine among persons aged ≥18 years (3). During April 13-23, CDC and FDA recommended a pause in use of Janssen vaccine after reports of six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia (platelet count <150,000/µL of blood) among Janssen vaccine recipients (4). Similar thrombotic events, primarily among women aged <60 years, have been described in Europe after receipt of the AstraZeneca COVID-19 vaccine, which uses a replication-incompetent chimpanzee adenoviral vector (5-7). The U.S. CVST cases that prompted the pause in Janssen vaccination, as well as subsequently detected CVST cases, are described elsewhere (8). This report summarizes adverse events among Janssen vaccine recipients, including non-CVST cases of thrombosis with thrombocytopenia syndrome (TTS), reported to the Vaccine Adverse Events Reporting System (VAERS), a passive surveillance system, and through v-safe, an active monitoring system. As of April 21, 2021, 7.98 million doses of the Janssen COVID-19 vaccine had been administered. Among 13,725 VAERS reports reviewed, 97% were classified as nonserious and 3% as serious,† including three reports among women of cases of thrombosis in large arteries or veins accompanied by thrombocytopenia during the second week after vaccination. These three cases and the previously detected CVST cases are consistent with 17 cases of TTS,§ a newly defined condition. Approximately 338,700 Janssen COVID-19 vaccine recipients completed at least one v-safe survey during the week after vaccination; 76% reported a systemic reaction, 61% reported a local reaction, and 34% reported a health impact.¶ Fatigue and pain were commonly reported symptoms in both VAERS and v-safe. The overall safety profile is consistent with preauthorization clinical trials data. Prompt review of U.S. vaccine safety data detected three additional cases of non-CVST TTS, in addition to the previously recognized CVST cases that initiated the pause in use of the Janssen COVID-19 vaccine. Ongoing monitoring of adverse events after COVID-19 vaccination, including vaccination with the Janssen single-dose vaccine, is essential for evaluating the risks and benefits of each vaccine.


Assuntos
/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Vigilância de Produtos Comercializados , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Idoso , Idoso de 80 Anos ou mais , Centers for Disease Control and Prevention, U.S. , Criança , Pré-Escolar , Aprovação de Drogas , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Medição de Risco , Retirada de Medicamento Baseada em Segurança , Trombose dos Seios Intracranianos/epidemiologia , Estados Unidos/epidemiologia , United States Food and Drug Administration , Adulto Jovem
18.
J Med Case Rep ; 15(1): 226, 2021 May 05.
Artigo em Inglês | MEDLINE | ID: mdl-33947461

RESUMO

BACKGROUND: Differentiation syndrome (DS) is a life-threatening complication that may be seen in patients with acute promyelocytic leukaemia undergoing induction therapy with all-trans retinoic acid or arsenic trioxide. It can lead to severe inflammatory response syndrome and shock if adequate measures are not taken immediately. The radiological features of lung nodules with changes in ground-glass opacity can represent DS. The principal unique feature of the case reported here is that the diagnosis of DS was based on imaging results in the absence of a low total leukocyte count. CASE PRESENTATION: A 14-year-old Indian girl diagnosed with acute promyelocytic leukaemia currently undergoing a chemotherapy regimen that included all-trans retinoic acid/arsenic trioxide was sent to the radiology department for investigation of respiratory distress which she had developed soon after the initiation of chemotherapy. Her chest radiograph showed bilateral lower zone lung infiltrates. Computed tomography (CT) revealed changes in ground-glass opacity in the lower lobes with multiple lung nodules. Differential diagnosis included bacterial, viral or fungal infections, leukemic infiltrates, drug toxicity, pulmonary haemorrhage or leukostasis. She was started on dexamethasone immediately after stopping the chemotherapy with all-trans retinoic acid/arsenic trioxide and given ventilatory support. Her condition subsequently improved and her follow-up chest radiograph and CT scan showed a significant reduction of abnormal lung findings. Based on the clinical improvement and the resolution of findings on imaging following the withdrawal of all-trans retinoic acid/arsenic trioxide, we made the diagnosis of DS. CONCLUSIONS: Though a rather unusual possibility, the treatment history of the patient enabled a rather crucial diagnosis in the nick of time and imaging played a pivotal role. This case further iterates the importance of keeping DS in mind when dealing with similar patients in the future.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Leucemia Promielocítica Aguda , Adolescente , Protocolos de Quimioterapia Combinada Antineoplásica , Trióxido de Arsênio/uso terapêutico , Feminino , Humanos , Leucemia Promielocítica Aguda/complicações , Leucemia Promielocítica Aguda/tratamento farmacológico , Síndrome , Tretinoína/efeitos adversos
19.
Zhongguo Zhong Yao Za Zhi ; 46(7): 1727-1737, 2021 Apr.
Artigo em Chinês | MEDLINE | ID: mdl-33982476

RESUMO

Methotrexate(MTX) is a commonly used antimetabolite, which can be used in the treatment of a variety of diseases. However, hepatotoxicity in the use of MTX severely limits its clinical use. Therefore, how to prevent and treat hepatotoxicity of MTX has become an urgent clinical problem. This paper summarizes and analyzes relevant literatures on the prevention and treatment of hepa-totoxicity caused by MTX with traditional Chinese medicines and natural medicines in recent years. MTX-induced hepatotoxicity mechanisms include folate pathway, oxidative stress damage and adenosine pathway, of which oxidative stress theory is the main research direction. A total of 14 kinds of traditional Chinese medicine and natural medicine extracts including white peony root, and 21 kinds of natural monomer compounds, including berberine, play an anti-MTX-induced hepatotoxic effect by resisting oxidative stress, inhibiting inflammation and regulating signal pathways. According to current studies on the prevention and treatment of hepatotoxicity induced by MTX with traditional Chinese medicines and natural medicines, there are insufficiencies, such as partial and superficial mechanism studies, inadequate combination of experimental research and clinical practice, non-standard experimental design and lack of application of advanced technologies and methods. This paper systematically reviewed the effects and mechanisms of traditional Chinese medicines and natural medicines against hepatotoxicity induced by MTX and defined current studies and deficiencies, in the expectation of proposing new study strategies and directions and providing scientific basis for rational clinical use of MTX and development of new drugs against MTX hepatotoxicity.


Assuntos
Doença Hepática Induzida por Substâncias e Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Doença Hepática Induzida por Substâncias e Drogas/tratamento farmacológico , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Doença Hepática Induzida por Substâncias e Drogas/prevenção & controle , Humanos , Fígado/metabolismo , Medicina Tradicional Chinesa , Metotrexato/toxicidade , Estresse Oxidativo
20.
Zhonghua Yu Fang Yi Xue Za Zhi ; 55(5): 574-582, 2021 May 06.
Artigo em Chinês | MEDLINE | ID: mdl-34034396

RESUMO

Adverse drug reactions are often encountered in the process of medication and are quite troublesome for clinicians. Skin is one of the most frequently affected organs by adverse drug reactions. Adverse drug reactions involving skin are called "drug-induced dermatitis" or "drug eruption". In some rare instances, drug eruption can be severe and life-threatening which is known as severe cutaneous adverse drug reaction. However, due to the mixed use of drugs, it is difficult to identify the culprit drug, which makes multiple drugs needed to be avoided. Recently, many studies have found that HLA alleles are closely related to the certain culprit drug. HLA genotyping before administration can significantly reduce the incidence of severe cutaneous adverse drug reaction related to certain drugs. Since limited HLA alleles are found, HLA genotyping can only prevent adverse drug reaction to a limited extent. At present, drug provocation tests are regarded as the "gold standard" to identify the culprit drug. However, this diagnostic program has not been widely developed because of the high risk. In addition, a variety of in vivo and in vitro diagnostic methods (including drug patch test, drug skin test, drug specific IgE test, basophil activation test, lymphocyte transformation test, et al) also provide evidences to identify the culprit drug.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Pele , Alelos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Humanos
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