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1.
Interv Neuroradiol ; : 15910199231182454, 2023 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-37322874

RESUMO

BACKGROUND AND PURPOSE: Cerebral venous thrombosis (CVT) is usually treated with systemic anticoagulation, but mechanical thrombectomy (MT) and local infusion of a thrombolytic agent have been proposed as an alternative therapy. In this study, we analyze National Inpatient Sample (NIS) to determine the trends of MT including discharge other than home (DOTH) and mortality. MATERIAL AND METHODS: Healthcare Utilization Program-NIS (HCUP-NIS) was queried between 2005 and 2018 for CVT and MT. Cochran-Armitage test was conducted to assess linear trend of proportion of utilization and DOTH of MT. Multivariable logistic regression was conducted to assess odds of undergoing MT among CVT admissions, odds of in-hospital mortality, and DOTH for all admissions involving MT for CVT. RESULTS: A total of 1331 (1.56%) admissions involved MT out of 85,370 CVT cases. Utilization of MT had an upward trend of 0.13% (p < 0.001) per year. Trend in proportion of incidence of DOTH among MT admission remained stationary (trend: 0.70%; p = 0.417). Patients with cerebral edema (odds ratio [OR]: 4.34; p < 0.001) or hematological disorders (OR: 2.28; p < 0.001) were more likely to receive MT for CVT. Additionally, patients with coma (OR: 3.17; p = 0.023) or cerebral edema (OR: 4.40; p = 0.001) had higher odds of mortality. CONCLUSION: There was an increasing trend of utilization of MT. Proportions of DOTH among MT procedures, however, remained stable. Patients with greater risk factors, including hematological disorders and cerebral edema, were more likely to undergo MT. Among patients treated with MT, those with coma or cerebral edema were more likely to die.

2.
AAPS PharmSciTech ; 22(5): 172, 2021 Jun 07.
Artigo em Inglês | MEDLINE | ID: mdl-34100150

RESUMO

Vaccination development and production was an essential question for the prevention and global control of COVID-19. The strong support from governing authorities such as Operation Warp Speed and robust funding has led to the development and authorization of the tozinameran (BNT162b2) vaccine. The BNT162b2 vaccine is a lipid nanoparticle-encapsulated mRNA that encodes for SARS-CoV-2 spike protein, the main site for neutralizing antibodies. Once it binds with the host cells, the lipid nanoparticles enable the transfer of the RNA, causing S antigens' expression of the SARS-CoV-2, conferring immunity. The vaccine is administered as a 2-dose regime 21 days apart for individuals 16 years and older. Pfizer-BioNTech's BNT162b2 vaccine was the first candidate to receive FDA-Emergency Use Authorization (EUA) on December 11, 2020. During phase 2/3 clinical trials, 95% efficacy was reported among 37,706 participants over the age of 16 who received the BNT162b2 vaccination; additionally, 52% efficacy was noted 12 days following the administration of the first dose of BNT162b2, reflecting early protection of COVID-19. The BNT162b2 vaccine has exhibited 100% efficacy in clinical trials of adolescents between the ages of 12 and 15. Clinical trials in pregnant women and children under the age of 12 are expected to also exhibit promising results. This review article encompasses tozinameran (BNT162b2) vaccine journey, summarizing the BNT162b1 and BNT162b2 vaccines from preclinical studies, clinical trial phases, dosages, immune response, adverse effects, and FDA-EUA.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/prevenção & controle , Ensaios Clínicos como Assunto/métodos , Aprovação de Drogas/métodos , SARS-CoV-2/efeitos dos fármacos , Animais , Anticorpos Neutralizantes/efeitos dos fármacos , Anticorpos Neutralizantes/metabolismo , Vacina BNT162 , COVID-19/epidemiologia , COVID-19/metabolismo , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/metabolismo , Ensaios Clínicos como Assunto/legislação & jurisprudência , Aprovação de Drogas/legislação & jurisprudência , Avaliação Pré-Clínica de Medicamentos/métodos , Exantema/induzido quimicamente , Feminino , Humanos , Masculino , SARS-CoV-2/metabolismo , Glicoproteína da Espícula de Coronavírus/efeitos dos fármacos , Glicoproteína da Espícula de Coronavírus/metabolismo , Vacinação/legislação & jurisprudência , Vacinação/métodos
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