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1.
Clin Exp Hepatol ; 7(3): 249-257, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34712825

RESUMO

Hepatocellular carcinoma (HCC) is the fifth most common malignancy worldwide. Patients commonly present with advanced/unresectable HCC where several treatment options are not effective. In this review, the authors discuss the indications and usage of lenvatinib, a multikinase inhibitor, as first-line therapy for advanced/unresectable HCC, its mode of action, efficacy, drug reactions, response to treatment and adverse effects. Since its approval in 2007, sorafenib has been used as first-line therapy for unresectable HCC. In 2018, a phase III multinational REFLECT trial on subjects with unresectable HCC (Child-Pugh class A) demonstrated that lenvatinib was non-inferior compared to sorafenib for overall survival, with a controllable toxicity profile, leading to its approval. In addition, our review discusses studies that compare the safety and efficacy profile of lenvatinib especially in patients who have a decline in their liver function to Child-Pugh class B. A current real world analysis of lenvatinib approval for unresectable HCC worldwide is reported.

2.
Cureus ; 13(7): e16618, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34447648

RESUMO

Acute esophageal necrosis (AEN), also termed "black esophagus," is a unique and uncommon occurrence observed in severely sick patients. Other terminologies include acute necrotizing esophagitis and Gurvits syndrome. This condition is described as a darkened distal third of the esophagus observed on endoscopy and presents as an upper gastrointestinal (GI) bleed, difficulty swallowing, abdominal pain, fever, syncope, nausea, and vomiting. The etiology of AEN has been linked to several possibilities, such as excessive gastric acid reflux, hypoperfusion, and ischemia due to impaired vascular supply and hemodynamic instability. Risk factors include increased age, sex (male), heart disease, hemodynamic insufficiency, alcohol use, gastric outlet obstruction, diabetic ketoacidosis (DKA), malnutrition, renal disease, and trauma which also have the propensity to complicate disease course. An esophageal biopsy is not warranted. Treatment of AEN is comprised of supportive management with intravenous fluids, proton pump inhibitors (PPI), sucralfate, parenteral nutrition, and antacids. Management of preexisting comorbidities associated with AEN is crucial to prevent exacerbation of the disease course that could result in a poor prognosis and increased mortality rates. This literature review article comprises epidemiology, etiology, pathogenesis, diagnosis, and management of AEN.

3.
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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