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1.
Rev Bras Ter Intensiva ; 32(3): 354-362, 2020.
Artigo em Português, Inglês | MEDLINE | ID: mdl-33053024

RESUMO

OBJECTIVE: The infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads worldwide and is considered a pandemic. The most common manifestation of SARS-CoV-2 infection (coronavirus disease 2019 - COVID-19) is viral pneumonia with varying degrees of respiratory compromise and up to 40% of hospitalized patients might develop acute respiratory distress syndrome. Several clinical trials evaluated the role of corticosteroids in non-COVID-19 acute respiratory distress syndrome with conflicting results. We designed a trial to evaluate the effectiveness of early intravenous dexamethasone administration on the number of days alive and free of mechanical ventilation within 28 days after randomization in adult patients with moderate or severe acute respiratory distress syndrome due to confirmed or probable COVID-19. METHODS: This is a pragmatic, prospective, randomized, stratified, multicenter, open-label, controlled trial including 350 patients with early-onset (less than 48 hours before randomization) moderate or severe acute respiratory distress syndrome, defined by the Berlin criteria, due to COVID-19. Eligible patients will be randomly allocated to either standard treatment plus dexamethasone (Intervention Group) or standard treatment without dexamethasone (Control Group). Patients in the intervention group will receive dexamethasone 20mg intravenous once daily for 5 days, followed by dexamethasone 10mg IV once daily for additional 5 days or until intensive care unit discharge, whichever occurs first. The primary outcome is ventilator-free days within 28 days after randomization, defined as days alive and free from invasive mechanical ventilation. Secondary outcomes are all-cause mortality rates at day 28, evaluation of the clinical status at day 15 assessed with a 6-level ordinal scale, mechanical ventilation duration from randomization to day 28, Sequential Organ Failure Assessment Score evaluation at 48 hours, 72 hours and 7 days and intensive care unit -free days within 28.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Pneumonia Viral/tratamento farmacológico , Síndrome do Desconforto Respiratório do Adulto/tratamento farmacológico , Adulto , Infecções por Coronavirus/fisiopatologia , Humanos , Unidades de Terapia Intensiva , Escores de Disfunção Orgânica , Pandemias , Pneumonia Viral/fisiopatologia , Estudos Prospectivos , Respiração Artificial , Síndrome do Desconforto Respiratório do Adulto/virologia , Fatores de Tempo
2.
N Z Med J ; 133(1520): 120-124, 2020 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-32994602

RESUMO

Spontaneous bleeding in the head and neck region is exceedingly rare, particularly in the absence of trauma or an underlying disorder. We describe a case of an atraumatic lingual haematoma in an 88-year-old male presenting with threatened airway obstruction. The only risk factor our patient had was Aspirin use. Our patient was able to be managed conservatively with observation in the hospital's high dependency unit (HDU) and intravenous steroid (Dexamethasone) and antibiotic (Amoxicillin + Clavulanic acid) therapy. We discuss this case to highlight the importance of recognising an impending airway emergency in the setting of deep space bleeding or swelling.


Assuntos
Obstrução das Vias Respiratórias/etiologia , Hematoma/complicações , Língua/patologia , Administração Intravenosa , Idoso de 80 Anos ou mais , Combinação Amoxicilina e Clavulanato de Potássio/uso terapêutico , Antibacterianos/uso terapêutico , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/uso terapêutico , Dexametasona/administração & dosagem , Dexametasona/uso terapêutico , Quimioterapia Combinada/métodos , Hematoma/tratamento farmacológico , Humanos , Masculino , Língua/irrigação sanguínea , Resultado do Tratamento
3.
Ann Hematol ; 99(11): 2589-2598, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32892275

RESUMO

The induction therapy containing ixazomib, an oral proteasome inhibitor, has shown favorable efficacy and safety in clinical trials, but its experience in real-life remains limited. In routine practice, few patients received ixazomib-based induction therapy due to reasons including (1) patients' preference on oral regimens, (2) concerns on adverse events (AEs) of other intravenous/subcutaneous regimens, (3) requirements for less center visits, and (4) fears of COVID-19 and other infectious disease exposures. With the aim of assessing the real-life effectiveness and safety of ixazomib-based induction therapy, we performed this multi-center, observational study on 85 newly diagnosed multiple myeloma (NDMM) patients from 14 medical centers. Ixazomib-based regimens included ixazomib-lenalidomide-dexamethasone (IRd) in 44.7% of patients, ixazomib-dexamethasone (Id) in 29.4%, and Id plus another agent (doxorubicin, cyclophosphamide, thalidomide, or daratumumab) in 25.9%. Different ixazomib-based therapies were applied due to (1) financial burdens or limitations on local health insurance coverage, (2) concerns on treatment tolerance, and (3) drug accessibility issue. Ten patients received ixazomib maintenance. The median age was 67 years; 43.5% had ISS stage III disease; 48.2% had an Eastern Cooperative Oncology Group performance score ≥ 2; and 17.6% with high-risk cytogenetic abnormalities. Overall response rate for all 85 patients was 95.3%, including 65.9% very good partial response or better and 29.5% complete responses. The median time to response was 30 days. The response rate was similar across different ixazomib-based regimens. Median progression-free survival was not reached. Severe AEs (≥ grade 3) were reported in 29.4% of patients. No grade 3/4 peripheral neuropathy (PN) occurred. Patients received a median of 6 (range 1-20) cycles of ixazomib treatment; 56.6% remained on treatment at data cutoff; 15.3% discontinued treatment due to intolerable AEs. These results support that the ixazomib-based frontline therapy was highly effective with acceptable toxicity in routine practice and the ixazomib oral regimens could be good alternative options for NDMM patients.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Compostos de Boro/administração & dosagem , Glicina/análogos & derivados , Mieloma Múltiplo/tratamento farmacológico , Doenças do Sistema Nervoso Periférico/induzido quimicamente , Adolescente , Adulto , Idoso , Anticorpos Monoclonais/administração & dosagem , Anticorpos Monoclonais/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Compostos de Boro/efeitos adversos , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Esquema de Medicação , Feminino , Glicina/administração & dosagem , Glicina/efeitos adversos , Humanos , Lenalidomida/administração & dosagem , Lenalidomida/efeitos adversos , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/mortalidade , Mieloma Múltiplo/patologia , Estadiamento de Neoplasias , Doenças do Sistema Nervoso Periférico/diagnóstico , Doenças do Sistema Nervoso Periférico/fisiopatologia , Indução de Remissão , Análise de Sobrevida , Talidomida/administração & dosagem , Talidomida/efeitos adversos , Resultado do Tratamento
4.
Ann Hematol ; 99(11): 2513-2520, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32945941

RESUMO

Primary immune thrombocytopenia (ITP) is an intriguing autoimmune disease characterized by autoantibodies against platelets and megakaryocytes. Clinical outcomes, response to treatment, and chronicity predictors were investigated. Patients with newly diagnosed primary ITP treated at a hematology referral center from 2008 to 2018 with complete medical and recent medication history were stratified by age as children < 16 years and adults > 16 years. Responses to treatment including steroids, splenectomy, rituximab, and eltrombopag were classified as response (R) and complete (CR). Factors for developing chronic ITP were determined by multiple regression with uni- and multivariate analysis. p < 0.05 was considered significant. A total of 175 patients were included, 52 children and 123 adults; women predominated with 57.7%. Response to first-line treatment in the whole cohort was 86.18%, CR 43.42% and R 42.76%. The initial response to steroids alone was 83.9% (n = 52/62), rituximab plus high-dose dexamethasone (HDD) 87.2% (n = 34/39), eltrombopag plus HDD 90.9% (n = 10/11), and children receiving IVIG alone 100% (n = 8/8); 9 children were under clinical observation and achieved spontaneous response; loss of response was documented in 15.21% children and 28.3% adults with a median time of 15.95 and 4.07 months respectively; 37.39% of adults and 30.76% of children progressed to a chronic course. Platelets ≥ 20 × 109/L and age ≥ 6 years were risk factors for chronic ITP in the univariate analysis in the adult and children groups, respectively. Clinical course and treatment outcomes for ITP are considerably heterogeneous. Higher platelet counts at diagnosis in adults and age ≥ 6 years in children were associated with an increased risk of chronicity.


Assuntos
Benzoatos/administração & dosagem , Dexametasona/administração & dosagem , Hidrazinas/administração & dosagem , Imunoglobulinas Intravenosas/administração & dosagem , Púrpura Trombocitopênica Idiopática/terapia , Pirazóis/administração & dosagem , Rituximab , Esplenectomia , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Doença Crônica , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas , Púrpura Trombocitopênica Idiopática/sangue , Estudos Retrospectivos
6.
Medicine (Baltimore) ; 99(39): e22299, 2020 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-32991435

RESUMO

INTRODUCTION: Hemophagocytic lymphohistiocytosis (HLH) is a condition characterized by a hyperinflammatory state and persistent macrophage activation, resulting in reactive phagocytosis of the hematopoietic elements. In children, it is usually a hereditary disorder, while in adults it is usually acquired secondary to viral infections, collagenoses, or tumors. Although accounting for 10% of hematologic malignancies, HLH is rarely associated with multiple myeloma (MM) and other plasmacytic dyscrasias. PATIENT CONCERNS: A 64-year-old Brazilian man seeked medical care with a 3-month history of intermittent fever, weight loss, night sweats, and progressive anemic symptoms. DIAGNOSIS: Total blood count showed severe bicytopenia (normocytic-normochromic anemia and thrombocytopenia), biochemical exams showed elevation of creatinine, as well as monoclonal peak in serum protein electrophoresis, high IgA dosage, and serum immunofixation with IgA kappa paraprotein. Bone marrow biopsy showed 30% of monoclonal and phenotypically anomalous plasmocytes, confirming the diagnosis of MM. Diagnosis of HLH was established by the presence of clinical and laboratory criteria: fever, splenomegaly, cytopenias, hypofibrinogenemia, hyperferritinemia, elevation of triglycerides, and several figures of erythrophagocytosis in bone marrow aspirate. INTERVENTIONS: The patient experienced pulse therapy with methylprednisolone for hemophagocytic lymphohistiocytosis, followed by initial therapy for multiple myeloma with cyclophosphamide and dexamethasone. OUTCOMES: Once the diagnosis of MM and secondary hemophagocytic syndrome was established, the patient had a rapid clinical deterioration despite the established therapeutic measures, evolving with cardiovascular failure, acute liver failure, acute disseminated intravascular coagulation, worsening renal dysfunction requiring dialysis support, respiratory dysfunction, and lowering of consciousness, characterizing rapid multiple organ dysfunction, ultimately leading to the death of the patient. INNOVATION: Here, we aimed to describe the sixth reported case of HLH associated with MM, according to cases cataloged in the PubMed database, and the first case evaluated by 18-fluordeoxyglucose positron emission tomography (18-FDG-PETCT). CONCLUSION: Our case report seeks to provide support for a better clinical and laboratory characterization of this rare paraneoplastic entity associated with MM, and aims to call the attention of hematologists and intensivists to this condition that falls within the scope of the differential diagnosis of rapid onset multiple organ failure in patients with plasmacytic neoplasms.


Assuntos
Linfo-Histiocitose Hemofagocítica/tratamento farmacológico , Linfo-Histiocitose Hemofagocítica/etiologia , Mieloma Múltiplo/complicações , Mieloma Múltiplo/tratamento farmacológico , Anemia/sangue , Anemia/etiologia , Antineoplásicos Alquilantes/administração & dosagem , Antineoplásicos Alquilantes/uso terapêutico , Medula Óssea/patologia , Brasil/epidemiologia , Ciclofosfamida/administração & dosagem , Ciclofosfamida/uso terapêutico , Dexametasona/administração & dosagem , Dexametasona/uso terapêutico , Quimioterapia Combinada , Evolução Fatal , Febre/diagnóstico , Febre/etiologia , Glucocorticoides/administração & dosagem , Glucocorticoides/uso terapêutico , Humanos , Linfo-Histiocitose Hemofagocítica/sangue , Linfo-Histiocitose Hemofagocítica/diagnóstico , Masculino , Metilprednisolona/administração & dosagem , Metilprednisolona/uso terapêutico , Pessoa de Meia-Idade , Mieloma Múltiplo/metabolismo , Insuficiência de Múltiplos Órgãos/complicações , Paraproteinemias/sangue , Plasmócitos/patologia , Esplenomegalia/diagnóstico , Esplenomegalia/etiologia , Trombocitopenia/sangue , Trombocitopenia/etiologia , Perda de Peso
7.
Clin Appl Thromb Hemost ; 26: 1076029620945398, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32883088

RESUMO

Venous thromboembolism, occlusion of dialysis catheters, circuit thrombosis in ECMO devices, all in the face of prophylactic and sometimes even therapeutic anti-coagulation, are frequent features of COVID-19 coagulopathy. The trials available to guide clinicians are methodologically limited. There are several unresolved controversies including 1) Should all hospitalized patients with COVID-19 receive prophylactic anti-coagulation? 2) Which patients should have their dosage escalated to intermediate dose? 3) Which patients should be considered for full-dose anti-coagulation even without a measurable thromboembolic event and how should that anti-coagulation be monitored? 4) Should patients receive post-discharge anti-coagulation? 5) What thrombotic issues are related to the various medications being used to treat this coagulopathy? 6) Is anti-phospholipid anti-body part of this syndrome? 7) How do the different treatments for this disease impact the coagulation issues? The aims of this article are to explore these questions and interpret the available data based on the current evidence.


Assuntos
Anticoagulantes/administração & dosagem , Transtornos da Coagulação Sanguínea/tratamento farmacológico , Transtornos da Coagulação Sanguínea/epidemiologia , Infecções por Coronavirus/epidemiologia , Produtos de Degradação da Fibrina e do Fibrinogênio/uso terapêutico , Pneumonia Viral/epidemiologia , Tromboembolia Venosa/prevenção & controle , Transtornos da Coagulação Sanguínea/diagnóstico , Estudos de Casos e Controles , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/terapia , Dexametasona/administração & dosagem , Feminino , Humanos , Masculino , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/terapia , Prognóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Medição de Risco , Síndrome Respiratória Aguda Grave/diagnóstico , Síndrome Respiratória Aguda Grave/epidemiologia , Análise de Sobrevida , Resultado do Tratamento , Tromboembolia Venosa/etiologia
8.
Ann Hematol ; 99(10): 2351-2356, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32865607

RESUMO

Lenalidomide (Len) and dexamethasone (dex) therapy is a standard therapy in patients with multiple myeloma. Elderly or unfit patients may reduce Len or dex doses to prevent toxicities that lead to treatment discontinuation. However, there have been few studies evaluating the efficacy and safety of lower doses of Len and dex. We conducted a phase II study of 1.5-year low-dose Len and dex therapy following melphalan and prednisolone (MP), the number of which cycles was determined by a response within 9 cycles. The Len dose was 10 mg daily and the dex dose was 20 mg weekly, which were continued for 1.5 years. Twenty-one patients were enrolled. The median number of cycles of MP was 3 (range, 2-9). The overall response rate was 81% and a very good partial response or better was achieved in 33.3% of patients. The median follow-up time for survivors was 70.5 months (range, 42-83 months), the median progression-free survival (PFS) was 27 months (95% CI, 21-33 months), and the median overall survival was not reached. Grade 3 or 4 adverse events were observed in 28.6% of patients. In conclusion, the low-dose Len and dex therapy safely achieved comparable efficacies to the standard-dose regimen in elderly patients with newly diagnosed multiple myeloma. UMIN000007889.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anemia/induzido quimicamente , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Relação Dose-Resposta a Droga , Esquema de Medicação , Neutropenia Febril/induzido quimicamente , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Lenalidomida/administração & dosagem , Lenalidomida/efeitos adversos , Masculino , Melfalan/administração & dosagem , Melfalan/efeitos adversos , Pessoa de Meia-Idade , Mieloma Múltiplo/genética , Prednisolona/administração & dosagem , Prednisolona/efeitos adversos , Intervalo Livre de Progressão , Indução de Remissão , Resultado do Tratamento , Adulto Jovem
9.
Medicine (Baltimore) ; 99(36): e22070, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899074

RESUMO

BACKGROUND: A number of recent studies have investigated the optimal dosage and timing of dexamethasone in total hip arthroplasty (THA) but have inconsistent findings. Therefore, we designed the randomized controlled research to look for the optimal intravenous dexamethasone dose for the treatment of early postoperative pain after the THA. METHODS: The Declaration of Helsinki principles was followed and the Consolidated Standards of Reporting Trials guidelines for randomized controlled trials was adhered in this study. The First Medical Center in People's Liberation Army General Hospital approved the study (2020-089). After written informed consent was obtained, patients aged between 18 and 80 years with Physical Status I to III of American Society of Anesthesiologists, scheduled for primary unilateral THA, were included in this present work. Randomization is the use of a computer-formed list via a secretary, at a ratio of 1:1:1. The major end points were pain scores at 24 hours, 48 hours, and 72 hours after surgery, with visual analog scale (VAS) utilized at rest, and at 45 degrees passive hip flexion. The secondary outcomes involved the total consumption of morphine, opioid-related side effects, hip range of motion, inflammation markers, and the length of hospital stay. RESULTS: We assumed that the patients who received 3 doses of dexamethasone intravenously possessed the best postoperative results compared to those who received 1 or 2 doses of the dexamethasone. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5864).


Assuntos
Anti-Inflamatórios/administração & dosagem , Artroplastia de Quadril/efeitos adversos , Dexametasona/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Administração Intravenosa , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Inflamatórios/uso terapêutico , Estudos de Casos e Controles , Dexametasona/uso terapêutico , Humanos , Mediadores da Inflamação/metabolismo , Tempo de Internação , Pessoa de Meia-Idade , Morfina/efeitos adversos , Entorpecentes/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Amplitude de Movimento Articular , Escala Visual Analógica , Adulto Jovem
10.
BMC Infect Dis ; 20(1): 669, 2020 Sep 14.
Artigo em Inglês | MEDLINE | ID: mdl-32928130

RESUMO

BACKGROUND: The parasite Entamoeba histolytica is the causal agent of amoebiasis, a worldwide emerging disease. Amebic brain abscess is a form of invasive amebiasis that is both rare and frequently lethal. This condition always begins with the infection of the colon by E. histolytica trophozoites, which subsequently travel through the bloodstream to extraintestinal tissues. CASE PRESENTATION: We report a case of a 71-year-old female who reported an altered state of consciousness, disorientation, sleepiness and memory loss. She had no history of hepatic or intestinal amoebiasis. A preliminary diagnosis of colloidal vesicular phase neurocysticercosis was made based on nuclear magnetic resonance imaging (NMRI). A postsurgery immunofluorescence study was positive for the 140 kDa fibronectin receptor of E. histolytica, although a serum analysis by ELISA was negative for IgG antibodies against this parasite. A specific E. histolytica 128 bp rRNA gene was identified by PCR in biopsy tissue. The final diagnosis was cerebral amoebiasis. The patient underwent neurosurgery to eliminate amoebic abscesses and was then given a regimen of metronidazole, ceftriaxone and dexamethasone for 4 weeks after the neurosurgery. However, a rapid decline in her condition led to death. CONCLUSIONS: The present case of an individual with a rare form of cerebral amoebiasis highlights the importance of performing immunofluorescence, NMRI and PCR if a patient has brain abscess and a poorly defined diagnosis. Moreover, the administration of corticosteroids to such patients can often lead to a rapid decline in their condition.


Assuntos
Abscesso Encefálico/diagnóstico , Abscesso Encefálico/parasitologia , Infecções Parasitárias do Sistema Nervoso Central/diagnóstico , Entamebíase/diagnóstico , Idoso , Animais , Abscesso Encefálico/tratamento farmacológico , Abscesso Encefálico/cirurgia , Ceftriaxona/administração & dosagem , Infecções Parasitárias do Sistema Nervoso Central/tratamento farmacológico , Infecções Parasitárias do Sistema Nervoso Central/patologia , Infecções Parasitárias do Sistema Nervoso Central/cirurgia , Terapia Combinada , DNA de Protozoário/análise , Dexametasona/administração & dosagem , Quimioterapia Combinada , Entamoeba histolytica/genética , Entamoeba histolytica/imunologia , Entamoeba histolytica/isolamento & purificação , Entamebíase/tratamento farmacológico , Entamebíase/patologia , Entamebíase/cirurgia , Evolução Fatal , Feminino , Humanos , Metronidazol/administração & dosagem , Procedimentos Neurocirúrgicos , Testes Sorológicos
11.
Medicine (Baltimore) ; 99(34): e21671, 2020 Aug 21.
Artigo em Inglês | MEDLINE | ID: mdl-32846782

RESUMO

BACKGROUND: Concerns exist regarding the analgesia effect and safety of multiple versus single doses dexamethasone in unicompartmental knee arthroplasty. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of the dexamethasone administration, and investigate its clinical applicability. We thus further designed a randomized controlled study to assess the different dose of dexamethasone on postoperative pain and complications in patients undergoing unicompartmental knee arthroplasty. METHODS: This randomized, prospective, controlled study was carried out between January 2018 and August 2019. It was approved by the institutional review board in our hospital (HBRM2020013). A total of 80 patients were randomly assigned to each group: the study group (n = 40) and the control group (n = 40). All surgical procedures were performed by a similar orthopedic surgeon. In the study group, patients received intravenously 20 mg dexamethasone (4 mL, Tianjin Kingyork group Co., Ltd., China) just after the anesthesia, and repeated at 24 hours after the surgery. Patients in the control group received intravenously 10 mg dexamethasone solution (2 mL) just after the anesthesia, and repeated at 24 hours after the surgery. CRP, IL-6, VAS pain scores at rest and walking, the VAS scores of nausea, and the incidence of postoperative vomiting and nausea (POVN) were recorded at 24, 48, and 72 hours postoperatively. CONCLUSION: We hypothesized that patients receiving multiple doses of dexamethasone was associated with better outcomes compared with patients receiving single dose of dexamethasone. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5770).


Assuntos
Artroplastia do Joelho , Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Náusea e Vômito Pós-Operatórios/dietoterapia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Artroplastia do Joelho/métodos , Dexametasona/efeitos adversos , Glucocorticoides/efeitos adversos , Humanos , Estudos Prospectivos , Resultado do Tratamento
12.
Trials ; 21(1): 743, 2020 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-32843098

RESUMO

OBJECTIVES: The aim of this study is to explore the effectiveness and safety of high dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to SARS-Cov-2 pneumonia. TRIAL DESIGN: Multicentre, randomized clinical trial, controlled, open label, parallel group, to evaluate the effectiveness and safety of high dose dexamethasone in adult patients with confirmed COVID-19, with Acute Respiratory Distress Syndrome. PARTICIPANTS: We will include patients with SARS-Cov-2 pneumonia who develop acute respiratory distress syndrome, in several intensive care units (ICU) in Buenos Aires, Argentina (CEMIC, Clinica Bazterrica, Sanatorio Sagrado Corazon) Inclusion criteria: Men and women, age ≥ 18 years old. Confirmed diagnosis of SARS-CoV-2 infection, by RT-PCR. Diagnosis of Acute Respiratory Distress Syndrome (hypoxemic respiratory failure not explained by cardiac disease + PaO2/FiO2 ratio < 300 with a Positive End-Expiratory Pressure ≥ 5 cm H2O + bilateral pulmonary infiltrates) Length of mechanical ventilation of at least 72 hours Informed consent (next of kin / legal guardian) Exclusion criteria: Pregnant or breast-feeding women. Terminal disease (advanced cancer; under palliative care; cardiovascular, respiratory, or renal disease with a life expectancy less ≤ 1 year). Therapeutic limitation (advance directives or do not resuscitate order) Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents, active cancer). Patients under chronic treatment with glucocorticoids for other diseases (≥ 8 mg prednisone, or equivalent) Participation in another randomized clinical trial. INTERVENTION AND COMPARATOR: Eligible patients will be randomized to receive standard ICU patient care (group 1) or standard ICU patient care plus high dose dexamethasone (group 2). Group 1: dexamethasone up to 6 mg/24 hours for up to 10 days + ventilatory, hemodynamic, nutritional, and antimicrobial support according to international guidelines. Group 2: dexamethasone 16 mg/24 hours for 5 days followed by dexamethasone 8 mg/24 hours for 5 days + ventilatory, hemodynamic, nutritional, and antimicrobial support according to international guidelines. MAIN OUTCOME: The main result is ventilator-free days at 28 days (Days without ventilator support in the first 28 days following randomization). Secondary outcomes are 28-days and 90-days mortality, frequency of nosocomial infections in the first 28 days after randomization, Sequential Organ Failure Assessment (SOFA) score variation and prone position in the first 10-days, viral shedding 28-days after randomization, and delirium and muscle weakness at ICU discharge. RANDOMISATION: Treatment will be assigned according to site stratified randomization by permuted random blocks sequence 1:1 generated with a table in R language concealed in a randomization tool in REDCap (Research Electronic Data CAPture) platform. BLINDING (MASKING): This is an open trial, so no masking of treatment assignment will be used. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Assuming a 3 days difference in ventilator-free days between treatment groups, with a mean of 9 days, and a standard deviation of 9 days; the necessary sample size would be 284 subjects (142 per group), with a power of 80% and a two-tailed alpha error of 0.05. TRIAL STATUS: The protocol with code 1264, version 3.0 on date: May 13, 2020 is approved by the local Ethics Committee. The trial is in the recruitment phase. Recruitment began May 22, 2020 and is anticipated to be complete by the end of December 2021. TRIAL REGISTRATION: The trial was registered under the title "Dexamethasone for COVID-19 Related ARDS: a Multicenter, Randomized Clinical Trial" with ClinicalTrials number NCT04395105, https://clinicaltrials.gov/ct2/show/NCT04395105 , registered on 20 May 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Infecções por Coronavirus/tratamento farmacológico , Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Pneumonia Viral/tratamento farmacológico , Síndrome do Desconforto Respiratório do Adulto/tratamento farmacológico , Argentina , Betacoronavirus , Infecções por Coronavirus/complicações , Infecção Hospitalar/epidemiologia , Delírio/epidemiologia , Humanos , Mortalidade , Escores de Disfunção Orgânica , Pandemias , Posicionamento do Paciente , Pneumonia Viral/complicações , Decúbito Ventral , Respiração Artificial/estatística & dados numéricos , Síndrome do Desconforto Respiratório do Adulto/etiologia , Eliminação de Partículas Virais
13.
PLoS One ; 15(8): e0237080, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32764779

RESUMO

We previously demonstrated corticosteroid administration on the neonatal intensive care unit was associated with reduced lung function at 11 to 14 years of age in children born very prematurely. The objective of this observational study was to assess if lung function remained impaired at 16 to 19 years of age in those who had received postnatal corticosteroids and whether the trajectory of lung function with increasing age differed between those who had and had not received corticosteroids. One hundred and fifty-nine children born prior to 29 weeks of gestational age had comprehensive lung function measurements; 49 had received postnatal dexamethasone. Lung function outcomes were compared between those who had and had not received postnatal dexamethasone after adjustment for neonatal factors. Forced expiratory flow at 75%, 50%, 25% and 25-75% of the expired vital capacity, forced expiratory volume in one second, peak expiratory flow and forced vital capacity and lung volumes (total lung capacity and residual volume) were assessed. The majority of results were significantly lower in those who received dexamethasone (between 0.61 to 0.78 standard deviations). Lung function reduced as the number of courses of dexamethasone increased. Between 11 and 14 years and 16 to 19 years, lung function improved in the unexposed group, but forced expiratory flow at 75% of the expired vital capacity and forced expiratory volume in one second deteriorated in those who had received postnatal corticosteroids (p = 0.0006). These results suggest that prematurely born young people who received postnatal corticosteroids may be at risk of premature onset of chronic obstructive pulmonary disease.


Assuntos
Displasia Broncopulmonar/prevenção & controle , Dexametasona/efeitos adversos , Lactente Extremamente Prematuro/fisiologia , Nascimento Prematuro/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/epidemiologia , Adolescente , Displasia Broncopulmonar/etiologia , Criança , Dexametasona/administração & dosagem , Feminino , Seguimentos , Volume Expiratório Forçado/efeitos dos fármacos , Volume Expiratório Forçado/fisiologia , Humanos , Recém-Nascido , Masculino , Nascimento Prematuro/fisiopatologia , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Fatores de Risco , Reino Unido/epidemiologia , Capacidade Vital/efeitos dos fármacos , Capacidade Vital/fisiologia
14.
s.l; RedARETS; ago. 2020.
Não convencional em Espanhol | LILACS, BRISA/RedTESA | ID: biblio-1116529

RESUMO

INTRODUCCIÓN: La infección con cuatro de las cepas de coronavirus más comunes (HCoV-229E, HCoV-OC43, HCoV-NL63 y HCoV-HKU1) generalmente conduce a cuadros leves y autolimitadas del tracto respiratorio superior1. Sin embargo, otros coronavirus están asociados con el síndrome respiratorio agudo severo (SARS-CoV) y el síndrome respiratorio del Medio Oriente (MERS-CoV). En marzo de 2020, la Organización Mundial de la Salud (OMS) declaró el brote de COVID-19 como una pandemia mundial, causada por el SARS-CoV-2, una variante del coronavirus. Los síntomas de infección generalmente son inespecíficos e incluyen fiebre, tos y mialgia, diarrea, con o sin el desarrollo posterior de disnea2. Durante la epidemia de SARS-CoV de 2003, se administraron corticosteroides sistémicos como parte del tratamiento en pacientes infectados que desarrollarán una enfermedad respiratoria grave. Existen experiencias con respecto a la utilización de los corticoides como parte del tratamiento de otras infecciones virales, por ejemplo influenza3 y virus respiratorio sincicial4, no habiéndose demostrado resultados beneficiosos y registrándose en algunos casos eventos adersos importantes e incluso incremento en la mortalidad. Teniendo en cuenta esta evidencia indirecta, múltiples organizaciones y autoridades sanitarias sostuvieron que que los corticosteroides no deberían usarse para el tratamiento de COVID-19. Por lo tanto, los efectos terapéuticos y secundarios de la terapia con glucocorticoides sistémicos en pacientes con COVID-19 actualmente no están claros. La reciente publicación de los resultados preliminares de un ensayo aleatorizado multicéntrico (RECOVERY) reportando efectividad del tratamiento con bajas dosis de dexametasona en pacientes con infección grave por SARS-CoV-2; plantea la necesidad de realizar una revisión exhaustiva de la literatura actualmente disponible con el objetivo de identificar y valorar críticamente la evidencia sobre la efectividad y seguridad de la terapia con dexametasona en pacientes adultos con COVID-19, considerando su impacto sobre desenlaces clínicamente relevantes. METODOLOGÍA: Se utilizó la metodología GRADE para la evaluación de la certeza en la evidencia incluída. Para este fin se conformó un equipo multidisciplinario e independiente de conflictos de interés para realizar un informe de ETS. Se realizó una búsqueda amplia, no sistemática, en numerosas bases de datos, organismos sanitarios nacionales e internacionales, repositorios y bases de datos de ETS de distintas agencias, Guías de Práctica Clínica o Protocolos basados en Evidencia. RESULTADOS: La evidencia incluida indicó que el uso de glucocorticoides (dexametasona 6 mg/día por 10 días) en pacientes con neumonía por COVID-19 mostró reducir la mortalidad global a los 28 días, (22.9% vs. 25.7; RR 0.83, IC 95% 0.75 a 0.93), es decir que sería necesario tratar a 33 pacientes para evitar una muerte (NNT 33), (ALTA CONFIANZA). Se observó una disminución global significativa de progresión del cuadro respiratorio con requerimiento de AVM de los pacientes tratados (5,7% vs. 7.8%; RR 0.77; IC 95% 0.62 a 0.95). (CONFIANZA MODERADA). CONCLUSIONES: Se recomienda la administración de dexametasona 6 mg/día durante 10 días en los pacientes con neumonía severa por COVID y requerimientos de oxigenoterapia o AVM, teniendo las precauciones habituales para el uso de dosis bajas de corticoides.


Assuntos
Humanos , Pneumonia Viral/tratamento farmacológico , Dexametasona/administração & dosagem , Infecções por Coronavirus/tratamento farmacológico , Avaliação da Tecnologia Biomédica , Avaliação em Saúde , Análise Custo-Benefício
15.
Respir Physiol Neurobiol ; 280: 103492, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32659271

RESUMO

In December 2019, an outbreak of severe pneumonia was reported in Wuhan, China. Later described as COVID-19 (coronavirus disease 2019), this infection caused by a virus from the Coronaviridae family (SARS-CoV-2) has spread globally. Effective therapies for this new disease are urgently needed. In this short communication, we will evaluate the use of corticosteroids as an adjunctive pharmacological therapy in the management of COVID-19 and describe its pros and cons in light of the latest available evidence.


Assuntos
Anti-Inflamatórios/administração & dosagem , Betacoronavirus/efeitos dos fármacos , Infecções por Coronavirus/tratamento farmacológico , Citocinas/antagonistas & inibidores , Glucocorticoides/administração & dosagem , Pneumonia Viral/tratamento farmacológico , Corticosteroides/administração & dosagem , Corticosteroides/efeitos adversos , Anti-Inflamatórios/efeitos adversos , Betacoronavirus/fisiologia , Infecções por Coronavirus/sangue , Infecções por Coronavirus/fisiopatologia , Citocinas/sangue , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Esquema de Medicação , Glucocorticoides/efeitos adversos , Humanos , Pandemias , Pneumonia Viral/sangue , Pneumonia Viral/fisiopatologia
18.
J Cancer Res Clin Oncol ; 146(11): 3063-3074, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-32617699

RESUMO

PURPOSE: Case reports suggest that ruxolitinib-containing treatment could increase the clinical response rate of patients with hemophagocytic syndrome (HPS). This study aimed to explore the effect of ruxolitinib-containing treatment for patients with lymphoma-associated hemophagocytic syndrome (LAHS). METHODS: This was a retrospective study of patients with LAHS hospitalized at the First Affiliated Hospital of Guangdong Pharmaceutical University between October 2017 and September 2019. Patients were treated with HLH-94 (etoposide and dexamethasone) or R-DED regimen (ruxolitinib, doxorubicin, etoposide, and dexamethasone). The clinical characteristics, treatment responses, and overall survival (OS) were compared. The patients were divided into the HLH-94 group (n = 34) and the R-DED group (n = 36). RESULTS: Compared with HLH-94, R-DED might effectively improve the clinical manifestations, including fever and splenomegaly in patients with LAHS, and control the systemic cytokine storm. The response rate at 2 weeks was 54.8% in the HLH-94 group, which was lower than in the R-DED group (83.3%) (p = 0.011). The OS was significantly prolonged in the R-DED group compared with the HLH-94 group (median, 5 vs. 1.5 months, p = 0.003). The multivariable analysis showed that lower IL-10 levels [hazard ratio (HR)] = 1.000, [95% confidence interval (CI)] 1.000-1.000, p = 0.012), R-DED regimen (HR = 0.196, 95% CI 0.084-0.457, p < 0.001), and non-NK/T-cell lymphoma (HR = 0.254, 95% CI 0.102-0.628, p = 0.003) were associated with better OS. The prognosis of patients with LAHS was generally poor. CONCLUSION: Ruxolitinib can be combined with chemotherapy in HPS. It is feasible, with no early signals of increased toxicity.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Linfo-Histiocitose Hemofagocítica/etiologia , Linfoma/complicações , Linfoma/tratamento farmacológico , Adulto , Dexametasona/administração & dosagem , Doxorrubicina/administração & dosagem , Etoposídeo/administração & dosagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pirazóis/administração & dosagem , Estudos Retrospectivos
20.
BMJ Case Rep ; 13(7)2020 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-32690571

RESUMO

A 45-year-old man presented with acute sinusitis. He was treated with a 10-day course of trimethoprim/sulfamethoxazole, and a subsequent 14-day course of amoxicillin-clavulanate with no improvement in symptoms. Culture of purulent nasal secretions revealed the rare enterobacter Cedecea lapagei The patient had complete resolution of his symptoms after a 14-day course of gentamicin/dexamethasone nasal rinses. Emerging pathogens have been a timeless concern for physicians, as witnessed by the current SARS-CoV-2 outbreak. C. lapagei has been reported to cause human infection only a dozen times since its discovery, all in severely compromised patients. This is the first documented case of sinusitis reported with C. lapagei and may portend a rising prevalence of disease burden in the general population. This case demonstrates the necessity of obtaining cultures when standard antibiotics result in treatment failure.


Assuntos
Dexametasona/administração & dosagem , Infecções por Enterobacteriaceae/tratamento farmacológico , Gentamicinas/administração & dosagem , Sinusite/tratamento farmacológico , Doença Aguda , Combinação Amoxicilina e Clavulanato de Potássio/uso terapêutico , Antibacterianos/uso terapêutico , Betacoronavirus , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Dexametasona/uso terapêutico , Quimioterapia Combinada/métodos , Enterobacteriaceae/isolamento & purificação , Infecções por Enterobacteriaceae/complicações , Gentamicinas/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Sinusite/microbiologia , Resultado do Tratamento , Combinação Trimetoprima e Sulfametoxazol/uso terapêutico
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