RESUMEN
Baricitinib and imatinib are considered therapies for coronavirus disease 2019 (COVID-19), but their ultimate clinical impact remains to be elucidated, so our objective is to determine whether these kinase inhibitors provide benefit when added to standard care in hospitalized COVID-19 patients. Phase-2, open-label, randomized trial with a pick-the-winner design conducted from September 2020 to June 2021 in a single Spanish center. Hospitalized adults with COVID-19 pneumonia and a symptom duration ≤10 days were assigned to 3 arms: imatinib (400 mg qd, 7 days) plus standard-care, baricitinib (4 mg qd, 7 days) plus standard-care, or standard-care alone. Primary outcome was time to clinical improvement (discharge alive or a reduction of 2 points in an ordinal scale of clinical status) compared on a day-by-day basis to identify differences ≥15% between the most and least favorable groups. Secondary outcomes included oxygenation and ventilatory support requirements, additional therapies administered, all-cause mortality, and safety. One hundred and sixty-five patients analyzed. Predefined criteria for selection of the most advantageous arm were met for baricitinib, but not for imatinib. However, no statistically significant differences were observed in formal analysis, but a trend toward better results in patients receiving baricitinib was found compared to standard care alone (hazard ratio [HR] for clinical improvement: 1.41, 95% confidence intervals [CI]: 0.96-2.06; HR for discontinuing oxygen: 1.46, 95% CI: 0.94-2.28). No differences were found regarding additional therapies administered or safety. Baricitinib plus standard care showed better results for hospitalized COVID-19 patients, being the most advantageous therapeutic strategy among those proposed in this exploratory clinical trial.
Asunto(s)
COVID-19 , Adulto , Humanos , Mesilato de Imatinib , SARS-CoV-2 , Tratamiento Farmacológico de COVID-19 , Resultado del TratamientoRESUMEN
Coronavirus disease 2019 (COVID-19) infection in elderly patients is more aggressive and treatments have shown limited efficacy. Our objective is to describe the clinical course and to analyze the prognostic factors associated with a higher risk of mortality of a cohort of patients older than 80 years. In addition, we assess the efficacy of immunosuppressive treatments in this population. We analyzed the data from 163 patients older than 80 years admitted to our institution for COVID-19, during March and April 2020. A Lasso regression model and subsequent multivariate Cox regression were performed to select variables predictive of death. We evaluated the efficacy of immunomodulatory therapy in three cohorts using adjusted survival analysis. The mortality rate was 43%. The mean age was 85.2 years. The disease was considered severe in 76.1% of the cases. Lasso regression and multivariate Cox regression indicated that factors correlated with hospital mortality were: age (hazard ratio [HR] 1.12, 95% confidence interval [CI]: 1.03-1.22), alcohol consumption (HR 3.15, 95% CI: 1.27-7.84), CRP > 10 mg/dL (HR 2.67, 95% CI: 1.36-5.24), and oxygen support with Venturi Mask (HR 6.37, 95% CI: 2.18-18.62) or reservoir (HR 7.87, 95% CI: 3.37-18.38). Previous treatment with antiplatelets was the only protective factor (HR 0.47, 95% CI: 0.23-0.96). In the adjusted treatment efficacy analysis, we found benefit in the combined use of tocilizumab (TCZ) and corticosteroids (CS) (HR 0.09, 95% CI: 0.01-0.74) compared to standard treatment, with no benefit of CS alone (HR 0.95, 95% CI: 0.53-1.71). Hospitalized elderly patients suffer from a severe and often fatal form of COVID-19 disease. In this regard, several parameters might identify high-risk patients upon admission. Combined use of TCZ and CS could improve survival.
Asunto(s)
Corticoesteroides/administración & dosificación , Anticuerpos Monoclonales Humanizados/administración & dosificación , Tratamiento Farmacológico de COVID-19 , COVID-19/mortalidad , Anciano de 80 o más Años , COVID-19/virología , Comorbilidad , Quimioterapia Combinada , Femenino , Mortalidad Hospitalaria , Hospitalización , Humanos , Masculino , Pronóstico , Estudios Retrospectivos , SARS-CoV-2/efectos de los fármacos , SARS-CoV-2/fisiología , España/epidemiología , Análisis de SupervivenciaRESUMEN
Immune thrombocytopenia, also known as immune thrombocytopenic purpura (ITP), has been reported as an important complication related to COVID-19.We present a 49-year-old male patient with systemic lupus erythematosus with lupus nephritis, antiphospholipid syndrome and history of ITP who developed an ITP flare in the context of COVID-19. He had no bleeding manifestations and had a good response to prednisone treatment.We review the characteristics of the cases reported to date in the literature, with an analysis of 57 patients. Mean age was 56 years (±19.6 SD), and 50.9% were male. This was the first episode of ITP in most of the patients (86.05%), with SARS-CoV-2 acting as the initial trigger. We found that ITP flares may appear in both mild and severe COVID-19 cases. They also appeared at any time during the course of the disease, 48.2% of patients developed it during hospitalization, while it was diagnosed at admission in the rest of the cases. Platelet counts were significantly lower than other ITP series, with a median nadir platelet count of 8 × 109/L (IQR 2-17.75 × 109/L). These patients show a higher bleeding rate (61.4%) compared with other ITP series. They also show a better response to treatment, with good response to the first line therapies in 76.9% of them. The most common first-line treatment was intravenous immunoglobulin (IVIG), used alone or combined with corticosteroids in 40.4% and 32.7% of cases respectively, while 25% of patients received only corticosteroids.Our review suggests that COVID-19-related ITP can be seen even in previously healthy patients. Clinicians must be aware that ITP may appear both in mild and severe COVID-19, at any time during its course. Given that this kind of ITP seems to be associated with a higher bleeding risk, its diagnosis in a clinical scenario such as COVID-19, where anticoagulant therapy is frequently used, may be critical. Treatment with IVIG and/or corticoids is often effective.
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COVID-19/complicaciones , Prednisona/administración & dosificación , Púrpura Trombocitopénica Idiopática/diagnóstico , Glucocorticoides/administración & dosificación , Humanos , Inmunoglobulinas Intravenosas/administración & dosificación , Lupus Eritematoso Sistémico/complicaciones , Masculino , Persona de Mediana Edad , Recuento de Plaquetas , Púrpura Trombocitopénica Idiopática/tratamiento farmacológico , Púrpura Trombocitopénica Idiopática/virología , Resultado del TratamientoAsunto(s)
Mano/diagnóstico por imagen , Hiperparatiroidismo/diagnóstico por imagen , Osteítis Fibrosa Quística/diagnóstico por imagen , Calcio/sangre , Humanos , Hiperparatiroidismo/sangre , Hiperparatiroidismo/cirugía , Masculino , Persona de Mediana Edad , Osteítis Fibrosa Quística/etiología , Hormona Paratiroidea/sangre , Neoplasias de las Paratiroides/cirugía , Paratiroidectomía , RadiografíaAsunto(s)
Betacoronavirus/patogenicidad , Infecciones por Coronavirus/tratamiento farmacológico , Mesilato de Imatinib/uso terapéutico , Pulmón/efectos de los fármacos , Neumonía Viral/tratamiento farmacológico , Inhibidores de Proteínas Quinasas/uso terapéutico , Adulto , Biomarcadores/sangre , Proteína C-Reactiva/metabolismo , COVID-19 , Infecciones por Coronavirus/diagnóstico por imagen , Infecciones por Coronavirus/patología , Infecciones por Coronavirus/virología , Combinación de Medicamentos , Femenino , Humanos , Hidroxicloroquina/administración & dosificación , Lopinavir/administración & dosificación , Pulmón/diagnóstico por imagen , Pulmón/patología , Pulmón/virología , Pandemias , Neumonía Viral/diagnóstico por imagen , Neumonía Viral/patología , Neumonía Viral/virología , Ritonavir/administración & dosificación , SARS-CoV-2 , Tomografía Computarizada por Rayos X , Resultado del TratamientoRESUMEN
(1) Background: COVID-19 has evolved during seven epidemic waves in Spain. Our objective was to describe changes in mortality and severity in our hospitalized patients. (2) Method: This study employed a descriptive, retrospective approach for COVID-19 patients admitted to the Hospital de Fuenlabrada (Madrid, Spain) until 31 December 2022. (3) Results: A total of 5510 admissions for COVID-19 were recorded. The first wave accounted for 1823 (33%) admissions and exhibited the highest proportion of severe patients: 65% with bilateral pneumonia and 83% with oxygen saturation under 94% during admission and elevated levels of CRP, IL-6, and D-dimer. In contrast, the seventh wave had the highest median age (79 years) and comorbidity (Charlson: 2.7), while only 3% of patients had bilateral pneumonia and 3% required intubation. The overall mortality rate was 10.3%. The first wave represented 39% of the total. The variables related to mortality were age (OR: 1.08, 1.07-1.09), cancer (OR: 1.99, 1.53-2.60), dementia (OR: 1.82, 1.20-2.75), the Charlson index (1.38, 1.31-1.47), the need for high-flow oxygen (OR: 6.10, 4.94-7.52), mechanical ventilation (OR: 11.554, 6.996-19.080), and CRP (OR: 1.04, 1.03-1.06). (4) Conclusions: The variables associated with mortality included age, comorbidity, respiratory failure, and inflammation. Differences in the baseline characteristics of admitted patients explained the differences in mortality in each wave. Differences observed between patients admitted in the latest wave and the earlier ones suggest that COVID-19 has evolved into a distinct disease, requiring a distinct approach.
Asunto(s)
COVID-19 , Epidemias , Humanos , Anciano , COVID-19/epidemiología , Estudios Retrospectivos , Hospitales , HospitalizaciónRESUMEN
Introducción: Debido a la inestabilidad rotatoria de las fracturas basicervicales, en estudios recientes, se sugiere el uso de una hoja espiral, doble tornillo o tornillos de compresión en lugar del tornillo cefálico único. Objetivo: Analizar los resultados de las fracturas basicervicales tratadas con tornillo cefálico único en nuestro centro. Materiales y Métodos: Estudio retrospectivo de una serie de casos formada a partir de la revisión de todas las fracturas extracapsulares de fémur proximal tratadas con clavo intramedular con tornillo cefálico único entre 2016 y 2020. Se revisaron las historias clínicas y las radiografías de 269 pacientes, y solo 12 (6,4%) de ellos cumplieron los criterios de inclusión (fracturas en dos fragmentos no patológicas y con seguimiento mínimo de 9 meses). Se evaluaron diferentes factores, como distancia punta-ápex, posición del tornillo cefálico, calidad de la reducción, tiempo quirúrgico, complicaciones y reintervención, y se analizaron las posibles diferencias entre los pacientes que sufrieron complicaciones y los que no. Resultados: Cuatro de los 12 pacientes tuvieron una falla de la fijación que evolucionó a cut-out (única complicación identificada en la muestra). No hubo diferencias estadísticamente significativas entre pacientes con cut-outo sin cut-out respecto al resto de las variables analizadas. Conclusiones: La elevada proporción de pacientes que desarrollaroncut-out sugiere considerar la hipótesis de que debería evitarse fijar las fracturas basicervicales con tornillo cefálico único. Dada su alta tasa de inestabilidad rotatoria, podría ser más apropiado el uso de implantes que la contrarresten. Nivel de Evidencia: IV
Background: Given the rotational instability of basicervical fractures, recent studies suggest using a spiral blade, a second screw or compression screws instead of single-screw cephalomedullary nail fixation. Objective: The aim of our study is to analyze the outcomes of basicervical fractures treated with single-screw cephalomedullary nails. Materials and Methods: This is a retrospective study based on a case series identified from all extracapsular femoral fractures treated with single-screw cephalomedullary nails in our hospital from 2016 to 2020. Clinical records and radiographs from 269 patients were reviewed; only 12 (6.4%) subjects met inclusion criteria (two-part non-pathologic fractures with at least a 9-month follow-up). Different factors were evaluated, including: tip-apex distance, cephalic screw position, reduction quality, surgical time, complications and re-operations; differences between patients who experienced complications and those who did not were also assessed. Results: Four subjects out of the 12 included patients experienced fixation failure and implant cut-out. There were no statistically significant differences between subjects with and without cut-out regarding the analyzed variables. Conclusions: The high cut-out rate observed in our sample suggests considering the hypothesis that single-screw cephalomedullary nail fixation should not be used in basicervical fractures. Alternative fixation devices capable of controlling the high rotational instability of these fractures may be preferable. Level of Evidence: IV