Safety and effectiveness of RBD-specific polyclonal equine F(ab´)2 fragments for the treatment of hospitalized patients with severe Covid-19 disease: A retrospective cohort study.

BACKGROUND: Passive immunotherapy has been evaluated as a therapeutic alternative for patients with COVID-19 disease. Equine polyclonal immunotherapy for COVID-19 (EPIC) showed adequate safety and potential efficacy in a clinical trial setting and obtained emergency use authorization in Argentina. We studied its utility in a real world setting with a larger population. METHODS: We conducted a retrospective cohort study at "Hospital de Campaña Escuela-Hogar" (HCEH) in Corrientes, Argentina, to assess safety and effectiveness of EPIC in hospitalized adults with severe COVID-19 pneumonia. Primary endpoints were 28-days all-cause mortality and safety. Mortality and improvement in modified WHO clinical scale at 14 and 21 days were secondary endpoints. Potential confounder adjustment was made by logistic regression weighted by the inverse of the probability of receiving the treatment (IPTW) and doubly robust approach. FINDINGS: Subsequent clinical records of 446 non-exposed (Controls) and 395 exposed (EPIC) patients admitted between November 2020 and April 2021 were analyzed. Median age was 58 years and 56.8% were males. Mortality at 28 days was 15.7% (EPIC) vs. 21.5% (Control). After IPTW adjustment the OR was 0.66 (95% CI: 0.46-0.96) P = 0.03. The effect was more evident in the subgroup who received two EPIC doses (complete treatment, n = 379), OR 0.58 (95% CI 0.39 to 0.85) P = 0.005. Overall and serious adverse events were not significantly different between groups. CONCLUSIONS: In this retrospective cohort study, EPIC showed adequate safety and effectiveness in the treatment of hospitalized patients with severe SARS-CoV-2 disease.

Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere®) in patients with neovascular age-related macular degeneration.

The present study was an open-label, prospective, uncontrolled and multicenter clinical trial to investigate the safety and effectiveness of bevacizumab (Lumiere®) administered by the intravitreal route for the treatment of neovascular age-related macular degeneration (nAMD). A total of 22 patients without previous treatment with anti-vascular endothelial growth factor were recruited. Monthly therapy with 1.25 mg intravitreal bevacizumab was applied. Adverse events (AE), visual acuity (VA) and central retinal thickness (CRT) were assessed at baseline, day 1 and day 28 after each injection. A total of 87 AEs were reported; most of them were not serious (96.6%), expected (65.5%) and occurred after the third injection (56.3%). The most frequent AE was 'conjunctival hemorrhage' (29.9% of AEs), attributed to the injection procedure. Treatment was not suspended due to safety reasons in any case. After six months, a statistically significant gain of +8.2 (SD±8.8) letters and a CRT reduction of -75.50 µm (SD±120.3) were achieved with unilateral therapy. VA improvement and CRT reduction were also achieved with bilateral therapy, although to a lesser extent. The results of the present study suggested that therapy with a minimum of 3 doses of bevacizumab over a 6-month period was well tolerated and resulted in a sustained response regarding VA improvement and CRT reduction from the beginning of therapy compared with the baseline value. The study protocol was registered at clinicaltrials.gov (ref. no. NCT03668054).

Síndrome de piernas inquietas / Syndrome of disturb legs

El Síndrome de las Piernas Inquietas (SPI) es un síndrome sensitivo motor que se caracteriza por presentar una sensación desagradable en los miembros inferiores que generan la necesidad de mover las extremidades, cediendo o atenuándose los síntomas con el movimiento. En general aparece y/o empeora por la noche y en los momentos de reposo. Es frecuente en la población general, usualmente subconsultado y subdiagnosticado a pesar que altera la calidad de vida del paciente. Se describe el SPI primario de etiología idiomática, de frecuente agregación familiar, y el secundario a deficiencia de hierro, embarazo, enfermedad renal avanzada y patología raquimedular. El diagnóstico es clínico y no requiere complejidad en los estudios complementarios. Se sugiere valorar a los pacientes con un hemograma, dosaje de ferritina, urea, creatinina y glucemia. El tratamiento consiste en tratar la causa secundaria cuando existe, principalmente la deficiencia de hierro. También se sugiere realizar cambios del estilo de vida y tratamiento no farmacológico; en caso de no responder, los agonistas dopaminérgicos, los opioides y los anticonvulsivantes constituyen tratamientos eficaces.

Ascitis en la práctica ambulatoria / Ascites in the ambulatory practice

El diagnóstico de la ascitis y de su causa se basa en datos de la historia clínica, del examen físico y del análisis del líquido peritoneal extraído por paracentesis. En general son innecesarios otras pruebas diagnósticas para encontrar la causa que origina el síndrome ascítico. Si el gradiente albúmino/albúmina es mayor a 1,1 pero los signos y síntomas no son concluyentes de enfermedad hepática, un valor elevado de proteínas en el líquido peritoneal ayuda a diferenciar una obstrucción al flujo hepático como la que ocurre en la insuficiencia cardíaca, la pericarditis y el síndrome de Budd Chiari ya que el nivel de proteínas es inferior a 2,5 gr/dl en la cirrosis y superior a dicha cifra en los trastornos hepáticos congestivos. En una pequeña cantidad de pacientes la evaluación clínica, las pruebas de función hepática y el análisis del líquido ascítico no proporcionan un diagnostico definitivo. En estos casos la laparoscopia ayuda al permitir una visualización directa de la cavidad peritoneal y la toma de muestra para biopsia hepática y/o peritoneal.

Enfermedad celíaca / Celiac disease

La enfermedad celíaca es una enfermedad autoinmune que cursa con una agresión inflamatoria sobre la mucosa del intestino delgado. Es precipitada por la ingesta de una fracción proteica del gluten de la dieta en personas susceptibles genéticamente. La manifestación es atípica u oligosintomática, siendo la forma clásica de síndrome de malabsorción, poco frecuente. La disponibilidad y seguridad de los test serológicos permiten identificar a los pacientes con la enfermedad. El testeo serológico debe ser considerado en pacientes genéticamente predispuestos como las personas con historia familiar de la enfermedad, los pacientes con DBT tipo I, dermatitis herpetiforme, diarrea crónica, anemia no explicada, fatiga crónica, pérdida de peso sin causa aparente, dispepsia y síndrome de colon irritable de mala evolución sintomática. La dieta libre de gluten lleva a la curación de las lesiones mucosas, a la desaparición de la mala absorción y podría reducir el riesgo de enfermedades linfoproliferativas y de adenocarcinoma.

The deep-breath test as a diagnostic maneuver for white-coat effect in hypertensive patients.

BACKGROUND: The white-coat effect is a common phenomenon in hypertensive patients, and there is no current useful office test to detect it. METHODS: This was a cross-sectional study. We evaluated the deep-breath maneuver at the office as a diagnostic test of the white-coat effect. Participants included 83 adult patients with uncontrolled office hypertension. We measured sensitivity, specificity, likelihood ratios of different cutoff points, area under receiver operating characteristic (ROC) curve, and 95% confidence intervals. The reference standard used was 24-hour ambulatory blood pressure monitoring. RESULTS: We included 73 patients [mean age, 58.7 +/- 9.5 years (mean +/- SD); 55% women]. The prevalence of white-coat effect was 62%. Comparing patients with white-coat effect versus those without, the deep-breath test resulted in a mean systolic blood pressure decrease of 17.8 and 10.9 mm Hg (P <.001) and a mean diastolic decrease of 6.6 and 5.4 mm Hg, respectively (P = not significant). The area under the ROC curve of systolic blood pressure change was 0.69 (95% confidence interval, 0.57 to 0.81). Interobserver agreement was very good. CONCLUSIONS: The deep-breath test can be a helpful maneuver for the detection of white-coat effect. It has no major adverse effects and it may help avoid overtreatment and unnecessary further testing procedures.