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Resumen Introducción: La inmunoterapia pasiva es una alternativa terapéutica para los pacientes con COVID-19. Métodos: Se tomó la decisión de realizar una base de datos prospectiva de los pacientes con diagnóstico de neumonía por SARS-CoV-2, no hipoxémica, tratados de forma ambulatoria en el Hospital de Bolívar, Dr. Miguel Capredoni, provincia de Buenos Aires, Argentina, con el objetivo de evaluar la eficacia del tratamiento con suero equino hiperinmune en la reducción de casos graves e internaciones. Realizamos un análisis retrospectivo del período comprendido entre el 26/05/2021 al 28/08/2021, se incluyeron 151 pacientes. Las opciones fueron meprednisona y colchicina asociadas a dos infusiones de suero equino (n = 92) o me prednisona y colchicina durante 10 días por vía oral (n = 59). Resultados: No se observaron diferencias en las características poblacionales y comorbilidades entre ambos grupos. El 46% (69) de los pacientes había recibido por lo menos una dosis de vacuna contra COVID-19. Durante el seguimiento el 23% (35) requirió internación, sin diferencias entre el grupo suero equino y el grupo control (p = 0.89). Se observó una tendencia no significa tiva al riesgo de internación prolongada del 15.7%. (Grupo suero equino 38.1% vs. grupo control 53.8%, Fisher Exact test p = 0.41). La mortalidad en el grupo suero equino fue del 3.97% (4), sin observarse diferencias entre ambos grupos. Se observaron diferencias entre los pacientes vacunados y no vacunados, en puntos duros como necesidad de ARM (0% vs. 8% p = 0.001) y muerte (0% vs. 8% p = 0.001). Discusión: Si bien las tasas de internación y muerte fueron menores de lo esperado, la utilización de suero equino hiperinmune en el escenario ambulatorio impresiona no aportar beneficio clínico.
Abstract Introduction: Passive immunotherapy is a therapeutic alternative for patients with COVID-19. Methods: The decision was made to create a prospective database of patients diagnosed with SARS-CoV-2 pneumonia, non-hypoxemic, treated on an outpatient basis at the Hospital de Bolívar, Dr. Miguel Capredoni, province of Buenos Aires, Argentina, with the aim of evaluating the efficacy in reducing severe cases and hospitalizations of treatment with hyperimmune equine serum in this subgroup of patients. We performed a retrospective analysis of the period from 05/26/2021 to 08/28/2021, where a total of 151 patients were included. The options were meprednisone plus colchicine associated with two equine serum infusions (n = 92) or oral meprednisone and colchicine for 10 days (59). Results: No differences were observed between the population characteristics and comorbidities between both groups. A 46% (69) of the patients had received at least one dose of vaccine against COVID-19. During follow-up, 23% (35) required hospitalization, with no differences between the equine serum group and the control group (p = 0.89). A non-significant trend of 15.7% was observed for the risk of prolonged hospitalization. (Equine serum group 38.1% vs. control group 53.8%, Fisher Exact test p = 0.41). Mortality between the equine serum group was 3.97% (4), with no differences between the two groups. Differences were observed between vaccinated and unvaccinated patients in hard points such as the need for MRA (0% vs. 8% p = 0.001) and death (0% vs. 8% p = 0.001). Discussion: Although the rate of hospitalization and death were lower than expected, the use of hyperimmune equine serum in the outpatient setting impresses as not providing clinical benefit.
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Abstract The treatment with hyperimmune sera constitute the only specific and effective therapy available against snakebite envenomation, most common in developing countries. Serum quality is an important factor on patient recovery time and in the incidence of death and permanent disability. To date, most sera consist of pepsin digested IgG antibodies harvested from hyperimmune animals. The use of animal derived enzymes, such as pepsin, to digest IgG, constitute a source of adventitious agents and contaminants, such as porcine circovirus. The present study aims to evaluate the use of the plant derived enzymes bromelain and ficin, as an alternative to pepsin. To this purpose, horse serum immunized against Bothrops venoms was purified with caprylic acid and digested with bromelain or ficin. SDS-PAGE results evidence the formation of F(ab)'2 fragments and suggest that a digestion time superior to 8 hours may be required to completely digest the antibodies with bromelain or ficin. F(ab)'2 fragments obtained by digestion with either bromelain or ficin digestion preserved the ability to recognize Bothrops sp. venom in western blotting assays. Therefore, both enzymes are suitable for use in large-scale production, minimizing contamination risks and increasing safety and efficiency of serotherapy treatments.
RESUMO
ABSTRACT The use of a commercial kit for the monocyte-activation test (MAT) was evaluated for assessing pyrogenic contamination of hyperimmune sera . Three batches of sera, two pyrogen free and one pyrogenic, were tested. Endotoxin spike recover indicated that sample dilutions from 1/2 to 1/10 are suitable. Kit transport and storage conditions were also evaluated, proving that an adequate cold chain must be assured to achieve good results. Furthermore, the commercial MAT kit seemed suitable to replace the rabbit pyrogen test (RPT) for pyrogen testing of hyperimmune sera, although further tests are needed to a full validation.