Avaliação comparativa do plasma hiperimune nas três sangrias de produção dos cavalos soroprodutores da Fazenda São Joaquim / Comparative evaluation of hyperimmune plasma in the three production bleeds of seroproducers at Fazenda São Joaquim

Hyperimmune plasma is the raw material for the production of heterologous serum, which corresponds to the main specific treatment against toxins from microorganisms and venomous animals. This work aims to perform a comparative analysis of the plasma collected in the three production bleeds, subjectively analyzing the production of immunoglobulins through the amount of total protein and measuring the levels of pH, glucose, leukocytes, density and fibrinogen. Samples were collected from 67 horses, divided into three groups according to the antigen to which they were immunized, being: Group 1 (G1) - immunized against tetanus toxoid, Group 2 (G2) - immunized against crotalic antigen and Group 3 ( G3) - immunized against scorpionic antigen. Samples were obtained during production bleeding procedures, by collecting whole blood in vacuum tubes with EDTA. The analyzes were performed using a refractometer to quantify total protein, density and fibrinogen and reagent strips for measuring pH, leukocytes and glucose. The results demonstrate significant variations between the three services studied, mainly in relation to total protein, where in G1 its peak production occurred in the second bleed, in G2 it remained stable in the first two bleeds with a slight drop in the third, and in G3 with peak in the first production bleed. Through the rapid tests proposed in this study it is possible to have an overview of the divergence of parameters between the three production bleeds, quickly and at a low cost, but to obtain more reliable results, especially with regard to immunoglobulins, indicated the adoption of more specific analysis techniques.

O plasma hiperimune é a matéria prima para produção de soro heterólogo, que corresponde ao principal tratamento específico contra toxinas oriundas de micro-organismos e animais peçonhentos. Este trabalho tem por objetivo realizar uma análise comparativa do plasma coletado nas três sangrias de produção, analisando subjetivamente a produção de imunoglobulinas através da quantidade de proteína total e dosar os níveis de pH, glicose, leucócitos, densidade e fibrinogênio. Foram coletadas amostras de 67 equinos, divididos em três grupos de acordo com o antígeno ao qual foram imunizados, sendo: Grupo 1 (G1) – imunizados contra o toxóide tetânico, Grupo 2 (G2) – imunizados contra o antígeno crotálico e Grupo 3 (G3) – imunizados contra o antígeno escorpiônico. As amostras foram obtidas durante os procedimentos de sangrias de produção, através da coleta de sangue total em tubos à vácuo com EDTA. As análises foram realizadas através do uso de refratômetro para quantificação de proteína total, densidade e fibrinogênio e de tiras reagentes para dosagem de pH, leucócitos e glicose. Os resultados demonstram significativas variações entre os três serviços estudados, principalmente em relação a proteína total, onde em G1 seu pico de produção ocorreu na segunda sangria, em G2 permaneceu estável nas duas primeiras sangrias com ligeira queda na terceira, e em G3 com pico na primeira sangria de produção. Através dos testes rápidos propostos nesse estudo é possível ter uma visão geral das divergências de parâmetros entre as três sangrias de produção, de forma rápida e com baixo custo, porém para se obter resultados mais fidedignos, principalmente no que se refere as imunoglobulinas, indica-se a adoção de técnicas mais específicas de análises.

A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom.

BACKGROUND: Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A2, cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. METHODS: In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. RESULTS: This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research - CONEP) and sanitation (National Health Surveillance Agency - ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. CONCLUSIONS: This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera. The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas.

A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom

Abstract Background Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A2, cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. Methods In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. Results This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research CONEP) and sanitation (National Health Surveillance Agency ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. Conclusions This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera. The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas.

A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom

Background Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A2, cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. Methods In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. Results This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research - CONEP) and sanitation (National Health Surveillance Agency - ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. Conclusions This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera. The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas.(AU)

Evolution and prophylaxis of human rabies

Rabies is a viral acute encephalitis of progressive and fatal outcome, particular of hot-blooded animals, and accidentally affecting men. Since it is a zoonosis with different animal species acting as a reservoir in the nature, this disease is a great public health problem in several countries in development. Prophylactic treatments for human rabies started in 1885 with Louis Pasteur, and developed in order to provide higher protection and lower incidence of side effects. Today, treatments of pre and post-exposure to the virus are well established, with excellent results of protection for individuals exposed to animals potentially contaminated by the rabies virus. These treatments consist of utilising the vaccine isolatedly or in combination with equine immunoglobulin, what contributes, in an important way, to the decrease in the number of cases of rabies.(AU)