RESUMO
We evaluated the safety, optimal dose, and preliminary effectiveness of a new-approach Africanized honeybee (Apis mellifera) Antivenom (AAV) in a phase I/II, multicenter, non-randomized, single-arm clinical trial involving 20 participants with multiple stings. Participants received 2 to 10 vials of AAV depending on the number of stings they suffered, or a predefined adjuvant, symptomatic, and complementary treatment. The primary safety endpoint was the occurrence of early adverse reactions within the first 24 h of treatment. Preliminary efficacy based on clinical evolution, including laboratory findings, was assessed at baseline and at various time points over the four following weeks. ELISA assays and mass spectrometry were used to estimate venom pharmacokinetics before, during, and after treatment. Twenty adult participants, i.e., 13 (65%) men and 7 (35%) women, with a median age of 44 years and a mean body surface area of 1.92 m2 (median = 1.93 m2) were recruited. The number of stings ranged from 7 to > 2,000, with a median of 52.5. Symptoms of envenoming were classified as mild, moderate, or severe in 80% (16), 15% (3), and 5% (1) of patients, respectively; patients with mild, moderate, or severe envenoming received 2, 6, and 10 vials of AAV as per the protocol. None of the patients had late reactions (serum sickness) within 30 d of treatment. There was no discontinuation of the protocol due to adverse events, and there were no serious adverse events. One patient had a moderate adverse event, transient itchy skin, and erythroderma. All participants completed the intravenous antivenom infusion within 2 h, and there was no loss to follow-up after discharge. ELISA assays showed venom (melittin and PLA2) concentrations varying between 0.25 and 1.479 ng/mL prior to treatment. Venom levels decreased in all patients during the hospitalization period. Surprisingly, in nine cases (45%), despite clinical recovery and the absence of symptoms, venom levels increased again during outpatient care 10 d after discharge. Mass spectrometry showed melittin in eight participants, 30 d after treatment. Considering the promising safety results for this investigational product in the treatment of massive Africanized honeybee attack, and its efficacy, reflected in the clinical improvements and corresponding immediate decrease in blood venom levels, the AAV has shown to be safe for human use. Clinical Trial Registration: UTN: U1111-1160-7011, identifier [RBR-3fthf8].
RESUMO
Relato de experiência de situação vivenciada, em 2009, por acadêmicas de enfermagem, durante estágio da disciplina Enfermagem em Doenças Transmissíveis, na enfermaria de dermatologia de um hospital de ensino do interior paulista, em que cuidaram de um paciente com Epidermodisplasia Verruciforme. Esta é uma genodermatose rara, com susceptibilidade à infecção por diferentes tipos de papiloma vírus humanos, ocasionando alterações físicas exacerbadas e impactando o psiquismo da pessoa acometida. A assistência foi baseada na complexidade assistencial indicada pela aplicação do Sistema de Classificação de Pacientes proposto por Perroca. A experiência proporcionou aprendizado no cuidado a paciente portador de doença rara, complexa e de difícil resolução, possibilitando a necessidade de assisti-lo integralmente, percebendo-o além das lesões. Conclui-se que este tipo de experiência muito contribuiu para o crescimento das acadêmicas como futuras profissionais de enfermagem.
Report of an experience of nursing students in providing care to a patient with epidermodysplasia verruciformis, during the internship in the discipline Nursing in Transmittable Diseases, at the dermatology ward of a teaching hospital, located in the state of São Paulo, Brazil, in 2009. This is a rare genodermatosis, susceptible to infection with different types of human papilloma viruses, that cause exacerbated physical changes that impact the psyche of the affected individual. Care delivery was based on the assistance complexity indicated by the application of the Patient Classification System proposed by Perroca. The experience allowed students to learn how to cope with a patient affected by a rare and complex disease, of difficult resolution, and to provide integral care to this individual, perceiving him beyond the lesions. One conclude that the experience has greatly contributed to the growth of the students as future professionals.
Relato de experiencia vivida por estudiantes de enfermería, en 2009, durante la pasantía de la disciplina de Enfermería en Enfermedades Transmisibles, en la sala de dermatología de un hospital universitario del estado de São Paulo, Brasil, donde cuidarán a uno paciente con Epidermodisplasia Verruciforme. Esta es una genodermatosis rara, con susceptibilidad para la infección por diferentes tipos de virus del papiloma humano, causando cambios físicos exasperados e impacto en la psiquis de la persona afectada. La asistencia esté basada en la complejidad de la atención, segundo la aplicación del Sistema de Clasificación de Pacientes propuesto por Perroca. A experiencia proporciono aprendizaje en el cuidado del paciente con una enfermedad rara, compleja y de difícil cura, dando la posibilidad a las estudiantes de asistirlo integralmente, más allá de las lesiones. Concluye-se que este tipo de experiencia contribuyó para el crecimiento de las estudiantes como futuros profesionales.