Comparison between somatostatin analog injections

SUMMARY OBJECTIVE: Long-acting depot formulations of somatostatin analogs, i.e., octreotide and lanreotide, are the first-line medical therapies for patients with acromegaly to whom surgery/radiotherapy cannot be performed or who have inadequate response. In this study, we aimed to evaluate the short-term local and systemic adverse reactions developed after the somatostatin analogs injections in the patients with acromegaly, in order to compare the side effects of somatostatin analogs injections. METHODS: Patients diagnosed with acromegaly who were referred to our endocrinology clinic for monthly somatostatin analogs injections were questionnaired. Wong-Baker Faces Pain Rating Scale was used to evaluate the injection-site pain at the time of injection. The existence of leg pain, nausea, diarrhea, and abdominal pain following the previous injection was also investigated during the next injection. RESULTS: A total of 49 patients were included in the study. The statistical difference could not be shown between the injection-site pain, anorexia, and leg pain frequencies of the groups, while the frequency of gastrointestinal disturbances, i.e., diarrhea and abdominal pain, was significantly lower in the octreotide group (p<0.001 and p=0.015, respectively). CONCLUSIONS: This is the first prospective study that compared the severity of the injection-site pain by using a scoring scale, following the long-acting somatostatin analogs injections. We have shown that there was no significant association of the injection-site pain severity with the somatostatin analogs regimen nor the dose differences within each somatostatin analogs treatment.

Surveillance of adverse events associated with 145 000 doses of COVID-19 vaccines in a Brazilian municipality / Vigilancia de eventos adversos asociados a 145 000 dosis de vacunas contra la COVID-19 en un municipio brasileño / Vigilância de eventos adversos associados a 145 mil doses de vacinas contra a COVID-19 em um município brasileiro

ABSTRACT There is a lack of real-world surveillance studies on reports of adverse events associated with COVID-19 vaccination, as well as comparative analyses of adverse events from vaccines with different platforms. This observational, descriptive, retrospective study based on secondary data describes the adverse events following immunization (AEFIs) related to the first 145 000 doses of COVID-19 vaccines delivered in Aracaju municipality, Sergipe state, northeast Brazil. Records of AEFIs were collected using the e-SUS Notifica database for January 19 to April 30, 2021. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for AEFIs and the type of COVID-19 vaccine, either CoronaVac (Sinovac-Butantan) or Oxford-AstraZeneca (Fiocruz). A total of 474 AEFIs (32.7 events/10 000 doses) from 254 individuals were reported and analyzed, and all of them were classified as non-serious. There was an association between the use of the CoronaVac vaccine and headache (OR = 2.1; 95% CI: 1.4-3.2), pain at the injection site (OR = 9.6; 95% CI: 3.9-23.8), lethargy (OR = 5.2; 95% CI: 1.8-14.8), fatigue (OR = 10.1; 95% CI: 2.4-42.3), diarrhea (OR = 4.4; 95% CI: 1.5-12.5) and cold-like symptoms (OR = 8.0; 95% CI: 1.9-34.0). However, the proportion of individuals reporting fever was higher among those who received the Oxford-AstraZeneca vaccine (OR = 3.1; 95% CI 1.5-6.4). This population-based observational study strengthens the evidence for the safety and tolerability of the CoronaVac and Oxford-AstraZeneca vaccines used against COVID-19.

RESUMEN Hay una carencia de estudios de vigilancia en el mundo real sobre la notificación de eventos adversos asociados a la vacunación contra la COVID-19, así como de análisis comparativos de los eventos adversos de vacunas con diferentes plataformas. En este estudio observacional, descriptivo y retrospectivo basado en datos secundarios se describen los eventos adversos supuestamente atribuibles a la vacunación o inmunización (ESAVI) relacionados con las primeras 145 000 dosis de vacunas contra la COVID-19 administradas en el municipio de Aracaju, estado de Sergipe, en la región Noreste de Brasil. Se recopilaron registros de los ESAVI del 19 de enero al 30 de abril del 2021 con la base de datos e-SUS Notifica. Se calcularon las razones de posibilidades (OR, por su sigla en inglés) y los intervalos de confianza (IC) del 95 % para los ESAVI y el tipo de vacuna contra la COVID-19 (CoronaVac [Sinovac-Butantan] o bien Oxford-AstraZeneca [Fiocruz]). Se notificaron y analizaron un total de 474 ESAVI (32,7 eventos/10 000 dosis) de 254 personas, y todos se clasificaron como no graves. Se encontró una relación entre el empleo de la vacuna CoronaVac y la cefalea (OR = 2,1; IC del 95 %: 1,4-3,2), dolor en el lugar de la inyección (OR = 9,6; IC del 95 %: 3,9-23,8), letargo (OR = 5,2; IC del 95 %: 1,8-14,8), cansancio (OR = 10,1; IC del 95 %: 2,4-42,3), diarrea (OR = 4,4; IC del 95 %: 1,5-12,5) y síntomas similares al resfriado (OR = 8,0; IC del 95 %: 1,9 a 34,0). Sin embargo, la proporción de pacientes que notificaron fiebre fue mayor entre los que recibieron la vacuna de Oxford-AstraZeneca (OR = 3,1; IC del 95 %: 1,5 a 6,4). Este estudio observacional poblacional refuerza la evidencia sobre la seguridad y tolerabilidad de las vacunas CoronaVac y Oxford-AstraZeneca empleadas contra la COVID-19.

RESUMO Faltam estudos de vigilância no mundo real sobre relatórios de eventos adversos associados à vacinação contra a COVID-19, bem como análises comparativas de eventos adversos decorrentes de vacinas com diferentes plataformas. Este estudo observacional, descritivo e retrospectivo baseado em dados secundários descreve os eventos adversos pós-vacinação (EAPV) relacionados com as primeiras 145 mil doses de vacinas contra a COVID-19 entregues no município de Aracaju, capital do estado de Sergipe, na região Nordeste do Brasil. Os registros de EAPV foram coletados usando o sistema e-SUS Notifica com referência ao período de 19 de janeiro a 30 de abril de 2021. Razões de chances (odds ratios, ORs) e intervalos de confiança (IC) de 95% foram calculados para os EAPV e o tipo de vacina contra a COVID-19: CoronaVac (Sinovac-Butantan) ou Oxford-AstraZeneca (Fiocruz). Um total de 474 EAPV (32,7 eventos/10 mil doses) de 254 indivíduos foram relatados e analisados, e todos foram classificados como não graves. Houve uma associação entre o uso da vacina CoronaVac e cefaleia (OR = 2,1; IC 95%: 1,4-3,2), dor no local da injeção (OR = 9,6; IC 95%: 3,9-23,8), letargia (OR = 5,2; IC 95%: 1,8-14,8), cansaço (OR = 10,1; IC 95%: 2,4-42,3), diarreia (OR = 4,4; IC 95%: 1,5-12,5 e sintomas gripais (OR = 8,0; IC 95%: 1,9-34,0). Contudo, a proporção de indivíduos que relataram febre foi superior entre os que receberam a vacina Oxford-AstraZeneca (OR = 3,1; IC 95%: 1,5-6,4). Este estudo observacional de base populacional reforça as evidências da segurança e tolerabilidade das vacinas CoronaVac e Oxford-AstraZeneca usadas contra a COVID-19.

Intramuscular injection safety without aspiration in the ventro-gluteal region during vaccination: randomized clinical trial / Seguridad de la inyección intramuscular sin aspiración en la región ventroglútea durante la vacunación: ensayo clínico aleatorizado / Segurança da injeção intramuscular sem aspiração na região ventro-glútea durante a vacinação: ensaio clínico randomizado

ABSTRACT Objectives: to compare adverse events after administrating hepatitis A vaccine intramuscularly in the ventro-gluteal region between techniques with and without aspiration. Methods: randomized double-blind clinical trial, using hepatitis A vaccine (inactivated) in the ventro-gluteal region, with a sample of 74 participants in the intervention group, vaccinated with the slow injection technique without aspiration, and 74 participants in the control group undergoing slow injection with aspiration. Daily assessment of participants was carried out in the 72 hours after vaccination, in order to ascertain local, systemic adverse events, local and contralateral temperatures. Results: the occurrence of local and systemic adverse events was homogeneous between the groups in the three days after vaccination (p>0.05). There was no influence of sex, race, pre-existing disease and use of medication. Conclusions: the intramuscular vaccination technique without aspiration in the ventro-gluteal region is safe for adverse events following immunization compared to the conventional technique with aspiration.

RESUMEN Objetivos: comparar eventos adversos después de la administración de la vacuna contra la hepatitis A por vía intramuscular en la región ventroglútea entre técnicas con y sin aspiración. Métodos: ensayo clínico aleatorizado doble ciego utilizando la vacuna Hepatitis A (inactivada) en la región ventroglútea, con una muestra de 74 participantes en el grupo de intervención, vacunados con la técnica de inyección lenta sin aspiración, y 74 participantes del grupo control sometidos a inyección con aspiración. La evaluación diaria de los participantes se llevó a cabo en las 72 horas posteriores a la vacunación, con el fin de conocer los eventos adversos locales, sistémicos, las temperaturas locales y contralaterales. Resultados: la ocurrencia de eventos adversos locales y sistémicos fue homogénea entre los grupos en los tres días posteriores a la vacunación (p>0.05). No hubo influencia de las variables sexo, raza, enfermedad preexistente y uso de medicación. Conclusión: la técnica de vacunación intramuscular sin aspiración en la región ventroglútea es segura para eventos adversos después de la vacunación en comparación con la técnica convencional con aspiración.

RESUMO Objetivos: comparar os eventos adversos após a administração da vacina hepatite A via intramuscular na região ventro-glútea entre as técnicas com e sem aspiração. Métodos: ensaio clínico randomizado duplo-cego, utilizando a vacina hepatite A (inativada) na região ventro-glútea, com amostra de 74 participantes no grupo intervenção, vacinados com a técnica de injeção lenta sem aspiração, e 74 participantes no grupo controle submetidos à injeção lenta com aspiração. Foi realizada avaliação diária dos participantes nas 72 horas pós-vacinação, com intuito de averiguar eventos adversos locais, sistêmicos, temperaturas locais e contralaterais. Resultados: a ocorrência de eventos adversos locais e sistêmicos foi homogênea entre os grupos nos três dias pós-vacinação (p>0,05). Não houve influência das variáveis sexo, raça, doença pré-existente e uso de medicamento. Conclusões: a técnica de vacinação intramuscular sem aspiração na região ventro-glútea é segura quanto aos eventos adversos pós-vacinação em comparação à técnica convencional com aspiração.

Assistência de Enfermagem aos pacientes com extravasamento de medicamentos antineoplásicos: revisão integrativa / Nursing care for patients with extravasation of antineoplastic drugs: an integrative review

Objetivo: Identificar as ações realizadas pela equipe de enfermagem no extravasamento de drogas antineoplásicas. Método: revisão integrativa de artigos científicos publicados em periódicos nacionais e internacionais, de 2015 a 2020.Resultados: foram identificadas 287 publicações, após a seleção e elegibilidade foram incluídos 5 artigos. Foram extraídas as recomendações gerais e específicas relacionadas ao extravasamento de drogas antineoplásicas. Conclusão: O extravasamento é uma complicação grave durante o tratamento quimioterápico, que pode afetar sua continuidade. Entre as competências da enfermagem estão as ações de prevenção, identificação e o manejo deste evento adverso.

Objective: To identify the actions taken by the nursing team in the ex­travasation of antioneoplastic drugs. Method: integrative review of scientific articles published in national and international journals, from 2015 to 2020. Results: 287 publications were identified, after selection and eligibility 5 articles were included. The general and specific recommendations related to the extravasation of antineoplastic drugs were extracted. Conclusion: Extravasation is a serious complication during chemotherapy, which can affect its continuity. Among the skills of nursing are the actions of prevention, identification and management of this adverse event.

Incidence of Injection Site Reactions Induced by Vinorelbine and Prevention with Hot Compresses / 医薬品情報学

<b>Objective: </b>Patients treated with vinorelbine(VNR)-containing chemotherapy often suffer from injection site reactions.  VNR is a moderate vesicant that is well known to cause local venous damage.  We conducted this study to identify clinical risk factors related to the incidence of injection site reactions caused by VNR, and whether applying a hot compress was effective for preventing such reactions.<br><b>Methods: </b>Medical records were retrospectively investigated for 48 patients treated with chemotherapy regimens containing VNR.  Injection site reactions were evaluated for every course and were graded according to the National Cancer Institute Common Toxicity Criteria (version 4.0).  Gender, age, body mass index, chemotherapy regimen, dose of VNR, and volume of fluid for flushing the vein were assessed as clinical variables.  A hot compress was applied to the vein proximal to the injection site during VNR injection.<br><b>Results: </b>The injection site reactions occurred in 29 (60%) among 48 patients received intravenous VNR injection.  According to multivariate analysis, use of gemcitabine (GEM) in combination with VNR showed a significant independent correlation with an increased risk of injection site reactions (<i>p</i>=0.019).  When hot compress was applied to 21 patients, who experienced phlebitis of VNR, the injection site reaction was occurred to only three patients (<i>p</i><0.001).<br><b>Conclusion: </b>In this study, the risk factor of the injection site reaction by VNR seems to be combination of GEM.  Application of hot compresses was effective for preventing injection site reactions by VNR.