Avaliação da liberação de óleo de silicone por seringas e agulhas utilizadas para injeção intravítrea
Arquivos
Data
2023-11-09
Autores
Cruz, Natasha Ferreira Santos da 
Orientadores
Farah, Michel Eid
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
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Resumo
Objetivos: Avaliar a liberação de óleo de silicone (OS) por seringas e agulhas utilizadas para injeção intravítrea. Dessa forma, foram conduzidos três estudos com os seguintes objetivos: 1 - Realizar uma revisão detalhada das técnicas e materiais utilizados em injeções intravítreas; 2 - Avaliar a variabilidade no número de partículas de OS liberadas em seringas do mesmo lote e o impacto que agulhas de diferentes calibres têm na quantidade de OS liberado pelas seringas; 3 - Avaliar o papel da agitação da seringa siliconizada e sem óleo de silicone no desenvolvimento de inflamação após injeção intravítrea de aflibercepte. Métodos: No estudo 1, uma revisão da literatura integrativa foi realizada, detalhando as técnicas e materiais utilizados em seringas e agulhas usados para injeções intravítreas. No estudo 2, quatro modelos de seringas e seis modelos de agulhas foram avaliados quanto à liberação de OS. Os dados foram analisados por citometria de fluxo com marcação fluorescente para óleo de silicone. No estudo 3, um ensaio clínico randomizado, duplocego, controlado incluiu indivíduos com indicação de injeção intravítrea de aflibercepte 48 horas antes da vitrectomia para retinopatia diabética proliferativa. Foram divididos em grupo agitação e sem agitação, com seringa siliconizada (SR) ou sem OS (HSWNormJect). Foi avaliada a presença de reação de câmara anterior (RCA) e amostras aquosas foram submetidas a Cytometric Bead Array (CBA) para quantificação de interleucinas e quimiocinas. Resultados: No estudo 1, foi possível elucidar aspectos relacionados a agulhas, seringas, processo de revestimento do óleo de silicone, métodos de esterilização, manuseio das seringas, anestesia e questões de segurança relacionadas a materiais e técnicas. No estudo 2, foi demonstrado que todos os modelos de seringa apresentaram um alto coeficiente de variação na liberação de OS entre as seringas do mesmo lote. A quantidade de OS foi significativamente maior na seringa quando a agulha foi colocada. O número de partículas de OS liberadas com a agulha BD 30G acoplada à seringa foi estatisticamente maior do que com a agulha de 27G (p = 0,005). Além disso, o número de partículas de OS foi maior na configuração seringa/agulha do que apenas em agulhas (p = 0,0024). No estudo 3, foram incluídos 41 indivíduos (21 no grupo agitação e 20 no grupo sem agitação). Após 48 horas da injeção de aflibercepte, 10% dos pacientes do grupo controle e 80% do grupo de agitação apresentaram RCA com a seringa SR. Não houve diferença nas variações médias das citocinas e quimiocinas por estado de agitação. Conclusão: 1 - As recomendações práticas mais importantes para aplicação das injeções intravítreas são a escolha de seringas sem óleo de silicone, evitar agitação das seringas e variações de temperatura das medicações. 2 – Houve uma alta variabilidade na quantidade de óleo de silicone liberado por seringas do mesmo lote. Além disso, não ocorreu uma associação clara entre o calibre da agulha e o número de partículas de OS liberadas. 3 - A agitação revelou ter um papel potencial no desenvolvimento de inflamação após injeção intravítrea de aflibercepte, especialmente se combinada a seringa siliconizada.
Objectives: To evaluate the release of silicone oil (SO) by syringes and needles used for intravitreal injection. For this purpose, three studies were conducted with the following objectives: 1 - Detailed review of the techniques and materials used in intravitreal injections; 2 – To assess the variability of silicone oil (SO) particles released across syringes from the same lot and the role of different needle gauges; 3 – To assess the role of silicone oil and syringe agitation in the development of inflammation after intravitreal injection of aflibercept. Methods: In study 1, a systematic review was performed, detailing the techniques and materials used in syringes and needles used for intravitreal injections. In study 2, four syringe models and six needle models were assessed for SO. The data were analyzed by imaging flow cytometry with fluorescent labeling for silicone oil. In Study 3, a randomized, double-blind, controlled clinical trial included subjects with an indication of intravitreal aflibercept 48 h prior to vitrectomy for proliferative diabetic retinopathy. They were divided into agitation and non-agitation groups, with a siliconized syringe (SR) or without SO (HSWNormJect). It was evaluated the presence of anterior chamber reaction (AC) and aqueous samples were collected and underwent cytometric bead array analysis for quantification of interleukins and chemokines. Results: In study 1, it was possible to elucidate aspects related to needles, syringes, silicone oil coating process, sterilization methods, syringe handling, anesthesia and safety issues related to materials and techniques. In study 2, it was demonstrated that all syringe models had a high coefficient of variation in SO release across syringes from the same lot. The amount of SO was significantly greater in the syringe when the needle was attached. SO particles with the BD 30G needle attached to the syringe were statistically greater than the 27G counterpart (p = 0.005). Finally, the number of SO particles was higher in the syringe/needle setup than in needles only (p = 0.0024). In study 3, 41 individuals were included (21 in the agitation group and 20 in the no-agitation group). After 48 hours of aflibercept injection, 10% of patients in the control group and 80% of the agitation group showed AC cells with the SR syringe. There were no differences in the mean variations of cytokines and chemokines by agitation status. Conclusion: 1 - The most important practical recommendations for the application of intravitreal injections are choosing silicone oil-free syringes, avoiding agitation of syringes and temperature variations of medications. 2 – A high variability was observed in SO content across syringes from the same lot. Additionally, there was no clear association between needle gauge and the number of SO particles. 3 - Agitation has been shown to have a potential role in the development of inflammation after intravitreal injection of aflibercept, especially if combined with a siliconized syringe.
Objectives: To evaluate the release of silicone oil (SO) by syringes and needles used for intravitreal injection. For this purpose, three studies were conducted with the following objectives: 1 - Detailed review of the techniques and materials used in intravitreal injections; 2 – To assess the variability of silicone oil (SO) particles released across syringes from the same lot and the role of different needle gauges; 3 – To assess the role of silicone oil and syringe agitation in the development of inflammation after intravitreal injection of aflibercept. Methods: In study 1, a systematic review was performed, detailing the techniques and materials used in syringes and needles used for intravitreal injections. In study 2, four syringe models and six needle models were assessed for SO. The data were analyzed by imaging flow cytometry with fluorescent labeling for silicone oil. In Study 3, a randomized, double-blind, controlled clinical trial included subjects with an indication of intravitreal aflibercept 48 h prior to vitrectomy for proliferative diabetic retinopathy. They were divided into agitation and non-agitation groups, with a siliconized syringe (SR) or without SO (HSWNormJect). It was evaluated the presence of anterior chamber reaction (AC) and aqueous samples were collected and underwent cytometric bead array analysis for quantification of interleukins and chemokines. Results: In study 1, it was possible to elucidate aspects related to needles, syringes, silicone oil coating process, sterilization methods, syringe handling, anesthesia and safety issues related to materials and techniques. In study 2, it was demonstrated that all syringe models had a high coefficient of variation in SO release across syringes from the same lot. The amount of SO was significantly greater in the syringe when the needle was attached. SO particles with the BD 30G needle attached to the syringe were statistically greater than the 27G counterpart (p = 0.005). Finally, the number of SO particles was higher in the syringe/needle setup than in needles only (p = 0.0024). In study 3, 41 individuals were included (21 in the agitation group and 20 in the no-agitation group). After 48 hours of aflibercept injection, 10% of patients in the control group and 80% of the agitation group showed AC cells with the SR syringe. There were no differences in the mean variations of cytokines and chemokines by agitation status. Conclusion: 1 - The most important practical recommendations for the application of intravitreal injections are choosing silicone oil-free syringes, avoiding agitation of syringes and temperature variations of medications. 2 – A high variability was observed in SO content across syringes from the same lot. Additionally, there was no clear association between needle gauge and the number of SO particles. 3 - Agitation has been shown to have a potential role in the development of inflammation after intravitreal injection of aflibercept, especially if combined with a siliconized syringe.
Descrição
Citação
CRUZ, Natasha Ferreira Santos da. Avaliação da liberação de óleo de silicone por seringas e agulhas utilizadas para injeção intravítrea. 2023. 123 f. Tese (Doutorado em Oftalmologia) – Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, 2023.