Silva Rosiana Estéfane da, Carvalho Janaína de Pina, Ramalho Dario Brock, Senna Maria Camilo Ribeiro De, Moreira Hugo Silva Assis, Rabello Ana, Cota Erika, Cota Gláucia
Centro de Referência em Leishmanioses, Pesquisa Clínica e Políticas Públicas em Doenças Infecto-Parasitárias, Centro de Pesquisas René Rachou, Fundação Oswaldo Cruz-Fiocruz, Belo Horizonte, MG, Brasil.
Instituto de Informática, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brasil.
Mem Inst Oswaldo Cruz. 2018 Feb;113(2):71-79. doi: 10.1590/0074-027601700125.
BACKGROUND Despite its recognised toxicity, antimonial therapy continues to be the first-line drug for cutaneous leishmaniasis (CL) treatment. Intralesional administration of meglumine antimoniate (MA) represents an alternative that could reduce the systemic absorption of the drug and its side effects. OBJECTIVES This study aims to validate the standard operational procedure (SOP) for the intralesional infiltration of MA for CL therapy as the first step before the assessment of efficacy and safety related to the procedure. METHODS The SOP was created based on 21 trials retrieved from the literature, direct monitoring of the procedure and consultation with experts. This script was submitted to a formal computer-aided inspection to identify readability, clarity, omission, redundancy and unnecessary information (content validation). For criterion and construct validations, the influence of critical condition changes (compliance with the instructions and professional experience) on outcome conformity (saturation status achievement), tolerability (pain referred) and safety (bleeding) were assessed. FINDINGS The median procedure length was 12 minutes and in 72% of them, patients classified the pain as mild. The bleeding was also classified as mild in 96.6% of the procedures. Full compliance with the SOP was observed in 66% of infiltrations. Despite this, in 100% of the inspected procedures, lesion saturation was observed at the end of infiltration, which means that it tolerates some degree of modification in its execution (robustness) without prejudice to the result. CONCLUSIONS The procedure is reproducible and can be used by professionals without previous training with high success and safety rates.
背景 尽管已认识到其毒性，但锑剂疗法仍是皮肤利什曼病（CL）治疗的一线药物。病灶内注射葡甲胺锑酸盐（MA）是一种可减少药物全身吸收及其副作用的替代方法。目的 本研究旨在验证用于CL治疗的MA病灶内注射标准操作程序（SOP），作为评估该程序有效性和安全性之前的第一步。方法 该SOP基于从文献中检索到的21项试验、对该程序的直接监测以及与专家的咨询而制定。该脚本提交给正式的计算机辅助检查，以识别可读性、清晰度、遗漏、冗余和不必要信息（内容验证）。对于标准和结构验证，评估关键条件变化（符合说明和专业经验）对结果一致性（达到饱和状态）、耐受性（疼痛程度）和安全性（出血情况）的影响。结果 该操作的中位时长为12分钟，其中72%的患者将疼痛程度评为轻度。96.6%的操作中出血情况也被评为轻度。66%的注射操作完全符合SOP。尽管如此，在100%的检查操作中，注射结束时均观察到病灶饱和，这意味着该操作在执行过程中可以耐受一定程度的调整（稳健性）而不影响结果。结论 该操作具有可重复性，未经事先培训的专业人员也可使用，成功率和安全性高。
