Drummond Paula Lana de Miranda, Santos Roberta Márcia Marques Dos, Carvalho Gabriela Oliveira, Pádua Cristiane Aparecida Menezes de
Divisão de Assuntos Regulatórios, Diretoria Industrial, Fundação Ezequiel Dias, Belo Horizonte, MG, Brasil.
Departamento de Farmácia Social, Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brasil.
Rev Soc Bras Med Trop. 2019 Apr 11;52:e20180385. doi: 10.1590/0037-8682-0385-2018.
Thalidomide, used to treat erythema nodosum leprosum (ENL), is associated with severe adverse events (AEs) and is highly teratogenic.
A cross-sectional study was conducted on thalidomide-treated patients with ENL. AEs and selected variables were investigated through interviews and assessment of medical records. Odds ratios with 95% confidence intervals were estimated via logistic regression.
Peripheral neuropathy symptoms and deep vein thrombosis (DVT) were the most common AEs reported. Although women of reproductive age used contraceptives, <50% of patients reported using condoms. Polypharmacy was associated with all endpoints, except DVT.
Pharmacovigilance is crucial to prevent harmful thalidomide-associated AEs.
用于治疗麻风结节性红斑（ENL）的沙利度胺与严重不良事件（AE）相关，且具有高度致畸性。
对接受沙利度胺治疗的ENL患者进行了一项横断面研究。通过访谈和病历评估对不良事件及选定变量进行了调查。通过逻辑回归估计了具有95%置信区间的比值比。
外周神经病变症状和深静脉血栓形成（DVT）是报告的最常见不良事件。尽管育龄期女性使用了避孕药具，但报告使用避孕套的患者不足50%。联合用药与除DVT之外的所有终点相关。
药物警戒对于预防与沙利度胺相关的有害不良事件至关重要。
