Adverse events in patients with leprosy on treatment with thalidomide

Abstract INTRODUCTION: Thalidomide, used to treat erythema nodosum leprosum (ENL), is associated with severe adverse events (AEs) and is highly teratogenic. METHODS: 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. RESULTS: 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. CONCLUSIONS: Pharmacovigilance is crucial to prevent harmful thalidomide-associated AEs.

摘要：
引言：沙利度胺可用于治疗麻风结节性红斑（erythema nodosum leprosum, ENL），其与严重不良事件（adverse events, AEs）相关且具有高度致畸性。
方法：本研究针对接受沙利度胺治疗的麻风结节性红斑患者开展横断面研究，通过访谈及病历评估对不良事件与选定变量进行调研，并采用logistic回归（logistic regression）分析估算比值比及95%置信区间。
结果：外周神经病变症状与深静脉血栓形成（deep vein thrombosis, DVT）为报告的最常见不良事件。尽管育龄女性患者采取了避孕措施，但仅有不足50%的患者报告使用安全套。多重用药与除深静脉血栓形成外的所有研究终点均存在关联。
结论：药物警戒（pharmacovigilance）对于预防沙利度胺相关的有害不良事件至关重要。