Rationale use of Thalidomide in erythema nodosum leprosum - A non-systematic critical analysis of published case reports

Abstract INTRODUCTION: Thalidomide is an anti- tumor necrosis factor alpha (TNF-a) drug used mainly in the management of moderate to severe form of Erythema Nodosum Leprosum (ENL). Because of its teratogenic potential it has to be used under proper supervision. Our critical analysis tries to look into the rationale with which it has been used by means of case reports on lepra reaction. METHODS: We looked for the case reports between December 2005 to June 2019 in databases like Pubmed, Embase and other relevant resources. We used search words like “erythema nodosum leprosum(ENL)”, “thalidomide”, “case report” in different combinations to get relevant reports that focus on thalidomide usage atleast once at any time point during management. The information extracted were indication of thalidomide use, dose, response, outcome, complication if any, along with all the demographic details and geographical distribution. RESULTS: We found 41 case reports eligible for analysis.The information was critically evaluated. From the analysis it was found that 7 of the case report mentioned the exact indication, 4 case report showed irrational use of thalidomide in the case of neuritis without use of steroids, 7 showed proper use of Clofazimine prior to thalidomide initiation, 26 case report showed case report of rationale dose range and in 4 case reports clofazimine was used prior to thalidomide along with the rational dose of thalidomide. CONCLUSIONS: This analysis helps to guide the rationale use of thalidomide focussing on few important points that anyone should keep in mind while managing a case of ENL.

【摘要 引言】沙利度胺是一种抗肿瘤坏死因子α（TNF-α）药物，主要用于治疗中重度麻风结节性红斑（Erythema Nodosum Leprosum，ENL）。由于其具有致畸潜能，必须在严格监督下使用。本批判性分析旨在通过麻风反应的病例报告，探讨沙利度胺临床应用的合理性。
方法：我们检索了2005年12月至2019年6月期间PubMed、Embase及其他相关数据库中的病例报告。以“erythema nodosum leprosum(ENL)”“thalidomide”“case report”为检索词进行不同组合检索，获取所有至少在治疗任意时间点使用过沙利度胺的相关报告。提取的信息包括沙利度胺的用药指征、剂量、疗效、转归、并发症（若有），以及所有人口统计学细节和地理分布情况。
结果：共纳入41篇符合分析标准的病例报告并进行批判性评估。分析结果显示，7篇病例报告明确提及了准确的用药指征，4篇报告显示在未使用糖皮质激素的情况下不合理使用沙利度胺治疗神经炎，7篇报告显示在启用沙利度胺前已合理使用氯法齐明（Clofazimine），26篇报告给出了合理的剂量范围，另有4篇报告提及在启用沙利度胺前联合使用氯法齐明，且沙利度胺剂量合理。
结论：本分析有助于指导沙利度胺的合理使用，明确了麻风结节性红斑诊疗过程中需牢记的若干关键要点。