Laboratoire de Pharmacologie Médicale et Clinique, UMR-INSERM U1027, Equipe de Pharmacoépidémiologie, Faculté de Médecine, Université de Toulouse, 37 allées Jules Guesdes, 31000, Toulouse, France,
Med Oncol. 2013 Dec;30(4):733. doi: 10.1007/s12032-013-0733-2. Epub 2013 Sep 28.
Thalidomide and lenalidomide are structural analogs and immunomodulatory drugs. Lenalidomide appears to have a different safety profile than thalidomide and could be less toxic, and as far as we know, we did not found any study comparing their safety profile. The objective of our study was to review and compare serious adverse drug reactions (SADRs) of thalidomide and lenalidomide spontaneously reported to the French Pharmacovigilance database. We extracted all medically confirmed spontaneous reports of SADR for lenalidomide-based regimens and thalidomide-based regimens from the French Pharmacovigilance database. A "serious" adverse drug reaction (ADR) was defined as an ADR that is fatal or life threatening, which causes hospitalization or prolongation of hospitalization, or permanent or significant disability. The study period was between marketing of 2 drugs and January 15, 2012. A total of 392 SADRs related to thalidomide-based regimens were identified in 244 patients and 377 SADRs related to lenalidomide-based regimens in 220 patients. In spite of their structural analogy, this study highlights interesting differences between lenalidomide and thalidomide's safety profile: nervous system and vascular disorders are more frequent with thalidomide-based regimens while hematologic, skin, infectious disorders and secondary primary cancers are more frequent with lenalidomide-based regimens.
沙利度胺和来那度胺是结构类似物和免疫调节药物。来那度胺的安全性似乎与沙利度胺不同，毒性可能更小，据我们所知，我们没有发现任何比较这两种药物安全性的研究。我们的研究目的是回顾和比较法国药物警戒数据库中自发报告的沙利度胺和来那度胺严重药物不良反应（SADR）。我们从法国药物警戒数据库中提取了来那度胺为基础的方案和沙利度胺为基础的方案的所有经医学证实的 SADR 自发报告。“严重”药物不良反应（ADR）定义为致命或危及生命的 ADR，导致住院或住院时间延长，或永久性或显著残疾。研究期间为 2 种药物上市至 2012 年 1 月 15 日。在 244 名患者中确定了 392 例与沙利度胺为基础的方案相关的 SADR，在 220 名患者中确定了 377 例与来那度胺为基础的方案相关的 SADR。尽管它们具有结构类似性，但这项研究强调了来那度胺和沙利度胺安全性特征之间的有趣差异：与沙利度胺为基础的方案相关的神经和血管疾病更常见，而与来那度胺为基础的方案相关的血液、皮肤、感染和继发性原发性癌症更常见。
