Fukihara Jun, Kondoh Yasuhiro
a Department of Respiratory Medicine and Allergy , Tosei General Hospital , Seto , Aichi , Japan.
Expert Rev Respir Med. 2016 Dec;10(12):1247-1254. doi: 10.1080/17476348.2016.1249854. Epub 2016 Oct 31.
Nintedanib is a new anti-fibrosis agent that is an intracellular tyrosine kinase inhibitor targeting platelet derived growth factor receptor, fibroblast growth factor receptor and vascular endothelial growth factor receptor. Although nintedanib is attracting much attention as a new treatment option for patients with idiopathic pulmonary fibrosis (IPF), the clinical evidence is limited mainly to the results from the dose-deciding phase II TOMORROW trial and phase III INPULSIS trials, which evaluated efficacy and safety of nintedanib for patients with IPF, prespecified subgroup analyses, pooled analyses and meta-analyses derived from those trials. Areas covered: In this document, we mainly reviewed reports on working mechanisms of nintedanib, and efficacy and safety of nintedanib for patients with IPF. The literature search was undertaken using Pub Med. Expert commentary: It is unknown whether the efficacy of nintedanib in patients enrolled in the clinical trials will be the same for the entire spectrum of patients, including patients unfit for the clinical trials due to age, severity, timing of IPF diagnosis or diagnosis of interstitial pneumonias other than IPF. Sufficient consideration should be given when selecting candidates for nintedanib in the real world.
尼达尼布是一种新型抗纤维化药物，是一种细胞内酪氨酸激酶抑制剂，可靶向血小板衍生生长因子受体、成纤维细胞生长因子受体和血管内皮生长因子受体。尽管尼达尼布作为特发性肺纤维化（IPF）患者的一种新的治疗选择备受关注，但其临床证据主要局限于剂量确定的II期TOMORROW试验和III期INPULSIS试验的结果，这些试验评估了尼达尼布对IPF患者的疗效和安全性、预先指定的亚组分析、汇总分析以及源自这些试验的荟萃分析。涵盖领域：在本文件中，我们主要回顾了关于尼达尼布作用机制以及尼达尼布对IPF患者疗效和安全性的报告。文献检索使用了PubMed。专家评论：尼达尼布在临床试验入组患者中的疗效对于所有患者群体（包括因年龄、病情严重程度、IPF诊断时间或除IPF之外的间质性肺炎诊断而不适合参加临床试验的患者）是否相同尚不清楚。在现实世界中选择尼达尼布的候选患者时应给予充分考虑。
