Mazzei Mariano E, Richeldi Luca, Collard Harold R
University of Buenos Aires, Buenos Aires, Argentina.
National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK.
Ther Adv Respir Dis. 2015 Jun;9(3):121-9. doi: 10.1177/1753465815579365. Epub 2015 Apr 10.
Idiopathic pulmonary fibrosis (IPF) is a progressive and ultimately fatal lung disease that occurs in older adults. The clinical course of IPF is variable and hard to predict in an individual patient. Nintedanib is a tyrosine kinase inhibitor that has recently been approved in the US and European Union for the treatment of IPF. Preclinical studies have shown that nintedanib interferes with processes active in fibrosis such as fibroblast proliferation, migration and differentiation and the secretion of extracellular matrix. The safety and efficacy of nintedanib have been investigated in the phase II TOMORROW trial and in two replicate 52-week randomized, placebo-controlled phase III trials known as the INPULSIS trials. These trials demonstrated that nintedanib slowed disease progression by reducing the annual rate of decline in forced vital capacity, with a manageable side-effect profile. In this review, we summarize key data supporting nintedanib as a treatment for patients with IPF and address key questions regarding the use of nintedanib in the clinical setting.
特发性肺纤维化（IPF）是一种发生于老年人的进行性且最终致命的肺部疾病。IPF的临床病程具有变异性，难以在个体患者中进行预测。尼达尼布是一种酪氨酸激酶抑制剂，最近已在美国和欧盟获批用于治疗IPF。临床前研究表明，尼达尼布可干扰纤维化过程中活跃的进程，如成纤维细胞增殖、迁移和分化以及细胞外基质的分泌。尼达尼布的安全性和有效性已在II期TOMORROW试验以及两项重复的为期52周的随机、安慰剂对照III期试验（即INPULSIS试验）中进行了研究。这些试验表明，尼达尼布通过降低用力肺活量的年下降率减缓了疾病进展，且副作用易于管理。在本综述中，我们总结了支持尼达尼布用于治疗IPF患者的关键数据，并探讨了在临床环境中使用尼达尼布的关键问题。
