Ty-jour t1 - 尼林尼布的安全和药代动力学和鉴性肺纤维化的皮里芬酮JF - 欧洲呼吸杂志Jo - Eur Respir J SP - 1382 LP - 1392 Do - 10.1183 / 09031936.00198013 VL - 45是 - 5 Au - Ogura,Takashi Au -Taniguchi,Hiroyuki Au - Azuma,Arata Au - 尤科奥 - Kondoh,Yasuhiro Au - Hasegawa,Yoshinori Au - Bando,Masashi Au - Abe,Shinji Au - Mochizuki,Yoshiro Au - Chida,Kingo Au - Klüglich,Matthias Au -富士岛,Tsuyoshi Au - Okazaki,Kotaro Au - Tadayasu,Yusuke Au - Sakamoto,Wataru Au - Sugiyama,Yukihiko Y1 - 2015/05/01 UR - //www.qdcxjkg.com/content/45/5/1382。摘要N2 - 进行了随机,双盲,II期,剂量升级试验,以评估酪氨酸激酶抑制剂尼宁尼,单独和在日本特发性肺纤维化患者中添加到正在进行的肺纤维化患者中的安全性,耐受性和药代动力学。将50名日本患者随机分为三个队列(每日两次或每日每天两次,每天两次)接受尼丁胺或安慰剂,或者每天两次,每天28天,每天两次28天)。接受Pirfenidone以含有的患者分层对每个尼丁胺剂量组和安慰剂分层。17例患者中九分之一的九个患者中报道不良事件,其中10名患者中的10例,其中10例接受Nintedanib加入Pirfenidone。所有不良事件的强度都很温和或中等。胃肠疾病是最常见的不良事件。当向Pirfenidone加入到Pirfenidone时,Nintedanib稳定状态下的最大血浆浓度和曲线下的曲线下的区域及其代谢物趋于较低。 Nintedanib had no effect on the pharmacokinetics of pirfenidone. In conclusion, further study is needed to evaluate the safety and tolerability profile of nintedanib when added to pirfenidone in patients with idiopathic pulmonary fibrosis. There was a trend toward lower exposure of nintedanib when it was added to pirfenidone. Nintedanib had acceptable safety and tolerability in Japanese patients with IPF http://ow.ly/DNG4k ER -