Toi Yukihiro, Kimura Yuichiro, Domeki Yutaka, Kawana Sachiko, Aiba Tomoiki, Ono Hirotaka, Aso Mari, Tsurumi Kyoji, Suzuki Kana, Shimizu Hisashi, Sugisaka Jun, Saito Ryohei, Terayama Keisuke, Kawashima Yosuke, Nakamura Atsushi, Yamanda Shinsuke, Honda Yoshihiro, Sugawara Shunichi
Department of Pulmonary Medicine, Sendai Kousei Hospital, 4-15, Hirosemachi, Aoba-ku, Sendai, Miyagi 980-0873, Japan.
Sarcoidosis Vasc Diffuse Lung Dis. 2019;36(1):74-78. doi: 10.36141/svdld.v36i1.7383. Epub 2019 May 1.
We have often encountered adverse events requiring dose reduction and/or discontinuation of nintedanib in patients with idiopathic pulmonary fibrosis.
The objectives of this study were to clarify the incidence of dose reduction and/or discontinuation following the commercialization of nintedanib and to investigate predictors of dose reduction and/or discontinuation of nintedanib at our hospital.
We retrospectively identified 25 patients who had received nintedanib 150 mg twice daily at Sendai Kousei Hospital and categorized them into two groups according to whether they had or had not required dose reduction and/or discontinuation and sought to identify predictors of dose reduction and/or discontinuation.
Seventeen patients developed adverse events, which included diarrhea (n=10, 44%), hepatotoxicity (n=7, 28%), and anorexia (n=2, 16%). No adverse event-related deaths occurred during the study period. Patients who required dose reduction and/or discontinuation were significantly older than those who did not (72 years vs 67 years; =0.047). Body surface area (BSA) was significantly lower in the group that needed dose reduction and/or discontinuation than in the group that did not (1.63 m vs. 1.78 m; =0.028). Multivariate logistic regression revealed that the association of low BSA with dose reduction and/or discontinuation was statistically significant.
A low BSA was associated with dose reduction and/or discontinuation of nintedanib in patients with idiopathic pulmonary fibrosis. Further studies in larger patient samples are needed to validate these findings.
我们在特发性肺纤维化患者中经常遇到需要降低尼达尼布剂量和/或停药的不良事件。
本研究的目的是明确尼达尼布商业化后降低剂量和/或停药的发生率，并调查我院尼达尼布剂量降低和/或停药的预测因素。
我们回顾性确定了在仙台兴生医院接受每日两次150mg尼达尼布治疗的25例患者，并根据是否需要降低剂量和/或停药将他们分为两组，试图确定剂量降低和/或停药的预测因素。
17例患者出现不良事件，包括腹泻（n = 10，44%）、肝毒性（n = 7，28%）和厌食（n = 2，16%）。研究期间未发生与不良事件相关的死亡。需要降低剂量和/或停药的患者明显比未降低剂量和/或停药的患者年龄大（72岁对67岁；P = 0.047）。需要降低剂量和/或停药的组的体表面积（BSA）明显低于未降低剂量和/或停药的组（1.63m²对1.78m²；P = 0.028）。多因素逻辑回归显示，低BSA与剂量降低和/或停药的关联具有统计学意义。
低BSA与特发性肺纤维化患者尼达尼布剂量降低和/或停药有关。需要在更大的患者样本中进行进一步研究以验证这些发现。
