Talwar Deepak, Prajapat Deepak Kumar, Talwar Dhruv
Deparatment of Internal Medicine, Metro Centre for Respiratory Diseases, Noida, Uttar Pradesh, India.
Department of Pulmonary, Critical Care, Allergy and Sleep Medicine, JNMC, Savangi, Maharashtra, India.
Lung India. 2022 Jan-Feb;39(1):27-33. doi: 10.4103/lungindia.lungindia_393_21.
Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis (IPF) has been established by multiple clinical trials. This study aims to assess the efficacy and safety of nintedanib in real-world IPF patients in India.
Clinical records of IPF patients (prescribed with nintedanib) visiting tertiary pulmonary care center, between June 2016 and December 2019, were analyzed retrospectively. Data were analyzed for forced vital capacity (FVC), Diffusing capacity of lung for carbon monoxide(DLCO), 6-min walk distance (6-MWD). Acute exacerbations and adverse events were also analyzed.
A total of 76 IPF patients were prescribed with nintedanib. Drug was prescribed at 100 and 150 mg BD dose to 37 and 39 patients. Ten patients (13.1%), of which eight were over the age of 60 years, died during the study period. Only 42 patients visited for follow-up. Mean baseline FVC was 1.67 L and mean annualized absolute change in FVC and FVC % predicted was -0.07 L and -1.80%, respectively. Mean baseline DLCO was 37.21% and mean annualized absolute change in DLCO % predicted was-2.20%. At follow-up, 1 (2.38%), 17 (40.47%), and 24 (57.14%) patients were at Deparatment of Internal Medicine stage I, II, and III, respectively. Acute exacerbations and adverse events were reported by 48 and 6 patients, respectively.
Our results support the findings from previous studies, that nintedanib leads to annual decline in parameters such as FVC and DLCO and increased 6-MWD. It was found to be well tolerated in the Indian patients with IPF.
多项临床试验已证实尼达尼布治疗特发性肺纤维化（IPF）的有效性和安全性。本研究旨在评估尼达尼布在印度真实世界IPF患者中的有效性和安全性。
回顾性分析2016年6月至2019年12月期间就诊于三级肺科护理中心的IPF患者（接受尼达尼布治疗）的临床记录。分析用力肺活量（FVC）、肺一氧化碳弥散量（DLCO）、6分钟步行距离（6-MWD）的数据。还分析了急性加重和不良事件。
共有76例IPF患者接受了尼达尼布治疗。分别有37例和39例患者接受了100 mg和150 mg每日两次的给药剂量。10例患者（13.1%）在研究期间死亡，其中8例年龄超过60岁。只有42例患者前来随访。平均基线FVC为1.67 L，FVC的年均绝对变化量和预测FVC%分别为-0.07 L和-1.80%。平均基线DLCO为37.21%，预测DLCO%的年均绝对变化量为-2.20%。随访时，分别有1例（2.38%）、17例（40.47%）和24例（57.14%）患者处于内科I期、II期和III期。分别有48例和6例患者报告了急性加重和不良事件。
我们的结果支持先前研究的发现，即尼达尼布会导致FVC和DLCO等参数出现年度下降，并增加6-MWD。在印度IPF患者中发现其耐受性良好。
