Kuo Ping-Hung, Tu Chih-Yen, Chen Chia-Hung, Kao Kuo-Chin, Hsu Jeng-Yuan, Lin Meng-Chih, Chong Inn-Wen, Sheu Chau-Chyun
Department of Internal Medicine, National Taiwan University Hospital, Taipei 100225, Taiwan.
Division of Pulmonary and Critical Care, Department of Internal Medicine, China Medical University Hospital, Taichung 404327, Taiwan.
Biomedicines. 2024 Oct 15;12(10):2348. doi: 10.3390/biomedicines12102348.
Idiopathic pulmonary fibrosis (IPF) is a serious, progressive lung disease for which treatments are scarce. Pirfenidone has been approved for the treatment of IPF in Taiwan since 2016. This study aimed to gain a better insight into pirfenidone's real-world safety and effectiveness in adult IPF patients in Taiwan.
We conducted a prospective, multicenter, post-marketing surveillance study, and analyzed data from a small sample of 50 IPF patients treated with pirfenidone.
Most patients were men, with a mean age of 72.8 years (±10.3). They were in physiology stage I or II with a baseline mean forced vital capacity (FVC) of 2.236 L (73.8% of predicted value). After treatment with pirfenidone, the mean FVC decreased by 0.088 L at week 24 and 0.127 L at week 52. The mean 6 min walk test was 325.5 m at baseline, increased by 8.1 m at week 24, but then decreased by 23.0 m at week 52. These changes from baseline did not reach statistical significance. Pirfenidone prevented worsening of cough but did not stabilize dyspnea. During 52 weeks of treatment, the incidence of total adverse drug reactions was 62.0%, with decreased appetite (32.0%) and pruritis (10.0%) being the most common. The adverse events leading to treatment discontinuation were decreased appetite (8.0%), nausea (4.0%), and respiratory failure (4.0%). No safety concern was raised by the study. Treatment with pirfenidone stabilized both FVC and the subjective symptom of cough in most patients.
This post-marketing surveillance study demonstrated that pirfenidone is an effective, safe, and well-tolerated treatment in patients with IPF in Taiwan.
特发性肺纤维化（IPF）是一种严重的、进行性肺部疾病，治疗方法稀缺。自2016年起，吡非尼酮已在台湾获批用于治疗IPF。本研究旨在更深入了解吡非尼酮在台湾成年IPF患者中的真实世界安全性和有效性。
我们进行了一项前瞻性、多中心、上市后监测研究，并分析了50例接受吡非尼酮治疗的IPF患者的小样本数据。
大多数患者为男性，平均年龄72.8岁（±10.3）。他们处于生理I期或II期，基线平均用力肺活量（FVC）为2.236L（预测值的73.8%）。接受吡非尼酮治疗后，第24周时平均FVC下降0.088L，第52周时下降0.127L。基线时平均6分钟步行试验为325.5m，第24周时增加8.1m，但第52周时下降23.0m。这些相对于基线的变化未达到统计学显著性。吡非尼酮可防止咳嗽加重，但不能稳定呼吸困难。在52周的治疗期间，药物不良反应总发生率为62.0%，食欲下降（32.0%）和瘙痒（10.0%）最为常见。导致停药的不良事件为食欲下降（8.0%）、恶心（4.0%）和呼吸衰竭（4.0%）。该研究未引发安全性担忧。吡非尼酮治疗使大多数患者的FVC和咳嗽主观症状稳定。
这项上市后监测研究表明，吡非尼酮在台湾IPF患者中是一种有效、安全且耐受性良好的治疗方法。
