Department of Pharmacy, UMass Memorial Medical Center, Worcester, MA, USA.
Ann Pharmacother. 2013 Mar;47(3):361-7. doi: 10.1345/aph.1R337. Epub 2013 Feb 12.
To evaluate the published clinical literature on the role of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF).
A systematic literature search was performed using the key words pirfenidone or Esbriet, alone and in combination, with IPF or idiopathic pulmonary fibrosis (expanded using MESH terminology). MEDLINE (1948-September 2012) was the primary database used for search purposes. In addition, all available articles and abstracts referenced by the articles identified via literature search were included.
The search was limited to English-language publications. All available clinical trials of pirfenidone pertinent to its pharmacology, pharmacokinetics, efficacy, and safety were included.
Pirfenidone is the first agent specifically developed for the treatment of IPF. It has been approved for use in Europe and Japan, but not in the US. Although Phase 3 trials have shown pirfenidone to improve certain clinical (6-minute walk test) and functional (change in forced vital capacity) outcomes in patients with IPF, an independent benefit on either mortality or acute exacerbation rates has yet to be demonstrated. Until more definitive supportive data are available, international guidelines have recommended against using pirfenidone to treat most patients with IPF.
Although pirfenidone appears to be an effective treatment for IPF, additional clinical trials are needed to better delineate its risk-benefit profile.
评估已发表的关于吡非尼酮治疗特发性肺纤维化（IPF）的临床文献。
使用关键词“吡非尼酮”或“Esbriet”，单独或联合，与“特发性肺纤维化”或“特发性肺纤维化（使用 MESH 术语扩展）”进行系统文献检索。MEDLINE（1948 年-2012 年 9 月）是主要的搜索数据库。此外，还包括通过文献检索确定的文章中所有可用的文章和摘要。
搜索仅限于英文出版物。所有与吡非尼酮的药理学、药代动力学、疗效和安全性相关的可用临床研究均包括在内。
吡非尼酮是专门开发用于治疗 IPF 的第一种药物。它已在欧洲和日本获得批准使用，但尚未在美国获得批准。尽管 3 期试验表明吡非尼酮可改善 IPF 患者的某些临床（6 分钟步行试验）和功能（用力肺活量变化）结局，但尚未证明其对死亡率或急性加重率有独立益处。在获得更明确的支持性数据之前，国际指南建议不要使用吡非尼酮治疗大多数 IPF 患者。
尽管吡非尼酮似乎是治疗 IPF 的有效药物，但仍需要更多的临床试验来更好地确定其风险效益特征。
