National Institutes of Health, Kidney Disease Branch, 10/CRC 5-5750, 9000 Rockville Pike, Bethesda, MD 20892-1268, USA.
Expert Opin Investig Drugs. 2010 Feb;19(2):275-83. doi: 10.1517/13543780903501539.
Many chronic diseases of various etiologies lead to fibrosis and organ dysfunction. Despite many advances in medicine in recent years, options to slow the progression of fibrotic diseases have remained limited. The recent availability of pirfenidone, an antifibrotic and anti-inflammatory investigational agent, thus offers a new hope for treating progressive fibrotic diseases.
This review provides concise review of the available data regarding the mechanism and pharmacokinetics of pirfenidone and preclinical and clinical data regarding efficacy and safety in fibrotic diseases of the kidney. It also reviews results of clinical trials involving pirfenidone in other fibrotic diseases.
The review will provide in-depth review of pirfenidone with a renal focus.
Because many of the available clinical trials have been small and/or uncontrolled, conclusive evidence regarding efficacy and safety of pirfenidone is lacking, particularly in patients with renal or hepatic dysfunction. Larger studies are needed to better understand long-term efficacy and safety of this medication in various patient populations.
许多病因不明的慢性疾病都会导致纤维化和器官功能障碍。尽管近年来医学取得了许多进展，但减缓纤维化疾病进展的选择仍然有限。最近出现的吡非尼酮是一种抗纤维化和抗炎的研究药物，为治疗进行性纤维化疾病带来了新的希望。
本综述简要回顾了吡非尼酮的作用机制、药代动力学、在肾脏纤维化疾病中的临床前和临床疗效和安全性数据，并回顾了涉及其他纤维化疾病的吡非尼酮临床试验结果。
本文将深入介绍以肾脏为重点的吡非尼酮。
由于许多已有的临床试验规模较小且/或未设对照组，因此缺乏关于吡非尼酮疗效和安全性的结论性证据，尤其是在有肾功能或肝功能障碍的患者中。需要更大规模的研究来更好地了解该药物在各种患者人群中的长期疗效和安全性。
