Pesce E, Struma E, Giri S N, Margolin S B
Local Health Unit of Parma, Bassa Est, N4, 43100 Parma, Italy.
Res Commun Mol Pathol Pharmacol. 2004;115-116:39-48.
The antirheumatic effect of pirfenidone was compared with a positive control drug, oxyphenbutazone which is used in patients suffering from rheumatoid arthritis, in a double blind clinical trial in humans. The data collected in this pilot project revealed that pirfenidone was more effective (p < 0.025) than oxyphenbutazone in providing relief from arthritic pain. In addition, a greater number (p < 0.025) of patients reported favorable response to oral pirfenidone than oral oxyphenbutazone. However, there were no significant differences in the number of patients who dropped out from the trial and the number of patients who tolerated the drugs for 21 days of the trial between the pirfenidone and oxyphenbutazone groups. It was concluded from this pilot study that pirfenidone potentially offers a novel therapeutic modality for the management of rheumatoid arthritis with little or no adverse effects unlike steroidal and non-steroidal anti-inflammatory drugs which are frequently used for this chronic debilitating disease.
在一项针对人类的双盲临床试验中，比较了吡非尼酮与一种用于类风湿性关节炎患者的阳性对照药物奥芬布扎宗的抗风湿效果。在这个试点项目中收集的数据显示，在缓解关节炎疼痛方面，吡非尼酮比奥芬布扎宗更有效（p < 0.025）。此外，报告对口服吡非尼酮有良好反应的患者数量比口服奥芬布扎宗的更多（p < 0.025）。然而，在退出试验的患者数量以及在试验的21天内耐受药物的患者数量方面，吡非尼酮组和奥芬布扎宗组之间没有显著差异。从这项试点研究得出的结论是，与常用于这种慢性衰弱性疾病的甾体和非甾体抗炎药不同，吡非尼酮可能为类风湿性关节炎的治疗提供一种新的治疗方式，且几乎没有不良反应。
