Oral pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot study.
Oral pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot study.
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DOI：
10.1186/1748-717x-2-19
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发表时间：
2007-05-31
期刊：
影响因子：
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通讯作者：
Camphausen KA
中科院分区：
文献类型：
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作者：
Simone NL;Soule BP;Gerber L;Augustine E;Smith S;Altemus RM;Mitchell JB;Camphausen KA
纤维化是电离辐射治疗后常见的副作用。已经采用了几种改善衰弱性纤维化的方法，但没有一致的结果。这项初步研究的目的是确定吡非尼酮，一种新的细胞因子基因表达调节剂，是否有可能改善已建立的辐射诱导的纤维化。对已完成放射治疗并已确定放射诱导纤维化的入组患者进行了800 mg每日三次口服吡非尼酮的开放标签、前瞻性初步研究。使用标准措施评估活动度（ROM），每三个月测量一次疼痛、疲劳、残疾和整体健康的主观指标。入组了7例患者，其中3例在1个部位进行了ROM评估，2例在2个部位进行了ROM评估。在这些评估中，6项显示药物干预期间ROM增加，1项显示ROM减少。SF 36的心理综合评分总体改善，而身体综合评分降低，活力评分不变。两名患者因晕厥发作而退出研究。一些患者的功能改善至少25%，并报告主观改善。吡非尼酮可能有益于放射性纤维化患者，值得进行更大规模的对照试验。
Fibrosis is a common side effect after treatment with ionizing radiation. Several methods to ameliorate debilitating fibrosis have been employed but without consistent results. The goal of this pilot study is to determine if Pirfenidone, a novel regulator of cytokine gene expression, has the potential to ameliorate established radiation-induced fibrosis. Open label, prospective pilot study of 800 mg three times/day, orally administered Pirfenidone was administered to enrolled patients who were had completed radiation therapy and who had established radiation-induced fibrosis. Range of motion (ROM) was assessed using standard measures, and subjective measures of pain, fatigue, disability and global health were measured every three months. Seven patients were enrolled of whom 3 had ROM assessments of 1 site and 2 had ROM assessments of 2 sites. Of these assessments, 6 revealed increased ROM during drug intervention while 1 revealed a decreased ROM. There was an overall improvement in the mental composite score of the SF36 while physical composite score was decreased and the vitality score was unchanged. Two patients were removed from the study because of syncopal episodes. Several patients experienced improved function of at least 25% and reported subjective improvement. Pirfenidone may benefit patients with radiation-induced fibrosis and is worthy of a larger well controlled trial.