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-  2015 

国产吡非尼酮治疗特发性肺纤维化Ⅱ期临床研究

DOI: doi:10.7507/1671-6205.2015059

Keywords: 特发性肺纤维化, 吡非尼酮

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Abstract:

目的探讨吡非尼酮片治疗特发性肺纤维化(IPF)的临床疗效和安全性。 方法采用多中心、随机、双盲、安慰剂对照的方法,筛选出87例IPF患者,所有受试者均经知情同意自愿参加。按照随机化数字方法分为两组:吡非尼酮组(A组,43例),口服国产吡非尼酮片,疗程48周,每次2片(0.4 g),每日3次(1.2 g/d),餐后服用;安慰剂组(B组,44例),口服安慰剂,疗程和用法同A组。观察时间为用药12、24、36和48周。观察指标包括:①临床疗效指标:肺功能变化,6分钟步行试验(6MWT),生活质量评分变化等;②安全性指标:不良事件发生率,以评价药物对IPF患者的临床有效性以及安全性。 结果主要疗效指标变化:用药12周,A组用力肺活量(FVC)增加(90±410) mL,B组下降(70±310)mL,两组患者FVC变化值比较,差异有统计学意义(P<0.05)。次要疗效指标变化:(1)第1秒用力呼气容积(FEV1):用药12和24周,两组患者FEV1变化值比较,差异有统计学意义(P<0.05);(2)两组患者一氧化碳弥散量(DLCO):两组患者DLCO变化值比较,差异无统计学意义(P>0.05);(3)6MWT:用药36和48周,两组患者6MWT行走距离变化值比较,差异有统计学意义(P<0.05);(4)生活质量评分:在用药12(症状除外)、24、36及48周各个时间点与基线的评分变化,两组患者圣乔治呼吸问卷(SGRQ)评分以及呼吸困难评分之间的差异均有统计学意义(P<0.05)。安全性:A组43例患者中有36例发生不良事件,发生率为83.72%;B组44例患者中有32例发生不良事件,发生率为72.73%;发生率组间比较,差异无统计学意义(P>0.05)。 结论国产吡非尼酮片治疗IPF具有良好的临床疗效和安全性

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