国产吡非尼酮治疗特发性肺纤维化Ⅱ期临床研究  

Clinical Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

作　　者：李惠萍[1] 王思勤[2] 周建英[3] 万欢英[4] 王利民[5] 王广发[6] 银培基 

机构地区：[1]同济大学附属上海市肺科医院,上海200433 [2]河南省人民医院,河南郑州450003 [3]浙江大学医学院附属第一医院,浙江杭州310003 [4]上海交通大学医学院附属瑞金医院,上海200025 [5]杭州市第一人民医院,浙江杭州310006 [6]北京大学第一医院,北京100034 [7]南京正大天晴制药有限公司,江苏南京210018

出　　处：《中国呼吸与危重监护杂志》2015年第3期229-235,共7页Chinese Journal of Respiratory and Critical Care Medicine

摘　　要：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)m L,B组下降(70±310)m L,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。Objective To evaluate the clinical efficacy and safety of pirfenidone in Chinese patients with idiopathic pulmonary fibrosis （IPF）. Methods In a multicenter, randomized, double-blind, comparative clinical trial, 87 patients with IPF were randomly divided into two groups. Group A （43 patients） were treated with pirfenidone （1 200 mg per day） for 48 weeks, while Group B （44 patients） were treated with placebo. Clinical features were compared between two groups including efficacy indicators （pulmonary function ,6MWT, and quality of life scores） and safety indicators （incidence of adverse events）. Results Forced vital capacity （FVC） was increased by （90 ± 410）mL in Group A and decreased by （70±310）mL in Group B （P 〈0. 05） ;In Group A,forced expiratory volume in 1 second was raised by （100 ± 330） mL and （110 ± 240 ）mL following 12 and 24 weeks after treatment, significantly different from group B （P 〈0.05）. There were significant differences in 6MWT between two groups 36 and 48 weeks after treatment respectively（ both P 〈 0. 05）. Quality of life scores, including the St. George＇ s score （ excluding symptoms） and dyspnea score,were significantly higher in Group A than Group B （both P 〈 0. 05 ）. There was no significant difference in the incidence of adverse events between Groups A and B （ 83.72% vs. 72. 73 % ,P 〉 O. 05）. Conclusion Domestic pirfenidone is clinically effective and safe for the treatment of IPF in Chinese patients.

关 键 词：特发性肺纤维化 吡非尼酮 

分 类 号：R563.9[医药卫生—呼吸系统]