国产吡非尼酮治疗特发性肺纤维化Ⅱ期临床研究

发布时间：2019-03-31 14:28

【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(P0.05)。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(P0.05);(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(P0.05);(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(P0.05);(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(P0.05)。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(P0.05)。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。
[Abstract]:Objective to investigate the clinical efficacy and safety of pirfenidone tablets in the treatment of idiopathic pulmonary fibrosis (IPF). Methods A multicenter, randomized, double-blind, placebo-controlled, multicenter, randomized, double-blind, placebo-controlled method was used to screen 87 patients with IPF, all of whom volunteered with informed consent. Two groups were randomly divided into two groups: group A (group A, 43 cases) were given domestic pirfenidone tablets for 48 weeks, 2 tablets (0.4 g), 3 times a day, 1.2g / d) for 48 weeks, and they were taken postprandial. The patients were divided into two groups: group A (group A, n = 43) and control group (n = 43). Placebo group (group B, 44 cases), oral placebo, course of treatment and use the same as group A. The observation time was 12,24,36 and 48 weeks. The results were as follows: (1) Clinical efficacy indexes: changes in pulmonary function, 6-minute walking test (6MWT), quality of life score, and so on; 2 Safety index: incidence of adverse events in order to evaluate the clinical efficacy and safety of drugs in patients with IPF. Results: after 12 weeks of treatment, forced vital capacity (FVC) of group A increased (90 卤410) mL, and group B decreased (70 卤310) m L,). There was a significant difference in the change of FVC between group A and group B (P0.05). Secondary therapeutic index changes: (1) forced expiratory volume (FEV1) in the first second: 12 and 24 weeks after treatment, the changes of FEV1 between the two groups were statistically significant (P0.05); (2) there was no significant difference in the change of DLCO between the two groups of patients (P0.05). The difference of carbon monoxide diffusing capacity (DLCO):) between the two groups was not statistically significant (P0.05). (3) 6MWT: after 36 and 48 weeks of treatment, the changes of 6MWT walking distance between the two groups were significantly different (P0.05). (4) quality of life score: changes in scoring at all time points and baseline at 12 (except symptoms), 24, 36 and 48 weeks; There was significant difference in (SGRQ) score and dyspnea score between the two groups (P0.05). Safety: 36 of 43 patients in group A had adverse events, the incidence of which was 83.72% in group B and 32 in 44 patients in group B (72.73%). There was no significant difference in incidence between groups (P0.05). Conclusion domestic pirfenidone tablets have good clinical efficacy and safety in the treatment of IPF.
【作者单位】：同济大学附属上海市肺科医院;河南省人民医院;浙江大学医学院附属第一医院;上海交通大学医学院附属瑞金医院;杭州市第一人民医院;北京大学第一医院;南京正大天晴制药有限公司;
【分类号】：R563.9

【共引文献】