TY - JOUR T1 -吡非尼酮联合吸入n -乙酰半胱氨酸治疗特发性肺纤维化:一个随机试验JF -欧洲呼吸杂志》乔和J - 10.1183/13993003.00348 -2020欧元六世- 57 - 1 SP - 2000348 AU -坂本,进盟,Kataoka Kensuke盟——Kondoh Yasuhiro盟,加藤正树盟——Mukae Motoyasu AU - Okamoto Hiroshi盟,也免不了Masashi盟,须Takafumi盟——Yatera Kazuhiro盟——Taninomanuscript公司AU - Kishaba,脱毛,非盟——服部年宏,现任非盟,田口Yoshio盟——斋藤Takefumi AU -西冈,Yasuhiko盟——Kuwano Kazuyoshi AU -岸,Kazuma盟——Inase Naohiko盟——佐佐木,Shinichi AU - Takizawa Hajime AU - Johkoh,武盟,酒井法子Fumikazu盟的丑行,A2,荣日本一项随机对照试验显示,吸入n -乙酰半胱氨酸单药治疗可以稳定一些早期特发性肺纤维化(IPF)患者强迫肺活量(FVC)的连续下降。然而,抗纤维化药物和吸入n -乙酰半胱氨酸联合治疗的疗效和耐受性尚不清楚。该试验为期48周,随机、开放标签、多中心3期,比较了吡非尼酮联合吸入n-乙酰半胱氨酸352.4 mg,每日2次,与吡非尼酮单独治疗IPF的疗效和耐受性。主要终点是肺活量的年下降率。探索性疗效测量包括肺一氧化碳扩散能力(DLCO)和6分钟步行距离(6MWD)的系列变化、无进展生存(PFS)、急性加重发生率和耐受性。结果81例患者按1:1随机分为吡非尼酮+吸入n -乙酰半胱氨酸组(n=41)和吡非尼酮组(n=40)。48周FVC的变化率分别为- 300 mL和- 123 mL(差值为- 178 mL, 95% CI为- 324 - - 31 mL;p = 0.018)。 Serial change in DLCO, 6MWD, PFS and incidence of acute exacerbation did not significantly differ between the two groups. The incidence of adverse events (n=19 (55.9%) for pirfenidone plus N-acetylcysteine; n=18 (50%) for pirfenidone alone) was similar between groups.Conclusions Combination treatment with inhaled N-acetylcysteine and pirfenidone is likely to result in worse outcomes for IPF.We compared the efficacy of pirfenidone plus inhaled N-acetylcysteine with results for pirfenidone alone for IPF. Combination treatment with inhaled N-acetylcysteine and pirfenidone is likely to result in worse outcomes for IPF. https://bit.ly/3eWEbvW ER -