TY - Jour T1 - Pirfenidone Plus吸入N-乙酰半胱氨酸用于特发性肺纤维化:A随机试验JF - 欧洲呼吸期刊Jo - Eur Respir J Do - 10.1183 / 13993003.00348-2020 VL - 57是 - 1 SP - 2000348 Au - Sakamoto,SusumuAu - KataOka,Kensuke Au - Kato,Yasuhiro Au - Kato,Motoyasu Au - Hiroshi Au - Mukae,Hiroshi Au - Bando,Masashi Au - Suda,Takafumi Au - Yatera,Kazuhiro Au - Tanino,Yoshinori Au - Kishaba,TomooAu - Hattori,Noboru Au - Taguchi,Yoshio Au - Saito,Takefum​​i Au - Nishioka,Yasuhiko Au - Kuwano,Kazuyoshi Au - Kishi,Kazuma Au - Inase,Naohiko Au - Sasaki,Shinichi Au - Takizawa,Hajime Au - Johkoh,TakehiAU - Sakai,Fumikazu Au - Homma,Sakae A2 - ,Y1 - 2021/01/01 Ur - //www.qdcxjkg.com/content/57/1/2000348.abstract n2 - 背景A日本随机对照试验在一些早期特发性脉冲脉冲患者中,吸入的N-乙酰半胱氨酸单疗法稳定在迫使生命能力(FVC)中的连续下降艾瑞纤维化(IPF)。然而,用抗蒸发剂和吸入的N-乙酰半胱氨酸的组合治疗的功效和耐受性是未知的。这48周,随机,开放标签,多元相3试验比较了与Pirfenidone Plus吸入的组合治疗的疗效和耐受性- 每天两次352.4毫克,除了Pirfenidone的结果,仅在IPF患者中。主要终点是FVC的年度下降率。探索性疗效测量包括肺部延伸能力的连续变化,用于一氧化碳(DLCO)和6分钟步行距离(6MWD),无进展的存活率(PFS),急性加重发病率,以及可耐受性。结果81例患者被随机分配在1:1的比例中接受pirfenidone加入N-乙酰半胱氨酸(n = 41)或pirfenidone(n = 40)。FVC的48周变化率分别为-300mL和-123mL(差异-178ml,95%CI -324--31mL; 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 -