吡非尼酮和尼达尼布对156例特发性肺纤维化患者的临床效果及对肺功能的影响  

Effect of Pirfenidone and Nintedanib on the efficacy and pulmonary function of 156 cases of patients with idiopathic pulmonary fibrosis

作　　者：姜涵毅[1] 刘小琴[1] 徐进[2] 余敏[1] 李燕[1] 黄妹[1] 曹敏[1] 肖永龙[1] 刘寅[1] JIANG Hanyi;LIU Xiaoqin;XU Jin;YU Min;LI Yan;HUANG Mei;CAO Min;XIAO Yonglong;LIU Yin(Department of Respiratory and Critical Care Medicine,Nanjing Drum Tower Hospital,Affiliated Hospital of Medical School,Nanjing,Jiangsu210008,China;School of Public Health Nanjing Medical University,Nanjing,Jiangsu211166,China)

机构地区：[1]南京大学医学院附属鼓楼医院呼吸与危重症医学科,江苏南京210008 [2]南京医科大学公共卫生学院,江苏南京211166

出　　处：《临床肺科杂志》2024年第11期1621-1627,共7页Journal of Clinical Pulmonary Medicine

基　　金：国家自然科学基金专项项目(No.82241085);国家自然科学基金青年项目(No.82000071)。

摘　　要：目的研究吡非尼酮和尼达尼布对特发性肺纤维化(IPF)患者的临床治疗效果及对肺功能相关指标的影响。方法选择2019年至2022年间,我院呼吸与危重症医学科收治的156例IPF患者,随机分成乙酰半胱氨酸对照组(n=48)、吡非尼酮观察组(n=51)和尼达尼布观察组(n=57),观察组分别给予吡非尼酮或尼达尼布进行治疗,对照组患者按照常规方法给药乙酰半胱氨酸治疗,疗程为48周。比较三组药物对IPF患者治疗前后的用力肺活量(FVC)、一秒量(FEV_(1))、一氧化碳弥散量占预计值比例(D_(L)CO%pred)指标的影响;检测血清涎液化糖链抗6(KL-6)、干扰素-γ、白介素-6(IL-6)和乳酸脱氢酶(LDH)表达;统计圣乔治呼吸问卷(St.George’s Respiratory Questionnaire,SGRQ)评分、复发率以及生存曲线。结果治疗48周后,吡非尼酮和尼达尼布观察组患者的FVC和FVC%pred指标较对照组相比均有统计学差异(P<0.05),尼达尼布观察组治疗48周后,FVC较对照组下降140 mL/年,吡非尼酮观察组较对照组下降110 mL/年,两观察组之间无统计学差异(P>0.05);对照组治疗前后患者的血清KL-6值和干扰素-γ值无统计学差异,而吡非尼酮和尼达尼布两观察组治疗前后患者血清KL-6和干扰素-γ值均显著下降(P<0.05),三组患者治疗前后的IL-6和LDH表达变化均无统计学差异(P>0.05)。治疗48周后随访,对照组患者急性发作率为45.83%,吡非尼酮观察组患者急性发作率为23.53%,尼达尼布观察组患者急性发作率为22.81%;治疗后两观察组患者的SGRQ评分显著降低,生活质量具有明显优势。结论吡非尼酮或尼达尼布均可延缓IPF患者肺功能下降,降低患者血清KL-6和干扰素-γ水平,治疗效果显著,治疗方案对临床使用具有重要的指导作用。Objective To investigate the clinical therapeutic effect of pirfenidone and nidanib on patients with idiopathic pulmonary fibrosis(IPF)and the effects on lung function indexes.Methods A total of 156 IPF patients admitted to the Department of Respiratory and Critical Care Medicine of our hospital from 2019 to 2022 were randomly divided into acetylcysteine control group(48 cases),pirfenidone observation group(51 cases),and nintedanib observation group(57 cases).The observation group was treated with pirfenidone or nintedanib respectively,and the patients in the control group were treated with acetylcysteine according to the routine method for 48 weeks.The changes of forced vital capacity(FVC),forced expiratory volume in one second(FEV_(1)),and diffusion capacity of carbon monoxide(D_(L) CO%pred)were compared among the three groups before and after treatments,The expression of serum salivary glycosylated anti-6(KL-6),interferon-γ,interleukin-6(IL-6)and lactate dehydrogenase(LDH)were detected.SGRQ(St.George′s Respiratory Questionnaire)score,recurrence rate,and survival curve were calculated.Results After 48 weeks of treatment,the FVC and FVC%pre indexes in the two observation groups were significantly decreased when compared with the control group(P<0.05).The decline in FVC with nintedanib was 140 mL/year,and the decline in FVC with pirfenidone was 110 mL/year when compared with the control group,while there were no significant differences between the two observation groups(P>0.05).Compared with the control group,the serum levels of KL-6 and IFN-γin the two observation groups were significantly decreased(P<0.05),and there was no significant difference in the control group(P>0.05),moreover,there show no significant difference in the expression of IL-6 and LDH among the three groups.After treatments,the recurrence rate of pirfenidone and nintedanib groups were 23.53%and 22.81%,while it shows 45.83%in the control group.The SGRQ score was significantly decreased and the quality of life was significantly better in bot

关 键 词：吡非尼酮 尼达尼布 特发性肺纤维化 血清涎液化糖链抗6 用力肺活量 

分 类 号：R563[医药卫生—呼吸系统]