吡非尼酮早期干预特发性肺纤维化的疗效和安全性评估

Efficacy and safety evaluation with pirfenidone in early intervention of idiopathic pulmonary fibrosis

目的评估吡非尼酮早期干预特发性肺纤维化(IPF)的疗效和安全性。方法回顾性分析2016年1月至2019年8月在杭州师范大学附属医院接受治疗的40例IPF患者的临床资料,其中接受吡非尼酮治疗的20例IPF患者为吡非尼酮组,未接受吡非尼酮治疗的20例IPF患者为对照组。随访观察治疗6、12个月后吡非尼酮组及对照组患者的临床数据,观察吡非尼酮的疗效及不良反应。结果治疗6、12个月后,两组FVC、D_(L)CO占预计值百分比与治疗前比较,差异无统计学意义(P>0.05),而对照组6 min步行距离与治疗前比较有所降低(P<0.05),吡非尼酮组6 min步行距离与治疗前比较,差异无统计学意义(P>0.05)。治疗6个月后,吡非尼酮组的FVC、D_(L)CO占预计值百分比及6 min步行距离高于对照组,差异有统计学意义(P<0.05);治疗12个月后,吡非尼酮组的FVC、D_(L)CO占预计值百分比及6 min步行距离高于对照组,差异有统计学意义(P<0.05)。吡非尼酮组患者在12个月治疗期间共有9例(45.00%)患者出现1种及以上轻中度不良反应,所有患者均未停药。结论随访12个月,口服吡非尼酮能够减缓IPF患者肺功能下降以及6 min步行距离的减少速度,并具有较好的耐受性。

Objective To evaluate the efficacy and safety of early intervention with pirfenidone in idiopathic pulmonary fibrosis(IPF).Methods A retrospective analysis was performed on the clinical data of 40 IPF patients with who received treatment at the Affiliated Hospital of Hangzhou Normal University from January 2016 to August 2019,20 IPF patients with who received pirfenidone as the pirfenidone group and 20 IPF patients were not treated with pirfenidone as the control group.The clinical data of the patients in the pirfenidone group and the control group after 6 and 12 months of treatment were followed up to observe the efficacy and adverse effects of pirfenidone.Results After 6 and 12 months of treatment,the percentages of FVC and D_(L)CO in the two groups were not significantly different from those before treatment(P>0.05),while the 6-minute walking distance in the control group decreased compared with that before treatment(P<0.05),the 6-minute walking distance in the pirfenidone group was not significantly different from that before treatment(P>0.05).After 6 months of treatment,the percentages of FVC,D_(L)CO and 6-minute walking distance in the pirfenidone group were higher than those in the control group,and the differences were statistically significant(P<0.05).The percentages of FVC,D_(L)CO and 6-minute walking distance in the group were higher than those in the control group,and the difference was statistically significant(P<0.05).A total of 9 patients(45.00%)in the pirfenidone group had one or more mild to moderate adverse reactions during the 12-month treatment period,and all patients did not stop taking the drug.Conclusion At 12-month follow-up,oral pirfenidone was able to reduce the decay speed of lung function and the reduce speed of 6-minute walk distance of IPF patients,with a good tolerance.