Pneumology Unit, University Hospital of Modena Policlinico, Modena, Italy.
Alma Mater University, Department of Clinical, Integrated and Experimental Medicine (DIMES), Respiratory and Critical Care Unit, S. Orsola-Malpighi Hospital Bologna, Bologna, Italy.
Respir Med. 2019 Nov;159:105803. doi: 10.1016/j.rmed.2019.105803. Epub 2019 Oct 18.
Real-life data on the use of pirfenidone and nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF) are still scarce.
We compared the efficacy of either pirfenidone (n = 78) or nintedanib (n = 28) delivered over a 24-month period in patients with IPF, followed at two regional clinic centers in Italy, with a group of patients who refused the treatment (n = 36), and who were considered to be controls. All patients completed regular visits at 1- to 3-month intervals, where primary [forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO)] and secondary outcomes (side effects, treatment compliance, and mortality) were recorded.
Over time, the decline in FVC and DLCO was significantly higher (p = 0.0053 and p = 0.037, respectively) in controls when compared with the combined treated group, with no significant difference between the two treated groups. Compared to patients with less advanced disease (GAP (Gender, Age, Physiology) stage I), those in GAP stages II and III showed a significantly higher decline in both FVC and DLCO irrespective of the drug taken. Side effects were similarly reported in patients receiving pirfenidone and nintedanib (5% and 7%, respectively), whereas mortality did not differ among the three groups.
This real-life study demonstrated that both pirfenidone and nintedanib were equally effective in reducing the decline of FVC and DLCO versus non-treated patients after 24 months of treatment; however, patients with more advanced disease were likely to show a more rapid decline in respiratory function.
关于吡非尼酮和尼达尼布治疗特发性肺纤维化(IPF)患者的真实数据仍然很少。
我们比较了在意大利的两个地区诊所中心接受吡非尼酮(n=78)或尼达尼布(n=28)治疗24个月的 IPF 患者的疗效,与拒绝治疗的一组患者(n=36)进行比较,并将其视为对照组。所有患者都定期在 1-3 个月的间隔进行就诊,记录主要(用力肺活量[FVC]和一氧化碳弥散量[DLCO])和次要(副作用、治疗依从性和死亡率)结果。
随着时间的推移,与联合治疗组相比,对照组的 FVC 和 DLCO 下降更为显著(p=0.0053 和 p=0.037),但两组治疗组之间无显著差异。与疾病进展程度较轻的患者(GAP[性别、年龄、生理学]分期 I)相比,GAP 分期 II 和 III 的患者无论服用哪种药物,FVC 和 DLCO 的下降均更为显著。服用吡非尼酮和尼达尼布的患者均报告有类似的副作用(分别为 5%和 7%),但三组患者的死亡率无差异。
这项真实世界的研究表明,在治疗 24 个月后,吡非尼酮和尼达尼布在降低 FVC 和 DLCO 下降方面与未治疗患者相比同样有效;然而,疾病进展程度更严重的患者可能会出现更快的呼吸功能下降。