特发性肺纤维化患者从吡非尼酮转换为尼达尼布治疗的可行性和安全性：一项真实世界观察性研究。
Feasibility and safety of treatment switch from Pirfenidone to Nintedanib in patients with idiopathic pulmonary fibrosis: a real-world observational study.
机构信息
Department of Pneumonology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.
出版信息
Eur Rev Med Pharmacol Sci. 2021 Oct;25(20):6326-6332. doi: 10.26355/eurrev_202110_27004.
OBJECTIVE
Idiopathic Pulmonary Fibrosis is a disease characterized by a devastating fibrosing process. Two anti-fibrotic agents, pirfenidone and nintedanib, have been found to alter the disease progression. In this study, we sought to determine whether switching treatment to nintedanib is feasible and safe in patients that had to discontinue treatment with pirfenidone due to side effects.
PATIENTS AND METHODS
We analyzed patients that had to discontinue pirfenidone due to side effects. Patients were prospectively enrolled for treatment with nintedanib between March 2015 and June 2019. Side effects and Pulmonary Function Tests were recorded.
RESULTS
12 patients received nintedanib after discontinuing treatment with pirfenidone. Side-effects that led to discontinuation were diarrhea (33.3%), nausea (16.6%), photosensitivity (33.3%) and difficulty adhering to pirfenidone's dosage scheme (16.6%). After the initiation of nintedanib, diarrhea was the most common side effect (66.6%). Four patients of these patients could not tolerate the full dose of 300 mg daily and had to reduce it to 200 mg daily. No patient has had experienced liver damage. During the last twelve months of treatment with pirfenidone, mean ΔFCV was +2.47 ± 3.69%, mean ΔDLco was -0.36 ± 2.64% and mean difference of the distance walked during the 6MWT was 5 ± 56.48 meters. During the first year of treatment with nintedanib, mean ΔFCV was -1.32 ± 1.12% (p=0.68), mean ΔDLco was -1.59 ± 3.45% (p=0.54) and mean difference of the distance walked during the 6MWT was 14.17 ± 59 meters (p=0.078). 50% of patients had stable disease under pirfenidone (6-month FVC decline < 5% and/or 6-month DLco decline < 10%) vs. 50% under nintedanib, 33.3% had marginal 6-month decline (5% ≤ 6-month FVC ≤ 10% and/or (≤ 10% 6- month DLco decline ≤15%) under pirfenidone vs. 33.3% under nintedanib and 16.6% had disease progression (6-month FVC decline > 10% and/or 6-month DLco decline > 15%) under pirfenidone vs. 16.6% under nintedanib.
CONCLUSIONS
These results suggest that nintedanib is a safe option for the treatment of patients that had to discontinue pirfenidone due to adverse reactions. Further studies with greater patient numbers are needed for accurate results concerning efficacy.
目的
特发性肺纤维化是一种以破坏性纤维化过程为特征的疾病。两种抗纤维化药物，吡非尼酮和尼达尼布，已被发现能改变疾病的进展。在这项研究中，我们试图确定在因副作用而不得不停止吡非尼酮治疗的患者中，改用尼达尼布治疗是否可行和安全。
患者和方法
我们分析了因副作用而不得不停止吡非尼酮治疗的患者。这些患者于 2015 年 3 月至 2019 年 6 月期间被前瞻性纳入尼达尼布治疗组。记录副作用和肺功能测试结果。
结果
12 名患者在停止吡非尼酮治疗后接受了尼达尼布治疗。导致停药的副作用有腹泻（33.3%）、恶心（16.6%）、光敏性（33.3%）和难以坚持吡非尼酮的剂量方案（16.6%）。在开始使用尼达尼布后，腹泻是最常见的副作用（66.6%）。其中 4 名患者不能耐受每日 300mg 的全剂量，不得不将剂量减少至 200mg 每日。没有患者出现肝损伤。在使用吡非尼酮的最后 12 个月中，平均 FCV 变化值为+2.47±3.69%，平均 DLco 变化值为-0.36±2.64%，6MWT 中行走距离的平均差值为 5±56.48 米。在使用尼达尼布的第一年，平均 FCV 变化值为-1.32±1.12%（p=0.68），平均 DLco 变化值为-1.59±3.45%（p=0.54），6MWT 中行走距离的平均差值为 14.17±59 米（p=0.078）。在吡非尼酮治疗下，有 50%的患者疾病稳定（6 个月 FVC 下降<5%和/或 6 个月 DLco 下降<10%），50%的患者疾病稳定（6 个月 FVC 下降<5%和/或 6 个月 DLco 下降<10%），50%的患者疾病稳定（6 个月 FVC 下降<5%和/或 6 个月 DLco 下降<10%），在尼达尼布治疗下有 50%的患者疾病稳定，33.3%的患者有轻微的 6 个月下降（5%≤6 个月 FVC≤10%和/或（≤10%6 个月 DLco 下降≤15%）在吡非尼酮治疗下有 33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，33.3%的患者疾病稳定，在尼达尼布治疗下有 16.6%的患者疾病进展（6 个月 FVC 下降>10%和/或 6 个月 DLco 下降>15%）。
结论
这些结果表明，尼达尼布是因不良反应而停止吡非尼酮治疗的患者的安全选择。需要进一步研究以获得关于疗效的更准确结果。
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