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西班牙特发性肺纤维化患者的抗纤维化治疗依从性、疗效及结局:一项真实世界证据研究

Antifibrotic treatment adherence, efficacy and outcomes for patients with idiopathic pulmonary fibrosis in Spain: a real-world evidence study.

作者信息

Romero Ortiz Ana Dolores, Jiménez-Rodríguez Beatriz María, López-Ramírez Cecilia, López-Bauzá Ángela, Pérez-Morales María, Delgado-Torralbo José Antonio, Villalba Moral Cristina, Alcazar-Navarrete Bernardino

机构信息

Respiratory Department, Hospital Universitario Virgen de las Nieves, Granada, Spain.

Respiratory Department, Hospital Universitario Virgen de las Nieves, Granada, Spain

出版信息

BMJ Open Respir Res. 2024 Apr 24;11(1):e001687. doi: 10.1136/bmjresp-2023-001687.

Abstract

BACKGROUND

Idiopathic pulmonary fibrosis (IPF) is a rare disorder associated with increased mortality and morbidity. There are currently two drugs approved for IPF but their safety and efficacy profile in real-world settings in Spain is not well understood.

METHODS

An observational, multicentre, prospective study was carried out among patients with IPF who started treatment with pirfenidone or nintedanib from 2015 to 2021. Data regarding clinical characteristics, drug adherence, safety profiles and clinical outcomes between these two drugs were collected.

RESULTS

232 patients were included in the analysis. There were no meaningful differences between both groups at baseline. Patients who started pirfenidone showed a decreased risk for treatment withdrawal compared with those starting nintedanib (HR 0.65 (95% CI 0.46 to 0.94; p=0.002)). Time to first adverse event and all-cause mortality was similar between study groups. Risk factors for withdrawal were female sex, diarrhoea and photosensitivity.

CONCLUSIONS

in this real-world study, both pirfenidone and nintedanib showed similar efficacy profiles. Pirfenidone was associated with less treatment discontinuations due to side effects.

摘要

背景

特发性肺纤维化(IPF)是一种罕见疾病,与死亡率和发病率增加相关。目前有两种药物被批准用于治疗IPF,但在西班牙的实际应用中,它们的安全性和疗效尚不明确。

方法

对2015年至2021年开始使用吡非尼酮或尼达尼布治疗的IPF患者进行了一项观察性、多中心、前瞻性研究。收集了关于这两种药物的临床特征、药物依从性、安全性概况和临床结局的数据。

结果

232例患者纳入分析。两组在基线时无显著差异。与开始使用尼达尼布的患者相比,开始使用吡非尼酮的患者治疗中断风险降低(风险比0.65(95%置信区间0.46至0.94;p = 0.002))。研究组之间首次出现不良事件的时间和全因死亡率相似。停药的风险因素包括女性、腹泻和光敏反应。

结论

在这项真实世界研究中,吡非尼酮和尼达尼布显示出相似的疗效。吡非尼酮因副作用导致的治疗中断较少。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cfa/11043774/5f2a513096a4/bmjresp-2023-001687f01.jpg

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本文引用的文献

1
Long-Term Safety of Antifibrotic Drugs in IPF: A Real-World Experience.
Biomedicines. 2022 Dec 12;10(12):3229. doi: 10.3390/biomedicines10123229.
3
Diagnostic and Therapeutic Developments in Progressive Pulmonary Fibrosis.
Arch Bronconeumol. 2022 May;58(5):418-424. doi: 10.1016/j.arbres.2021.12.006. Epub 2022 Jan 5.
8
Effectiveness and safety of pirfenidone for idiopathic pulmonary fibrosis.
Eur J Hosp Pharm. 2020 Nov;27(6):350-354. doi: 10.1136/ejhpharm-2018-001806. Epub 2019 May 7.
10
Real-life comparison of pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis: A 24-month assessment.
Respir Med. 2019 Nov;159:105803. doi: 10.1016/j.rmed.2019.105803. Epub 2019 Oct 18.

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