目的:多项随机对照研究表明,吡非尼酮和尼达尼布对治疗特发性肺纤维化有效且安全。本研究旨在评估其疗效,安全,在现实世界中的耐受性。
方法:我们搜索了PubMed,Embase,科克伦图书馆,和ClinicalTrials.gov数据库,用于截至2023年3月3日发表的关于吡非尼酮和尼达尼布治疗特发性肺纤维化的真实世界研究。
结果:共纳入74项研究,23,119名参与者。经过12个月的治疗,预测FVC百分比(%FVC)相对于基线的变化:吡非尼酮为-0.75%,尼达尼布为-1.43%.预测的DLCO百分比(%DCLO)相对于基线的变化对于吡非尼酮为-2.32%,对于尼达尼布为-3.95%。特发性肺纤维化(AE-IPF)急性加重的发生率为吡非尼酮的12.5%和尼达尼布的14.4%。吡非尼酮和尼达尼布与IPF相关的死亡率分别为13.4%和7.2%,分别。吡非尼酮的全因死亡率为20.1%,尼达尼布为16.6%。在吡非尼酮组中,16.6%的患者因不良事件中断治疗,在尼达尼布小组中,16.2%的患者因不良事件停止治疗。吡非尼酮和尼达尼布的不良事件发生率分别为56.4%和69.7%,分别。
结论:这项研究的结果表明,吡非尼酮和尼达尼布均可有效减缓现实环境中IPF患者的肺功能下降。吡非尼酮的不良事件发生率低于尼达尼布,但两者都低于临床试验数据,并且没有观察到新的主要不良事件。两种药物因不良反应导致的停药率与临床试验数据一致,表明良好的耐受性。然而,这两种药物在现实环境中的死亡率和AE-IPF发病率高于以前的临床试验,吡非尼酮患者的死亡率较高。需要进一步的大样本研究来调查这些药物在这些方面的风险。此外,我们建议未来的真实世界研究更多关注患者的主观症状,并根据患者的基线肺功能等因素,对吡非尼酮和尼达尼布的疗效和安全性进行分层分析,合并症,和年龄,以期在临床实践中为IPF患者提供更个性化的用药建议。
OBJECTIVE: Multiple randomized controlled studies have shown that pirfenidone and nintedanib are effective and safe for treating idiopathic pulmonary fibrosis. This study aimed to evaluate their efficacy, safety, and tolerability in a real-world setting.
METHODS: We searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases for real-world studies published up to March 3, 2023, on pirfenidone and nintedanib for idiopathic pulmonary fibrosis.
RESULTS: A total of 74 studies with 23,119 participants were included. After 12 months of treatment, the change from baseline in percent predicted FVC (%FVC) was - 0.75% for pirfenidone and - 1.43% for nintedanib. The change from baseline in percent predicted DLCO (%DCLO) was - 2.32% for pirfenidone and - 3.95% for nintedanib. The incidence of acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) was 12.5% for pirfenidone and 14.4% for nintedanib. The IPF-related mortality rates of pirfenidone and nintedanib were 13.4% and 7.2%, respectively. The all-cause mortality was 20.1% for pirfenidone and 16.6% for nintedanib. In the pirfenidone group, 16.6% of patients discontinued treatment because of adverse events, and in the nintedanib group, 16.2% of patients discontinued treatment because of adverse events. The incidence of adverse events was 56.4% and 69.7% for pirfenidone and nintedanib, respectively.
CONCLUSIONS: The results of this study indicate that pirfenidone and nintedanib are both effective in slowing down the decline of lung function in IPF patients in real-world settings. The incidence of adverse events with pirfenidone is lower than that with nintedanib, but both are below the clinical trial data, and no new major adverse events have been observed. The discontinuation rates due to adverse reactions of the two drugs are consistent with clinical trial data, indicating good tolerability. However, the mortality rates and AE-IPF incidence rates of these two drugs in real-world settings are higher than those in previous clinical trials, with pirfenidone patients showing a higher mortality rate. Further large-sample studies are needed to investigate the risks of these drugs in these aspects. Additionally, we recommend that future real-world studies pay more attention to patients\' subjective symptoms and conduct stratified analyses of the efficacy and safety of pirfenidone and nintedanib based on factors such as patients\' baseline lung function, comorbidities, and age, in order to provide more personalized medication advice for IPF patients in clinical practice.