进行性肺纤维化患者的急性加重
Acute exacerbations in patients with progressive pulmonary fibrosis.
作者信息
Kreuter Michael, Belloli Elizabeth A, Bendstrup Elisabeth, Cerri Stefania, Flaherty Kevin R, Shapera Shane, Song Jin Woo, Mueller Heiko, Rohr Klaus B, Kondoh Yasuhiro
机构信息
Center for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Center and Pulmonary, Critical Care & Sleep Medicine, Marienhaus Clinic Mainz, Mainz, Germany.
Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA.
出版信息
ERJ Open Res. 2024 Dec 2;10(6). doi: 10.1183/23120541.00403-2024. eCollection 2024 Nov.
BACKGROUND
Acute exacerbations of fibrosing interstitial lung diseases (ILDs) are associated with high mortality. We used prospective data from the INBUILD trial to investigate risk factors for acute exacerbations and the impact of these events in patients with progressive pulmonary fibrosis.
METHODS
Patients with progressive fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF) were randomised to receive nintedanib or placebo. Associations between baseline characteristics and time to first acute exacerbation were assessed using pooled data from both treatment groups using Cox proportional hazard models, firstly univariable models and then a multivariable model using forward stepwise selection. The risk of death was estimated based on the Kaplan-Meier method.
RESULTS
Over a median follow-up of approximately 19 months, acute exacerbations were reported in 58 (8.7%) of 663 patients. In the risk factor analysis, the final model included diffusing capacity of the lung for carbon monoxide ( ) % predicted, treatment and age. Lower % predicted was associated with an increased risk of acute exacerbation with a hazard ratio (HR) of 1.56 (95% CI 1.21-2.02) per 10 units lower (p<0.001). Age ≥65 years was associated with a numerically increased risk (HR 1.55, 95% CI 0.87-2.77; p=0.14). Treatment with nintedanib conferred a numerically reduced risk placebo (HR 0.60, 95% CI 0.35-1.02; p=0.06). The estimated risks of death ≤30 days and ≤90 days after an acute exacerbation were 19.0% (95% CI 8.9-29.2) and 32.0% (95% CI 19.7-44.2).
CONCLUSIONS
Acute exacerbations of progressive pulmonary fibrosis may have similar risk factors and prognostic impact as acute exacerbations of IPF.
背景
纤维化间质性肺疾病（ILDs）的急性加重与高死亡率相关。我们使用INBUILD试验的前瞻性数据来研究急性加重的危险因素以及这些事件对进行性肺纤维化患者的影响。
方法
除特发性肺纤维化（IPF）外的进行性纤维化ILDs患者被随机分配接受尼达尼布或安慰剂。使用Cox比例风险模型，首先是单变量模型，然后是使用向前逐步选择的多变量模型，对两个治疗组的汇总数据进行分析，评估基线特征与首次急性加重时间之间的关联。基于Kaplan-Meier方法估计死亡风险。
结果
在约19个月的中位随访期内，663例患者中有58例（8.7%）报告了急性加重。在危险因素分析中，最终模型包括一氧化碳肺弥散量（）预测值百分比、治疗和年龄。预测值每降低10个单位，预测值百分比降低与急性加重风险增加相关，风险比（HR）为1.56（95%CI 1.21-2.02）（p<0.001）。年龄≥65岁与风险数值增加相关（HR 1.55，95%CI 0.87-2.77；p=0.14）。尼达尼布治疗使风险数值降低 安慰剂（HR 0.60，95%CI 0.35-1.02；p=0.06）。急性加重后≤30天和≤90天的估计死亡风险分别为19.0%（95%CI 8.9-29.2）和32.0%（95%CI 19.7-44.2）。
结论
进行性肺纤维化的急性加重可能与IPF的急性加重具有相似的危险因素和预后影响。
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