Division of Respiratory Medicine, Saiseikai Kumamoto Hospital, 5-3-1 Chikami, Chuo-ku, Kumamoto, 861-4101, Japan.
Department of Respiratory Medicine, Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto, 860-8556, Japan.
BMC Pulm Med. 2023 Jun 8;23(1):199. doi: 10.1186/s12890-023-02455-y.
Interstitial lung abnormalities (ILAs) are subtle or mild parenchymal abnormalities observed in more than 5% of the lungs on computed tomography (CT) scans in patients in whom interstitial lung disease was not previously clinically suspected and is considered. ILA is considered to be partly undeveloped stages of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). This study aims to clarify the frequency of subsequent IPF or PPF diagnosis, the natural course from the preclinical status of the diseases, and the course after commencing treatment.
This is an ongoing, prospective, multicentre observational cohort study of patients with ILA referred from general health screening facilities with more than 70,000 annual attendances. Up to 500 participants will be enrolled annually over 3 years, with 5-year assessments every six months. Treatment intervention including anti-fibrotic agents will be introduced in disease progression cases. The primary outcome is the frequency of subsequent IPF or PPF diagnoses. Additionally, secondary and further endpoints are associated with the efficacy of early therapeutic interventions in cases involving disease progression, including quantitative assessment by artificial intelligence.
This is the first prospective, multicentre, observational study to clarify (i) the aetiological data of patients with ILA from the largest general health check-up population, (ii) the natural course of IPF or PPF from the asymptomatic stage, and (iii) the effects and outcomes of early therapeutic intervention including anti-fibrotic agents for progressive cases of ILA. The results of this study could significantly impact the clinical practice and treatment strategy for progressive fibrosing interstitial lung diseases.
UMIN000045149.
在计算机断层扫描（CT）扫描中，超过 5%的肺部出现间质肺异常（ILA），而这些患者之前并未临床怀疑间质肺疾病，被认为存在间质性肺病。ILA 被认为是特发性肺纤维化（IPF）或进行性肺纤维化（PPF）的部分未发育阶段。本研究旨在阐明后续 IPF 或 PPF 的诊断频率、疾病临床前状态的自然病程以及开始治疗后的病程。
这是一项正在进行的、前瞻性的、多中心观察性队列研究，研究对象为来自每年有超过 70000 人次就诊的常规健康筛查机构的 ILA 患者。在 3 年内，每年将招募多达 500 名参与者，每 6 个月进行 5 年评估。在疾病进展病例中，将引入治疗干预措施，包括抗纤维化药物。主要结局是后续 IPF 或 PPF 的诊断频率。此外，还将评估与疾病进展病例中早期治疗干预的疗效相关的次要和进一步终点，包括人工智能的定量评估。
这是第一项前瞻性、多中心、观察性研究，旨在阐明（i）来自最大常规健康检查人群的 ILA 患者的病因数据，（ii）无症状阶段的 IPF 或 PPF 的自然病程，以及（iii）包括抗纤维化药物在内的早期治疗干预对 ILA 进展病例的效果和结果。该研究结果可能会对进展性纤维性间质性肺病的临床实践和治疗策略产生重大影响。
UMIN000045149。
