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西班牙特发性肺纤维化患者的临床管理和急性加重:OASIS 研究结果。

Clinical management and acute exacerbations in patients with idiopathic pulmonary fibrosis in Spain: results from the OASIS study.

机构信息

Servicio de Neumología, ILD Unit, Hospital Universitario Lucus Augusti, C/Ulises Romero N 1, 27003, Lugo, Spain.

Servicio de Neumología, Hospital Universitario Virgen de Las Nieves, Granada, Spain.

出版信息

Respir Res. 2022 Sep 7;23(1):235. doi: 10.1186/s12931-022-02154-y.

Abstract

BACKGROUND

Idiopathic pulmonary fibrosis (IPF) is a progressive disease associated with decline in lung function and poor prognosis entailing significant impairment in quality of life and high socioeconomic burden. The aim of this study was to characterize clinical management and resources utilization of patients with IPF in Spain, according to predicted forced vital capacity (FVC) % at baseline.

METHODS

Prospective, non-interventional, multicentric real-world data study in patients with IPF in Spain with 12-months follow-up. Clinical management and resources utilization during study period were recorded and compared between groups. FVC decline and acute exacerbations occurrence and associated healthcare resource use were also analysed. FVC decline after 12 months was estimated as relative change.

RESULTS

204 consecutive patients with IPF were included and divided according to baseline FVC % predicted value. At baseline, patients with FVC < 50% received significantly more pharmacological and non-pharmacological treatments, and more help from caregiver. During the 12-months follow-up, patients with FVC < 50% required more specialized care visits, emergency visits, hospitalizations, pulmonary functions tests, non-health resource use (special transportation), and pharmacological treatments (p < 0.05 for all comparisons). Moreover, patients with FVC < 50% at baseline experienced more AE-IPF (p < 0.05), requiring more health-related resources use (primary care visits, p < 0.05). FVC decline was observed in all groups over the 12 months. FVC decreased on average by 2.50% (95% CI: - 5.98 to 0.98) along the year. More patients experienced an FVC decline > 10% in the more preserved lung function groups than in the FVC < 50% group, because of their already deteriorated condition.

CONCLUSIONS

We observed a significantly higher annual IPF-related resource use in patients with more impaired lung function at baseline. Since FVC decreases irrespective of FVC% predicted at baseline, slowing IPF progression to maintain patients at early disease stages is relevant to improve IPF management and to optimize resource use.

TRIAL REGISTRATION

EU PAS register number EUPAS19387 [June 01, 2017].

摘要

背景

特发性肺纤维化(IPF)是一种进行性疾病,与肺功能下降和预后不良相关,导致生活质量显著受损和高社会经济负担。本研究的目的是根据基线时预测的用力肺活量(FVC)%,描述西班牙 IPF 患者的临床管理和资源利用情况。

方法

这是一项在西班牙进行的前瞻性、非干预性、多中心真实世界研究,纳入了 12 个月随访的 IPF 患者。记录并比较了研究期间的临床管理和资源利用情况。还分析了 FVC 下降和急性加重发作的发生情况以及相关的医疗资源利用情况。12 个月后 FVC 的下降程度估计为相对变化。

结果

共纳入 204 例连续 IPF 患者,并根据基线时预测的 FVC%进行分组。基线时,FVC<50%的患者接受了更多的药物和非药物治疗,以及更多的护理人员帮助。在 12 个月的随访期间,FVC<50%的患者需要更多的专科就诊、急诊就诊、住院、肺功能检查、非医疗资源使用(特殊交通)和药物治疗(所有比较均 P<0.05)。此外,基线时 FVC<50%的患者发生 AE-IPF 的次数更多(P<0.05),需要更多的与健康相关的资源使用(初级保健就诊,P<0.05)。所有组在 12 个月内均观察到 FVC 下降。FVC 在 1 年内平均下降 2.50%(95%CI:-5.98 至 0.98)。由于病情已经恶化,在肺功能保存较好的组中,更多的患者经历了 FVC 下降>10%,而在 FVC<50%的组中则较少。

结论

我们观察到基线时肺功能受损更严重的患者的年度与 IPF 相关的资源使用显著增加。由于 FVC 下降与基线时预测的 FVC%无关,因此减缓 IPF 进展以维持患者处于早期疾病阶段对于改善 IPF 管理和优化资源利用至关重要。

试验注册

EUPAS19387[2017 年 6 月 1 日],EU PAS 登记号。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed26/9450456/292038956aff/12931_2022_2154_Fig1_HTML.jpg

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