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抗纤维化治疗对非特发性肺纤维化性肺纤维化性间质性肺疾病的疾病进展、全因死亡率和急性加重风险的影响:来自随机对照试验和前瞻性对照研究的荟萃分析证据。

Impact of antifibrotic therapy on disease progression, all-cause mortality, and risk of acute exacerbation in non-IPF fibrosing interstitial lung diseases: evidence from a meta-analysis of randomized controlled trials and prospective controlled studies.

机构信息

Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.

Baoshan Branch, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241232561. doi: 10.1177/17534666241232561.

Abstract

BACKGROUND

Nintedanib and pirfenidone are preferred pharmacological therapies for patients with idiopathic pulmonary fibrosis (IPF). However, evidence favoring antifibrotic therapy in patients with non-IPF fibrosing interstitial lung diseases (ILD) is limited.

OBJECTIVE

To investigate the effects of antifibrotic therapy on disease progression, all-cause mortality, and acute exacerbation (AE) risk in patients with non-IPF fibrosing ILDs.

DESIGN

Meta-analysis.

DATA SOURCES AND METHODS

Electronic databases were searched for articles published before 28 February 2023. Studies that evaluated the efficacy of antifibrotic agents in patients with fibrosing ILDs were selected. The primary outcome was the disease progression risk, and the secondary outcomes included all-cause mortality and AE risk. The GRADE criteria were used for the certainty of evidence assessment.

RESULTS

Nine studies with 1990 participants were included. Antifibrotic therapy reduced the rate of patients with disease progression (five trials with 1741 subjects; relative risk (RR), 0.56; 95% CI, 0.42-0.75;  < 0.0001;  = 0; high-certainty evidence). Antifibrotic therapy did not significantly decrease all-cause mortality (nine trials with 1990 subjects; RR, 0.76; 95% CI, 0.55-1.03;  = 0.08;  = 0; low-certainty evidence). However, in patients with progressive fibrosing ILDs (PF-ILD), antifibrotic therapy decreased all-cause mortality (four trials with 1100 subjects; RR, 0.69; 95% CI, 0.48-0.98;  = 0.04;  = 0; low-certainty evidence).

CONCLUSION

Our study supports the use of antifibrotic agents in patients with PF-ILDs, which could slow disease progression and decrease all-cause mortality.

TRIAL REGISTRATION

This study protocol was registered with PROSPERO (registration number: CRD42023411272).

摘要

背景

尼达尼布和吡非尼酮是特发性肺纤维化(IPF)患者的首选药物治疗方法。然而,在非特发性肺纤维化纤维化间质性肺疾病(ILD)患者中,支持抗纤维化治疗的证据有限。

目的

研究抗纤维化治疗对非特发性肺纤维化纤维化间质性肺疾病患者疾病进展、全因死亡率和急性加重(AE)风险的影响。

设计

荟萃分析。

数据来源和方法

检索了截至 2023 年 2 月 28 日发表的文章的电子数据库。选择评估抗纤维化药物在纤维化间质性肺疾病患者中的疗效的研究。主要结局是疾病进展风险,次要结局包括全因死亡率和 AE 风险。使用 GRADE 标准评估证据的确定性。

结果

纳入了 9 项研究,共 1990 名参与者。抗纤维化治疗降低了疾病进展患者的比例(五项试验,1741 名受试者;相对风险(RR)为 0.56;95%CI,0.42-0.75;<0.0001;I²=0;高确定性证据)。抗纤维化治疗并未显著降低全因死亡率(9 项试验,1990 名受试者;RR,0.76;95%CI,0.55-1.03;I²=0.08;I²=0;低确定性证据)。然而,在进行性纤维化间质性肺疾病(PF-ILD)患者中,抗纤维化治疗降低了全因死亡率(四项试验,1100 名受试者;RR,0.69;95%CI,0.48-0.98;I²=0.04;I²=0;低确定性证据)。

结论

我们的研究支持在 PF-ILD 患者中使用抗纤维化药物,这可以减缓疾病进展并降低全因死亡率。

试验注册

本研究方案在 PROSPERO(注册号:CRD42023411272)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/81e3/10901065/499d94f52960/10.1177_17534666241232561-fig1.jpg

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