尼达尼布治疗特发性肺纤维化的疗效和安全性：一项系统回顾和荟萃分析

IF 2.6 4区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Heart & Lung Pub Date : 2025-05-17 DOI:10.1016/j.hrtlng.2025.05.008

Shamikha Cheema MBBS , Muhammad Nabeel Saddique MBBS , Anurag Jha MBBS , Ayesha Sehar MBBS , Umaima Cheema MBBS , Fatima Shahid MBBS , Muhammad Faique Hassan MBBS , Hammad Javaid MBBS , Valeria Chiara Lanari MBBS , Ali Nawaz MBBS

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引用次数: 0

摘要

背景：特发性肺纤维化（IPF）是一种以瘢痕形成为特征的进行性、潜在致命性肺部疾病，可导致肺功能降低和呼吸衰竭。Nintedanib是一种酪氨酸激酶抑制剂，显示出减缓IPF进展的潜力，但其长期疗效和安全性仍不确定。目的评价尼达尼布治疗特发性肺纤维化的疗效和安全性。方法综合检索PubMed、Cochrane、Scopus、Embase和ClinicalTrials.gov网站从成立到2024年8月的文献，根据预先设定的资格标准选择研究。二分类结果合并为风险比（RR），连续结果合并为平均差异（MD），均有95%的置信区间（CI），使用随机效应模型来解释潜在的异质性。采用I²和X²统计量评估异质性，p值为<；0.05认为具有统计学意义。所有计算均使用RevMan 5.4进行。结果本荟萃分析纳入4项随机对照试验，共1665例患者，其中79.7%为男性吸烟者。IPF进展（RR=0.61, 95% CI 0.34-1.08, I²=41%）、鼻咽炎（RR=0.82, 95% CI 0.62-1.08, I²=0%）、咳嗽（RR=0.98, 95% CI 0.71-1.33, I²=0%）、支气管炎（RR=0.90, 95% CI 0.63-1.28, I²=0%）、呼吸道感染（RR=1.01, 95% CI 0.59-1.75, I²=0%）、呼吸困难（RR=0.68, 95% CI 0.46-1.00, I²=0%）、心脏疾病（RR=0.89, 95% CI 0.50-1.58, I²=0%）方面无显著差异，表明尼达尼布对这些风险没有显著改变。然而，尼达尼布显著增加了胃肠道不良事件，可能影响依从性和生活质量。结论：尼达尼布在减缓疾病进展方面有希望，但存在较高的不良事件风险。有限的样本量和短暂的随访需要更大规模的研究来证实其有效性和安全性。

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Efficacy and safety of Nintedanib in idiopathic pulmonary fibrosis: A systematic review and meta-analysis

Background

Idiopathic pulmonary fibrosis (IPF) is a progressive, potentially fatal lung disorder characterized by scarring, leading to reduced lung function and respiratory failure. Nintedanib, a tyrosine kinase inhibitor, shows potential in slowing IPF progression, but uncertainties remain about its long-term efficacy and safety.

Objective

To evaluate the efficacy and safety of Nintedanib in idiopathic pulmonary fibrosis.

Methods

A comprehensive literature search was conducted across PubMed, Cochrane, Scopus, Embase, and ClinicalTrials.gov from inception to August 2024, selecting studies based on predefined eligibility criteria. Dichotomous outcomes were pooled as risk ratios (RR) and continuous outcomes as mean differences (MD), both with 95% confidence intervals (CI), using random-effects models to account for potential heterogeneity. Heterogeneity was assessed using I² and X² statistics, with a p-value of <0.05 considered statistically significant. All calculations were performed using RevMan 5.4.

Results

This meta-analysis included 4 randomized controlled trials with 1,665 patients, 79.7% of whom were male smokers. There was no significant difference in IPF progression (RR=0.61, 95% CI 0.34-1.08, I²=41%) or in nasopharyngitis (RR=0.82, 95% CI 0.62-1.08, I²=0%), cough (RR=0.98, 95% CI 0.71-1.33, I²=0%), bronchitis (RR=0.90, 95% CI 0.63-1.28, I²=0%), respiratory infections (RR=1.01, 95% CI 0.59-1.75, I²=0%), dyspnea (RR=0.68, 95% CI 0.46-1.00, I²=0%), or cardiac disorders (RR=0.89, 95% CI 0.50-1.58, I²=0%), indicating nintedanib does not notably alter these risks. However, nintedanib significantly increased gastrointestinal adverse events, potentially affecting adherence and quality of life.

Conclusion

Nintedanib shows promise in slowing disease progression but carries a higher risk of adverse events. Limited sample sizes and short follow-up necessitate larger studies to confirm its efficacy and safety.

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来源期刊

Heart & Lung 医学-呼吸系统

CiteScore

4.60

自引率

3.60%

发文量

184

审稿时长

35 days

期刊介绍： Heart & Lung: The Journal of Cardiopulmonary and Acute Care, the official publication of The American Association of Heart Failure Nurses, presents original, peer-reviewed articles on techniques, advances, investigations, and observations related to the care of patients with acute and critical illness and patients with chronic cardiac or pulmonary disorders. The Journal''s acute care articles focus on the care of hospitalized patients, including those in the critical and acute care settings. Because most patients who are hospitalized in acute and critical care settings have chronic conditions, we are also interested in the chronically critically ill, the care of patients with chronic cardiopulmonary disorders, their rehabilitation, and disease prevention. The Journal''s heart failure articles focus on all aspects of the care of patients with this condition. Manuscripts that are relevant to populations across the human lifespan are welcome.