比较宁替达尼起始剂量对结缔组织病相关间质性肺疾病患者的安全性和有效性。

IF 2.2 4区 医学 Q3 RHEUMATOLOGY Scandinavian Journal of Rheumatology Pub Date : 2024-07-01 Epub Date: 2024-04-02 DOI:10.1080/03009742.2024.2327159
M Ayano, K Tsubouchi, K Suzuki, Y Kimoto, Y Arinobu, K Akashi, T Horiuchi, I Okamoto, H Niiro
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引用次数: 0

摘要

研究目的本研究旨在分析在结缔组织病(CTD)相关间质性肺病患者中,减量开始宁替达尼治疗是否能提高治疗持续率,同时保持疗效:共对51名患者(年龄61.6 ± 13.2岁;38名女性,13名男性)进行了回顾性分析。主要终点是不良事件导致的累计停药率。次要终点包括药物剂量的变化、根据强迫生命容量(FVC)的年度变化评估疗效,以及根据不良事件发生频率评估安全性:18名以300毫克标准剂量开始治疗的患者(标准剂量组)与33名以减量剂量开始治疗的患者(减量剂量组)进行了比较。系统性硬化症是最常见的 CTD(n = 32),其次是特发性炎症性肌病,罕见的是类风湿性关节炎。两组患者因不良事件导致的累计停药率相当,不良事件发生频率相似。两组患者的维持剂量无明显差异;但减量组患者在长达52周的累积剂量低于标准剂量组患者。两组患者的肺活量变化无明显差异:结论:没有证据表明两组患者在停药率、疗效和安全性方面存在差异。结论:没有证据表明两组患者在停药率、疗效和安全性方面存在差异。为了提供进一步的证据,未来的研究有必要采用更精确的剂量递增方案。
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Comparing the safety and efficacy of nintedanib starting dose in patients with connective tissue disease-associated interstitial lung diseases.

Objective: This study aimed to analyse whether initiating nintedanib treatment at a reduced dose could improve the treatment continuation rate while maintaining efficacy in patients with connective tissue disease (CTD)-associated interstitial lung disease.

Method: In total, 51 patients (age 61.6 ± 13.2 years; 38 women, 13 men) were retrospectively analysed. The primary endpoint was the cumulative discontinuation rate due to adverse events. Secondary endpoints included changes in drug dosage, efficacy evaluated based on annual changes in forced vital capacity (FVC), and safety assessed based on the frequency of adverse events.

Results: Eighteen patients who started treatment at the standard dose of 300 mg (standard dosage group) were compared with 33 patients who started treatment at a reduced dose (reduced dosage group). Systemic sclerosis was the most common CTD (n = 32), followed by idiopathic inflammatory myopathies and, rarely, rheumatoid arthritis. Both groups exhibited comparable cumulative discontinuation rates due to adverse events and similar frequencies of adverse events. No significant differences were observed in maintenance doses between the two groups; however, patients in the reduced dosage group had a lower cumulative dose for up to 52 weeks than those in the standard dosage group. No significant differences were observed in changes in FVC between the two groups.

Conclusion: There was no evidence for a difference between the two groups in terms of discontinuation rates, efficacy, and safety. To provide further evidence, future studies using more precise dose-escalation protocols are warranted.

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来源期刊
CiteScore
3.70
自引率
4.80%
发文量
90
审稿时长
6-12 weeks
期刊介绍: Scandinavian Journal of Rheumatology is the official journal of the Scandinavian Society for Rheumatology, a non-profit organization following the statutes of the Scandinavian Society for Rheumatology/Scandinavian Research Foundation. The main objective of the Foundation is to support research and promote information and knowledge about rheumatology and related fields. The annual surplus by running the Journal is awarded to young, talented, researchers within the field of rheumatology.pasting The Scandinavian Journal of Rheumatology is an international scientific journal covering clinical and experimental aspects of rheumatic diseases. The journal provides essential reading for rheumatologists as well as general practitioners, orthopaedic surgeons, radiologists, pharmacologists, pathologists and other health professionals with an interest in patients with rheumatic diseases. The journal publishes original articles as well as reviews, editorials, letters and supplements within the various fields of clinical and experimental rheumatology, including; Epidemiology Aetiology and pathogenesis Treatment and prophylaxis Laboratory aspects including genetics, biochemistry, immunology, immunopathology, microbiology, histopathology, pathophysiology and pharmacology Radiological aspects including X-ray, ultrasonography, CT, MRI and other forms of imaging.
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