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吡非尼酮治疗干燥综合征合并非特异性间质性肺炎疗效的临床观察研究

Clinical Observational Study on the Therapeutic Efficacy of Pirfenidone in Sjögren's Syndrome Complicated with Nonspecific Interstitial Pneumonia.

作者信息

Wei Wei, Zou Wei, Han Wei, Liu Jingjing

出版信息

Altern Ther Health Med. 2024 Sep;30(9):307-311.

Abstract

OBJECTIVE

This study aimed to evaluate the therapeutic impact of pirfenidone in patients with nonspecific interstitial pneumonia (NSIP) secondary to Sjögren's syndrome, comparing its effectiveness against conventional treatments.

METHODS

A controlled clinical trial was conducted on a cohort of patients diagnosed with primary Sjögren's syndrome complicated by interstitial lung disease. The study included a total of 120 patients, divided equally into two groups: a control group comprising 60 patients and an observation group with another 60 patients. Random assignment placed patients in either a control group receiving hydroxychloroquine and prednisone or an observation group supplemented with pirfenidone. Pulmonary function parameters, Warrick scores from high-resolution CT scans, and Leicester Cough Quality of Life Questionnaire (LCQ) scores were assessed before and after treatment. Adverse reactions were monitored for treatment safety.

RESULTS

Before treatment, no statistically significant differences in pulmonary function indicators (FVC%, FEV1%, DLco%) were observed between the groups (P > .05). Post-treatment, both groups showed significant improvements in these parameters (P < .05). Importantly, the observation group demonstrated superior improvements in pulmonary function compared to the control group (P < .05). Warrick's scores improved significantly in both groups after treatment, with the observation group achieving a more substantial reduction in scores compared to the control group (P < .05). LCQ scores showed no significant differences between the groups before treatment (P > .05). However, after treatment, both groups exhibited significant improvements, with the observation group consistently scoring higher (P < .05). Safety assessments revealed a slightly higher incidence of adverse reactions, including neurosensory abnormality and drowsiness, in the observation group compared to the control group.

CONCLUSIONS

This study suggests that adding pirfenidone to the treatment regimen for NSIP secondary to Sjögren's syndrome leads to significant improvements in pulmonary function, high-resolution CT scores, and quality of life compared to conventional treatments.

摘要

目的

本研究旨在评估吡非尼酮对干燥综合征继发的非特异性间质性肺炎(NSIP)患者的治疗效果,并将其有效性与传统治疗方法进行比较。

方法

对一组诊断为原发性干燥综合征合并间质性肺病的患者进行了一项对照临床试验。该研究共纳入120例患者,平均分为两组:对照组60例患者,观察组60例患者。随机分配患者至接受羟氯喹和泼尼松的对照组或补充吡非尼酮的观察组。在治疗前后评估肺功能参数、高分辨率CT扫描的沃里克评分以及莱斯特咳嗽生活质量问卷(LCQ)评分。监测不良反应以评估治疗安全性。

结果

治疗前,两组间肺功能指标(FVC%、FEV1%、DLco%)无统计学显著差异(P > 0.05)。治疗后,两组这些参数均有显著改善(P < 0.05)。重要的是,观察组的肺功能改善优于对照组(P < 0.05)。治疗后两组的沃里克评分均显著改善,与对照组相比,观察组的评分降低幅度更大(P < 0.05)。治疗前两组的LCQ评分无显著差异(P > 0.05)。然而,治疗后两组均有显著改善,观察组的评分始终更高(P < 0.05)。安全性评估显示,与对照组相比,观察组的不良反应发生率略高,包括神经感觉异常和嗜睡。

结论

本研究表明,在干燥综合征继发的NSIP治疗方案中添加吡非尼酮,与传统治疗相比,可显著改善肺功能、高分辨率CT评分和生活质量。

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