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药物相关的肌腱病和韧带疾病:一项使用不成比例分析的回顾性药物警戒研究结果

Drug-Associated Tendinopathies and Ligament Disorders: Results from a Retrospective Pharmacovigilance Study Using Disproportionality Analysis.

作者信息

Sridharan Kannan

机构信息

Arabian Gulf University, Manama, Kingdom of Bahrain.

出版信息

Hosp Pharm. 2025 May 19:00185787251337621. doi: 10.1177/00185787251337621.

Abstract

Tendinopathies and ligament disorders are significant musculoskeletal adverse events associated with various drugs, leading to restricted mobility and reduced quality of life. Although certain drug classes such as fluoroquinolones and corticosteroids have established links to these conditions, there is limited research on other potential drug associations. This study aimed to comprehensively evaluate drugs associated with tendinopathies and ligament disorders using data from the USFDA Adverse Event Reporting System (AERS). A retrospective pharmacovigilance study utilizing spontaneous reports from the USFDA AERS database between March 2004 and June 2024 was conducted. The Standardized Medical Dictionary for Regulatory Activities (MedDRA) query "Tendinopathies and ligament disorders" and relevant Preferred Terms were used to identify cases. Disproportionality analysis was performed using both frequentist and Bayesian methods. Subgroup analyses were conducted by age, gender, and clinical outcomes. Out of 29 153 222 reports, 40 485 unique reports were included, with 6641 related to tendon rupture and 2121 to ligament rupture. Fluoroquinolones, corticosteroids, lipid-modifying agents, immunosuppressants, and bisphosphonates were confirmed to have strong associations with tendon and ligament disorders. Emergent signals were identified for anti-inflammatory drugs, and various other drugs, including vaccines. Hospitalization rates were significantly higher in cases of tendon rupture compared to ligament rupture ( < .0001). This study confirms established drug associations and identifies new signals for tendinopathies and ligament disorders. Continued pharmacovigilance is necessary to validate these findings and enhance our understanding of drug-induced musculoskeletal disorders.

摘要

肌腱病和韧带疾病是与多种药物相关的重大肌肉骨骼不良事件,会导致活动受限和生活质量下降。尽管某些药物类别(如氟喹诺酮类和皮质类固醇)已被证实与这些病症有关,但关于其他潜在药物关联的研究有限。本研究旨在利用美国食品药品监督管理局不良事件报告系统(AERS)的数据,全面评估与肌腱病和韧带疾病相关的药物。开展了一项回顾性药物警戒研究,利用2004年3月至2024年6月期间美国食品药品监督管理局AERS数据库中的自发报告。使用《监管活动医学标准词典》(MedDRA)查询“肌腱病和韧带疾病”以及相关首选术语来识别病例。采用频率法和贝叶斯方法进行不成比例分析。按年龄、性别和临床结局进行亚组分析。在29153222份报告中,纳入了40485份独特报告,其中6641份与肌腱断裂有关,2121份与韧带断裂有关。氟喹诺酮类、皮质类固醇、调脂药、免疫抑制剂和双膦酸盐被证实与肌腱和韧带疾病有很强的关联。发现了抗炎药以及包括疫苗在内的各种其他药物的新信号。肌腱断裂病例的住院率显著高于韧带断裂病例(<0.0001)。本研究证实了已有的药物关联,并识别出肌腱病和韧带疾病的新信号。持续的药物警戒对于验证这些发现并增进我们对药物性肌肉骨骼疾病的理解是必要的。

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