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比较特立帕肽和阿巴洛帕肽在骨质疏松症中引发肌肉骨骼和结缔组织疾病的风险:基于美国食品药品监督管理局不良事件报告系统(FAERS)的分析

Comparing musculoskeletal and connective tissue disorder risks of teriparatide and abaloparatide in osteoporosis: an analysis based on FDA adverse event reporting system (FAERS).

作者信息

Wen Ming-Tao, Luo Di, Li Jia-Cheng, Lu Bo-Wen, Ling Pei-Xue, Liu Fei, Li Gang

机构信息

The First Clinical Medical School, Shandong University of Traditional Chinese Medicine, Jinan, China.

Orthopaedic, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.

出版信息

Expert Opin Drug Saf. 2024 Jul 18:1-10. doi: 10.1080/14740338.2024.2382228.

Abstract

BACKGROUND

Osteoporosis (OP), characterized by low bone mass and increased fracture risk, is a prevalent skeletal disorder. Teriparatide (TP) and abaloparatide (ABL) are anabolic agents that may reduce fracture incidence, but their impact on musculoskeletal and connective tissue disorders (MCTD) risk is uncertain.

RESEARCH DESIGN AND METHODS

A retrospective, observational disproportionality analysis was conducted utilizing FAERS data from Q1 2004 to Q3 2023, where TP or ABL was identified as the primary suspect drug. Multiple data mining algorithms, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed to detect MCTD safety signals.

RESULTS

A total of 366,747 TP-related and 422,377 ABL-related cases were identified, predominantly among female patients aged ≥45 years. The top specific AEs involved musculoskeletal, connective tissue, and administration site disorders. Comparative analysis revealed a higher frequency of AEs related to the nervous, cardiovascular, and gastrointestinal systems for ABL compared to TP. Both drugs exhibited strong signals for arthralgia, limb pain, back pain, muscle spasms, bone pain, muscle pain, and muscle weakness.

CONCLUSION

The analysis suggests a potential MCTD risk with TP and ABL treatment in OP patients, highlighting the need for AE monitoring and management in clinical practice. This contributes to a better understanding of the safety profiles of these anabolic medications.

摘要

背景

骨质疏松症(OP)是一种常见的骨骼疾病,其特征为骨量低和骨折风险增加。特立帕肽(TP)和阿巴洛肽(ABL)是可能降低骨折发生率的促合成代谢药物,但其对肌肉骨骼和结缔组织疾病(MCTD)风险的影响尚不确定。

研究设计与方法

利用2004年第一季度至2023年第三季度的FAERS数据进行回顾性观察性不成比例分析,其中TP或ABL被确定为主要可疑药物。采用多种数据挖掘算法,包括报告比值比(ROR)、比例报告比值比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项目伽马泊松收缩器(MGPS),来检测MCTD安全信号。

结果

共识别出366,747例与TP相关的病例和422,377例与ABL相关的病例,主要发生在年龄≥45岁的女性患者中。最常见的特定不良事件涉及肌肉骨骼、结缔组织和给药部位疾病。比较分析显示,与TP相比,ABL与神经、心血管和胃肠道系统相关的不良事件发生率更高。两种药物在关节痛、肢体疼痛、背痛、肌肉痉挛、骨痛、肌肉疼痛和肌肉无力方面均显示出强烈信号。

结论

该分析表明,OP患者使用TP和ABL治疗存在潜在的MCTD风险,强调了临床实践中对不良事件进行监测和管理的必要性。这有助于更好地了解这些促合成代谢药物的安全性。

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