Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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：
■骨质疏松症（OP）是一种常见的骨骼疾病，其特征是骨量减少和骨折风险增加。已引入合成代谢药物如特立帕肽（TP）和阿帕罗肽（ABL）以刺激骨形成并减少骨折发生率。然而,它们的使用是否会增加肌肉骨骼和结缔组织疾病(MCTD)的风险尚不清楚.
■回顾，我们利用2004年第1季度至2023年第3季度的FAERS数据进行了观察性不成比例分析,其中TP或ABL被确定为主要可疑药物.多种数据挖掘算法,包括报告赔率比(ROR)，比例报告比率(PRR)，贝叶斯置信度传播神经网络(BCPNN)，和多项目伽玛泊松收缩器(MGPS)，用于检测MCTD安全信号。
■共发现了366,747例TP相关病例和422,377例ABL相关病例，主要是年龄≥45岁的女性患者。最高的特异性AE涉及肌肉骨骼，结缔组织,和给药部位紊乱。比较分析显示，与神经相关的AE的频率更高，心血管,与TP相比，ABL和胃肠道系统。两种药物都表现出强烈的关节痛信号，四肢疼痛,背痛,肌肉痉挛,骨痛,肌肉疼痛，肌肉无力。
这个基于FAERS的数据挖掘分析强调了骨质疏松症患者与TP和ABL治疗相关的潜在MCTD风险特征，强调在临床实践中监测和管理这些AE的重要性。这些发现有助于更深入地了解这些合成代谢骨质疏松症药物的安全性。
■回顾，我们利用2004年第1季度至2023年第3季度的FAERS数据进行了观察性不成比例分析,其中TP或ABL被确定为主要可疑药物.多种数据挖掘算法,包括报告赔率比(ROR)，比例报告比率(PRR)，贝叶斯置信度传播神经网络(BCPNN)，和多项目伽玛泊松收缩器(MGPS)，用于检测MCTD安全信号。
■共发现了366,747例TP相关病例和422,377例ABL相关病例，主要是年龄≥45岁的女性患者。最高的特异性AE涉及肌肉骨骼，结缔组织,和给药部位紊乱。比较分析显示，与神经相关的AE的频率更高，心血管,与TP相比，ABL和胃肠道系统。两种药物都表现出强烈的关节痛信号，四肢疼痛,背痛,肌肉痉挛,骨痛,肌肉疼痛，肌肉无力。
这个基于FAERS的数据挖掘分析强调了骨质疏松症患者与TP和ABL治疗相关的潜在MCTD风险特征，强调在临床实践中监测和管理这些AE的重要性。这些发现有助于更深入地了解这些合成代谢骨质疏松症药物的安全性。
