基于FAERS和CVARD的罗特西普不良事件数据挖掘与分析

寸淑华; 杨琰茗; 马晓玲; 陈炅; 范金成; 翁稚颖

doi:10.2095-3593.2026.050001

中国药物评价 >

2026 , Vol. 43 >Issue 3: 250 - 250-256

DOI: https://doi.org/10.2095-3593.2026.050001

药品评价

基于FAERS和CVARD的罗特西普不良事件数据挖掘与分析

寸淑华 ,
杨琰茗 ,
马晓玲 ,
陈炅 ,
范金成 ,
翁稚颖

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1.昆明医科大学药学院暨云南省天然药物药理重点实验室，云南昆明 650500；
2.昆明市儿童医院药剂科，云南昆明 650228；
3.云南省中医医院临床药理研究中心，云南昆明 650000

寸淑华，女，在读硕士，研究方向：临床药学

收稿日期: 2026-01-21

修回日期: 2026-03-15

录用日期: 2026-08-05

网络出版日期: 2026-08-12

基金资助

云南省国际科技合作平台—滇美分子药物联合研究中心项目(2015IC001)；昆明医科大学一流学科团队(2024XKTDPY21)

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Data Mining and Analysis of Adverse Events of Luspatercept Based on FAERS and CAVRD

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1.School of Pharmaceutical Science， Kunming Medical University， Yunnan Key Laboratory of Pharmacology
for Natural Products， Yunnan Kunming 650500，China；
2.Department of Pharmacy， Kunming Children′s Hospital， Yunnan Kunming 650228， China；
3.Research Center of Clinical Pharmacology， Yunnan Provincial Hospital of Traditional Chinese Medicine，
Yunnan Kunming 650000， China

Received date: 2026-01-21

Revised date: 2026-03-15

Accepted date: 2026-08-05

Online published: 2026-08-12

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摘要

目的：基于美国FDA不良事件报告系统（FAERS）和加拿大药物警戒不良反应数据库（CVARD）评估罗特西普的安全性特征，识别其潜在不良反应信号，为临床安全用药提供循证依据。方法：提取 FAERS和CVARD中罗特西普的相关不良事件报告，并利用报告比值比法（ROR）及贝叶斯置信区间递进神经网络（BCPNN）法对药物相关报告进行数据处理及分析。结果：FAERS中罗特西普不良事件发生频次排名第一的是全身性疾病及给药部位各种反应，CVARD中主要涉及各种手术及医疗操作；除药品说明书中提及的骨痛、高血压等外，还挖掘到多个说明书中未明确记录的不良反应，主要包括死亡、骨折等。结论：罗特西普在真实世界应用中，除已知不良反应外，还存在包括骨折在内的潜在药物不良反应信号。临床应用时应加强针对性监测，以优化风险管理，保障患者用药安全。

关键词： ; font-size:medium; ">罗特西普；药物不良事件；信号挖掘；报告比值比；真实世界研究

本文引用格式

寸淑华 , 杨琰茗 , 马晓玲 , 陈炅 , 范金成 , 翁稚颖 . 基于FAERS和CVARD的罗特西普不良事件数据挖掘与分析[J]. 中国药物评价, 2026 , 43(3) : 250 -250-256 . DOI: 10.2095-3593.2026.050001

Abstract

Objective： To evaluate the safety profile of luspatercept and identify potential adverse reaction signals based on the FDA Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction Database (CVARD)， providing evidence-based support for safe medication use. Methods： Adverse event（AE） reports for luspatercept were extracted from FAERS and CVARD. Reporting odds ratio (ROR) analysis and Bayesian confidence propagation neural network (BCPNN) were applied to process and analyze drug-related AE reports. Results： In FAERS， the most freqment AE of luspatercept are general disorders and administration site conditions. CVARD data showed SOCs as Surgical and medical procedures. In addition to labeled adverse reactions， such as bone pain and hypertension， novel signals including death and fractures were detected. Conclusion： In real-world use， luspatercept is associated with potential adverse drug reaction signals beyond its known safety profile， including fracture. Targeted monitoring should be strengthened in clinical practice to optimize risk management and ensure medication safety.

Key words： ; font-size:medium; "> ; Luspatercept； Drug adverse event； Signal mining； Reporting odds ratio； Real-world studies

参考文献

[1] Badawy SM， Morrone K， Thompson A， et al. Computer and mobile technology interventions to promote medication adherence and disease management in people with thalassemia [J]. Cochrane Database Syst Rev， 2019， 6(6)： CD012900.
     [2] Hoeks M， Yu G， Langemeijer S， et al. Impact of treatment with iron chelation therapy in patients with lower-risk myelodysplastic syndromes participating in the European MDS registry [J]. Haematologica， 2020， 105(3)：640-651.
     [3] Malcovati L， Stevenson K， Papaemmanuil E， et al. SF3B1-mutant MDS as a distinct disease subtype： a proposal from the International Working Group for the Prognosis of MDS [J]. Blood， 2020， 136(2)： 157-170.
     [4] NIH. An Efficacy and safety study of luspatercept (ACE-536) versus placebo in adults who require regular red blood cell transfusions due to beta (β) thalassemia (BELIEVE) [EB/OL]. (2020-01-27). https: //www. clinicaltrials. gov/study/NCT02604433? term=NCT02604433 &rank=1.
     [5] Bian S， Li L， Wang Z， et al. Neuropsychiatric side reactions of leukotriene receptor antagonist， antihistamine， and inhaled corticosteroid： A real-world analysis of the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) [J]. World Allergy Organ J， 2021， 14(10)： 100594.
     [6] Health Canada. Instructions for the Canada Vigilance Adverse Reaction Online Database [EB/OL]. （2013） [2020-02-03]. Available： http：//www. hc-sc.gc. ca/dhp-mps/medeff/databasdon/instructions-eng. php.
     [7] Wang T， Lu W， Tang H， et al. Assessing the association between GLP-1 receptor agonist use and diabetic retinopathy through the FDA adverse event reporting system [J]. Diabetes Care， 2019， 42(2)：e21-e23.
     [8] 赵敏，黄承龙，黄振光，等. 基于美国FDA不良事件报告系统评价钠-葡萄糖共转运蛋白2抑制剂致急性胰腺炎的风险[J]. 中国医院药学杂志， 2021， 41(8)： 816-819.
     [9] Bate A， Lindquist M， Edwards IR， et al. A Bayesian neural network method for adverse drug reaction signal generation[J]. Eur J Clin Pharmacol， 1998， 54(4)：315-321.
     [10] Markham A. Luspatercept： frirst approval [J]. Drugs， 2020， 80(1)：85-90.
     [11] Platzbecker U， Germing U， Gtze KS， et al. Luspatercept for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes (PACE-MDS)： a multicentre， open-label phase 2 dose-finding study with long-term extension study [J]. Lancet Oncol， 2017， 18(10)： 1338-1347.
     [12] Fenaux P， Platzbecker U， Mufti GJ， et al. Luspatercept in patients with lower-risk myelodysplastic syndromes [J]. N Engl J Med， 2020， 382(2)： 140-151.
     [13] Platzbecker U， Della Porta MG， Santini V， et al. Efficacy and safety of luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive， transfusion-dependent， lower-risk myelodysplastic syndromes (COMMANDS)： interim analysis of a phase 3， open-label， randomised controlled trial [J]. Lancet， 2023， 402(10399)： 373-385.
     [14] Wobus M， Mies A， Schfer R， et al. Luspatercept restores SDF1 mediated hematopoietic support by MDS derived mesenchymal stromal cells [J]. Leukemia. 2021；35(6)：17741780.
     [15] Li J， Zhang H， Chen L. CCL2/CCR2 axis regulates splenic extramedullary hematopoiesis by modulating TGFβ signaling in tumorbearing hosts [J]. J Hematol Oncol. 2020；13(1)：87.
     [16] Lanino L， Restuccia F， Perego A， et al. Real-world efficacy and safety of luspatercept and predictive factors of response in patients with lower risk myelodysplastic syndromes with ring side oblasts [J]. Am J Hematol， 2023， 98(8)： E204-E208.
     [17] Zou ML， Chen ZH， Teng YY， et al. The smad dependent TGF-β and BMP signaling pathway in bone remodeling and therapies [J]. Front Mol Biosci， 2021， 8：593310.
     [18] 孙京男，杨岩. 骨髓增生异常综合征精准诊断及治疗进展[J]. 中国实用内科杂志，2023，43(7)：534-539.
     [19] Wang L， Fang L， Shi H， et al. Treatment of myelofibrosis with refractory anemia with luspatercept： a multicenter Chinese study [J]. Ann Hematol， 2024， 103(9)： 3605-3613.
     [20] 廖桂萍，刘冬梅，周天红，等. 地中海贫血靶向药物治疗研究进展[J]. 内科，2023，18(6)：580-584.
     [21] Suragani RN， Cawley SM， Li R， et al. Modified activin receptor ⅡB ligand trap mitigates ineffective erythropoiesis and disease complications in murine β-thalassemia [J]. Blood， 2014， 123(25)： 3864-3872.
     [22] Wang S， Jayarangaiah A， Malone M， et al. Risk of hepatitis B reactivation and cytomegalovirus related infections with Mogamulizumab： A retrospective study of international pharmacovigilance database [J]. E Clin Med， 2020， 28：100601.
     [23] Hu Y， Lu W， Tang B， et al. Urinary incontinence as a possible signal of neuromuscular toxicity during immune checkpoint inhibitor treatment： case report and retrospective pharmacovigilance study [J]. Front Oncol， 2022， 12：954468.

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