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西那卡塞和依特卡肽不良事件信号的挖掘与分析
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王红力 ，钟贵遵 ，李东炫 ，沈正泽 （1.重庆医科大学附属永川医院药学部，重庆 402100；2.重庆医科大学
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附属第三医院药剂科，重庆 401100）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2024）08-0986-05
DOI 10.6039/j.issn.1001-0408.2024.08.15
摘 要 目的 挖掘并分析西那卡塞和依特卡肽的不良事件（ADE）信号，为临床安全用药提供参考。方法 利用OpenVigil在线工
具，收集美国FDA不良事件报告系统数据库2004年1月1日至2023年6月30日的西那卡塞和依特卡肽相关ADE报告，采用贝叶
斯置信区间递进神经网络法对重点系统的ADE信号进行检测，并根据《国际医学用语词典》（26.0版）ADE术语集中的首选术语进
行编码。结果 分别检索到西那卡塞、依特卡肽ADE报告41 709、1 710份，重点系统阳性信号29、45个，未被药品说明书收录的阳
性信号20、36个。低钙血症/血钙降低、血清甲状旁腺素（PTH）异常/血清PTH升高或降低是两药常见的ADE，均被检出；在未被药
品说明书收录的信号中，检出了西那卡塞致钙化防御（代谢及营养类疾病）、骨饥饿综合征和高转换型骨病（肌肉骨骼及结缔组织
类疾病）等新的中强、强信号，以及依特卡肽致猝死、坏死及治疗无反应（全身及给药部位反应），不稳定型心绞痛、心肌缺血（心脏
器官疾病），肠穿孔、胃窦血管扩张、胃溃疡（胃肠道疾病）等新的中强、强信号。结论 临床应用两药时，除需关注低钙血症、血清
PTH异常等常见ADE外，还应监测一些新的潜在的ADE信号，如西那卡塞致骨饥饿综合征、钙化防御、心室疾病等，依特卡肽致
猝死、心肌缺血、不稳定型心绞痛、肠穿孔及胃溃疡等；当出现新的ADE时，临床应及时评估患者的治疗获益与风险，更新治疗方
案和药学监护计划，以保障患者用药安全。
关键词 西那卡塞；依特卡肽；药物不良事件；信号检测；拟钙剂
Mining and analysis of adverse drug event signals of cinacalcet and etelcalcetide
WANG Hongli ，ZHONG Guizun ，LI Dongxuan ，SHEN Zhengze （1. Dept. of Pharmacy， the Affiliated
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Yongchuan Hospital of Chongqing Medical University， Chongqing 402100， China；2. Dept. of Pharmacy， the
Third Affiliated Hospital of Chongqing Medical University， Chongqing 401100， China）
ABSTRACT OBJECTIVE To explore and analyze the adverse drug event （ADE） signals of cinacalcet and etelcalcetide， to
provide a reference for safe drug use in the clinic. METHODS ADE reports related to cinacalcet and etelcalcetide were extracted
from the FDA Adverse Event Reporting System from January 1st， 2004 to June 30th， 2023 using the OpenVigil online tool. The
Bayesian confidence propagation neural network method was adopted to detect the signals of ADE from the key organ systems. The
signals were encoded according to the preferred term in the ADE terminology set of the Medical Dictionary for Regulatory Activities
（26.0 edition）. RESULTS A total 41 709 and 1 710 ADE reports were extracted， and 29 and 45 safety signals were detected in key
systems for cinacalcet and etelcalcetide， respectively； 20 and 36 positive signals were not included in the drug instructions.
Hypocalcemia/decreased serum calcium， abnormal blood parathyroid hormone （PTH）/increased or decreased serum PTH were
common ADEs of the two drugs， which were detected in the study. Among the signals not included in the drug instructions， new
moderate and strong signals were detected， such as cinacalcet-induced calcification defense （metabolic and nutritional diseases），
bone starvation syndrome and high conversion bone diseases （musculoskeletal and connective tissue diseases） as well as
etelcalcetide-induced sudden death， necrosis and treatment of non-responders （general disorders， administration site）， unstable
angina pectoris， myocardial ischemia （cardiac diseases）， intestinal perforation， gastric antrum vasodilation and gastric ulcer
（gastrointestinal diseases）. CONCLUSIONS In the clinical application of the two drugs， apart from the common ADEs such as
hypocalcemia and abnormal blood PTH， the surveillance of some new potential ADEs should also be carried out， such as bone
starvation syndrome， calcification defense， ventricular disease and other cinacalcet-induced ADEs， sudden death， myocardial
ischemia， unstable angina pectoris， intestinal perforation，
Δ 基金项目 重庆市科卫联合医学科研项目（No.2022MSXM-
gastric ulcer and other etecalcetide-induced ADEs. If new
047）；重庆市临床药学重点专科建设项目（No.渝卫办发〔2023〕69号）；
ADEs appear， clinic should promptly assess the benefits and
重庆医科大学未来医学青年创新团队发展支持计划项目（No.W0067）
＊第一作者 药师，硕士。研究方向：临床药学、药物警戒。E-mail： risks， and update the treatment plan and pharmacological
wanghongli1217@163.com monitoring plan to ensure the safety of patient medication.
# 通信作者 副主任药师，硕士。研究方向：临床药学。E-mail： KEYWORDS cinacalcet； etelcalcetide； adverse drug event；
317229355@qq.com signal detection； calcimimetic agent
· 986 · China Pharmacy 2024 Vol. 35 No. 8 中国药房 2024年第35卷第8期
