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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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| 篇名： | 西那卡塞和依特卡肽不良事件信号的挖掘与分析 |
| TITLE： | Mining and analysis of adverse drug event signals of cinacalcet and etelcalcetide |
| 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41709、1710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。 |
| 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， gastric ulcer and other etecalcetide-induced ADEs. If new ADEs appear， clinic should promptly assess the benefits and risks， and update the treatment plan and pharmacological monitoring plan to ensure the safety of patient medication. |
| 期刊： | 2024年第35卷第08期 |
| 作者： | 王红力；钟贵遵；李东炫；沈正泽 |
| AUTHORS： | WANG Hongli，ZHONG Guizun，LI Dongxuan，SHEN Zhengze |
| 关键字： | 西那卡塞；依特卡肽；药物不良事件；信号检测；拟钙剂 |
| KEYWORDS： | cinacalcet； etelcalcetide； adverse drug event； |
| 阅读数： | 16 次 |
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