基于OpenFDA对依洛尤单抗及阿利西尤单抗不良反应的比较分析

doi:10.19803/j.1672-8629.2021.10.15

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (10): 965-968.
DOI: 10.19803/j.1672-8629.2021.10.15

基于OpenFDA对依洛尤单抗及阿利西尤单抗不良反应的比较分析

李江帆, 胡晔, 庞宏贤, 赵丹, 李欣茹, 王旭红^*

首都医科大学附属北京潞河医院临床药理科,北京 101149

收稿日期:2021-03-05 出版日期:2021-10-15 发布日期:2021-10-27
通讯作者: ^*王旭红,女,硕士,主任医师,临床药理。E-mail：wangxuhong72@126.com
作者简介:李江帆,男,硕士,临床药理。

Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA

LI Jiangfan, HU Ye, PANG Hongxian, ZHAO Dan, LI Xinru, WANG Xuhong^*

Department of Clinical Pharmacology, Beijing Luhe Hospital, Capital Medical University, Beijing 101149, China

Received:2021-03-05 Online:2021-10-15 Published:2021-10-27

摘要/Abstract

摘要： 目的通过美国食品药品监督管理局公共数据项目（the US Food and Drug Administration Public Data Open Project, OpenFDA）数据库中对前蛋白转化酶枯草溶菌素/溶菌素9（PCSK9）抑制剂依洛尤单抗和阿利西尤单抗的药品不良反应（adverse drug reaction, ADR）进行检索,对其ADR的具体情况进行对比分析,为临床合理使用提供借鉴。方法依据OpenFDA数据库中ADR端点交互式图表板块中的应用程序接口（API）功能,对依洛尤单抗和阿利西尤单抗在2004年1月1日至2021年1月18日的ADR报告数据进行详细检索。结果依洛尤单抗和阿利西尤单抗的ADR报告数分别为76 412和8 004份;ADR上报职业中依洛尤单抗主要为医师和消费者或非卫生专业人员,阿利西尤单抗主要为消费者或非卫生专业人员和其他卫生专业人员;ADR多数发生于美国;用药患者女性多于男性且年龄主要在成年人和老年人;用药的适应证主要为心血管疾病;ADR常见的类型：依洛尤单抗是注射部位疼痛,阿利西尤单抗是肌肉疼痛;转归情况多数未知。结论临床使用过程中应关注依洛尤单抗和阿利西尤单抗的ADR,促进药物的合理使用。

关键词: 药品不良反应, 依洛尤单抗, 阿利西尤单抗, 美国食品药品监督管理局公共数据项目

Abstract: Objective To search the database of the US Food and Drug Administration public data open project (OpenFDA) for adverse drug reactions (ADR) of PCSK9 inhibitors evolocumab and alirocumab, and to compare and analyze the related ADR so as to provide reference for clinical rational use. Methods Using the API module in the interactive chart section of the ADR endpoint in OpenFDA database, the data on ADR reports of evolocumab and alirocumab harvested between January 1, 2004 and January 18, 2021 was retrieved. Results The number of ADR reports of evolocumab and alirocumab was 71 676 and 8 006, respectively. ADR reports of evolocumab mostly came from doctors, consumers and non-health professionals, compared with consumers, non-health professionals and other health professionals for alirocumab. Most of the ADR occurred in the United States. Female patients outnumbered male ones. Adults and the elderly made up the majority of the patients. The main indications for the drug were cardiovascular diseases. The dominating ADR related to elouzumab was pain at the injection site, and myalgia for alirocumab. The outcomes of most of these patients were unknown. Conclusion In the process of using evolocumab and alirocumab clinically, clinicians should be alert to the related ADR so as to promote the rational use of drugs.

Key words: adverse drug reaction, evolocumab, alirocumab, OpenFDA

中图分类号:

R994.11

李江帆, 胡晔, 庞宏贤, 赵丹, 李欣茹, 王旭红. 基于OpenFDA对依洛尤单抗及阿利西尤单抗不良反应的比较分析[J]. 中国药物警戒, 2021, 18(10): 965-968.

LI Jiangfan, HU Ye, PANG Hongxian, ZHAO Dan, LI Xinru, WANG Xuhong. Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA[J]. Chinese Journal of Pharmacovigilance, 2021, 18(10): 965-968.

参考文献

[1] Cardiovascular diseases (CVDs)[S/OL].(2017-05-17)[2021-01-18].https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds).
[2] Krzysztof J, Piotr J, Kosior DA.PCSK9 inhibitors-from discovery of a single mutation to a groundbreaking therapy of lipid disorders in one decade[J]. Archives of Medical Science Ams, 2017, 13: 914-929.
[3] Navarese EP, Robinson JG, Kowalewski M, et al.Association between baseline LDL-C level and total and cardiovascular mortality after LDL-C lowering: a systematic review and meta-analysis[J]. JAMA, 2018, 319(15): 1566.
[4] Zhang H, Plutzky J, Skentzos S, et al.Discontinuation of statins in routine care settings: a cohort study[J]. Annals of Internal Medicine, 2013,158(7): 526-34.
[5] Sabatine MS.PCSK9 inhibitors: clinical evidence and implemen-tation[J]. Nat Rev Cardiol, 2019, 16(3): 155-165.
[6] Seidah NG.Proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors in the treatment of hypercholesterolemia and other pathologies[J].Current Pharmaceutical Design, 2013, 19(17): 3161-3172.
[7] Melendez QM, Krishnaji ST, Wooten CJ, et al. Hypercholesterolemia: the role of PCSK9[J]. Archives of Biochemistry and Biophysics, 2017, 625-626: 39-53.
[8] FDA. What is openFDA?[S/OL]. (2021-01-18)[2021-01-18].https://open.fda.gov/about/.
[9] Geng YY, Cai J, Xie H, et al.Adverse drug reactions of fentanyl citrate and sufentanil citrate based on openFDA[J]. Central South Pharmacy(中南药学), 2020, 18(4): 706-710.
[10] Meng L, Tang XW, Ji HH.Mining and evaluation of statin-associated adverse events signals: data mining of the public version of the OpenFDA adverse event reporting system[J]. Chinese Journal of New Drugs(中国新药杂志), 2019, 28(2): 120-124.
[11] FDA. What adverse reactions are frequently reported?[S/OL]. (2021-05-07)[2021-05-07].https://open.fda.gov/apis/drug/event/example-api-queries/.
[12] Fierce Pharma Amgen escalates PCSK9 pricing war with permanent 60% price cut on Repatha[S/OL].(2019-10-25) [2021-01-18].https://www.fiercepharma.com/pharma/cholesterol-war-escalates-as-amgen-makes-60-price-cut-repatha-permanent.
[13] Xing WQ, Wu JR, Mao QR.Self-reporting of adverse drug reactions by inpatients based on internet plus big data technology[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2020, 17(7): 408-411.
[14] Ferri N, Ruscica M, Coggi D, et al.Sex-specific predictors of PCSK9 levels in a European population: the IMPROVE study[J]. Atherosclerosis, 2020, 309: 39-46.
[15] Cui Q, Ju X, Yang T, et al.Serum PCSK9 is associated with multiple metabolic factors in a large Han Chinese population[J]. Atherosclerosis, 2010, 213(2): 632-636.
[16] Blom DJ, Harada-Shiba M, Rubba P, et al.Efficacy and safety of alirocumab in adults with homozygous familial hypercholesterolemia: the ODYSSEY HoFH trial[J]. J Am Coll Cardiol, 2020, 76(2): 131-142.
[17] Zong X Wang YL. On OpenFDA and enlightenments for data management of Food and Drug Administration in China[J]. Chinese Pharmaceutical Affairs(中国药事), 2017, 31(9): 976-979.
[18] Ling T, Xu RJ, Ge WH.Comparative analysis of adverse drug reactions of rivaroxaban and apixaban based on OpenFDA[J].Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 1818, 780-783.

基于OpenFDA对依洛尤单抗及阿利西尤单抗不良反应的比较分析

Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	贾晋生, 刘红亮, 王青, 侯永芳, 李馨龄. 基于知识图谱联合ERNIE-DPCNN模型的药品不良反应自动关联性评价方法研究[J]. 中国药物警戒, 2024, 21(2): 163-166.
[2]	李应芬, 韩雷. 319例注射用脑蛋白水解物药品不良反应报告分析[J]. 中国药物警戒, 2024, 21(2): 195-198.
[3]	徐伟佳, 彭崎, 黄海渝, 张磊姣, 肖华, 吴雪. 285例新型抗肿瘤药物不良反应分析[J]. 中国药物警戒, 2024, 21(2): 199-203.
[4]	郭清华, 彭笑笑, 朱萍, 刘西霖, 杨颖华, 陈志海. 氨氯地平过量致多器官功能障碍综合征1例分析[J]. 中国药物警戒, 2024, 21(2): 204-207.
[5]	方美琳, 郑慧敏, 王存泽, 王凌, 阮君山. 注射用奥沙利铂致全身肌肉疼痛1例分析[J]. 中国药物警戒, 2024, 21(2): 208-210.
[6]	陈玉艳, 张明霞, 张涛, 张晋. 斯鲁利单抗注射液致间质性肺炎不良反应1例分析[J]. 中国药物警戒, 2024, 21(2): 213-215.
[7]	曹桂萍, 邓琳琳, 朱干红, 陆颖, 马爽, 陈玲玲, 刘丽丽. 天麻首乌片致严重肝损伤1例分析[J]. 中国药物警戒, 2024, 21(2): 216-218.
[8]	高云娟, 赵旭, 白天凯, 柏兆方, 王伽伯, 宋海波, 肖小河. 基于不良反应监测大数据的药品安全风险发现与识别策略[J]. 中国药物警戒, 2024, 21(1): 1-5.
[9]	郭龙鑫, 高云娟, 吴承钊, 龙敏娟, 祝胜凯, 宋海波, 赵旭, 肖小河. 基于不良反应监测大数据的中药药源性肝损伤风险信号新发现及易感因素初探[J]. 中国药物警戒, 2024, 21(1): 15-19.
[10]	蒋文硕, 杨莉. 694例癫痫医师药师联合门诊患者药品不良反应分析[J]. 中国药物警戒, 2024, 21(1): 102-106.
[11]	陈华炎, 江东波, 郭春连, 杨家琪, 黎雨欣, 蔡伟明. 326例奈玛特韦片/利托那韦片治疗新型冠状病毒感染安全性分析[J]. 中国药物警戒, 2024, 21(1): 107-110.
[12]	刘赛月, 吕小琴, 周耘. 疑似药品不良反应死亡病例调查及报告实施要点[J]. 中国药物警戒, 2023, 20(9): 971-974.
[13]	里筱竹, 王蔷, 逄瑜, 张轶菁. 个例药品不良反应报告管理浅析与思考[J]. 中国药物警戒, 2023, 20(9): 975-977.
[14]	逄瑜, 刘博, 吕少俐, 王涛, 邢颖, 秦星宇, 田月洁, 吴文宇. 基于国际药物警戒经验探讨收集患者报告的意义[J]. 中国药物警戒, 2023, 20(9): 978-981.
[15]	刘文东, 崔欢欢, 王晓晗, 苏娴, 王海学. 我国儿童用药临床试验期间药物警戒监管体系现状及思考[J]. 中国药物警戒, 2023, 20(9): 1002-1006.