基于FAERS数据库的秋水仙碱相关神经毒性风险分析

doi:10.19803/j.1672-8629.20230531

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (3): 341-345.
DOI: 10.19803/j.1672-8629.20230531

基于FAERS数据库的秋水仙碱相关神经毒性风险分析

吴汀溪¹, 赵志刚¹, 石延枫², 张杨³, 张伊楠¹, 朱斌^1,*

¹首都医科大学附属北京天坛医院药学部,北京 100070;
²首都医科大学附属北京天坛医院,国家神经系统疾病临床医学研究中心卒中多组学创新中心,北京 100070;
³首都医科大学附属北京友谊医院药学部,北京100050

收稿日期:2023-08-28 出版日期:2024-03-15 发布日期:2024-03-18
通讯作者: ^*朱斌,男,博士,副主任药师,临床药学。E-mail: zbtcm@163.com
作者简介:吴汀溪,女,硕士,副主任药师,临床药学。
基金资助:
北京市医院管理局临床医学发展专项扬帆计划（ZYLX201827）; 中国毒理学会临床毒理专项（CST2021CT205）

Risk assessment of colchicine-associated neurological adverse events based on FAERS database

WU Tingxi¹, ZHAO Zhigang¹, SHI Yanfeng², ZHANG Yang³, ZHANG Yinan¹, ZHU Bin^1,*

¹Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China;
²Center of Excellence for Omics Research, National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China;
³Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China

Received:2023-08-28 Online:2024-03-15 Published:2024-03-18

摘要/Abstract

摘要： 目的评价秋水仙碱相关神经系统不良事件（nAEs）的风险及特征,为临床用药安全提供参考。方法基于美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）,检索2004年1月1日至2022年12月31日的秋水仙碱相关nAEs报告,采用比例失衡法和贝叶斯分析法对nAEs及缺血性、出血性中枢神经系统血管疾病不良事件进行信号挖掘,并分析事件发生时间及患者结局。结果共提取秋水仙碱相关nAEs 906例,报告例数排名前3位的不良事件分别是头痛（ROR₀₂₅=1.09,IC₀₂₅=0.30）、感觉减退（ROR₀₂₅=1.79,IC₀₂₅=1.09）、意识丧失（ROR₀₂₅=1.62,IC₀₂₅=0.99）,在缺血性和出血性中枢神经血管疾病中均不存在信号。秋水仙碱相关nAEs发生时间中位数为30 d,7.42%的患者死亡。结论秋水仙碱在缺血性和出血性中枢神经血管疾病中未检测到信号,但临床应警惕一些其他罕见神经毒性不良事件,加强监测。

关键词: 秋水仙碱, 中枢神经系统, 神经毒性, 缺血性, 出血性, 美国食品药品监督管理局不良事件报告系统, 不良事件, 信号挖掘

Abstract: Objective To evaluate the neurological adverse events (nAEs) caused by colchicine and provide evidence for safe use of colchicine in stroke. Methods The nAEs related to colchicine that occurred between 2004 and 2022 were retrieved from the FDA Adverse Event Reporting System (FAERS) database to mine the signals via disproportionality analysis and Bayesian analysis. Results A total of 906 cases of colchicine-associated nAEs were collected, and the top three nAEs were headache (ROR₀₂₅=1.09, IC₀₂₅=0.30), and hypoaesthesia (ROR₀₂₅=1.79, IC₀₂₅=1.09), and loss of consciousness(ROR₀₂₅=1.62, IC₀₂₅=0.99). Overall, no signal was detected in the ischaemic and haemorrhagic disorders of the central nervous system. The median onset-time of colchicine-associated nAEs was 30d while the fatality rate was 7.42%. Conclusion Although no association is found between colchicine and ischaemic and haemorrhagic disorders of the central nervous system, more attention should be paid to some other rare neurological AEs during clinical practice.

Key words: colchicine, central nervous system, neurotoxic, ischemic, hemorrhagic, FDA Adverse Event Reporting System (FAERS), adverse event, data mining

中图分类号:

R994.11

吴汀溪, 赵志刚, 石延枫, 张杨, 张伊楠, 朱斌. 基于FAERS数据库的秋水仙碱相关神经毒性风险分析[J]. 中国药物警戒, 2024, 21(3): 341-345.

WU Tingxi, ZHAO Zhigang, SHI Yanfeng, ZHANG Yang, ZHANG Yinan, ZHU Bin. Risk assessment of colchicine-associated neurological adverse events based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 341-345.

导出引用管理器 EndNote|Ris|BibTeX

链接本文: https://www.zgywjj.com/CN/10.19803/j.1672-8629.20230531

https://www.zgywjj.com/CN/Y2024/V21/I3/341

参考文献

[1] ZHENG G.The role and clinical significance of colchicine in cardiovascular disease prevention and treatment[J]. Chin J Geriatr Heart Brain Vessel Dis(中华老年心脑血管病杂志), 2022, 24(2): 216-218.
[2] NIDORF S M, FIOLET A T L, MOSTERD A, et al. Colchicine in patients with chronic coronary disease[J]. N Engl J Med, 2020, 383(19): 1838-1847.
[3] TARDIF J C, KOUZ S, WATERS DD, et al.Efficacy and Safety of Low-dose colchicine after myocardial infarction[J]. N Engl J Med, 2019, 381(26): 2497-2505.
[4] NIDORF SM, EIKELBOOM JW, BUDGEON CA, et al.Low-dose colchicine for secondary prevention of cardiovascular disease[J]. J Am Coll Cardiol, 2013, 61(4): 404-410.
[5] AL-ATTA A, KUZEMCZAK M, ALKHALIL M.Colchicine for the prevention of ischemic stroke: An updated Meta-analysis of randomized clinical trials[J]. Brain Circ, 2021, 7(3): 187-193.
[6] TONG D C, QUINN S, NASIS A, et al.Colchicine in patients with acute coronary syndrome: the australian COPS randomized clinical trial[J]. Circulation, 2020, 142(20): 1890-900.
[7] SOBICZEWSKI W, WIRTWEIN M, TRYBALA E, et al.Severity of coronary atherosclerosis and stroke incidence in 7-year follow-up[J]. J Neurol, 2013, 260(7): 1855-1858.
[8] NIDORF SM, FIOLET ATL, EIKELBOOM JW, et al.The effect of low-dose colchicine in patients with stable coronary artery disease: the LoDoCo2 trial rationale, design, and baseline characteristics[J]. Am Heart J, 2019, 218: 46-56.
[9] STEWART S, YANG KCK, ATKINS K, et al.Adverse events during oral colchicine use: a systematic review and Meta-analysis of randomised controlled trials[J]. Arthritis Res Ther, 2020, 22(1): 28.
[10] ALAYLI G, CENGIZ K, CANTÜRK F, et al. Acute myopathy in a patient with concomitant use of pravastatin and colchicine[J]. Ann Pharmacother, 2005, 39(7-8): 1358-1361.
[11] CHEN G, NING L J, QIN Y, et al.Acute kidney injury following the use of different proton pump inhibitor regimens: A real-world analysis of post-marketing surveillance data[J]. J Gastroenterol Hepatol, 2021, 36(1): 156-162.
[12] DAI F, SHU LX, CHU C, et al.Brief analysis the application of several signal monitoring methods in adverse drug events[J]. Journal of Pharmaceutical Practice(药学实践杂志) , 2012, 30(5): 380-383.
[13] SAFOURIS A, MAGOUFIS G, TSIVGOULIS G.Emerging agents for the treatment and prevention of stroke: progress in clinical trials[J]. Expert Opin Investig Drugs, 2021, 30(10): 1025-1035.
[14] Emergency Physicians Branch of the Chinese Medical Association, Emergency Medicine Branch of the Chinese Medical Association, Emergency Resusc-itation and Disaster Medicine Professional Committee of the Chinese Medical Association, et al. Expert Consensus on Clinical Management of Colchicine Poisoning[J]. Chin J Emerg Med(中华急诊医学杂志), 2023, 32(2): 162-168.
[15] LI Y, ZHANG Y, LU J, et al.Anti-inflammatory mechanisms and research progress of colchicine in atherosclerotic therapy[J]. J Cell Mol Med, 2021, 25(17): 8087-8094.
[16] TSIVGOULIS G, KATSANOS AH, GIANNOPOULOS G, et al.The Role of Colchicine in the Prevention of Cerebrovascular Ischemia[J]. Curr Pharm Des, 2018, 24(6): 668-674.
[17] CIMMINO G, TARALLO R, CONTE S, et al.Colchicine reduces platelet aggregation by modulating cytoskeleton rearrangement via inhibition of cofilin and LIM domain kinase 1[J]. Vascul Pharmacol, 2018, 111: 62-70.
[18] FINKELSTEIN Y, AKS SE, HUTSON JR, et al.Colchicine poisoning: the dark side of an ancient drug[J]. Clin Toxicol (Phila), 2010, 48(5): 407-414.
[19] FIOLET ATL, OPSTAL TSJ, MOSTERD A, et al.Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and Meta-analysis of randomized trials[J]. Eur Heart J, 2021, 42(28): 2765-2775.
[20] BENSIMON G, CHERMAT R.Microtubule disruption and cognitive defects: effect of colchicine on learning behavior in rats[J]. Pharmacol Biochem Behav, 1991, 38(1): 141-145.
[21] OKYAR BAŞ A, YARDIMCI G K, GÜNER OYTUN M, et al. Cognitive status is better in older adults under colchicine treatment: a case-control study[J]. Exp Aging Res, 2022, 1-11.
[22] LEIBOVITZ A, LIDAR M, BAUMOEHL Y, et al.Colchicine therapy and the cognitive status of elderly patients with familial Mediterranean fever[J]. Isr Med Assoc J, 2006, 8(7): 469-472.
[23] KESKINDEMIRCI G, ESKIKURT G, AYAZ NA, et al.Does familial mediterranean fever affect cognitive function in children? Electrophysio-logical preliminary study[J]. Int J Neurosci, 2018, 128(1): 10-14.
[24] PERZON O, KENIG A, FELLIG Y, et al.Use of colchicine for pericardial inflammation: risks and toxicities-a cautionary tale[J]. JACC Case Rep, 2022, 4(21): 1449-1452.
[25] KUNCL RW, DUNCAN G, WATSON D, et al.Colchicine myopathy and neuropathy[J]. N Engl J Med, 1987, 316(25): 1562-1568.
[26] IMAZIO M, NIDORF M.Colchicine and the heart[J]. Eur Heart J, 2021, 42(28): 2745-2760.
[27] MASSON W, LOBO M, MOLINERO G, et al.Role of colchicine in stroke prevention: an updated meta-analysis[J]. J Stroke Cerebrovasc Dis, 2020, 29(5): 104756.
[28] KELLY P, WEIMAR C, LEMMENS R, et al.Colchicine for prevention of vascular inflammation in non-cardioembolic stroke (CONVINCE) - study protocol for a randomised controlled trial[J]. Eur Stroke J, 2021, 6(2): 222-228.

基于FAERS数据库的秋水仙碱相关神经毒性风险分析

Risk assessment of colchicine-associated neurological adverse events based on FAERS database

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]	张健, 张伶俐, 李歆. 424例替雷利珠单抗致免疫相关不良事件分析[J]. 中国药物警戒, 2024, 21(4): 435-439.
[2]	韩丽, 陈力, 陈乾, 肖洪涛. 基于美国FAERS数据库索磷布韦/维帕他韦和来迪派韦/索磷布韦不良反应信号分析[J]. 中国药物警戒, 2024, 21(4): 440-446.
[3]	游晓炎, 郑盈盈, 王宪英. 基于FAERS数据库的英夫利西单抗不良事件信号挖掘分析[J]. 中国药物警戒, 2024, 21(3): 335-340.
[4]	王珊, 谢波, 刘慧敏, 李志浩. 基于FAERS数据库对塞来昔布不良事件信号的分析[J]. 中国药物警戒, 2024, 21(2): 190-194.
[5]	沈艳杰, 吴奕卿. 临床试验期间不良事件管理的实践与思考[J]. 中国药物警戒, 2023, 20(9): 982-986.
[6]	何雄, 马俊龙, 阳国平. 基于FAERS对靶向HER2抗体偶联药品不良反应/事件的分析[J]. 中国药物警戒, 2023, 20(8): 915-920.
[7]	李谈, 张杨, 张望德, 王云. 不同镇痛药物方案治疗下肢缺血性疼痛的疗效和安全性分析[J]. 中国药物警戒, 2023, 20(6): 680-683.
[8]	赵稳华, 舒鹤, 倪晨明, 郭晋敏. 基于FAERS数据库的氨吡啶缓释片不良反应信号挖掘分析[J]. 中国药物警戒, 2023, 20(6): 684-690.
[9]	陈亚昆, 门鹏, 王攀. 基于FAERS数据库的4种磷酸二酯酶5抑制剂安全性分析[J]. 中国药物警戒, 2023, 20(6): 691-696.
[10]	彭苗新, 王艳琼, 许佩佩, 杨永公. 来那度胺致高级别B细胞淋巴瘤患者似癫痫样发作1例分析[J]. 中国药物警戒, 2023, 20(5): 585-587.
[11]	梁士兵, 余泽宇, 孔令垚, 晏利姣, 韩梅, 吴嘉瑞, 刘兆兰, 刘建平. 文献计量法在中药药物警戒领域中的应用价值及展望[J]. 中国药物警戒, 2023, 20(5): 591-594.
[12]	资文瑞, 杨秋月, 苏俊, 谢江安. 我国上市人乳头瘤病毒疫苗接种及安全性研究[J]. 中国药物警戒, 2023, 20(3): 311-316.
[13]	叶培, 张鹤巍, 吕强, 叶小飞, 许金芳, 郭晓晶. 基于FAERS 数据库舒更葡糖逆转神经肌肉阻滞安全性研究[J]. 中国药物警戒, 2023, 20(3): 321-325.
[14]	郝晓慧, 张萍, 武璐璐, 王丽华. 基于FAERS数据库的枸橼酸伊沙佐米胶囊安全信号挖掘研究[J]. 中国药物警戒, 2023, 20(12): 1427-1431.
[15]	姜坤, 谭飞龙, 王重娟, 谭宏程, 游丽娜. 洛拉替尼片致中枢神经系统毒性1例分析[J]. 中国药物警戒, 2023, 20(12): 1432-1434.