Mining and analysis of adverse drug event signals of lacosamide

YIN Yueqin; ZHOU Zhujun; LI Chengmin; XU Ni; LOU Yuefen

doi:10.6039/j.issn.1001-0408.2024.10.17

您当前的位置：

首页 >

文章列表页 >

Mining and analysis of adverse drug event signals of lacosamide

更新时间：2025-09-25

- Mining and analysis of adverse drug event signals of lacosamide
- ZHONGGUO YAOFANG Vol. 35, Issue 10, Pages: 1249-1253(2024)
- 作者机构：
  
  上海市第四人民医院药剂科，上海　200434
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.10.17
  CLC： R969.3
- Received：08 November 2023，
  
  Revised：2024-04-26，
  
  Accepted：06 May 2024，
  
  Published：30 May 2024
- 稿件说明：
移动端阅览
尹悦勤,周朱珺,李成敏,等.拉考沙胺的药物不良事件信号挖掘与分析[J].中国药房,2024,35(10):1249-1253.

YIN Yueqin,ZHOU Zhujun,LI Chengmin,et al.Mining and analysis of adverse drug event signals of lacosamide[J].ZHONGGUO YAOFANG,2024,35(10):1249-1253.
尹悦勤,周朱珺,李成敏,等.拉考沙胺的药物不良事件信号挖掘与分析[J].中国药房,2024,35(10):1249-1253. DOI： 10.6039/j.issn.1001-0408.2024.10.17.

YIN Yueqin,ZHOU Zhujun,LI Chengmin,et al.Mining and analysis of adverse drug event signals of lacosamide[J].ZHONGGUO YAOFANG,2024,35(10):1249-1253. DOI： 10.6039/j.issn.1001-0408.2024.10.17.

摘要

目的

挖掘拉考沙胺的药物不良事件（ADE）信号，为临床安全用药提供参考。

方法

收集美国FDA不良事件报告系统2009年1月1日－2022年12月31日上报的拉考沙胺ADE数据，采用报告比值比法和贝叶斯可信区间递进神经网络法进行数据挖掘，利用《国际医学用语词典》（25.0版）ADE术语集中的系统器官分类（SOC）、首选术语（PT）进行分类统计。

结果

共得到拉考沙胺ADE报告21 360份，包含203个ADE信号，涉及24个SOC，其中19个信号未被其药品说明书记录。发生频次排名前5位的PT分别为用药过量、装置使用过程中的技术性错误、产品使用问题、有意误用产品、治疗中断；信号强度排名前5位的PT分别为癫痫表现类型变化、先天性口角降肌发育不全、多重耐药性、脑手术、迷走神经刺激器植入。其药品说明书未记录的ADE包括先天性口角降肌发育不全、多重耐药性、线粒体DNA突变、分裂性身份识别障碍、先天性外耳异常等。

结论

对于拉考沙胺发生频次多且药品说明书已记录的ADE，如心动过缓、房室传导阻滞等，临床在治疗期间应根据患者情况适时调整剂量，避免出现严重的ADE；对于新的可疑的ADE（如先天性口角降肌发育不全、线粒体DNA突变、过熟儿、分裂性身份识别障碍、色素尿、行为障碍、分离性障碍等）应警惕和识别，以确保患者用药安全。

Abstract

OBJECTIVE

To mine adverse drug event （ADE） signals of lacosamide， and to provide references for clinically safe drug use.

METHODS

ADE data for lacosamide reported to the United States FDA adverse event reporting system from January 1， 2009， to December 31， 2022， were collected. Data mining was conducted using the reporting odds ratio method and Bayesian confidence propagation neural network method. Classification statist

ics were performed using the system organ class （SOC） and preferred terms （PT） from ADE terminology set of

Medical Dictionary for Regulatory Activities

（Version 25.0）.

RESULTS

A total of 21 360 lacosamide ADE reports were received， identifying 203 ADE signals across 24 SOCs， with 19 signals not included in the drug’s instruction. The top five PTs ranked by occurrence frequency were medication overdose， technical errors during device use， product use issues， intentional product misuse， and therapy discontinuation. The top five PTs ranked by signal strength were changes in seizure presentation type， congenital hypoplasia of depressor anguli oris muscle， multidrug resistance， brain surgery， and vagus nerve stimulator implantation. ADEs not recorded in the drug instruction included congenital hypoplasia of depressor anguli oris muscle， multidrug resistance， mitochondrial DNA mutation， dissociative identity disorder， and congenital auricular anomaly.

CONCLUSIONS

For lacosamide-induced ADEs that occur frequently and are already listed in the drug’s instructions， such as bradycardia and atrioventricular block， the clinical application should be careful and attentive， adjusting the dosage timely according to the patient’s condition to avoid severe ADEs. Newly discovered suspect ADEs， such as congenital hypoplasia of depressor anguli oris muscle， mitochondrial DNA mutation， overmature infant， dissociative identity disorder， pigmenturia， behavioral disorders， and dissociative disorders， should be vigilantly recognized to ensure the safety of drug use.

关键词

Keywords

references

KANNER A M ， BICCHI M M . Antiseizure medications for adults with epilepsy：a review [J ] . JAMA ， 2022 ， 327 （ 13 ）： 1269 - 1281 .

CURIA G ， BIAGINI G ， PERUCCA E ， et al . Lacosamide：a new approach to target voltage-gated sodium currents in epileptic disorders [J ] . CNS Drugs ， 2009 ， 23 （ 7 ）： 555 - 568 .

BABAR R K ， BRESNAHAN R ， GILLESPIE C S ， et al . Lacosamide add-on therapy for focal epilepsy [J ] . Cochrane Database Syst Rev ， 2021 ， 5 （ 5 ）： CD008841 .

LI J Y ， SUN M Z ， WANG X F . The adverse-effect profile of lacosamide [J ] . Expert Opin Drug Saf ， 2020 ， 19 （ 2 ）： 131 - 138 .

GUAN Y Y ， JI L ， ZHENG L ， et al . Development of a drug risk analysis and assessment system and its application in signal excavation and analysis of 263 cases of fluoroquinolone-induced adverse reactions [J ] . Front Pharmacol ， 2022 ， 13 ： 892503 .

HOY S M . Lacosamide：a review in focal-onset seizures in patients with epilepsy [J ] . CNS Drugs ， 2018 ， 32 （ 5 ）： 473 - 484 .

郭铭花，张敬军 . 癫痫流行病学调查研究 [J/OL ] . 中华脑科疾病与康复杂志（电子版）， 2013 ， 3 （ 5 ）： 338 - 340 [ 2023-10-27 ] . https：//zhnkjbykfzz.cma-cmc.com.cn/CN/2095-123X/home.shtml.DOI：10.3877/cma.j.issn.2095-123X.2013.05.012 https://zhnkjbykfzz.cma-cmc.com.cn/CN/2095-123X/home.shtml.DOI:10.3877/cma.j.issn.2095-123X.2013.05.012 .

GUO M H ， ZHANG J J . Epidemiological investigation of epilepsy [J/OL ] . Chin J Brain Dis Rehabil Electron Ed ， 2013 ， 3 （ 5 ）： 338 - 340 [ 2023-10-27 ] . https：//zhnkjbykfzz.cma-cmc.com.cn/CN/2095-123X/home.shtml.DOI：10.3877/cma.j.issn.2095-123X.2013.05.012 https://zhnkjbykfzz.cma-cmc.com.cn/CN/2095-123X/home.shtml.DOI:10.3877/cma.j.issn.2095-123X.2013.05.012 .

THURMAN D J ， FAUGHT E ， HELMERS S ， et al . New-onset lesional and nonlesional epilepsy in the US popu-lation：patient characteristics and patterns of antiepileptic drug use [J ] . Epilepsy Res ， 2019 ， 157 ： 106210 .

ABOU KHALED K ， KHOURY J ， MACARON G ， et al . Forced normalization and psychosis following use of lacosamide [J ] . Seizure ， 2016 ， 41 ： 96 - 99 .

CASCELLA N G ， SCHRETLEN D J ， SAWA A . Schizophrenia and epilepsy：is there a shared susceptibility? [J ] . Neurosci Res ， 2009 ， 63 （ 4 ）： 227 - 235 .

张莎，祝德秋 . 基于美国FAERS数据库的新型降脂药前蛋白转化酶枯草溶菌素9抑制剂药物不良信号的数据挖掘与分析 [J ] . 中南药学， 2021 ， 19 （ 12 ）： 2582 - 2587 .

ZHANG S ， ZHU D Q . Adverse drug events signals of PCSK9 inhibitors based on the FAERS database [J ] . Cent South Pharm ， 2021 ， 19 （ 12 ）： 2582 - 2587 .

阳宇，李宽 . 基于OpenFDA不良事件数据库对拉考沙胺和左乙拉西坦的分析 [J ] . 海峡药学， 2023 ， 35 （ 4 ）： 84 - 88 .

YANG Y ， LI K . Analysis of adverse drug reactions induced by lacosamide and levetiracetam based on OpenFDA [J ] . Strait Pharm J ， 2023 ， 35 （ 4 ）： 84 - 88 .

李建萍，王飞，许传洁，等 . 基于FAERS对第三代抗癫痫药物相关精神系统不良事件药物警戒信号的挖掘 [J ] . 中国医院药学杂志， 2022 ， 42 （ 11 ）： 1147 - 1151 .

LI J P ， WANG F ， XU C J ， et al . Pharmacovigilance signals mining for the third-generation anti-epileptic drugs related to psychiatric system adverse events based on FAERS [J ] . Chin J Hosp Pharm ， 2022 ， 42 （ 11 ）： 1147 - 1151 .

MANTEGAZZA M ， CURIA G ， BIAGINI G ， et al . Voltage-gated sodium channels as therapeutic targets in epilepsy and other neurological disorders [J ] . Lancet Neurol ， 2010 ， 9 （ 4 ）： 413 - 424 .

HOELTZENBEIN M ， SLIMI S ， FIETZ A K ， et al . Increasing use of newer antiseizure medication during pregnancy：an observational study with special focus on lacosamide [J ] . Seizure ， 2023 ， 107 ： 107 - 113 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Signal mining and analysis of adverse drug events of tirzepatide

Signal mining and analysis of adverse drug event signals of darolutamide

Data mining and analysis of oxaliplatin-related adverse events of nervous system

Risk signal mining of ixazomib based on the database of FAERS

Mining and analysis of lorlatinib-induced adverse drug event signals

Related Author

CHEN Jisheng

CAO Weiling

ZHENG Guimei

LIANG Zhuoru

XIE Zeyu

KANG Jian

QIAO Lijuan

CHEN Jinhua

Related Institution

Dept. of Pharmacy， Shenzhen Luohu People’s Hospital

Key Specialty of Clinical Pharmacy， the First Affiliated Hospital of Guangdong Pharmaceutical University

Dept. of Pharmacy， the First Affiliated Hospital of Zhengzhou University

Dept. of Pharmacy， the Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital

Dept. of Pharmacy， the Fourth People’s Hospital of Jinan

Address：8th Floor, Sihuan Building, No. 129 Daping Main Street, Yuzhong District, Chongqing, China Postal code：400042
Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号公网安备50010302001817
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰