Signal mining of valproic acid-induced adverse drug events based on FAERS

DING Yanming; LIU Lili; LIU Yanping; WEN Xiaona; ZHANG Feiyu; ZHU Minghui

doi:10.6039/j.issn.1001-0408.2023.23.16

您当前的位置：

首页 >

文章列表页 >

Signal mining of valproic acid-induced adverse drug events based on FAERS

更新时间：2023-12-08

- Signal mining of valproic acid-induced adverse drug events based on FAERS
- ZHONGGUO YAOFANG Vol. 34, Issue 23, Pages: 2906-2909(2023)
- 作者机构：
  
  天津市第三中心医院药剂科，天津　300170
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.23.16
  CLC： R969.3
- Published：15 December 2023，
  
  Received：21 April 2023，
  
  Revised：11 October 2023，
扫描看全文
丁雁鸣,柳丽丽,刘艳萍等.基于FAERS数据库的丙戊酸不良事件信号挖掘 ^Δ[J].中国药房,2023,34(23):2906-2909.

DING Yanming,LIU Lili,LIU Yanping,et al.Signal mining of valproic acid-induced adverse drug events based on FAERS[J].ZHONGGUO YAOFANG,2023,34(23):2906-2909.
丁雁鸣,柳丽丽,刘艳萍等.基于FAERS数据库的丙戊酸不良事件信号挖掘 ^Δ[J].中国药房,2023,34(23):2906-2909. DOI： 10.6039/j.issn.1001-0408.2023.23.16.

DING Yanming,LIU Lili,LIU Yanping,et al.Signal mining of valproic acid-induced adverse drug events based on FAERS[J].ZHONGGUO YAOFANG,2023,34(23):2906-2909. DOI： 10.6039/j.issn.1001-0408.2023.23.16.

摘要

目的

对抗癫痫药物丙戊酸（VPA）不良事件（AE）信号进行挖掘分析，为临床安全合理用药提供参考。

方法

采用比例失衡法中的报告比值比（ROR）法和贝叶斯置信传播神经网络（BCPNN）法对美国FDA不良事件报告系统（FAERS）数据库中2013年第1季度至2022年第4季度VPA相关AE报告进行数据挖掘及分析。

结果

共得到首选语（PT）阳性信号1 253个（ROR法）和1 109个（BCPNN法），涉及27个系统器官（SOC），主要集中在各类神经系统疾病、精神类疾病、全身性疾病及给药部位各种反应等方面；挖掘出药品说明书中未出现的阳性信号主要累及眼器官疾病、感染及侵染类疾病2个SOC。

结论

VPA作为一线广谱抗癫痫治疗药物，在临床应用中，除了要关注药品说明书中常见的AE外，也需要关注眼毒性及感染风险。

Abstract

OBJECTIVE

To provide reference for clinically safe and rational drug use through mining and analyzing adverse drug event （AE） signals induced by valproic acid （VPA）.

METHODS

Reporting Odds Ratio （ROR） and Bayesian Confidence Propagation Neural Network （BCPNN） methods of Measures of Disproportionality were performed to mine and analyze the data of VPA-related AE reports in the US FDA Adverse Event Reporting System （FAERS） database from the first quarter of 2013 to the fourth quarter of 2022.

RESULTS

A total of 1 253 （ROR） and 1 109 （BCPNN） valid signals of preferred terms （PT） were obtained after data processing by the two analysis methods， involving 27 system organs （SOC）， mainly focusing on nervous system disorders， psychiatric disorders， general disorders and administration site conditions. Signals that did not appear in the instruction were associated with 2 SOCs： ear and labyrinth disorders， infections and infestations.

CONCLUSIONS

As a first-line broad-spectrum anti-epileptic drug， attention should also be paid to eye toxicity and infection risk in the clinical application in addition to paying attention to common adverse events in the instruction.

关键词

丙戊酸药品不良事件比例失衡法美国FDA不良事件报告系统抗癫痫药物

Keywords

adverse drug eventMeasures of DisproportionalityFDA adverse drug event reporting systemantiepileptic drugs

references

吴冬燕，朱国行. 抗癫痫药物的分类、作用机制与不良反应[J]. 上海医药，2015，36（9）：3-7.

WU D Y，ZHU G X. Classification，mechanism and adverse effects of antiepileptic drugs[J]. Shanghai Med Pharm J，2015，36（9）：3-7.

王绚，张永，张媛媛. 基于AERS的丙戊酸不良反应信号挖掘与数据分析[J]. 中国医院药学杂志，2020，40（1）：71-77.

WANG X，ZHANG Y，ZHANG Y Y. Data analysis and signal excavation of valproic acid induced ADR based on the AERS[J]. Chin J Hosp Pharm，2020，40（1）：71-77.

CANTELMI T，LEPORE E，UNFER V R，et al. Safety of inositol supplementation in patients taking lithium or valproic acid：a pilot clinical study[J]. Eur Rev Med Pharmacol Sci，2022，26（19）：7269-7276.

侯永芳，王玲，郭秀花，等. 信号检测在药品不良反应监测系统中的应用[J]. 中国药物警戒，2012，9（9）：539-541.

HOU Y F，WANG L，GUO X H，et al. Signal detection in the software for adverse drug reaction monitoring[J]. Chin J Pharmacovigil，2012，9（9）：539-541.

ANG P S，CHEN Z J，CHAN C L，et al. Data mining spontaneous adverse drug event reports for safety signals in Singapore：a comparison of three different disproportionality measures[J]. Expert Opin Drug Saf，2016，15（5）：583-590.

HOU Y F，YE X F，WU G Z，et al. A comparison of disproportionality analysis methods in national adverse drug reaction databases of China[J]. Expert Opin Drug Saf，2014，13（7）：853-857.

陈琪莹，李毅敏，陈文发. 基于FAERS对沙库巴曲缬沙坦不良反应的分析研究[J]. 中国医院药学杂志，2021，41（3）：264-268.

CHEN Q Y，LI Y M，CHEN W F. Analytical study of adverse reactions of sacubitril/valsartan based on FAERS[J]. Chin J Hosp Pharm，2021，41（3）：264-268.

LANSNER A，HOLST A. A higher order Bayesian neural network with spiking units[J]. Int J Neural Syst，1996，7（2）：115-128.

GALLAGHER R M，BIRD K A，MASON J R，et al. Adverse drug reactions causing admission to a paediatric hospital：a pilot study[J]. J Clin Pharm Ther，2011，36（2）：194-199.

郭雪芬. 丙戊酸钠的血药浓度监测和合理用药分析[J]. 世界最新医学信息文摘，2018，18（26）：101-102.

GUO X F. Monitoring of blood concentration of sodium valproate and analysis of rational drug use[J]. World Latest Med Inf，2018，18（26）：101-102.

WANG Y，HU W Q，LI Z P. Influence of age and co-medication on the concentration and efficacy of valproic acid in Chinese epilepsy children[J]. Pak J Pharm Sci，2020，33（2）：537-542.

MURALIDHARAN A，RAHMAN J，BANERJEE D， et al. Parkinsonism：a rare adverse effect of valproic acid[J]. Cureus，2020，12（6）：e8782.

KIM D W，KIM W，LEE C H，et al. Thrombocytopenia during intravenous valproic acid therapy in the neurological intensive care unit[J]. J Clin Pharm Ther，2020，45（5）：1014-1020.

WU J H，LI J Y，JING W，et al. Valproic acid-induced encephalopathy：a review of clinical features，risk factors，diagnosis，and treatment[J]. Epilepsy Behav，2021，120：107967.

仇东婷，张艳娟. 丙戊酸钠相关性高血氨脑病1例及药学监护讨论[J]. 中国药物滥用防治杂志，2023，29（3）：423-426.

QIU D T，ZHANG Y J. Clinical pharmacists participate in the pharmaceutical care of a case of sodium valproate-related hyperammonemia encephalopathy[J]. Chin J Drug Abuse Prev Treat，2023，29（3）：423-426.

WONG Y J，FAN J L，WAN A，et al. Valproic acid-associated hyperammonemia：a systematic review[J]. J Clin Psychopharmacol，2023，43（3）：283-294.

XIONG W X，LU L，ZHANG Y Y，et al. Attenuation of retinal nerve fibre layer in people with epilepsy receiving valproate[J]. Epilepsy Res，2019，154：144-148.

GOGRI P Y，BHALERAO S，VUYYURU S. Sodium valproate-induced cataract[J]. BMJ Case Rep，2021，14（1）：e240997.

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

新型抗癫痫药物的治疗药物监测研究进展

Related Author

许倍铭

陈冰

Related Institution

No data

Address：8/F,129 Daping Main Street,Yuzhong District,Chongqing 400042,P.R.China
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