Data mining of risk signals for linaclotide based on FAERS database

ZHANG Ke; LI Bo; SONG Yin; SUN Xuan; SHAO Jia; LI Zhengxiang

doi:10.6039/j.issn.1001-0408.2022.22.14

您当前的位置：

首页 >

文章列表页 >

Data mining of risk signals for linaclotide based on FAERS database

更新时间：2025-09-26

- Data mining of risk signals for linaclotide based on FAERS database
- ZHONGGUO YAOFANG Vol. 33, Issue 22, Pages: 2758-2761(2022)
- 作者机构：
  
  1.天津医科大学总医院药剂科，天津　300052
  2.天津市第一中心医院药学部，天津　300192
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2022.22.14
  CLC： R969.3;R975
- Received：11 May 2022，
  
  Revised：2022-08-04，
  
  Published：30 November 2022
- 稿件说明：
移动端阅览
张科,李波,宋崟,等.基于FAERS数据库的利那洛肽风险信号挖掘[J].中国药房,2022,33(22):2758-2761.

ZHANG Ke,LI Bo,SONG Yin,et al.Data mining of risk signals for linaclotide based on FAERS database[J].ZHONGGUO YAOFANG,2022,33(22):2758-2761.
张科,李波,宋崟,等.基于FAERS数据库的利那洛肽风险信号挖掘[J].中国药房,2022,33(22):2758-2761. DOI： 10.6039/j.issn.1001-0408.2022.22.14.

ZHANG Ke,LI Bo,SONG Yin,et al.Data mining of risk signals for linaclotide based on FAERS database[J].ZHONGGUO YAOFANG,2022,33(22):2758-2761. DOI： 10.6039/j.issn.1001-0408.2022.22.14.

摘要

目的

挖掘利那洛肽的风险信号，为该药的临床安全使用提供参考。

方法

使用OpenVigil 2.1数据平台，获取美国FDA不良事件报告系统（FAERS）数据库中2012年8月30日－2021年12月31日的利那洛肽相关不良事件（ADE）报告数据。采用比例失衡法中的报告比值比（ROR）法和比例报告比值（PRR）法进行数据挖掘，利用《国际医学用语词典》（23.1版）中药物不良反应术语集的首选系统器官分类（SOC）和首选术语（PT）对挖掘到的风险信号进行分类和描述。

结果

共检索到利那洛肽相关ADE报告17 590份，其中严重的ADE报告有5 494份（占31.23%）。共检测到相关风险信号120个。按发生频次排序，前10位的风险信号（以PT表示）依次是腹泻、药物无效、超说明书用药、腹胀、腹痛、给药时间不当、上腹痛、胃肠胀气、产品存储错误、故意误用产品；按信号强度排序，双氢睾酮增加（ROR值为271.258，PRR值为271.131）位列首位，双氢睾酮增加和椎间盘压迫这2个信号均未被药品说明书收录。2种排序方式所得风险信号的SOC以各类检查、胃肠系统疾病、全身性疾病及给药部位各种反应等为主。

结论

应用利那洛肽时，除药品说明书中提及的不良反应外，临床还须密切关注其药品说明书未提及的安全风险（如双氢睾酮增加和椎间盘压迫），以保证患者的用药安全。

Abstract

OBJECTIVE

To mine the risk signals of linaclotide， so as to provide evidence for clinically safe drug use.

METHODS

OpenVigil 2.1 data platform was used to obtain the adverse drug event （ADE） report data of linaclotide from August 30， 2012 to December 31， 2021 in the database of FDA adverse event reporting system （FAERS）. The reporting odds ratio （ROR） and proportional report ratio （PRR） of the proportional imbalance method were used to mine the data of ADE reports. The mined risk signals were statistically classified and described by the preferred system organ class （SOC） and preferred term （PT） stated in the

Medical Dictionary for Regulatory Activities

（23.1 edition）.

RESULTS

There were 17 590 ADE reports related to linaclotide， including 5 494 reports of severe ADE， accounting for about 31.23%. A total of 120 risk signals were detected. According to the frequency of occurrence， top 10 risk signals （measured by PT） were diarrhea， ineffective drugs， off-label drug use， abdominal distension， abdominal pain， improper administration time， epigastric pain， flatulence， product storage error and intentional misuse of products. According to the signal intensity， the increase of dihydrotestosterone （ROR was 271.258， PRR was 271.131） ranked the first， and two signals such as the increase of dihydrotestosterone and the compression of intervertebral disc were not mentioned in the drug instructions. The SOC of risk signals obtained by two sorting methods mainly included various examinations， gastrointestinal diseases， systemic diseases and various reactions at the administration site.

CONCLUSIONS

In clinical application of linaclotide， in addition to the adverse drug reactions mentioned in the drug instructions， close attention should be paid to safety risks such as increase of dihydrotestosterone and the compression of intervertebral disc， which are not mentioned in the instructions， so as to guarantee the safety of drug use.

关键词

Keywords

references

BRENNER D M . Best practices for the management of chronic idiopathic constipation and irritable bowel syndrome with constipation：a round table discussion and review [J ] . Am J Gastroenterol ， 2022 ， 117 （ 4S ）： S1 .

SAYUK G S ， WALDMAN S A ， BRENNER D M . Mechanisms of action of current pharmacologic options for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation [J ] . Am J Gastroenterol ， 2022 ， 117 （ 4S ）： S6 - S13 .

苏琪茗，伊丽娜，吴晓玮，等 . 利那洛肽的研究进展及适应证的拓展 [J ] . 中国中西医结合消化杂志， 2022 ， 30 （ 2 ）： 159 - 162 .

玉燕萍，郑松柏，张闪，等 . 利那洛肽治疗便秘型肠易激综合征的疗效和安全性的meta分析 [J ] . 胃肠病学， 2020 ， 25 （ 9 ）： 534 - 539 .

程能能 . 新型、口服肠上皮细胞鸟苷酸环化酶C激动剂：利那洛肽 [J ] . 中国临床药学杂志， 2019 ， 28 （ 4 ）： 291 - 295 .

邹多武 . 利那洛肽：慢性便秘和便秘型肠易激综合征的新选择 [J ] . 中华消化杂志， 2019 ， 39 （ 4 ）： 286 - 288 .

黄佳，钟薇，王浩，等 . 基于美国FAERS数据库的恩美曲妥珠单抗不良事件信号挖掘与分析 [J ] . 中国医院药学杂志， 2022 ， 42 （ 1 ）： 49 - 53 .

吴紫阳，何娜，程吟楚，等 . 基于美国FAERS数据库的恩美曲妥珠单抗和维布妥昔单抗不良反应信号挖掘 [J ] . 中国药房， 2022 ， 33 （ 6 ）： 740 - 744 .

伏箫燕，陈力，陈成，等 . 基于FAERS数据库利拉鲁肽不良反应信号挖掘与分析 [J ] . 中国医院药学杂志， 2020 ， 40 （ 18 ）： 1957 - 1961 .

BÖHM R ， BULIN C ， WAETZIG V ， et al . Pharmacovi-gilance-based drug repurposing：the search for inverse signals via OpenVigil identifies putative drugs against viral respiratory infections [J ] . Br J Clin Pharmacol ， 2021 ， 87 （ 11 ）： 4421 - 4431 .

张雅娟，陈慧，杨悦 . 面向未来的中国药物警戒制度实施的思考 [J ] . 中国新药杂志， 2021 ， 30 （ 22 ）： 2017 - 2023 .

于玥琳，张云静，缪珂，等 . 国内外药品上市后安全性监管体系及监管要求比较 [J ] . 药物流行病学杂志， 2022 ， 31 （ 2 ）： 113 - 120 .

FUKUDO S ， MIWA H ， NAKAJIMA A ， et al . A rando-mized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan [J ] . Neurogastroenterol Motil ， 2018 ， 30 （ 12 ）： e13444 .

国家药品监督管理局药品审评中心 . 上市药品信息：利那洛肽胶囊 [EB/OL ] .（ 2021-03-31 ）[ 2022-04-25 ] . https：//www.cde.org.cn/main/xxgk/postmarketpage?acceptidCODE=907cd896f18298a2b39b55bfb508f078 https://www.cde.org.cn/main/xxgk/postmarketpage?acceptidCODE=907cd896f18298a2b39b55bfb508f078 .

Views

274

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS

Related Author

YAO Minghong

LIN Lijun

MIAO Huiqing

LIN Kai

Related Institution

Center for Pharmacovigilance of Hainan Province

Hainan Drug and Medical Device Evaluation Service Center

China Evidence-Based Medicine Center， West China Hospital， Sichuan University

Center for Pharmacovigilance of Haikou

⁰