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基于FAERS数据库的利那洛肽风险信号挖掘
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| 篇名： | 基于FAERS数据库的利那洛肽风险信号挖掘 |
| TITLE： | Data mining of risk signals for linaclotide based on FAERS database |
| 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OpenVigil2.1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17590份，其中严重的ADE报告有5494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. |
| 期刊： | 2022年第33卷第22期 |
| 作者： | 张科，李波，宋崟，孙璇，邵佳，李正翔 |
| AUTHORS： | ZHANG Ke，LI Bo，SONG Yin，SUN Xuan，SHAO Jia，LI Zhengxiang |
| 关键字： | 利那洛肽；美国FDA不良事件报告系统；风险信号；报告比值比法；比例报告比值法 |
| KEYWORDS： | linaclotide； FDA adverse event reporting system； risk signal； reporting odds ratio； proportional report ratio |
| 阅读数： | 366 次 |
| 本月下载数： | 20 次 |
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