Page 79 - 《中国药房》2022年15期

·药物与临床·

基于FAERS数据库的司美格鲁肽药品不良事件信号挖掘 Δ

卢伟涛 ，何家汝，陈文瑛（南方医科大学第三附属医院药学部，广州 510630）
#
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中图分类号 R977.1；R969.3 文献标志码 A 文章编号 1001-0408（2022）15-1865-06
DOI 10.6039/j.issn.1001-0408.2022.15.14
摘 要 目的 挖掘司美格鲁肽的药品不良事件（ADE）信号，为临床合理用药提供依据。方法 采用比例失衡法对美国FDA不良
事件报告系统（FAERS）自建库起至2021年9月所有的司美格鲁肽ADE报告进行信号挖掘。分析报告病例的基本情况；映射得到
对应的系统器官分类（SOC），并与药品说明书记录的不良反应进行对比；对不同适应证患者的首选语（PT）进行分析。结果 共提
取到6 661例司美格鲁肽ADE报告，挖掘到194个有效信号。6 661例ADE报告中男性（43.40％）所占比例低于女性（52.65％）；年
龄主要分布于＞40～65岁（29.00％）和＞65岁（22.61％）；上报国家以美国为主（83.88％）；报告年份主要集中在2021年（40.88％），
并呈逐年递增趋势；结局以严重ADE报告中的住院或住院时间延长（17.78％）为主。司美格鲁肽ADE信号映射到主SOC上主要
为胃肠系统疾病，各类损伤、中毒和操作并发症，代谢与营养类疾病，各类检查。以报告优势比＞10或ADE报告例数＞50例进行筛
选，在药品说明书的基础上增添了48个新的潜在不良反应。在报告例数排在前2位的适应证（即2型糖尿病和肥胖、超重、体质量
控制）中，以恶心、呕吐、腹泻为代表的胃肠系统相关ADE报告频次均较高，与药品说明书相似。结论 本研究在司美格鲁肽药品说
明书的基础上补充了48个新的潜在不良反应，目前可认为司美格鲁肽的安全性较好。
关键词 司美格鲁肽；FDA不良事件报告系统；药品不良事件；信号挖掘；比例失衡法

Adverse drug event signal mining of semaglutide based on FDA Adverse Event Reporting System database
LU Weitao，HE Jiaru，CHEN Wenying（Dept. of Pharmacy，the Third Affiliated Hospital of Southern Medical
University，Guangzhou 510630，China）

ABSTRACT OBJECTIVE To excavate the adverse drug event （ADE） signals of semaglutide and provide reference for its
clinical rational use. METHODS The proportional unbalance method was used to mine the signals of all semaglutide ADE reports
from FDA Adverse Event Reporting System （FAERS） up to September 2021. The basic situations of the reported cases were
analyzed. The corresponding system organ classification（SOC）was mapped and compared with the adverse drug reactions recorded
in the drug instructions. Preferred terms（PT）of patients with different indications were analyzed. RESULTS A total of 6 661
semaglutide ADE reports were extracted and 194 valid signals were mined. Among 6 661 cases of ADE，the proportion of men
（43.40％）was lower than women（52.65％）；the age was mainly distributed in ＞40-65 years old（29.00％）and ＞65 years old
（22.61％）；the reporting country was mainly the United States （83.88％）；the report year was mainly concentrated in 2021
（40.88％），with an increasing trend year by year；the main outcome was hospitalization or prolonged hospitalization in serious
ADE reports（17.78％）. Semaglutide ADE signal was mapped to the main SOC，mainly including gastrointestinal diseases，various
injuries，poisoning and operation complications，metabolic and nutritional diseases，various examinations. The screening criteria
were based on the report odds ratio ＞10 or ADE reported cases ＞50，and 48 new potential adverse drug reactions were added to
the drug description. Among the indications with the top two reported cases （type 2 diabetes and obesity，overweight，weight
control），the frequency of gastrointestinal system related ADE reports represented by nausea，vomiting and diarrhea was higher，
which was similar to the drug instructions. CONCLUSIONS This study supplemented 48 new potential adverse drug reactions
based on the drug instructions of semaglutide. At present，it can be considered that semaglutide is safe.
KEYWORDS semaglutide；FDA Adverse Event Reporting System；adverse drug events；signal mining；proportional unbalance
method

胰高血糖素样肽 1 受体激动剂（glucagon-like pep-
Δ 基金项目 广东省普通高校特色创新类项目（No.2018KTSCX033） tide 1 receptor agonists，GLP-1RA）属于肠促胰素类药
＊第一作者 硕士研究生。研究方向：临床药学。E-mail：lu-
物，近年来广泛应用于2型糖尿病的治疗。目前，我国已
weitao012345@163.com
上市的 GLP-1RA 有艾塞那肽注射液、艾塞那肽周制剂
# 通信作者 主任药师，硕士生导师，博士。研究方向：临床药学、
[1]
重症药学监护。电话：020-62784827。E-mail：chenwenying2016@163. 和利拉鲁肽注射液等 。司美格鲁肽注射液（商品名
com Ozempic）和司美格鲁肽片（商品名 Rybelsus）分别于

中国药房 2022年第33卷第15期 China Pharmacy 2022 Vol. 33 No. 15 ·1865 ·