Page 105 - 《中国药房》2024年9期

3种第三代四环素类抗菌药物ADE信号的挖掘与分析
Δ

#
＊
梁碧怡 ，杨惠霞，黄小梅，任剑雄（佛山市中医院临床药学室，广东 佛山 528000）
中图分类号 R978.1+4 文献标志码 A 文章编号 1001-0408（2024）09-1123-06
DOI 10.6039/j.issn.1001-0408.2024.09.17

摘 要 目的 基于美国FDA不良事件报告系统（FAERS）数据库，挖掘3种第三代四环素类抗菌药物（替加环素、奥马环素、依拉
环素）的药物不良事件（ADE）信号，为临床安全使用该类药物提供依据。方法 检索美国FAERS数据库中2005年第1季度至2023
年第2季度替加环素、奥马环素、依拉环素的ADE报告，采用报告比值比法和比例报告比值法对3种药物的ADE信号进行挖掘，并
进行分析。结果 共获得以替加环素、奥马环素、依拉环素为首要怀疑药物的ADE报告2 538份，其中替加环素2 135份、奥马环素
349份、依拉环素54份。替加环素的ADE阳性信号有131个，共涉及19个系统器官分类（SOC），主要集中在各类检查、肝胆系统
疾病、血液及淋巴系统疾病、胃肠系统疾病等；信号较强的首选术语（PT）分别是低纤维蛋白原血症和血纤维蛋白原降低等；肾衰、
急性肾损伤、出血等14种ADE在其说明书中未提及。奥马环素的ADE阳性信号有24个，共涉及6个SOC，主要集中在胃肠系统
疾病、各类检查等；信号较强的 PT 分别是牙齿变色、喷射样呕吐、粪便松软等；其说明书未提及的 ADE 有唇部肿胀、胃食管反流
病、嗜酸粒细胞增多症、皮肤变色、粪便松软、盗汗。依拉环素的ADE阳性信号有5个，共涉及4个SOC，主要集中在各类检查、胃
肠系统疾病等；信号较强的PT分别是血纤维蛋白原降低和低纤维蛋白原血症。结论 3种第三代四环素类药物涉及胃肠系统的
ADE最多，使用时尤其要注意替加环素所致胰腺炎类疾病和奥马环素口服所致胃食管反流病的ADE。在用药期间应定期监测患
者肝功能、肾功能（使用替加环素时）、凝血功能（使用替加环素、依拉环素时），以防范严重ADE的发生。
关键词 替加环素；奥马环素；依拉环素；药物不良事件；信号挖掘；胰腺炎；胃食管反流病；FAERS数据库

Data mining and analysis for ADE signals of three third-generation tetracycline antibiotics
LIANG Biyi，YANG Huixia，HUANG Xiaomei，REN Jianxiong（Clinical Pharmacy Room， Foshan Hospital of
Traditional Chinese Medicine， Guangdong Foshan 528000， China）

ABSTRACT OBJECTIVE To excavate the adverse drug event （ADE） signals of three third-generation tetracycline antibiotics
（tigecycline， omadacycline， eravacycline） based on FDA adverse event reporting system （FAERS）， and to provide reference for
the safe use of them. METHODS The ADE reports of tigecycline， omadacycline and eravacycline from the first quarter of 2005 to
the second quarter of 2023 were retrieved from FAERS database. The ADE signals of 3 kinds of drugs were mined by the method
of reporting odds ratio method and the proportional reporting ratio method. RESULTS Totally 2 538 ADE reports with tigecycline，
omadacycline and eravacycline as the primary suspected drugs were obtained， including 2 135 tigecycline ADE reports， 349
omadacycline ADE reports and 54 eravacycline ADE reports. A total of 131 ADE positive signals of tigecycline were mined，
involving 19 system organ classes （SOCs）， mainly concentrated in investigations， hepatobiliary system， blood and lymphatic
system， and gastrointestinal system， etc； the preferred terminologies （PT） with intense signal were hypofibrinogenaemia and blood
fibrinogen decreased. Fourteen ADE signals were not mentioned in the drug instruction， such as renal failure， acute kidney injury
and hemorrhage. Totally 24 ADE positive signals of omadacycline were mined， involving 6 SOCs， mainly concentrated in the
gastrointestinal system and various examinations； the PTs with intense signals were tooth discoloration， jet-like vomiting and loose
feces， etc. ADE signals were not mentioned in the drug instructions， included lip swelling， gastroesophageal reflux disease，
eosinophilia， skin discoloration， feces softening， and night sweats. Five ADE positive signals of eravacycline were mined，
involving 4 SOCs， mainly concentrated in various examinations， gastrointestinal system， etc. The most intense ADE signals were
blood fibrinogen decreased and hypofibrinogenaemia. CONCLUSIONS ADE of the gastrointestinal system are mostly identified in
the three third-generation tetracycline antibiotics， especially pancreatitis caused by tigecycline and gastroesophageal reflux disease
caused by oral administration of omadacycline. The liver
Δ 基金项目 佛山市科技局科技创新项目（No.2220001005371） function， renal function （for tigecycline） and coagulation
＊第一作者 副主任药师，硕士。研究方向：抗感染药物。E-mail：
function （for tigecycline， eravacycline） should be monitored
biyiliang@hotmail.com
# 通信作者 主任中药师。研究方向：中药临床药学、药事管理。 regularly during medication， so as to prevent the occurrence of
电话：0757-83068120。E-mail：1727313578@qq.com serious ADE.

中国药房 2024年第35卷第9期 China Pharmacy 2024 Vol. 35 No. 9 · 1123 ·