Page 85 - 《中国药房》2021年24期

·药物与临床·

山东省EGFR-TKI致不良反应报告分析 Δ

刘宝生 ，周秀丽 ，宫凯凯（1.潍坊市中医院临床药学科，山东 潍坊 261000；2.阳光融和医院药学部，山东
2 #
1＊
3
潍坊 261000；3.滨州医学院附属医院肿瘤研究实验室，山东 滨州 256603）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2021）24-3019-06
DOI 10.6039/j.issn.1001-0408.2021.24.13
摘 要 目的：分析表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）致不良反应（ADR）的临床表现和特点，为临床安全用药提
供参考。方法：汇总2018年1月－2020年12月山东省ADR监测中心自发呈报系统收集到的EGFR-TKI致ADR报告的相关数据，
对报告涉及的患者年龄、性别、药物品种、ADR分类、用法用量、ADR发生时间、累及器官/系统及主要临床表现、转归情况等进行
统计、分析。结果与结论：共纳入 EGFR-TKI 致 ADR 报告 120 份，涉及患者 120 例。120 例患者中，女性（60.83％）多于男性
（39.17％），年龄以50～79岁（79.16％）为主。共涉及吉非替尼、奥希替尼、阿法替尼、埃克替尼和厄洛替尼等5种药物，分别有72、
11、15、6、16例使用上述药品的患者发生了ADR；ADR以一般的（70.83％）为主，其次为严重的（22.50％）、新的一般的（5.00％）和
新的严重的（1.67％）。所有患者均为口服给药，有2例使用埃克替尼的患者存在超说明书用药情况，其余均符合药品说明书用药
要求。有61例（50.83％）患者的ADR发生在用药后1个月内，34例（28.33％）发生在用药后1～3个月，25例（20.83％）发生在用药
后4～12个月，用药12个月以后未有ADR发生。ADR累及器官/系统以皮肤及其附件损害、胃肠系统损害和肝胆系统损害为主，
主要临床表现为皮疹、腹泻和肝功能异常；此外，有患者出现间质性肺炎、骨髓抑制、舌肿胀和脑梗死等严重的或新的严重的
ADR。102例患者经停药或对症处理后痊愈或好转，12例转归情况不详，6例未好转。建议临床应加强对患者用药后 1个月内的
药学监护，警惕新的、严重的ADR的发生，保障患者临床用药安全。
关键词 表皮生长因子受体酪氨酸激酶抑制剂；药品不良反应；报告分析；用药安全；山东省

Analysis of the Reports of Adverse Dug Reaction Induced by EGFR-TKI in Shandong Province
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1
LIU Baosheng ，ZHOU Xiuli ，GONG Kaikai （1. Dept. of Clinical Pharmacy，Weifang Hospital of TCM，
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Shandong Weifang 261000， China； 2. Dept. of Pharmacy， Sunshine Union Hospital， Shandong Weifang
261000，China；3. Cancer Research Laboratory，Binzhou Medical University Hospital，Shandong Binzhou
256603，China）
ABSTRACT OBJECTIVE：To analyze the clinical manifestations and characteristics of adverse drug reactions（ADR）induced by
EGFR-TKI，and to provide reference for safe use of drugs in clinic. METHODS：The relevant data of EGFR-TKI-induced ADR
reports which were reported to Shandong ADR Monitoring Center from January 2018 to December 2020 were summarized，and
analyzed statistically in respects of age，gender，drug variety，ADR classification，usage and dosage，occurrence time，involved
organs/systems，clinical manifestations and prognosis of patients. RESULTS & CONCLUSIONS：A total of 120 ADR reports
induced by EGFR-TKI were included，involving 120 patients. Among 120 patients，the female（60.83％）was more than the male
（39.17％），and the age was mainly 50-79 years old（79.16％）. A total of 5 drugs including gefitinib，ositinib，afatinib，ektinib
and erlotinib were involved. ADR occurred in 72，11，15，6 and 16 patients using the above drugs respectively；the main ADR
was general ADR（70.83％），followed by severe ADR（22.50％），new general ADR（5.00％）and new severe ADR（1.67％）. All
patients were given drugs orally，off-label use was found in 2 patients who used ektinib，and the rest met the medication
requirements of the drug instructions. ADR occurred in 61 patients （50.83％） within 1 month after medication，34 patients
（28.33％）within 1-3 months after medication，25 patients（20.83％）within 4-12 months after medication，and no ADR occurred
after 12 months. ADR of organs/systems involved were mainly the lesion of skin and its appendant injury，gastrointestinal system
injury and hepatobiliary system injury. The main clinical manifestations were rash，diarrhea and abnormal liver function；in
addition，some patients developed severe or new severe ADR such as interstitial pneumonia，bone marrow suppression，tongue
swelling and cerebral infarction. Totally 102 patients recovered or improved after drug withdrawal or symptomatic treatment，12
patients had unknown outcome，and 6 patients did not improve. It is suggested that pharmaceutical care should be strengthened
within 1 month after EGFR-TKI administration，so as to guard
Δ 基金项目：国家自然科学基金资助项目（No.81903537）
against the occurrence of new and serve ADR and ensure the
＊主管药师，硕士。研究方向：药事管理与临床药学。电话：
safety of clinical medication.
0536-8060676。E-mail：1057080284@qq.com
# 通信作者：主管药师，硕士。研究方向：药事管理与临床药学。 KEYWORDS EGFR-TKI；ADR；Report analysis；Safety of
电话：0536-6960663。E-mail：xiulizhou1990@163.com drug use；Shandong province

中国药房 2021年第32卷第24期 China Pharmacy 2021 Vol. 32 No. 24 ·3019 ·