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山东省EGFR-TKI致不良反应报告分析
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| 篇名： | 山东省EGFR-TKI致不良反应报告分析 |
| TITLE： | Analysis of the Reports of Adverse Dug Reaction Induced by EGFR-TKI in Shandong Province |
| 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。 |
| 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 against the occurrence of new and serve ADR and ensure the safety of clinical medication. |
| 期刊： | 2021年第32卷第24期 |
| 作者： | 刘宝生，周秀丽，宫凯凯 |
| AUTHORS： | LIU Baosheng ，ZHOU Xiuli，GONG Kaikai |
| 关键字： | 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 |
| KEYWORDS： | EGFR-TKI；ADR；Report analysis ；Safety of |
| 阅读数： | 226 次 |
| 本月下载数： | 10 次 |
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