抗肿瘤靶向药物相关不良反应的监测结果分析

Analysis of monitoring results of drug-related adverse reactions of targeted antitumor drugs

目的分析医院使用抗肿瘤靶向药物后产生不良反应的规律及特点,为临床合理用药提供参考。方法回顾性分析医院发生的166例药品不良反应(adverse drug reaction,ADR)病例,收集其一般信息、用药种类、给药途径、ADR累及系统等信息,进行结果分析。结果靶向药物致ADR共166例,患者年龄集中在51~60岁,共63例(37.95%),其他依次为61~70岁(33.13%)、41~50岁(13.25%),不同年龄段的男性和女性的构成比比较差异均无统计学意义;12种抗肿瘤靶向药物中以吉非替尼所致ADR的占比最高(26.51%),其次为埃克替尼(12.65%)、阿法替尼(12.05%)、阿帕替尼(10.84%)。Kaplan-Meier生存曲线显示,三代表皮生长因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor-tyrosine kinase inhibitor,EGFR-TKI)所致临床ADR发生率显著高于抗血管类药物、间变性淋巴瘤激酶(anaplastic lymphoma kinase,ALK)及间充质-上皮细胞转化(mesenchymal-epithelial transition,MET)抑制剂(P<0.05);抗肿瘤靶向药物所致ADR以胃肠道反应最为常见,发生率为31.25%,其次为皮肤系统损害(28.47%)、鼻腔口黏膜反应(10.42%)、肝肾损害(10.42%);在166例ADR患者中,共有155例患者在减量或停用药物后发生症状好转或消失。结论临床在治疗恶性肿瘤疾病过程中应严格监测ADR发生情况,尤其对使用EGFR-TKI三代相关药物的患者进行严密观察,做好相应预后方案,在保证疗效的前提下提高用药安全。

Objective To investigate and analyze the adverse reactions after the use of targeted antineoplastic drugs in the hospital.Methods A total of 166 cases of adverse drug reactions(ADR)in the hospital were retrospectively analyzed.The general information,drug types,route of administration,ADR involved system and other information were collected and analyzed.Results A total of 166 ADRs were caused by targeted drugs,among which 63 cases(37.95%)were aged 51-60 years,the others were 33.13%aged 61-70 years and 13.25%aged 41-50 years.There was no significant difference in the composition ratio of male and female in different age groups.Among the 12 anti-tumor targeted drugs,the ADR caused by gefitinib accounted for the highest proportion(26.51%),followed by ectinib(12.65%),afatinib(12.05%)and apatinib(10.84%).Kaplan-Meier survival curve showed that the incidence of clinical ADR caused by the third-generation EGFR-TKI drugs was significantly higher than that of antivascular drugs,ALK and MET inhibitors(P<0.05).The most common ADR caused by anti-tumor targeted drugs was gastrointestinal reaction(31.25%),followed by skin system damage(28.47%),nasal and oral mucosa reaction(10.42%),and liver and kidney damage(10.42%).Of the 166 cases of ADR patients,155 had symptoms that improved or disappeared after drug reduction or discontinuation.Conclusion The occurrence of ADR should be strictly monitored in the clinical treatment of malignant tumor diseases,especially for patients using EGFR-TKI third-generation related drugs,so as to improve the safety of medication on the premise of ensuring the efficacy.