533例抗肿瘤药物不良反应报告分析

Analysis of 533 cases of adverse drug reactions induced by antineoplastic drugs

摘要:

目的 分析我院抗肿瘤药物不良反应（ADR）报告，以期为临床安全、合理使用抗肿瘤药物提供参考。方法 收集2013年—2020年我院上报的533例抗肿瘤药物ADR报告，分别从患者年龄、性别、药品种类、累及系统、临床表现及给药途径等方面进行统计和分析。结果 533例抗肿瘤药物ADR中，男性256例，女性277例；发生ADR的患者年龄主要集中在61~70岁（28.5%）和51~60岁（25.7%）。ADR涉及的抗肿瘤药物种类占比最高的依次为抗肿瘤植物药（23.3%）、新型抗肿瘤药物（23.3%）和抗代谢类药物（22.0%）。ADR临床表现例次排名前3位的抗肿瘤药物分别为紫杉醇、多西他赛和奥沙利铂；排名前3位的新型抗肿瘤药物分别为利妥昔单抗、贝伐珠单抗和西妥昔单抗。ADR主要累及血液系统损害（30.6%）、胃肠系统损害（19.4%）、全身性损害（15.5%）和皮肤及其附件损害（14.4%）。静脉给药引起的ADR最多（81.2%）；给药后1 d内更易发生ADR，15 d内发生的ADR约占86.8%。严重的ADR有102例，主要涉及多西他赛、表柔比星和紫杉醇；新型抗肿瘤药物引起的严重ADR共13例，主要涉及贝伐珠单抗和尼妥珠单抗。结论 应加强抗肿瘤药物ADR监测，关注特殊人群和重点药物，可采取预防措施来减少ADR的发生，对出现的ADR应尽早采取有效措施，提高患者的用药安全性。

Abstract:

Objective To analyze the characteristics and regularity of adverse drug reactions (ADR) induced by antineoplastic drugs and provide references for clinically reasonable and safe use of antineoplastic drugs.Methods A total of 533 reports of ADR induced by antineoplastic drugs in our hospital from 2013 to 2020 were collected and retrospectively analyzed in terms of age, gender, drug type, system/organ involved in ADR, clinical manifestations, route of administration, etc.Results Among the 533 cases of ADR, 256 were male and 277 were female. Patients with ADR were mainly 61~70 years old (28.5%) and 51~60 years old (25.7%). The ADR-related antineoplastic drugs with top proportion were plant-derived drugs (23.3%), novel anti-tumor drugs (23.3%) and anti-metabolism drugs (22.0%). The top 3 antineoplastic drugs in ADR clinical manifestations were paclitaxel, docetaxel, and oxaliplatin; The top 3 novel anti-tumor drugs in ADR clinical manifestations were rituximab, bevacizumab and cetuximab. ADR mainly involved blood system damage (30.6%), gastrointestinal system damage (19.4%), systemic damage (15.5%) and skin and its accessories damage (14.4%). Intravenous administration caused the most of ADR (81.2%). ADR were more likely to occur within one day after administration, and 86.8% of ADR occurred within 15 days. There were 102 cases of severe ADR, mainly involving docetaxel, epirubicin, and paclitaxel. There were 13 cases of severe ADR caused by novel anti-tumor drugs, mainly involving bevacizumab and nimotuzumab.Conclusion It is necessary to strengthen the monitoring of ADR in clinical use of antineoplastic drugs. We should focus on the special population and key drugs, take preventive measures to reduce the occurrence of ADR, and take effective treatment measures as soon as possible to improve the safety of medication for patients.