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阿帕替尼治疗卵巢癌的不良反应及其影响因素

Influencing factors of adverse drug reaction induced by ovarian cancer treated with Apatinib

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【作者】 乐凯迪田春华闫加庆马颖林王涛刘敏李国辉

【Author】 LE Kai-di;TIAN Chun-hua;YAN Jia-qing;MA Ying-lin;WANG Tao;LIU Min;LI Guo-hui;Department of Pharmacy,National Cancer Center,National Clinical Research Center for Cancer,Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College;Center for Drug Reevaluation,National Medical Products Administration;

【通讯作者】 刘敏;李国辉;

【机构】 国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院药剂科国家药品监督管理局药品评价中心

【摘要】 目的评估中国医学科学院肿瘤医院使用阿帕替尼治疗卵巢癌患者的安全性,并分析患者的临床特征与不良反应的相关性,为临床合理用药提供参考。方法回顾性分析2016年1月至2019年12月在该院接受阿帕替尼治疗的54例卵巢癌患者临床资料,利用医院HIS系统检索并记录患者病历资料,采用美国国家癌症研究所常见不良反应事件评价标准(NCI-CTCAE)5.0版评价安全性;患者的临床特征与阿帕替尼的不良反应相关性采用logistic回归分析。结果 54例患者中,共有31例(57.41%)患者发生不良反应,常见的不良反应为高血压(38.89%)、蛋白尿(22.22%)和手足综合征(22.22%)。多因素logistic回归分析显示,联合化疗和多线化疗是阿帕替尼致不良反应的影响因素(P<0.05);超重(体质指数>25 kg/m~2)和存在过敏史是阿帕替尼致高血压的影响因素(P<0.05)。结论阿帕替尼治疗卵巢癌的不良反应较轻,多为1~2级,联合化疗和多线化疗是阿帕替尼致不良反应的影响因素,过敏史和超重是阿帕替尼致高血压的影响因素。

【Abstract】 Objective To evaluate the safety of Apatinib treatment for ovarian cancer,and analyze the correlation between characteristics and adverse drug reactions in order to provide references for clinical application. Mehods Medical records of 54 cases with advanced ovarian cancer treated with Apatinib from January 2016 to December 2019 were analyzed retrospectively. The safety was evaluated according to National Cancer Institute-Common Terminology Criteria for Adverse Events(NCI-CTCAE)version 5. 0. Logistic regression analysis was applied to investigate the correlation between characteristics and adverse drug reactions(ADRs). Results Of the 54 patients,31(57. 41%)had ADRs. The most common adverse events were hypertension(38. 89%),proteinuria(22. 22%)and hand-foot syndrome(22. 22%). Multivariate logistic regression showed that combination chemotherapy and multi-line chemotherapy were associated with the occurrence of ADR induced by Apatinib(P<0. 05),overweight(body mass index>25 kg/m~2)and allergic history were influencing factors for hypertension(P<0. 05). Conclusion The treatment of advanced ovarian cancer with Apatinib has lower toxicity,most were grade 1 to 2. Combination chemotherapy and multi-line chemotherapy are influencing factors for ADRs in patients treated with Apatinib. Overweight and allergic history were influencing factors for hypertension.

【基金】 基于真实世界的甲磺酸阿帕替尼片安全性研究(20183X002);国家药品监督管理局中国药品监管科学研究行动计划重点项目(CDRZ20193027)
  • 【文献出处】 临床药物治疗杂志 ,Clinical Medication Journal , 编辑部邮箱 ,2021年06期
  • 【分类号】R737.9
  • 【被引频次】3
  • 【下载频次】141
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