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真实世界阿帕替尼治疗乳腺癌的不良反应及危险因素分析
引用本文:马颖林,乐凯迪,闫加庆,田春华,王涛,刘敏,李国辉. 真实世界阿帕替尼治疗乳腺癌的不良反应及危险因素分析[J]. 中国药学杂志, 2022, 57(4): 310-314. DOI: 10.11669/cpj.2022.04.011
作者姓名:马颖林  乐凯迪  闫加庆  田春华  王涛  刘敏  李国辉
作者单位:1.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, 北京 100021;
2.国家药品监督管理局药品评价中心, 北京 100022
摘    要:目的 评估真实世界乳腺癌患者使用阿帕替尼的安全性,分析使用阿帕替尼的患者发生药品不良反应的危险因素,为阿帕替尼在乳腺癌患者中的安全使用提供参考.方法 回顾性分析某院2016年3月~2020年3月接受阿帕替尼治疗的乳腺癌患者193例,收集患者的基本病例资料及不良反应,采用Logistic回归分析患者的临床特征与药品不良反...

关 键 词:阿帕替尼  乳腺癌  不良反应  危险因素
收稿时间:2021-01-20

Analysis of the Adverse Reactions and Risk Factors of Apatinib in the Treatment of Breast Cancer in Real World
MA Ying-lin,LE Kai-di,YAN Jia-qing,TIAN Chun-hua,WANG Tao,LIU Min,LI Guo-hui. Analysis of the Adverse Reactions and Risk Factors of Apatinib in the Treatment of Breast Cancer in Real World[J]. Chinese Pharmaceutical Journal, 2022, 57(4): 310-314. DOI: 10.11669/cpj.2022.04.011
Authors:MA Ying-lin  LE Kai-di  YAN Jia-qing  TIAN Chun-hua  WANG Tao  LIU Min  LI Guo-hui
Affiliation:1. Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China;
2. Center for Drug Reevaluation, National Medical Products Administration, Beijing 100022, China
Abstract:OBJECTIVE To evaluate the safety of using apatinib in breast cancer patients in real world, analyze the risk factors of adverse drug reactions, and provide reference for the use of apatinib in breast cancer patients. METHODS Retrospective analysis of 193 cases of breast cancer patients treated with apatinib in our hospital from March 2016 to March 2020 was conducted. The basic case data and adverse reactions were collected. The correlation between clinical characteristics and adverse drug reactions was analyzed by logistic regression. RESULTS Among 193 patients, 132 patients (68.39%) had adverse reactions, most of which were grade 1 or grade 2. The most common adverse reactions were hypertension (27.46%) and hand foot syndrome (21.76%). Multivariate logistic regression analysis showed that patients with initial dose of 425 mg/500 mg had an increased risk of ADR compared with patients with 250 mg (OR=4.719, 95%CI: 2.315-9.621), and patients with combination chemotherapy had an increased risk of ADR compared with patients treated with single drug (OR=4.569, 95% CI: 2.082-10.030). Compared with patients without history of hypertension, patients with previous hypertension history had higher risk of hypertension adverse reactions (OR=2.528, 95% CI: 1.084-5.891). Patients with initial dose of 425 mg/500 mg had higher risk of adverse reactions of hypertension than patients with 250 mg (OR=3.622, 95% CI: 1.762-7.448). Patients with combined chemotherapy had a higher incidence of adverse reactions of hypertension than patients treated with single drug (OR=3.386, 95% CI: 1.106-10.369). CONCLUSION The adverse reactions of apatinib in the treatment of breast cancer are tolerable, the initial dose and combined chemotherapy are the risk factors of ADR; the history of hypertension, initial dosage and combined chemotherapy are the risk factors of adverse reactions of hypertension.
Keywords:apatinib  breast cancer  adverse drug reactions  risk factor   
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