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

马颖林, 乐凯迪, 闫加庆, 田春华, 王涛, 刘敏, 李国辉

中国药学杂志 ›› 2022, Vol. 57 ›› Issue (4) : 310-314.

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中国药学杂志 ›› 2022, Vol. 57 ›› Issue (4) : 310-314. DOI: 10.11669/cpj.2022.04.011
论著

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

  • 马颖林1, 乐凯迪1, 闫加庆1, 田春华2, 王涛2, 刘敏1*, 李国辉1*
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Analysis of the Adverse Reactions and Risk Factors of Apatinib in the Treatment of Breast Cancer in Real World

  • MA Ying-lin1, LE Kai-di1, YAN Jia-qing1, TIAN Chun-hua2, WANG Tao2, LIU Min1*, LI Guo-hui1*
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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应的相关性。结果 193例患者中,有132例(68.39%)患者发生不良反应,多为1级或2级,最常见的不良反应为高血压(27.46%)、手足综合征(21.76%)。多因素Logistic回归分析显示,初始服药剂量为425 mg/500 mg的患者相比250 mg的患者发生不良反应(ADR)的风险增加(OR=4.719,95%CI:2.315~9.621);联合化疗患者相对单药治疗患者发生ADR的风险增加(OR=4.569,95%CI:2.082~10.030)。既往有高血压病史的患者相比无高血压病史的患者发生高血压的风险增加(OR=2.528,95%CI:1.084~5.891);初始服药剂量为425 mg/500 mg的患者相比250 mg的患者发生高血压的风险增加(OR=3.622,95%CI:1.762~7.448);联合化疗患者相对单药治疗患者发生高血压不良反应的风险增加(OR=3.386,95%CI:1.106~10.369)。结论 阿帕替尼治疗乳腺癌不良反应可耐受,初始服药剂量和联合化疗是发生ADR的危险因素;既往高血压病史,初始服药剂量和联合化疗是发生高血压不良反应的危险因素。

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.

关键词

阿帕替尼 / 乳腺癌 / 不良反应 / 危险因素

Key words

apatinib / breast cancer / adverse drug reactions / risk factor

引用本文

导出引用
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 https://doi.org/10.11669/cpj.2022.04.011
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 https://doi.org/10.11669/cpj.2022.04.011
中图分类号: R95    R969   

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