中国药物警戒 ›› 2022, Vol. 19 ›› Issue (12): 1362-1367.
DOI: 10.19803/j.1672-8629.20210746

• 安全与合理用药 • 上一篇    下一篇

4 864例应用贝伐珠单抗住院患者致血小板减少自动监测及相关影响因素分析

李伯妍1,2, 郭代红2,*, 朱雨1,2, 王嘉熙2,3, 张博1,2, 郭海丽1,2   

  1. 1解放军医学院,北京 100853;
    2中国人民解放军总医院医疗保障中心药剂科,北京 100853;
    3重庆医科大学药学院,重庆 400016
  • 收稿日期:2021-08-09 出版日期:2022-12-15 发布日期:2022-12-21
  • 通讯作者: *郭代红,女,主任药师·硕导,临床药学与药物警戒。E-mail: guodh301@163.com
  • 作者简介:李伯妍,女,硕士,药师,临床药学研究。
  • 基金资助:
    2017年军事医学创新工程重点项目（17CXZ010）; 中国研究型医院学会（Y2021FH-YWPJ01）

Automatic monitoring of thrombocytopenia caused by bevacizumab in 4 864 inpatients and related influencing factors

LI Boyan1,2, GUO Daihong2,*, ZHU Yu1,2, WANG Jiaxi2,3, ZHANG Bo1,2, GUO Haili1,2   

  1. 1Medical School of PLA, Beijing 100853, China;
    2Department of Pharmacy, the Medical Supplies Center, General Hospital of PLA, Beijing 100853, China;
    3School of Pharmacy, Chongqing Medical University, Chongqing 400016, China
  • Received:2021-08-09 Online:2022-12-15 Published:2022-12-21

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摘要： 目的 了解大样本真实世界中住院患者使用贝伐珠单抗出现血小板减少的情况,计算发生率并探究风险因素。方法 借助医疗机构药物不良事件主动监测与智能评估警示系统-II（ADE-ASAS-II）,回顾性监测某院2010年1月1日至2020年12月31日所有使用贝伐珠单抗的住院患者电子病历信息,确定阳性病例后,应用倾向性评分1∶1匹配对照组,通过二元逻辑回归识别相关风险因素。结果 4 864例使用贝伐珠单抗的住院患者中有455例在用药后出现血小板减少,发生率为10.00%。血小板基值<150×109·L-1（OR=11.896,95%CI：8.270~17.111）,白细胞基值偏低（OR=1.801,95%CI：1.213~2.675）,红细胞基值偏低（OR=1.561,95%CI：1.085~2.246）,肿瘤分期（TNM分期）为Ⅳ期（OR=1.814,95%CI：1.059~3.107）,总化疗次数≥10次（OR=2.537,95%CI：1.675~3.842）,联用紫杉醇、铂类（OR=2.658,95%CI：1.267~5.578）为应用贝伐珠单抗后出现血小板减少的风险因素;联用铂类、培美曲塞方案（OR=0.289,95%CI：0.147~0.568）为应用贝伐珠单抗后出现血小板减少的保护因素。结论 临床使用贝伐珠单抗时,对具有血小板基值偏低、多疗程、与紫杉醇和铂类联合治疗等相关风险因素的住院患者应予以严密关注。

关键词: 贝伐珠单抗, 药品不良反应, 自动监测, 风险因素

Abstract: Objective To find out about the incidence of thrombocytopenia in large samples of hospitalized patients using bevacizumab in the real world, and to identify the risk factors. Methods The electronic information of all inpatients who used bevacizumab in our hospital between 2010 and 2020 was retrospectively monitored with the help of Adverse Drug Events Active Surveillance and Assessment System-II (ADE-ASAS-II). After the positive cases were determined, the propensity score 1:1 was used to match the control group, and the related risk factors were identified using binary logistic regression. Results Among the 4 864 inpatients treated with bevacizumab, 455 developed thrombocytopenia, with an incidence of 10.00%. A platelet base value < 150 ×109·L-1（OR=11.896,95%CI：8.270~17.111）, low leukocyte base value（OR=1.801,95%CI：1.213~2.675）, low erythrocyte base value（OR=1.561,95%CI：1.085~2.246）, stage Ⅳtumor (TNM stage)（OR=1.814,95%CI：1.059~3.107）, total number of times of chemotherapy≥ 10（OR=2.537, 95%CI：1.675~3.842）, and combination with paclitaxel and platinum（OR=2.658,95%CI：1.267~5.578） were risk factors for thrombocytopenia after using bevacizumab while the combination of platinum and pemetrexed regimen （OR=0.289,95% CI：0.147~0.568）was a protective factor for thrombocytopenia. Conclusion When bevacizumab is used in clinic, close attention should be paid to inpatients with risk factors such as a low platelet base value, multiple courses of treatment, combined treatment with paclitaxel and platinum.

Key words: bevacizumab, adverse drug reaction, automatic monitoring, risk factor

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