中国药物警戒 ›› 2017, Vol. 14 ›› Issue (12): 755-759.

• 安全性评价与合理用药 • 上一篇    下一篇

国产与进口多西他赛致乳腺癌患者血系不良反应的自动监测研究

寇炜1,郭代红1*,赵博宇2,贾王平1,田小燕2,王啸宇1,胡鹏洲2   

  1. 1解放军总医院药品供应中心，北京 100853；
    2重庆医科大学药学院，重庆 401331
  • 收稿日期:2017-05-11 修回日期:2018-01-19 出版日期:2017-12-20 发布日期:2018-01-19
  • 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: 寇炜，男，主治医师，硕士，临床药物治疗学。
  • 基金资助:
    2014年全军后勤科研重点项目（BWS14R039）：军队药品风险监测防控技术与支撑平台的研究。

Study on Hematologic Adverse Drug Reactions Related to Domestic and Imported Docetaxel in the Treatment of Breast Cancer by Automatic Surveillance

KOU Wei1 , GUO Dai-hong1*, ZHAO Bo-yu2, JIA Wang-ping1, TIAN Xiao-yan2 , WANG Xiao-yu1, HU PENG-zhou2   

  1. 1Department of Pharmaceutical Care, PLA General Hospital, Beijing 100853, China;
    2Chongqing Medical University, Chongqing 401331, China
  • Received:2017-05-11 Revised:2018-01-19 Online:2017-12-20 Published:2018-01-19

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摘要： 目的 比较多帕菲与泰素帝化疗致乳腺癌患者血液系统药品不良反应（ADR）发生率，并分析其相关影响因素。方法 采用回顾性分析，利用“医疗机构ADE主动监测与智能评估警示系统”，自动监测并筛选我院2015年1月1日至2016年12月31日使用多帕菲与泰素帝的乳腺癌住院患者，药师对系统报警病例人工评价甄定后进行血液系统ADR发生率比较，并对其发生影响因素分析。结果 多帕菲与泰素帝血液系统ADR总发生率分别为47.10%和53.67%，两者间差异无统计学意义（P =0.232）。两种药品严重ADR均为白细胞减少和中性粒细胞减少，其发生率多帕菲为4.52%和3.23%，泰素帝为2.26%和2.26%，差异均无统计学意义（P =0.252，P =0.840）。两药均未致严重血小板减少和贫血。本研究显示BMI（OR：0.940,95% CI：0.885-0.999，P =0.047）与肺转移（OR：2.005,95% CI：1.022-3.933，P =0.043）均为多西他赛血液系统ADR发生的独立影响因素。结论 多帕菲与泰素帝血液系统ADR发生率均高，临床应用中要密切监测并采取必要防治措施，减少严重ADR发生。借助专项软件能够高效、快捷的开展重点药物、重点ADR安全性研究，值得推广。

关键词: 多西他赛, 乳腺癌, 血细胞减少, 药品不良反应, 自动监测

Abstract: Objective To compare the incidence of hematologic adverse drug reactions caused by domestic and imported docetaxel in the treatment of breast cancer and research its influencing factors. Methods This research was analyzed retrospectively. The hospitalized patients in our hospital, who suffered from breast cancer and received chemotherapy of domestic and imported docetaxel between Jan 1, 2015 and Dec 31, 2016 were screened out by adverse drug events' active moniroring and assessment system. The suspected cases were reviewed manually for further study. Results The incidence of hematologic ADRs related to domestic and imported docetaxel was 47.10% and 53.67% respectively. And there was no significant difference in incidence of hematologic ADRs caused by domestic and imported docetaxel (P =0.232).Their severe ADRs were both leukopenia and neutropenia. The incidence of leukopenia and neutropenia induced by domestic docetaxel was 4.52% and 3.23%, while the incidence of imported docetaxel was 2.26% and 2.26%, and no significant differences existed between them(P =0.252, P =0.840). Neither of them induced severe thrombocytopenia and anemia. BMI (OR:0.940, 95% CI:0.885-0.999, P =0.047) and lung metastasis (OR:2.005, 95% CI:1.022-3.933, P =0.043) were independent influencing factors of hematologic ADRs caused by docetaxel. Conclusion The incidence of hematologic ADRs caused by domestic and imported docetaxel was high and both should be closely monitored in the course of clinical use to prevent the occurrence of severe ADRs and treat timely. The safety study on key drugs and related ADRs can be accomplished efficiently by the system, and it's worth popularizing.

Key words: docetaxel, breast cancer, hypocytosis, adverse drug reaction, automatic surveillance

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