中国药物警戒 ›› 2020, Vol. 17 ›› Issue (12): 913-916.
DOI: 10.19803/j.1672-8629.2020.12.14

• 安全与合理用药 • 上一篇    下一篇

应用CHPS初步监测皮下注射国产硼替佐米的安全性

潘道苇1,2, 宛蕾1*   

  1. 1贵州医科大学基础医学院药理学教研室,贵州 贵阳 550025;
    2贵阳市第一人民医院药剂科,贵州 贵阳 550002
  • 收稿日期:2019-10-10 修回日期:2020-12-07 出版日期:2020-12-15 发布日期:2020-12-07
  • 通讯作者: *宛蕾,女,教授,药理学。E-mail:1325164635@qq.com
  • 作者简介:潘道苇,女,本科,主管药师、临床药学。

Monitoring of Safety of Home-made Subcutaneous Bortezomib by CHPS

PAN Daowei1,2, WAN Lei1*   

  1. 1Department of Pharmacology,School of Basic Medicine,Guizhou Medical University,Guiyang Guizhou 550025,China;
    2Department of Pharmacy,Guiyang first people's Hospital,Guiyang Guizhou 550002,China
  • Received:2019-10-10 Revised:2020-12-07 Online:2020-12-15 Published:2020-12-07

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摘要： 目的 运用中国医院药物警戒系统(Chinese Hospital Pharmacovigilance System,CHPS)对皮下注射国产硼替佐米的相关药品不良事件(adverse drug event,AE)实施主动监测。方法 用CHPS抽取贵阳市第一人民医院2019年1~6月皮下注射国产硼替佐米的病例32份,人工统计出全部AE,再结合该药进口药品说明书中所列出的AE,制定CHPS中的药品试验评价方案,最后用该方案筛选这32份病例中所有的AE,对比两种方法得到的AE情况。结果 CHPS阳性检出率为73.07%(20项),100%检出达6项,同时人工统计和CHPS检出两组数据差异无统计学意义(P>0.05)。结论 CHPS中的药品试验评价方案用于皮下注射国产硼替佐米AE检测有一定的可行性,但仍然需要进一步完善、发掘、利用其主动监测的功能。

关键词: 中国医院药物警戒系统, 药品不良事件, 硼替佐米, 国产药, 安全性

Abstract: Objective To monitor adverse drug events (AE) induced by home-made bortezomib for subcutaneous injection using the Chinese hospital pharmacovigilance system (CHPS).Methods Thirty-two cases involving the use of home-made bortezomib injected subcutaneously of Guiyang first people's Hospital from January to June 2019 were selected by the CHPS, and all the AE were calculated manually. Combined with the AE listed in the specifications of imported drugs, the drug trial evaluation scheme in the CHPS was formulated. Finally, all the AE related to the 32 cases were screened by the scheme, and the numbers of AE obtained by the two methods were compared.Results The positive rate of the CHPS was 73.07% (20 items), and 100% in 6 items. There was no significant difference between the two groups(P>0.05).Conclusion The drug test evaluation scheme in the CHPS is applicable to the detection of home-made bortezomib AE for subcutaneous injection, but it still needs to be further improved.

Key words: Chinese hospital pharmacovigilance system, adverse drug event, bortezomib, home-made drugs, safety

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