中国药物警戒 ›› 2016, Vol. 13 ›› Issue (12): 745-747.

• 安全性评价与合理用药 • 上一篇    下一篇

马来酸桂哌齐特注射液相关血细胞减少的自动监测研究

胡鹏洲1, 马亮1, 郭代红1*, *, 刘佳2, 王啸宇1, 寇炜1, 贾王平1   

  1. 1解放军总医院药品供应中心,北京 100853;
    2国家食药监管总局药品评价中心,北京 100045
  • 收稿日期:2017-01-13 修回日期:2017-01-13 出版日期:2016-12-20 发布日期:2017-01-13
  • 通讯作者: 郭代红,女,主任药师,硕士生导师,临床药学与药物警戒。E-mail: guodh301@163.com
  • 作者简介:胡鹏洲,男,在读硕士,临床药学。
  • 基金资助:
    2014年全军后勤科研重点项目（BWS14R039）; 国家药品评价中心安全研究专项

Automatic Surveillance for Hemocytopenia Caused by Cinepazide Maleate

HU Peng-zhou1, MA Liang1, GUO Dai-hong1, *, LIU Jia2, WANG Xiao-yu1, KOU Wei1, JIA Wang-ping1   

  1. 1 Department of Pharmaceutical Care, PLA General Hospital, Beijing 100853, China;
    2 Center for Rug Reevaluation, CFDA, Beijing 100045, China
  • Received:2017-01-13 Revised:2017-01-13 Online:2016-12-20 Published:2017-01-13

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摘要： 目的 利用自动监测软件开展马来酸桂哌齐特注射液致血细胞减少的主动监测研究。方法 借助“医疗机构 ADE 主动监测与智能评估警示系统”自动监测我院2015年8月1日到2016年7月31间使用马来酸桂哌齐特注射液的住院患者,双人甄别其报警疑似病例,并进行结果分析。结果 纳入自动监测患者3 181人次,血小板、白细胞减少发生率分别为0.14%、0.28%,符合药品说明书及文献报道,8例白细胞减少中7例伴有中性粒细胞减少;血红蛋白减少0.48%,未见文献提及。血细胞减少总发生率0.72%,无严重ADR病例;用药者平均69岁,不同年龄段的发生率无统计学差异。结论 应用专项软件开展重点品种重点ADR的主动监测,针对性强,快捷准确,成本低廉。桂哌齐特相关的血细胞减少发生率为偶见（0.1%~1.0%）,未观察到严重粒细胞减少,而血红蛋白减少发生率相对最高。了解患者用药史并加强血象监测,有助于ADR的预防和尽早发现。

关键词: 桂哌齐特, 药品不良反应, 自动监测, 白细胞减少, 血小板减少, 血红蛋白减少

Abstract: Objective To study the incidence of cinepazide maleate related hematologic adverse drug reaction by monitoring software. Method The research objects were screened out by adverse drug events’ active surveillance and assessment system developed by our hospital. The collected data of the hospitalized patients in General Hospital of PLA who received cinepazide maleate between August 1, 2015 and July 31, 2016 were analyzed retrospectively. Alarm cases submitted by system were evaluated by 2 professionals. Results A total of 3 181 patients using cinepazide maleate were automatically monitored. The incidences of thrombocytopenia and leukopenia were 0.14% and 0.28%, respectively, which were consistent with the literature’s report, only 1 case without granulocytopenia in 8 cases of leukopenia. The incidence of anemia was 0.48%, it was a new ADR. The total incidence of hemocytopenia was about 0.72%, severe ADR was not observed. The average age is 69, there was no statistical difference in different age groups. Conclusion By using the automatic surveillance and assessment system, pharmacists can effectively and accurately screen the hematologic ADR induced by cinepazide. The incidence of hemocytopenia was between 0.1% and 1.0%, severe granulocytopenia was not observed. The incidence of anemia was relatively high. The ADRs caused by cinepazide can be prevented effectively and discovered as early as possible by fully understanding medication history and strengthening hemogram monitoring.

Key words: cinepazide maleate, adverse drug reaction, automatic surveillance, white brood cell decreased, blood platelet decreased, anemia

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