中国药物警戒 ›› 2020, Vol. 17 ›› Issue (12): 890-893.
DOI: 10.19803/j.1672-8629.2020.12.09

• 安全与合理用药 • 上一篇    下一篇

注射用头孢哌酮钠舒巴坦钠相关血小板减少的自动监测研究

栗啸阳1, 郭代红1*, 刘思源1, 杨鸿溢2, 姚翀1, 齐榛1   

  1. 1解放军总医院临床药学中心,北京 100853;
    2重庆医科大学药学院,重庆 400016
  • 收稿日期:2019-10-12 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: *郭代红,女,硕士,主任药师·硕导,临床药学与药物警戒。E-mail:guodh301@163.com
  • 作者简介:栗啸阳,男,在读硕士,药师,临床药学。
  • 基金资助:
    2017年军事医学创新工程重点项目(17CXZ010):基于大数据的军队药物警戒体系建设研究

Automatic Surveillance of Cases of Cefoperazone Sodium and Sulbactam Sodium-related Thrombocytopenia

LI Xiaoyang1, GUO Daihong1*, LIU Siyuan1, YANG Hongyi2, YAO Chong1, QI Zhen1   

  1. 1Department of Pharmaceutical Care,PLA General Hospital,Beijing 100853,China;
    2School of Pharmacy,Chongqing MedicalUniversity,Chongqing 400016,China
  • Received:2019-10-12 Revised:2020-12-07 Online:2020-12-15 Published:2020-12-07

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摘要： 目的 高效获取大样本用药人群中注射用头孢哌酮钠舒巴坦钠相关血小板减少的真实世界发生率等风险数据。方法 采用回顾性研究方法,借助“医疗机构药品不良事件主动监测与智能评估警示系统”(ADE-ASAS)自动监测我院2013年7月1日至2018年6月30日期间使用注射用头孢哌酮钠舒巴坦钠的住院患者,双人评价系统报警病例,获得注射用头孢哌酮钠舒巴坦钠相关血小板减少的发生率与发生特征;并利用病例对照研究进行影响因素分析。结果 17 569例次用药患者的血小板减少发生率为2.73%。合并肝病患者发生重度血小板减少的比例更高。多因素Logistic回归分析显示,基础血小板值、肌酐清除率、身体质量指数、用药时长为注射用头孢哌酮钠舒巴坦钠致血小板减少的影响因素。结论 注射用头孢哌酮钠舒巴坦钠相关血小板减少发生率属常见,与团队前期研究结果(3.0%)相吻合。患者用药伊始即监测血小板值能够及时发现并规避风险,病情复杂患者更应警惕严重药品不良反应发生,合理控制用药时长、并重点关注肾功能不全、低BMI患者可减少药品不良反应发生风险。

关键词: 注射用头孢哌酮钠舒巴坦钠, 药品不良反应, 自动监测, 血小板减少, 医疗机构药品不良事件主动监测与智能评估警示系统

Abstract: Objective To efficiently obtain such real-world risk data as the incidence of cefoperazone sodium and sulbactam sodium-related thrombocytopenia in a large sample of drug users.Methods A retrospective study was conducted to automatically monitor inpatients using cefoperazone sodium and sulbactam sodium for injection in our hospital between July 2013 and June 2018 using ADE-ASAS. The incidence and characteristics of cefoperazone sodium and sulbactam sodium-related thrombocytopenia were obtained via the double evaluation system. Case-control study was conducted to analyze the risk factors.Results The incidence of thrombocytopenia among 17 569 patients was 2.73%. Severe thrombocytopenia was more common in patients with liver diseases. Multivariate logistic regression analysis showed that the basic platelet value, creatinine clearance rate, BMI and duration of treatment were the risk factors for thrombocytopenia induced by cefoperazone sodium and sulbactam sodium.Conclusion The incidence of cefoperazone sodium and sulbactam sodium-related thrombocytopenia is high, which is consistent with the results of the team's previous study (3.0%). Monitoring platelet values from the beginning of treatment can detect and avoid risks in time. Patients with complex conditions should be more vigilant about the occurrence of severe ADRs. Proper control of the duration of treatment and focus on patients with renal insufficiency and low BMI can reduce the risk of ADR.

Key words: cefoperazone sodium and sulbactam sodium, adverse drug reaction, automatic surveillance, thrombocytopenia, ADE-ASAS

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