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| 12 930例莫西沙星用药人群中肝损害及血细胞减少的多中心自动监测研究 |
| Multicenter Automatic Surveillance and Evaluation of Moxifloxacin related Hepatic Impairment and Hypocytosis among 12 930 Patients in 6 Hospitals |
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| DOI： |
| 中文关键词: 莫西沙星 药品不良反应 自动监测 多中心 药品不良事件主动监测与智能评估警示系统 |
| 英文关键词:Moxifloxacin Adverse drug reactions Automatic surveillance Multicenter ADE active surveillance and assessment system |
| 基金项目:2014年全军后勤科研重点项目（编号：BWS14R039）；2017年军事医学创新专项（编号：17CXZ010） |
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| 中文摘要: |
| 摘 要 目的：获取莫西沙星致肝损害和血细胞减少相关数据；探讨实施多中心自动监测与评价的规律和相关因素；提供莫西沙星的安全性再评价参考依据。方法：由经过集训的哨点医院人员，按照“医疗机构ADE主动监测与智能评估警示系统”（ADE ASAS）统一方案，开展住院患者莫西沙星相关“肝功能”“血小板”“血红蛋白”“白细胞”回顾性自动监测。ADE ASAS报警病例经临床药师人工再评价确定阳性病例后，进行汇总分析。 结果：6所医院12 930例用药人群中，莫西沙星相关肝损害、血小板减少、白细胞减少、贫血的发生率分别为3.88%，0.49%，0.95%，2.21%。结论：专项软件ADE ASAS可以高效、快捷、精准地获得多个哨点医院的莫西沙星相关ADR发生率。基于信息化技术的ADE ASAS是开展重点药物风险监测研究，特别是多中心自动监测研究的有效工具。 |
| 英文摘要: |
| ABSTRACT Objective: To investigate and analyze the incidence of hepatic impairment and hypocytosis caused by moxifloxacin and finish automatic surveillance in 6 hospitals with inpatient's ADE active surveillance and assessment system (ADE ASAS). Methods:The data of hospitalized patients using moxifloxacin in 6 hospitals were extracted and analyzed retrospectively. Event configuration parameters for “liver function”, “blood platelet”, “hemoglobin”, “white blood cell” were set according to the method in our hospital, and incidence of adverse drug reactions were analyzed. Results:A total of 12 930 cases using moxifloxacin were automatically observed. The incidence of hepatic impairment, thrombopenia, anemia and leukopenia in multi center hospitals was respectively 3.88%, 0.49%, 2.21% and 0.95%. Conclusion: This study could use ADE ASAS to quickly, accurately, and accurately obtain the incidence of ADR related moxifloxacin in 6 hospitals. The ADE ASAS based on information technology was an effective tool for monitoring risk of key drug in multi center hospitals. |
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