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基于真实世界的奥硝唑注射液临床应用分析
Application Investigation of Ornidazole Injections Based on Real World Research
  
DOI:
中文关键词:  奥硝唑注射液  医院集中监测  上市后再评价  临床应用  药品不良反应
英文关键词:Ornidazole injection  Centralized monitoring  Post marketing reassessment  Clinical use  Adverse drug reaction
基金项目:湖北省药品(医疗器械)不良反应监测中心项目(编号:2015BA19);中央高校基本科研业务费专项资金(编号:2014QN063)
作者单位
赵瑛 黄璞 华小黎 郑思维 钱君怡 陈相龙 史琛 ①华中科技大学同济医学院附属协和医院药剂科(武汉 430022)②湖北省食品药品监督管理局 
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中文摘要:
      摘 要 目的:对奥硝唑注射液上市后临床应用情况进行综合评价,为临床合理用药、完善使用说明书提供参考。 方法:对本院2015年7月1日~10月31日入院并使用奥硝唑注射液的住院患者进行集中监测,对患者的人群特征、药品临床使用和不良反应发生情况进行总结分析。 结果:监测期内使用奥硝唑注射液的住院患者1 450例,以中老年女性居多,主要用于手术前预防感染和手术后厌氧菌感染的治疗(1 023例,76.51%)、腹部感染(105例,7.85%)及盆腔感染治疗(95例,7.67%)。临床使用中存在不合理用药现象,主要表现在用药次数不正确、滴速过快和使用疗程过长。监测期内共收集3例药品不良反应,发生率为2.07‰,程度为“轻度”。结论:我院奥硝唑注射液临床应用存在不合理现象,应加强管控,保障患者用药安全;建议生产厂家进行滴速和联合用药相关研究,规范临床用药;集中监测能更全面收集药物使用的风险信号,反映药物临床使用情况。
英文摘要:
      ABSTRACT Objective:To assess the clinical application and occurrence of adverse reactions of ornidazole injection, try to provide suggestions for rational use in the clinical, and improve the content of drug package insert. Methods:A drug use investigation of the ornidazole injection in Wuhan Union hospital from July 2015 to October 2015 were conducted,and its clinical use by the hospital centralized monitoring method were evaluated. The patients’ characteristics, medicine clinical use, and the adverse drug reaction were summarized analyzed.Results:A total of 1 450 inpatients were enrolled in this study. Most of them were middle aged female patients and the ornidazole injection were mainly used for preoperative or postoperative anti anaerobic infections (1 023 cases, 76.51%), abdominal infections (105 cases, 7.85%) and pelvic inflammation therapy (95 cases,7.67%). The irrational use of ornidazole injection exhibited in improper use frequency, fluid drop too fast and too long in intravenous treatment. The ADR incidence of ornidazole injection was 2.07%, and severity of adverse events were judged to “mild”. Conclusion:Irrational use of ornidazole injection was existed in clinics, and the use should be strengthened, regulated and try to avoiding the ADR happen. Further investigations of dripping speed and combination drug use are needed to be considered. Hospital centralized monitoring method could overall collect risk signal of drug use and show the clinical use of the drug.
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