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基于数据库的小牛血清去蛋白注射液药物流行病学评价
Epidemiological Evaluation of Deproteinized Calf Serum Injection Based on Two Databases
  
DOI:
中文关键词:  小牛血清去蛋白注射液  药品不良反应  药物利用
英文关键词:Deproteinized calf serum injection  Adverse drug reaction  Drug utilization
基金项目:国家自然科学基金资助项目(编号:71503089)
作者单位
余早勤 赵丽 张程亮 黄锐 刘金玉 刘东 ①华中科技大学同济医学院附属同济医院药学部(武汉430030)②湖北省药品(医疗器械)不良反应监测中心③华中科技大学同济医学院药学院。 
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中文摘要:
      摘 要 目的:研究小牛血清去蛋白注射液的药物利用与不良反应发生情况,为临床合理用药提供参考。方法:对2012~2014年湖北省药品不良反应监测中心数据库及长江流域医院用药信息网提供的小牛血清去蛋白注射液不良反应(ADR)报告及药物利用情况进行分析,归纳、总结其所致ADR患者的年龄、性别、用药情况、不良反应发生时间、临床表现及转归等。结果:小牛血清去蛋白注射液所致ADR未见明显性别差异,在51~60岁人群中构成比较高,占32.94%;ADR多在用药60 min内出现(47.06%),累及系统 器官主要为皮肤及附件损害(50.00%)和全身性损害(18.26%),主要临床表现为皮疹、瘙痒、荨麻疹、寒战、发热等。2012~2014年小牛血清去蛋白注射液的年销售金额和DDDs亦逐年增加。结论:小牛血清去蛋白注射液在临床使用不断增加,但ADR也暴露该药具有一定风险性,临床应引起重视,进一步评价其疗效和安全性。
英文摘要:
      ABSTRACT Objective:To study the drug utilization and safety of deproteinized calf serum injection and to provide reference for its rational use. Methods:Adverse drug reaction (ADR) reports and drug utilization on deproteinized calf serum injection were collected from the adverse reactions center in Hubei province and Hospital information network in the Yangtze River Basin during the period of 2012 2014. These datas were classified and summarized in repsects of gener, age,occurrence time,clinical manifestation,outcome,utilization, etc.Results:Deproteinized calf serum injection induced ADR had no significant gender differences, with higher incidence rate in the population aged 51-60, accounting for 32.94%. ADR mainly occurred within 60 min (47.06%), which involved the main system and organs were skin and accessory damage (50.00%) and systemic damage (18.26%). The main clinical manifestations were rash, pruritus, urticaria, chills, fever. The annual sale amounts and DDDs of deproteinized calf serum injection were increased gradually from 2012 to 2014. Conclusion:The clinical use of deproteinized calf serum injection continued to increase. However, ADR reports exposed that this drug exists certain risk, which needed to be paid more attention, and to further evaluate its efficacy and safety.
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