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某院近3年注射剂不良反应报告分析
Analysis of Injection Preparation Adverse Drug Reactions in Recent Three Years in a Hospital
  
DOI:
中文关键词:  药品不良反应  注射剂  药物警戒  药学监护
英文关键词:Adverse drug reactions  Injection preparation  Pharmacovigilance  Pharmaceutical care
基金项目:
作者单位
方欢 复旦大学附属金山医院(上海 201508)
 
曹怡 上海漕河泾街道社区卫生服务中心 
方忠宏 复旦大学附属金山医院 
蔡蕴敏 复旦大学附属金山医院 
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中文摘要:
      摘 要 目的:了解新形势下某院注射剂不良反应的特点和规律,并探讨其对临床工作的意义。方法:采用回顾性研究方法,收集某院近3年所有上报的注射剂不良反应报告,按照性别、年龄、原发病、既往过敏史、药品品种、损害表现进行统计分析。结果:年龄(45岁为界)和既往过敏史是影响不良反应发生率的重要因素,差异有统计学意义(P<0.01),不良反应人群中以慢性基础性疾病患者比例较大,药品品种以抗菌药所占比例最高,损害类型以变态反应和肝损害为主。结论:全面了解患者情况是进行诊疗的基础,医护人员设计给药方案和实际用药前应该根据患者的年龄、基础疾病、过敏及不良反应史结合拟用药物进行药品不良反应风险判断,对高危患者除了应该谨慎选择药物外,用药时和用药后还应该予以药学监护,对出现的不适应注意严重不良反应发生的可能。
英文摘要:
      ABSTRACT Objective:To analyze the characteristics of injection preparation ADR in one hospital under new circumstances and explore its significance to clinical work. Methods:The injection preparation ADR data from January 1,2012 to June 1,2015 were gathered and the retrospective study method was used. The classification factors, such as gender and age, drugs, protopathy diseases, ADR symptoms, and allergy history were compared, counted and analyzed with the clinical work.Results: Age over 45 years or allergy history was the important impact factor of incidence of ADR, which both were statistically significant(P<0.01). The antibiotics caused more ADR and the cases with underlying chronic illnesses were in higher amounts. The most usual injury types were allergic reaction and liver injury. Conclusion:The information of age, protopathy diseases, the allergy history should be analysed with drugs for estimation of ADR possibility before dosage regimen design and injection. Besides careful selection of drug, the high risk patients required pharmaceutical care when and after administration, and enough attention should be paid to the possibility of serious ADR if discomfort follows the administration.
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