文章摘要
韩晓娟,吕雅婷.84例重点监控辅助性用药不良反应/不良事件特点分析[J].中国药事,2020,34(9):1104-1108
84例重点监控辅助性用药不良反应/不良事件特点分析
Analysis of 84 Cases of ADR/ADE Induced by Key Monitoring Auxiliary Drugs
  
DOI:10.16153/j.1002-7777.2020.09.016
中文关键词: 重点监控辅助性用药  药品不良反应/事件  安全用药
英文关键词: key monitoring auxiliary drugs  adverse drug reaction/event (ADR/ADE)  safe medication
基金项目:
作者单位
韩晓娟 郑州大学附属郑州中心医院,郑州 450000 
吕雅婷 天津新丰制药有限公司,天津 300000 
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中文摘要:
      目的:探讨重点监控辅助性用药不良反应(ADR)/不良事件(ADE)发生特点。方法:回顾性分析我院ADR/ADE数据,比较重点监控辅助性用药与非重点监控辅助性用药ADR/ADE观察发生率、性别与年龄分布、报告类型及临床表现。结果:重点监控辅助性用药ADR/ADE观察发生率1.74%,明显高于非重点监控辅助性用药0.85%(P<0.05)。重点监控辅助性用药ADR/ADE女性占比(64%~29%)明显高于非重点监控辅助性用药(52.31%)(P<0.05);两组患者年龄分布均呈现出随年龄增加而逐渐升高的趋势。重点监控辅助性用药ADR/ADE新的及严重ADR/ADE发生率为61.90%,明显高于非重点监控辅助性用药ADR/ADE 35.77%(P<0.05)。重点监控辅助性用药发热、寒战构成比明显高于非重点监控辅助用药,而消化系统不良反应明显低于非重点监控辅助用药(P<0.05)。结论:重点监控辅助性用药 ADR/ADE具有发生率高(尤其女性)、报告类型新的及严重ADR/ADE占比高、临床表现为发热寒战构成比高的特点,临床应用过程中应加强监测,规范操作,减少ADR/ADE的发生。
英文摘要:
      Objective: To investigate the characteristics of ADR/ADE induced by key monitoring auxiliary drugs. Methods: The data of ADR/ADE in our hospital were analyzed retrospectively, and the observed incidence, gender, age, the type of report and clinical features were compared under two situations: ADR/ADE induced by key monitoring auxiliary drugs and ADR/ADE induced by non-key monitoring auxiliary drugs. Results: The observed incidence of ADR/ADE induced by key monitoring auxiliary drugs was 1.74%, which was significantly higher than that of non-key monitoring auxiliary drugs (0.85%)(P<0.05).The proportion of women with ADR/ADE induced by key monitoring auxiliary drugs was significantly higher( 64% to 29% ) than that of non-key monitoring auxiliary drugs(52.31%), and the difference was statistically significant (P<0.05). The age distribution of patients in both situations showed a trend of increasing occurrence with age increasing. The incidence rate of new and serious ADR/ ADE induced by key monitoring auxiliary drugs was 61.90%, which was significantly higher than that of non-key monitoring auxiliary drugs (35.77%)(P<0.05). The constituent ratio of fever and chills caused by key monitoring auxiliary drugs was significantly higher than that of non-key monitoring auxiliary drugs, while the adverse reaction of digestive system was significantly lower than that of non-key monitoring auxiliary drugs (P<0.05). Conclusion: ADR/ADE induced by key monitoring auxiliary drugs has the characteristics of high incidence (especially females), high proportion of new and serious ADR/ADE, high proportion of fever and chills. Therefore, it is necessary to strengthen monitoring and standardize operation so as to reduce the occurrence of ADR/ADE in clinical application.
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