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中药注射剂超说明书用药与不良反应的关系探讨

Study on the Relation Between Adverse Reactions and Off label Uses about Traditional Chinese Medicine Injections

DOI：

中文关键词: 中药注射剂超说明书用药不合理用药药品不良反应

英文关键词:Traditional Chinese medicine injection Off label uses Irrational drug use Adverse drug reaction

基金项目:

作者	单位
廖小娟¹ 尹桃² 李逃明² 邹乐²	1.湖南中医药大学第二附属医院药剂科，长沙 410005；2.中南大学湘雅医院药学部

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中文摘要:

摘要目的：分析使用中药注射剂的住院患者发生药品不良反应（ADR）的相关危险因素，并进一步探讨超说明书用药与ADR的关系，为中药注射剂超说明书用药的科学管理提供依据。方法：采用横断面调查方法，随机抽取2014年1~12月中南大学湘雅医院和湖南中医药大学第二附属医院两家医院使用中药注射剂的住院患者病历，统计并循证分析超说明书用药情况，汇总分析ADR的类型及影响因素，分析不同程度的超说明书用药与ADR的关系。结果：以ADR因果关系判断为“很可能有关”和“可能有关”的报告确认为中药注射剂所致ADR，中药注射剂的ADR发生率为1.6%（54/3 380），病区、超说明书使用与联用中药注射剂是ADR的影响因素。其中不合理用药显著性地增加ADRs的发生率（P<0.01）。结论：超说明书使用和（或）联合使用中药注射剂会增加ADR的发生概率；中药注射剂在临床使用过程中超出说明书的范畴越大，ADR的发生概率越大。

英文摘要:

ABSTRACT Objective:Analyzing the risk factors of adverse drug reactions (ADRs) in hospitalized patients using traditional Chinese medicine (TCM) injections, exploring the relation between off label uses and ADRs, in order to provide bases for the scientific management of TCM injections. Methods:By cross sectional study and randomly sampling, summarized and analyzed off label uses about TCM injections explored primary factors which affected ADRs of inpatients used TCM injections in 2014 in Xiangya Hospital and the Second Affiliated Hospital of Hunan University of Chinese Medicine. Results:The rate of ADR about TCM injections was 1.6% (54/3 380). Logistic regression analysis showed that patients from different wards, TCM injections with off label uses, combined using other TCM injections, increased the risk of ADR. The irrational using group could increase the rate of ADR tremendously (P<0.01). Conclusion:TCM injections off label use, using other TCM injections together, all those were adding the risk of ADR. The rate of TCM injections off label use was higher, the relationship between ADR and TCM injections was stronger.

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