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纸质出版日期:2011
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王燕萍, 焦凯, 何忠芳. 喜炎平注射剂不良反应文献的系统评价[J]. 中国实验方剂学杂志, 2011,17(24):236-239.
WANG Yan-ping, JIAO Kai, HE Zhong-fang. Systematic Evaluation of Adverse Drug Reactions of Xiyanping Injection From Documents[J]. Chinese journal of experimental traditional medical formulae, 2011, 17(24): 236-239.
目的 :了解喜炎平注射剂不良反应的发生情况及其相关因素
探索药品上市后不良反应再评价的方法。 方法 :收集静脉滴注喜炎平注射剂不良反应文献资料
并分为同期对照临床研究、不良反应监测或病案系列报告、个案或典型病例报告3类
进行归类、整理、分析。 结果 :不同研究方法显示喜炎平注射剂平均不良反应发生率为2.02%
不良反应类型以变态反应为主
且发现多种说明书记载以外的罕见类型;在121例个案报道中
0~10岁儿童是高发人群
不良反应发生率为45.45%;过敏性体质或有过敏史患者易发生不良反应
占10.74%;不良反应发生时间多为用药后30 min内
占54.55%;在不良反应治疗与转归中
除1例有基础疾病与过敏史患者死亡外
其余均经治疗痊愈。 结论 :规范喜炎平注射剂的临床合理使用
尽量减少不良反应的发生;针对有效可利用的文献报告情况
建议临床研究者应尽量详细报告所研究药物的不良反应情况
提高文献质量。
Objective : To find out the occurrence rate of adverse drug reactions (ADR) following the intravenous administration of Xiyanping Injection and to understand the relative factors such as the type and constitution of ADR. To preliminarily explore the methods for reevaluation of the drug after marketing. Method : A comprehensive collection of literature was classified into 3 categories
synchronous clinical study
monitoring of ADR and analysis of medical records
as well as individual or typical case reports. Result: Different study methods indicated that the mean occurrence rate of ADR in Xiyanping Injection was2.02%;ADR manifested mainly as anaphylactic reaction. In addition
a variety of rare types of ADR was discovered
which was not indicated in the instructions of the product. Conclusion: The ADR of Xiyanping injection represented mainly as anaphylactic reaction
especially with anaphylactic shock.
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