清开灵注射剂ADRS分析研究

目的:调查分析清开灵注射剂不良反应的特点及其产生原因。方法:检索1994年至2004间CHKD期刊知识库(China Hospital Knowledge Database,即中国医院知识仓库,简称CHKD)中相关清开灵注射剂不良反应病例报道,按不良反应判定标准筛选病例84例,将病例建为数据库,对其进行统计、分析。结果:清开灵注射液所致的不良反应主要为变态反应,其中皮肤反应40例(占47.62%),过敏性休克21例(占25%),药物热6例(占7.14%),神经系统10例(占11.90%),呼吸系统5例(占5.95%),血液系统2例(占2.38%)。结论:清开灵注射剂导致不良反应的原因较多,与制剂本身的性质、工艺,病人的个体特性、给药方式、速度、剂量、配伍等均有相关,建议临床使用时综合考虑各因素,尽量避免不良反应的发生。

Analysis of ADR Cases Induced by Qingkailing Injection

Objective: To explore the general rule and characteristics of adverse drug reaction(ADR) induced by Qingkailing injection.Method: 84 ADR cases of Qingkailing injection reported in China Hospital Knowledge Database from 1994 to 2004 were collected and satistically analyzed.Result:The main ADR of Qingkailing injection respectively were allergic reactions,then dermoreaction 40 cases(47.62%),allergic shock 21 cases(25%),drug fever 6 cases(7.14%),the nerve system damage 10 cases(11.90%),the respiratory system damage 5 cases(5.95%) and the blood system damage 2 cases(2.38%).Conclusion: There were many factors related with the occurrence of ADRS to Qingkailing injection,such as characters of medicines and patients ,dosages,the ways and the speed of injection,etc.So,we should use Qingkailing injection rationally and pay attention to the prevention and decreasion of ADR.