10.)二等奖(喜炎平注射液不良反应文献的系统评价).doc

喜炎平注射剂不良反应文献的系统评价 王燕萍 （兰州大学第一医院药剂科，甘肃 兰州 730000） 摘要： 目的 全面了解喜炎平注射剂不良反应的发生情况及其相关因素，并探索药品上市后再评价的方法。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30min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。 关键词： 喜炎平注射剂；药品不良反应；系统评价；上市后再评价 Systematic Evaluation of Adverse Drug Reactions of Xiyanping Injection From Documents WANG Yan-ping (The first hospital of Lanzhou university, Gansu Lanzhou, 730000, China) ABSTRACT: 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 appeared on market. METHODS 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. Referring to systemic evalutions and methods for the investigation of ADR. RESULTS Different study methods indicated that the mean occurrence rate of ADR in Xiyanping Injection was ;ADR manifested mainly as anaphylactic reaction. In addition, a variety of rare types of ADR were discovered which were not indicated in the instructions of the product. CONCLUSION The ADR of Xiyanping injection represented mainly as anaphylactic reaction,especially with anaphylactic shock. KEY WORDS: Xiyanping Injection; adverse drug rection(ADR); systematic evalution; reevaluation after appeared on market 喜炎平注射液系纯中药制剂，其主要成份为穿心莲内酯磺化物。作用清热解毒, 止咳止痢。用于支气管炎、扁桃体炎、细菌性痢疾等，常用于上呼吸道感染，因疗效显著，临床应用日益广泛。随着该药在临床上的广泛使用, 其不良反应的报告也日益增加，并有严重不良反应的出现。从文献报道的情况看[1-3]，该药物的不良反应发生率从0%-3%不等，其涉及的内容包括变态反应、消化系统反应、呼吸系统反应等。为进一步阐明该制剂的不良反应概况，更好地指导临床合理用药