摘要
目的：探讨复方对乙酰氨基酚片（Ⅱ）致不良反应的特点及相关因素。方法：收集浙江省2010～2015年上报的复方对乙酰氨基酚片（Ⅱ）不良反应报告370份,分别按病例的性别、年龄、用药原因、用药情况、不良反应类型、不良反应转归等进行统计和分析,并统计不良反应报告的上报单位情况。结果：复方对乙酰氨基酚片（Ⅱ）导致不良反应以20～50岁的人居多（74.59%）;一般不良反应主要为经营企业上报,严重不良反应主要为医疗机构上报;不良反应累及系统/器官主要为消化系统、皮肤及其附件和全身性反应,严重不良反应累及系统/器官主要为皮肤及其附件、全身性反应、肝胆系统和泌尿系统。结论：临床应重视复方对乙酰氨基酚片（Ⅱ）引起的不良反应,尤其是过敏性休克等严重不良反应;生产企业应及时修订和完善药品说明书安全性信息。
Objective： To explore the characteristics and related factors of adverse drug reactions（ ADRs） caused by compound acetaminophen tablets（ Ⅱ）. Methods： 370 cases of compound acetaminophen tablets（ Ⅱ）-caused ADRs report in Zhejiang province were collected from 2010 to 2015. Respectively statisitical analysised according to the case of gender,age,medication,medication situation,the types of adverse reactions,adverse outcomes,and statisticed report unit of adverse reactions. Results： Compound acetaminophen tablets（ Ⅱ）-caused ADRs mostly occurred in the patients aged between 20-50 years old（ 74. 59%）; General ADRs were mainly reported by business enterprises,but serious ADRs were mostly reported by hospitals; ADRs involved organs / systems were mainly the digestive system,skin and its accessories,systemic reaction; serious ADRs involved organs / systems were mainly skin and its accessories,systemic reaction,hepatic and biliary system,urinary system. Conclusion： We should pay more attention to ADRs caused by compound acetaminophen tablets（ Ⅱ）,especially the severe adverse reactions such as allergic shock. Production enterprises should promptly revise and improve the safety information of drug instructions.
出处
《药物流行病学杂志》
CAS
2016年第7期440-444,共5页
Chinese Journal of Pharmacoepidemiology
