128例氨磺必利片不良反应报告分析

128 Cases of Adverse Drug Reactions Induced by Amisulpride Tablets

目的探究氨磺必利片所致不良反应的一般规律与特点,为临床合理用药提供参考。方法采用回顾性分析方法,对2011年1月至2019年5月国家药品不良反应监测系统河南省平台上报的128例氨磺必利片不良反应报告,分别按患者性别、年龄、原患疾病、用药情况、不良反应表现等进行统计和分析。结果氨磺必利片所致不良反应以15~44岁的患者居多(75.78%);累及系统主要为中枢及外周神经系统、内分泌系统、胃肠系统、心血管系统的损害等,临床主要表现为锥体外系症状、高催乳素血症、窦性心动过缓、便秘、白细胞减少等。结论临床应重视和警惕氨磺必利片所致的不良反应,加强氨磺必利片应用时的监测,谨防严重不良反应的发生。

Objective To analyze the characteristics and patterns of adverse drug reactions(ADRs)induced by amisulpride and promote clinically rational use of this drug.Methods The clinical data on 128 cases of ADRs caused by amisulpride tablets was retrospectively analyzed.These cases were collected by Henan ADR monitoring system between January 2011 and May 2019.The patients’gender,age,medical history,medication and adverse drug reactions were analyzed.Results ADRs caused by amisulpride mostly occurred in patients aged 15 to 44(75.78%).Most of the ADRs were neurologcial disorders,endocrine disorders,gastrointestinal disorders and cardiovascular disorders.Clinical manifestations included extrapyramidal disorders,hyperprolactinaemia,sinus bradycardia,constipation and leucopenia.Conclusion We should be alert to the occurrence of adverse reactions,strengthen the monitoring and risk management of drug use,and ensure the safety of drug use.