头孢哌酮钠舒巴坦钠的儿童药品不良反应分析

Adverse drug reactions of cefoperazone sodium and sulbactam sodium in children

目的分析头孢哌酮钠舒巴坦钠的儿童药品不良反应(adverse drug reaction,ADR)的特点,为临床应用提供参考。方法收集2014年1月1日至2018年12月31日年河南儿科医疗联盟儿童使用头孢哌酮钠舒巴坦钠后发生ADR的报告,对患儿性别、年龄、ADR发生类型、累及系统-器官等信息进行统计分析。结果共收集877份报告,男性536份,女性341份;新生儿组50份(5.70%),婴儿组126份(14.37%),幼儿组319份(36.37%),学龄前期儿童208份(23.72%),学龄期儿童95份(10.83%),青春期组79份(9.01%)。用药当日至第3天是ADR高峰期;严重ADR 83份(0.95%),学龄前期儿童组严重ADR占比最高(3.42%)。该药在儿童中ADR的临床表现以皮肤损害(65.90%)和消化道损害(20.07%)为主,血液系统损害较低(0.98%)。严重ADR主要表现为重症皮疹、抽搐、癫痫等。结论头孢哌酮钠舒巴坦钠的儿童ADR有其独特的表现,临床应用应予以重视。

Objective To analyze the characteristics of adverse drug reactions(ADR)of cefoperazone sodium and sulbactam sodium in children,and to provide data for clinical decision-making.Methods ADR reports of cefoperazone sodium and sulbactam sodium in children in Henan Pediatric Medical Alliance between 2014 and 2018 were collected.The gender,age distribution,types of ADR and involved systems and organs were analyzed.Results A total of 877reports were collected,536 of which involved males and 341 involved females.There were 50 reports related to the neonatal group(5.70%),126 the 1-12-month-old group(14.37%),319 the 1-3-year-old group(36.37%),208 the preschool age group(23.72%),95 the school-age group(10.83%),and 79 related to the adolescent group(9.01%).The peak of ADR occurred between the day of administration and the third day.There were 83 reports(0.95%)on serious cases,and the proportion of severe ADR in the pre-school age group was the highest(3.42%).The clinical manifestations of ADR in children were mainly skin lesions(65.90%)and digestive system lesions(20.07%),and hematological system lesions were rarely reported(0.98%).Severe ADR included severe skin rash,convulsions and epilepsy.Conclusion There is something unique about ADR of cefoperazone sodium and sulbactam sodium in children,which is worthy of attention in clinic.