基于livertox数据库的药物说明书乙型肝炎再激活风险警示标注情况调查分析

Analysis of hepatitis B reactivation risk warning label in drug instructions based on livertox database

目的调查和分析996种药物HBV再激活(HBV reactivation,HBVr)在livertox数据库的记录情况与药品说明书中HBVr用药警示信息进行对比分析。方法统计livertox数据库中药物的HBVr提示信息,并与丁香园用药助手系统中收录的药品说明书HBVr用药警示信息标注进行对比。结果livertox数据库中共有47个药物和1类药物有HBVr风险信息提示并已在我国上市。其中糖皮质激素类药物和10个药物说明书并无HBVr风险信息提示,有2个药物部分说明书有提示,部分没有。结论药品生产企业及时修订药品说明,根据最新信息增加警示标语。临床医师及药师在临床使用中,需加强对病毒性感染患者的用药监护。

Objective To investigate and analyze the record of 996 drugs associated with hepatitis B reactivation(HBVr)documented in the livertox database,and to compare this information with the HBVr medication warnings provided in the drug instructions.Methods The HBVr prompt information of drugs in the Livertox database was counted and compared with the HBVr medication warning information in the drug instructions included in the DRUGS.dxy.cn.Results The Livertox database contained information on 47 drugs and 1 drug class,all of which had HBVr risk information prompts and were marketed in China.It was concerning to note that glucocorticoid drugs and 10 drug instructions did not mention HBVr risk information,while 2 drug instructions only partially mentioned the risk.Conclusion Drug manufacturer should promptly update drug descriptions and add warning labels based on the latest HBVr risk information.Clinicians and pharmacists need to enhance medication monitoring for patients with viral infection to promote safe drug use.