核苷类抗乙型肝炎药物不良反应693例分析

Analysis of 693 cases of adverse reactions of nucleoside anti-hepatitis B drugs

目的对核苷类抗乙型肝炎药物不良反应进行研究以指导用药.方法分析上海市药品不良反应监测平台及上海市中老年用药监测与评价平台中5类核苷类抗乙肝药物的不良反应数据,进行统计分析.结果共收集2013年10月1日至2018年9月30日上报国家药品不良反应监测中心药品不良反应/药品不良事件(ADR/ADE)报告693例,其中最多的反应类型为一般的ADR/ADE,医药公司呈报比例最高,18~65岁患者占比最多,74.2%患者使用了恩替卡韦,所有报告中核苷类抗乙型肝炎药物的中位用量为88.00限定日剂量(DDD),累及的器官/系统主要依次是神经系统损害、胃肠系统损害和皮肤损害,用药开始至发生ADR/ADE的中位时间为61 d,发生ADR/ADE后好转的比例最高.结论核苷类抗乙型肝炎药物的长期治疗可有不同程度的不良反应,应注意不宜随意加大剂量,对于长期使用的患者应告知随诊时间和相关检验指标,做到防范于未然.

Objective To study theadverse reactions of nucleoside analogs to guide medication.Method We analyzed the adverse reaction data of the five types of nucleoside anti-hepatitis B drugs in the Shanghai Adverse Drug Reaction Monitoring Platform and Shanghai Middle-aged and Older Adult Drug Monitoring and Evaluation Platform for statistical analysis.Result A total of 693 ADR/ADE reports from October 1,2013 to September 30,2018 were reported to the National Center for Adverse Drug Reaction Monitoring.The most common type of response is ADR/ADE,which is mostly reported by pharmaceutical companies.The proportion of patients aged 18-65 is the largest.Entecavir is used by 74.2%of patients.The median dosage of nucleoside anti-hepatitis B drugs in all reports is 88.00 DDD.The organs/systems involved were mainly nervous system,gastrointestinal system,and skin.The median time from the start of medication to the occurrence of ADR/ADE was 61 days.Conclusion Long-term application of nucleoside anti-hepatitis B drugs may have different degrees of adverse reactions.It should be noted that it is not appropriate to increase the dose arbitrarily.For patients with long-term use,they should be informed the follow-up time and relevant testing indicators to prevent adverse reactions from occurring.