2014~2018年湖北省对乙酰氨基酚不良反应报告回顾性分析

目的:探究对乙酰氨基酚(APAP)所致不良反应(ADR)的特点,为临床安全用药提供参考依据。方法:采用回顾性研究方法,对2014~2018年湖北省药品(医疗器械)不良反应监测中心收集的179份APAP所致ADR报告的上报单位、ADR类型与关联性评价、患者性别年龄、ADR发生时间、ADR累及系统-器官及所涉及的临床症状和转归、药物剂型与联合用药情况等进行统计分析。结果:179份ADR主要来自药品经营企业和医疗机构上报,关联性评价为"可能"的报告比例最高。一般的ADR有156例(87.15%),严重的ADR有13例(7.26%),新的ADR有10例(5.59%),新的严重的ADR有1例(0.56%)。患者男女比例为1.43∶1,年龄主要分布在0~10岁(35.20%);ADR多在用药1~2 d发生(87.15%),累及多个系统-器官,主要为皮肤及附件损害、胃肠系统损害、中枢及外周神经系统损害、全身性系统损害等;导致ADR的APAP剂型以片剂(62.01%)和栓剂(22.35%)为主。174例ADR患者经停药或积极对症处理后治愈或好转。结论:APAP所致ADR主要以皮肤及附件损害和胃肠系统损害为主,长期或者过量使用可产生严重皮肤反应和肝肾功能损害,临床应密切监测患者用药情况,给予相应处理措施,保证患者用药安全。

Retrospective Analysis on Adverse Reactions of Acetaminophen from 2014 to 2018 in Hubei Province

Objective:To investigate the characteristics and rules of acetaminophen(APAP)-induced adverse reactions(ADR), so as to provide a basis for safe and rational clinical use. Methods: Retrospective study was conducted on 179 ADR reports caused by APAP collected from 2014 to 2018 in the Hubei provincial drug(medical devices) adverse reactions monitoring center. Statistical analysis was conducted according to gender, age, time of occurrence of ADR, clinical manifestations, drug dosage forms, combination therapy and adverse reaction outcomes. Results:179 ADR were mainly reported by drug dealers and medical institutions, with the highest proportion of reports with relevance evaluations as "possible". There were 156 cases of general ADR(87.15%), 13 cases of severe ADR(7.26%), 10 cases of new ADR(5.59%) and one case of new severe ADR(0.56%). The male-female ratio was 1.43∶1, and the age of patients mainly distributed between 0-10 years old(35.20%). Most patients developed ADR at 1-2 days. APAP-induced ADR involved multiple systems, including skin and accessory damage, gastrointestinal damage, central and peripheral nervous system damage, systemic system damage. The dosage forms associated with ADR were mainly tablets(62.01%) and suppositories(22.35%). Conclusion:ADR caused by APAP is mainly caused skin and accessory damage and gastrointestinal system damage, long-term or excessive use of APAP can produce severe skin reaction and liver and kidney function damage. Patients should be closely monitored in clinical medication, and appropriate treatment measures should be taken to improve the safety of medication.