环磷腺苷葡胺制剂严重不良反应用药风险研究

Risks of severe adverse drug reactions to cyclic adenosine monophosphate-related agents

目的探讨环磷腺苷葡胺制剂致严重药品不良反应(ADR)的现状及原因,提升企业关注度和临床重视程度,保障用药安全。方法采用回顾性分析方法,对济宁市2014~2019年及文献报道中环磷腺苷葡胺制剂发生的严重ADR报告数据,分别从新严报告数量、严重ADR累及系统、患者年龄分布、原患疾病以及文献报道个案数量等方面进行统计和分析。结果严重ADR报告占全部报告的17.74%,新严报告占全部报告的40.86%,呈现逐年上升趋势;50岁以上老年患者占84.85%,严重ADR可累及呼吸系统、心血管系统等全身性多个器官/系统,甚至危及生命。结论生产企业应加强对ADR数据的分析,开展质量工艺研究,及时修订说明书;临床使用时应警惕过敏性休克等严重ADR,避免配伍禁忌,控制药物滴速,注意临床症状鉴别,严格防范ADR发生。

Objective To investigate the current status and causes of severe adverse drug reactions(ADRs)to cyclic adenosine monophosphate(cAMP)-related agents,in order to highlight focuses of enterprises and clinical emphasis on securing a safe medication use.Methods A retrospective analysis was performed.Data from references on severe ADRs to cAMP-related agents from 2014 to 2019,encompassing the number of new and severe ADR reports,systemthreatening severe ADRs,age distribution,pre-existing diseases and the number of case studies,were statistically analyzed.Results Severe ADR reports accounted for 17.74%of total references,while the new and severe ADR reports comprised 40.86%of the total,growing from year to year.Patients aged over 50 years possessed 84.85%,with severe ADRs threatening multiple organs/systems such as the respiratory system,the cardiovascular system and even life.Conclusion Analyses of ADR-related data should be strengthened and researches on quality evaluations of drugs and pharmaceutical technologies must be conducted in drug manufacturing plants,with timely revisions of drug labels.Severe ADRs like allergic shock must be highlighted and prevented by avoiding drug incompatibility,adjusting the speed of infusion and differentiating symptoms carefully,for the rigorous prevention of ADRs.