290例葡萄糖酸钙注射液不良反应/不良事件报告分析

Analysis of the Adverse Drug Reaction/Adverse Drug Event Caused by Calcium Gluconate Injection in 290 Cases

目的促进葡萄糖酸钙注射液临床安全、合理使用。方法选取河南省药品不良反应监测系统2010年至2018年收到的葡萄糖酸钙注射液相关药品不良反应(ADR)/药品不良事件(ADE)报告,回顾性研究患者的性别年龄、原患疾病、不良反应发生时间、用法用量、不良反应表现、合并用药等情况。结果290例ADR/ADE报告中,男女比例为1∶1(严重ADR/ADE中男女比例为1.67∶1),年龄段主要集中在15~44岁;存在一定的超适应证、超剂量等不合理用药现象;ADR最易累及胃肠系统(最常见的严重ADR为全身性损害);多在用药后30 min内发生;主要不良反应有恶心、发热、呕吐、寒战、心悸等,严重不良反应为过敏性休克;患者不良反应转归基本为痊愈或好转。结论临床应警惕葡萄糖酸钙注射液引发的ADR,完善说明书中安全性信息提示,提高临床合理用药水平,保障用药安全。

Objective To promote the clinical safety and rational use of calcium gluconate injection.Methods The adverse drug reaction(ADR)/adverse drug event(ADE)report of calcium gluconate injection received by Henan Provincial Adverse Drug Reaction Monitoring System from 2010 to 2018 were selected to retrospectively study the sex,age,primary disease,occurrence timeof adverse reactions,usage and dosage,manifestation of adverse reactions,combined medication,etc.Results In the 290 ADR/ADE reports,the male to female ratio was 1∶1(severe ADR/ADE male to female ratio was 1.67∶1),and the age group was mainly concentrated between 15 and 44 years old;there were certain unreasonable medicationssuch as off-label and over-dose;ADR was most likely to involve the gastrointestinal system(the most common serious ADR was systemic damage);mostly occurred within 30 min after injection;the main adverse reactions were nausea,fever,vomiting,chills,palpitations,etc.,and serious adverse reaction was anaphylactic shock;the clinical outcome of the adverse reaction was basically cured or improved.Conclusion In the clinic,we should be alert to the ADR caused by calcium gluconate injection,improve the safety information prompts in the instructions,improve the level of clinical rational medication,and ensure the safety of medication.