硫酸阿米卡星注射液上市后安全性及临床应用真实世界研究  

Real-world Research on Post-marketing Safety and Clinical Application of Amikacin Sulphate Injections

作　　者：柯英[1] KE Ying(Clinical Pharmacy Department,Sichuan Mianyang 404 Hospital,Mianyang,Sichuan 621000,China)

机构地区：[1]四川绵阳四〇四医院临床药学部,四川绵阳621000

出　　处：《药学与临床研究》2021年第4期305-308,共4页Pharmaceutical and Clinical Research

基　　金：绵阳市卫健委2019年鼓励科研课题项目(201917)。

摘　　要：目的:探讨临床应用硫酸阿米卡星注射液的情况,为安全合理用药提供参考。方法:从医院信息系统(HIS)收集近年来使用过硫酸阿米卡星注射液的患者信息,运用统计学方法对患者一般信息、诊断、临床用药等进行分析。结果:①阿米卡星使用存在不合理现象,纤维支气管镜下冲洗、结膜下注射给药为超说明书用药,目前无循证证据支持其有效性和安全性;②阿米卡星使用剂量有93.11%患者存在不足,有少部分存在溶媒用量不足、配置浓度过高等现象;③合并用药:未发现单独使用者;④统计数据中有31例患者出现不同程度血肌酐进行性升高、尿量减少和血尿,排除其他因素后考虑为阿米卡星引起的肾毒性,发生率为2.81%,且主要发生在老年伴基础疾病多者。结论:医院应做好阿米卡星注射液的合理使用和安全风险管理工作;如何减轻阿米卡星的肾毒性是研究的重点和热点;阿米卡星肾毒性发生机制是否存在基因等方面因素值得进一步探索。Objective:This paper discusses the real world of the clinical application of amikacin sulphate injections and provides reference for safe and reasonable drug use.Methods:Inpatient information were collected from the Hospital Information System(HIS),including patient general information,diagnostic information,clinical medication information,etc.,to analyze the use of amikacin sulphate injections in recent years using statistical methods.Results:1.There were unreasonable amikacin use,fiberbronchoscope flushing or conjunctiva injection were over-instruction drug use with no evidence-base;2.Amikacin dose was insufficient in 93.11%patients,there were cases of insufficient solvent or high concentration;3.Combined drug use appeared in all cases;4.The data showed that 31 patients had different degrees of blood creatinine progressive elevation,decreased urine volume and blood urine,excluding other factors,their renal toxicity were possibly caused by amikacin,the incidence was 2.81%and mainly occurred in the elderly with basic diseases.Conclusions:According to the actual situation,a good clinical job should be done on the rational use of amikacin injections and safety risk management;How to reduce the renal toxicity of amikacin is the focus and hot spot of research.Whether there are genetic factors in the mechanism of renal toxicity of amikacin deserves further exploration.

关 键 词：硫酸阿米卡星注射液 安全性 临床应用 

分 类 号：R969.3[医药卫生—药理学]