湖北省5家哨点医院奥硝唑注射液不良反应的集中监测  

Central Monitoring on Adverse Reaction of Ornidazole Injection in Five Sentinel Hospitals in Hubei Provice

作　　者：华小黎[1] 黄璞[1] 胡艳珂[2] 史琛[1] 赵瑛[1] Hua Xiaoli Huang Pu Hu Yanke Shi Chen Zhao Ying(Department of Pharmacy Department of Information, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China)

机构地区：[1]华中科技大学同济医学院附属协和医院药剂科,武汉430022 [2]华中科技大学同济医学院附属协和医院计算机管理中心,武汉430022

出　　处：《药物流行病学杂志》2016年第10期632-636,共5页Chinese Journal of Pharmacoepidemiology

基　　金：湖北省药品(医疗器械)不良反应中心项目(编号:2015Q93)

摘　　要：目的：了解奥硝唑注射液的使用规律及安全性,为临床用药安全提供依据。方法：湖北省纳入5家哨点医院,对观察期内（2015年7-10月）所有使用奥硝唑注射剂的住院患者进行集中监测,并对患者的人口学信息、临床诊断、药物用法用量、疗程、溶媒、联合用药及不良反应（ADR）发生率进行统计分析,找出影响不良反应发生的风险因素。结果：纳入的4 396份病例中,发生ADR 11例,发生率为0.25%。其中18-50岁患者占91.24%,ADR多发生在5-30 min内（54.55%）,程度为＂轻度＂,以用药部位损伤最为常见（63.64%）,主要联合用药为头孢菌素。不同性别、不同年龄段、不同剂型、不同原患疾病的患者ADR发生率差异无统计学意义（P〉0.05）;有无过敏史的患者ADR发生率差异有统计学意义（P〈0.05）。结论：临床使用奥硝唑注射液时,应减慢滴速;与头孢菌素联用时,应注意冲管;应密切观察患者,尤其是有过敏史患者的用药反应,减少ADR的发生,保障患者用药安全。Objective：To study using rules and safety of ornidazole injection and provide reference for clinically reasonable application.Methods：In five sentinel hospital of Hubei province,all hospitalized patients using ornidazole injection were monitored centralizedly in observation period（July 1,2015 to October 31,2015）.The patient＇s demographic information,clinical diagnosis,drug usage and dosage,course of treatment,solvent,combination and incidence of adverse drug reactions（ADRs） were analyzed,and the risk factors influencing ADRs were studied.Results：A total of 4 396 cases were recorded,11 cases of ADRs appeared（0.25%）.Patients aged in 18-50 years accounted for 91.24%.ADRs occured mostly in 5-30 min after medication.All ADRs were mild,pain at application site was the most common（63.64%）.The main combined drugs were cephalosporin antibiotics.In incidence rate of ADR between different genders,age groups,diseases and dosage form,there were no statistically significant difference（P〉0.05）.But ADR and allergic history had significant difference（P〈 0.05）.Conclusion：In clinical use of ornidazole injection,the infusion rate should be controlled,and the pipe should be washed after using cephalosporin drugs used in combination.To avoid or reduce ADRs,it was important to closely observe patients＇ allergic reactions,especially those had a history of allergy.

关 键 词：奥硝唑注射液 药品不良反应 安全用药 集中监测 

分 类 号：R978.61[医药卫生—药品]