基于医院信息管理系统的注射用雷贝拉唑钠临床安全性评价:真实世界研究  

Clinical Safety of Rabeprazole Sodium for Injection Based on the HIS Database:a Real World Study

作　　者：宁美英[1] 房太勇[2] 尹忠鹏 陈虎[4] NING Meiying;FANG Taiyong;YIN Zhongpeng;CHEN Hu(Department of Pharmacy,Cangzhou Central Hospital,Cangzhou 061000,China;Department of Gastroenterology,Second Affiliated Hospital of Fujian Medical University,Quanzhou 362000,China;Department of Pharmacy,Cangzhou People's Hospital,Cangzhou 061000,China;Scientific Research Office,Cangzhou Central Hospital,Cangzhou 061000,China)

机构地区：[1]河北省沧州市中心医院药学部,061000 [2]福建医科大学附属第二医院消化内科,福建省泉州市362000 [3]河北省沧州市人民医院药学部,061000 [4]河北省沧州市中心医院科研处,061000

出　　处：《中国全科医学》2020年第24期3060-3063,3069,共5页Chinese General Practice

摘　　要：背景雷贝拉唑属于质子泵抑制剂,而注射用雷贝拉唑钠相对于口服雷贝拉唑具有起效迅速、对胃肠黏膜刺激小等特点。目前注射用雷贝拉唑钠的已知药物不良反应主要来源于药品说明书、国家药物不良反应中心反馈及现有的文献报道,缺乏真实世界广泛人群应用的安全性评价数据。目的通过真实世界研究方法,评估注射用雷贝拉唑钠(奥加明■)在广泛人群使用中的安全性,包括药物不良反应类别、严重程度、发生率等,以期为提高临床用药安全性和合理性提供参考。方法采用单臂开放、非干预性、病例登记、多中心临床研究的设计方法,收集沧州市中心医院、沧州市人民医院、哈励逊国际和平医院、福建医科大学附属第二医院、新乡市中心医院2016年11月-2018年6月使用注射用雷贝拉唑钠的3 004例住院患者的病历信息,5家研究中心的患者病历信息由各医院信息管理系统(HIS系统)导出。收集患者病历信息中的一般情况、生命体征、临床诊断、用药情况(用药剂量、用药频次、用药时间)、药物不良反应。结果 3 004例患者来源于沧州市中心医院600例,沧州市人民医院385例,哈励逊国际和平医院198例,福建医科大学附属第二医院1 322例,新乡市中心医院499例。3 004例患者临床诊断,前4位分别是高血压338例(11.25%),肠部肿瘤258例(8.59%),肠梗阻254例(8.46%),消化道出血199例(6.62%)。3 004例患者注射用雷贝拉唑钠使用情况:单次剂量为10 mg/次13例(0.43%),20 mg/次2 949例(98.17%),30 mg/次5例(0.17%),40 mg/次21例(0.70%),80 mg/次1例(0.03%),有15例未记录单次剂量;给药频次为1次/d 1 924例(64.05%),2次/d 911例(30.33%),3次/d 23例(0.77%),有146例未记录给药频次;用药时间为≤5 d 1 620例(53.93%),6~10 d 886例(29.49%),11~20 d 405例(13.48%),>20 d 80例(2.66%),有13例未记录用药时间。61例(2.03%)患者在接受注射用雷贝拉唑钠治疗过程中�Background Rabeprazole is a proton pump inhibitor.Rabeprazole sodium for injection has the characteristics of rapider onset and less irritation of gastrointestinal mucosa compared with oral rabeprazole.At present,the known adverse reactions of rabeprazole sodium for injection mainly come from package inserts,reports from the National Center for ADR Monitoring,China,and available literature reports,but there is a lack of safety evaluation data for a wide range of real world applications.Objective To evaluate the safety of rabeprazole sodium for injection(Ogamin®)widely used in a population based on real-world research,including the type,severity,and incidence of adverse reactions,with a view to improve the safety and rationality of clinical medication.Methods An open-label,single-arm,non-interventional,multi-center clinical study with registered cases was conducted.From the hospital information system of 5 hospitals(Cangzhou Central Hospital,Cangzhou People's Hospital,Harrison International Peace Hospital,Second Affiliated Hospital of Fujian Medical University,Xinxiang Central Hospital),electronic medical records of 3004 eligible inpatients treated with rabeprazole sodium for injection during November 2016 to June 2018 were collected,including the general information,vital signs,clinical diagnosis,medication situation(medication dose,frequency,and duration)and adverse reactions.Results Of the participants(600 from Cangzhou Central Hospital,385 from Cangzhou People's Hospital,198 from Harrison International Peace Hospital,1322 from Second Affiliated Hospital of Fujian Medical University,and 499 from Xinxiang Central Hospital),the top four clinical diagnoses(of illness)were hypertension(n=338,11.25%),intestinal tumors(n=258,8.59%),intestinal obstruction(n=254,8.46%),and digestive tract bleeding(n=199,6.62%).Rabeprazole sodium for injection was administered in a single dose of 10 mg per time in 13 cases(0.43%),20 mg per time in 2949 cases(98.17%),30 mg per time in 5 cases(0.17%),40 mg per time in 21 cases(0.77%),and

关 键 词：给药系统 医院 雷贝拉唑 药物毒性 真实世界研究 医院信息管理系统 安全性评价 

分 类 号：R452[医药卫生—治疗学]