Abstract: 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 3 004 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，1 322 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 2 949 cases （98.17%），30 mg per time in 5 cases （0.17%），40 mg
per time in 21 cases （0.77%），and 80 mg per time in one case （0.03%）.And the single dose use information was missed in 15 cases.Rabeprazole sodium for injection was used once daily in 1 924 cases （64.05%），twice daily in 911 cases（30.33%），and three times a day in 23 cases （0.77%）.Administration frequency for other 146 cases was not recorded.Administration duration was no more than 5 days in 1 620 cases（53.93%），6-10 days in 886 cases（29.49%），11-20 days in 405 cases （13.48%），more than 20 days in 80 cases （2.66%），and missed in 13 cases.Adverse reactions occurred in 61 cases（2.03%），among which the incidence rates of decreased white blood cell count，elevated ALT，creatine kinase，systolic and diastolic blood pressure，AST，and γ-GT，decreased neutrophil count，and platelet count were 0.10%-0.50%，but within the reference range in the package insert，the incidence rate of prolonged APTT was 0.03%，which was lower than the reference value （0.10%）.The incidence rate of elevated creatine kinase was 0.30%，but there was no corresponding reference value in the package insert.No rare，new，and unexpected adverse reactions and drug-drug interactions were found.All the adverse reactions were mild，and were dealt with routine clinical treatment.Conclusion　Rabeprazole sodium for injection has mild common adverse reactions，without serious drug-drug interactions，indicating that it has high safety，meeting the clinical safety requirements.

Key words: Medication systems, hospital；Rabeprazole；Drug toxicity；Real world study；Hospital information system；Safety evaluation

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发生药物不良反应，其白细胞计数降低、丙氨酸氨基转移酶升高、肌酸激酶升高、收缩压升高、天冬氨酸氨基转移酶升高、谷氨酰转肽酶升高、中性粒细胞计数降低、血小板计数降低、舒张压升高的发生率均介于0.10%~0.50%，在注射用雷贝拉唑钠的药物不良反应说明书提供的参考范围内；活化部分凝血活酶时间延长的发生率为0.03%，低于注射用雷贝拉唑钠的药物不良反应说明书提供的参考值（0.10%）；注射用雷贝拉唑钠的药物不良反应说明书中未提供肌酸激酶升高发生率的参考值，本研究中患者肌酸激酶升高的发生率为0.30%；未发现罕见、新的、非预期的药物不良反应及药物间相互作用。患者发生的药物不良反应轻微，医生均根据临床经验做出相应治疗及处理。结论　注射用雷贝拉唑钠常见药物不良反应轻微，临床应用安全性高，未发现严重的药物间相互作用，可满足临床用药安全需求。

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