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

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