基于自动监测系统的罗沙替丁与奥美拉唑临床用药安全性评价研究

摘 要 目的：开展罗沙替丁与奥美拉唑的不良反应自动监测并进行安全性比较。方法：采用回顾性队列研究方法，借助“医疗机构ADE主动监测与智能评估警示系统”，信息化主动监测并比较罗沙替丁与奥美拉唑的9种药品不良反应发生情况。结果：两组各300例基线匹配的用药患者中，罗沙替丁组、奥美拉唑组药品不良反应发生例数分别为5例（发生率1.7%）和10例（发生率3.3%），两组差异无统计学意义。其中血红蛋白减少两组各发生1例（0.3%）；肝损害分别发生4例（1.3%）、7例（2.3%）；奥美拉唑组发生胰酶异常1例（0.3%），皮肤损害反应1例（0.3%），而罗沙替丁组未发生。两组均未出现血小板减少、白细胞减少、肾损害、过敏性休克、心电异常等不良反应。结论：奥美拉唑组与罗沙替丁组药品不良反应发生率差异无统计学意义。利用自动监测专用软件系统有助于便捷高效地开展药物安全性评价与比较。

Clinical medication safety study of roxatine and omeprazole by automatic surveillance

ABSTRACT Objective:To develop the active surveillance of adverse reactions of roxatidine and omeprazole and make safety comparison. Methods:With the help of the active surveillance and assessment system of adverse drug events, the 9 ADR occurrence of roxatidine and omeprazole was informatization actively monitored and compared by the method of retrospective cohort study. Results: There were 300 baseline matching medication patients in each group. 5 cases (1.7%) and 10 cases (3.3%) of ADRs in the roxatidine group and the omeprazole group, and there was no statistical difference between the two groups. 1 case of decreased hemoglobin (0.3%) in each group; 4 cases (1.3%) and 7 cases (2.3%) of hepatic lesion in the roxatidine group and the omeprazole group; 1 case (0.3%) of pancreatic enzyme abnormality and skin lesion in the omeprazole group, while none in the roxatidine group. Thrombocytopenia, leukocytopenia, renal damage, anaphylactic shock and abnormal electrocardiogram reaction were not found in both groups. Conclusion:There was no statistical difference between the incidence of adverse reactions of the roxatidine group and the omprazole group.The application of the automatic surveillance special software system was helpful to develop the evaluation and comparison of drug safety conveniently and efficiently.