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
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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。
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.
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.
引文
1史秀梅.我院质子泵抑制剂临床应用131例合理性分析[J].临床合理用药杂志,2012,8(5):42-43
2 梁茂本,孟祥梅.114例质子泵抑制剂不良反应病例分析[J].中国药物警戒,2013,10(1):39-41
3 陈超,郭代红,刘皈阳,等.医疗机构药品不良反应监测的优化实践[J].中国药物警戒,2010,7(3):164-168
4 陈超,郭代红,薛万国,等.住院患者药品不良事件主动监测与评估警示系统的研发[J].中国药物警戒,2013,10(7):411-414,418
5 国家药品不良反应监测中心.药品不良反应术语使用指南[Z].监测与评价综[2016]77号
6 国家食品药品监督管理总局.药品不良反应报告和监测管理办法[Z].[2011]卫生部令第81号
7 National Cancer Institute(NCI).Common terminolgy criteria for adverse events(CTCAE)v4.03[EB/OL].(2017-08-01)[2010-06-14]https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf
8 郭代红,苏畅,王啸宇,等.住院患者药源性肝损害的信息化自动监测研究与实践[J].中国医院用药评价与分析,2017,17(8):1019-1021
9 李琦恒,倪鸿昌.奥美拉唑78例不良反应分析[J].安徽医药,2007,11(2):190-191
10 苏珊珊.奥美拉唑致白细胞减少19例分析[J].右江医学,2005,33(1):56
11 曾红.奥美拉唑静脉滴注致白细胞减少5例[J].中国药师,2006,9(6):550-551
12 张建华,齐晓涟.注射用奥美拉唑致血液系统不良反应的调查分析[J].医药导报,2007,26(6):684-685
13 Laheij RJF,Sturkenboom MCJM,Hassing RJ,et al.Risk of Community-Acquired Pneumonia and Use of Gastric Acid–Suppressive Drugs[J].JAMA,2004,292(16):1955-1960
14 Howell MD,Novack V,Grgurich P,et al.Iatrogenic Gastric Acid Suppression and the Risk of Nosocomial Clostridium difficile Infection[J].Archives of Internal Medicine,2010,170(9):784-790
15 Maclaren R,Reynolds PM,Allen RR,et al.Histamine-2 Receptor Antagonists vs Proton Pump Inhibitors on Gastrointestinal Tract Hemorrhage and Infectious Complications in the Intensive Care Unit[J].Jama Internal Medicine,2014,174(4):564-574
16 Krag M,Perner A,Wetterslev J,et al.Stress ulcer prophylaxis in the intensive care unit:an international survey of 97units in 11 countries[J].Acta Anaesthesiologica Scandinavica,2015,59(5):576-585
2 梁茂本,孟祥梅.114例质子泵抑制剂不良反应病例分析[J].中国药物警戒,2013,10(1):39-41
3 陈超,郭代红,刘皈阳,等.医疗机构药品不良反应监测的优化实践[J].中国药物警戒,2010,7(3):164-168
4 陈超,郭代红,薛万国,等.住院患者药品不良事件主动监测与评估警示系统的研发[J].中国药物警戒,2013,10(7):411-414,418
5 国家药品不良反应监测中心.药品不良反应术语使用指南[Z].监测与评价综[2016]77号
6 国家食品药品监督管理总局.药品不良反应报告和监测管理办法[Z].[2011]卫生部令第81号
7 National Cancer Institute(NCI).Common terminolgy criteria for adverse events(CTCAE)v4.03[EB/OL].(2017-08-01)[2010-06-14]https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf
8 郭代红,苏畅,王啸宇,等.住院患者药源性肝损害的信息化自动监测研究与实践[J].中国医院用药评价与分析,2017,17(8):1019-1021
9 李琦恒,倪鸿昌.奥美拉唑78例不良反应分析[J].安徽医药,2007,11(2):190-191
10 苏珊珊.奥美拉唑致白细胞减少19例分析[J].右江医学,2005,33(1):56
11 曾红.奥美拉唑静脉滴注致白细胞减少5例[J].中国药师,2006,9(6):550-551
12 张建华,齐晓涟.注射用奥美拉唑致血液系统不良反应的调查分析[J].医药导报,2007,26(6):684-685
13 Laheij RJF,Sturkenboom MCJM,Hassing RJ,et al.Risk of Community-Acquired Pneumonia and Use of Gastric Acid–Suppressive Drugs[J].JAMA,2004,292(16):1955-1960
14 Howell MD,Novack V,Grgurich P,et al.Iatrogenic Gastric Acid Suppression and the Risk of Nosocomial Clostridium difficile Infection[J].Archives of Internal Medicine,2010,170(9):784-790
15 Maclaren R,Reynolds PM,Allen RR,et al.Histamine-2 Receptor Antagonists vs Proton Pump Inhibitors on Gastrointestinal Tract Hemorrhage and Infectious Complications in the Intensive Care Unit[J].Jama Internal Medicine,2014,174(4):564-574
16 Krag M,Perner A,Wetterslev J,et al.Stress ulcer prophylaxis in the intensive care unit:an international survey of 97units in 11 countries[J].Acta Anaesthesiologica Scandinavica,2015,59(5):576-585