969例环磷腺苷葡胺注射剂不良反应报告分析
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摘要
目的探讨环磷腺苷葡胺注射剂致不良反应的特点及其可能的原因,为临床安全合理用药提供参考。方法采用回顾性分析方法,对浙江省ADR数据库中2010年1月-2017年2月上报的969例环磷腺苷葡胺注射剂不良反应报告,分别按不良反应类型、报告数量趋势、患者性别、年龄、原患疾病、用药情况、不良反应表现等进行统计和分析。结果环磷腺苷葡胺注射剂新的不良反应占58%,以45岁以上的患者居多(85.45%);不良反应累及系统-器官主要为全身性反应、消化系统和皮肤及其附件,严重不良反应累及系统-器官主要为全身性反应、皮肤及其附件和呼吸系统。结论临床应重视环磷腺苷葡胺注射剂引起的不良反应,尤其是过敏性休克等严重不良反应;生产企业应完善药品说明书安全性信息,加强临床合理用药,保障用药安全。
Objective To investigate the occurrence and characteristics of adverse drug reactions(ADRs) caused by meglumine adenosine cyclophosphate injection, so as to provide reference for rational drug use in the clinic. Methods The retrospective study method was used to analyze 969 cases of ADRs caused by meglumine adenosine cyclophosphate injection. These ADRs were collected by Zhejiang ADRs monitoring system from Jan.2010 to Feb.2017.The analysis includes the type of reports, quantity trends, the case of gender, age, medication situation and adverse drug reactions.Results 54% cases were new ADR reports. ADRs caused by meglumine adenosine cyclophosphate injection mostly occurred in the patients aged above 45 years old(85.45%). The SOCs mostly involved in ADRs were systemic reaction,the digestive system, skin and its accessories. The serious ADRs involving SOCs were mainly systemic reaction, skin and its accessories, and respiratory system. Conclusion More attention should be paid to ADRs caused by meglumine adenosine cyclophosphate injection in clinic, especially the serious adverse reactions such as allergic shock. Drug manufacturers should promptly improve the safety information of drug instructions.The rational drug use should be strengthened to improve the safety of drug use in patients.
Objective To investigate the occurrence and characteristics of adverse drug reactions(ADRs) caused by meglumine adenosine cyclophosphate injection, so as to provide reference for rational drug use in the clinic. Methods The retrospective study method was used to analyze 969 cases of ADRs caused by meglumine adenosine cyclophosphate injection. These ADRs were collected by Zhejiang ADRs monitoring system from Jan.2010 to Feb.2017.The analysis includes the type of reports, quantity trends, the case of gender, age, medication situation and adverse drug reactions.Results 54% cases were new ADR reports. ADRs caused by meglumine adenosine cyclophosphate injection mostly occurred in the patients aged above 45 years old(85.45%). The SOCs mostly involved in ADRs were systemic reaction,the digestive system, skin and its accessories. The serious ADRs involving SOCs were mainly systemic reaction, skin and its accessories, and respiratory system. Conclusion More attention should be paid to ADRs caused by meglumine adenosine cyclophosphate injection in clinic, especially the serious adverse reactions such as allergic shock. Drug manufacturers should promptly improve the safety information of drug instructions.The rational drug use should be strengthened to improve the safety of drug use in patients.
引文
[1]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》(卫生部令第81号)[EB/OL].(2011-05-04)[2017-07-28].http://www.sda.gov.cn/WS01/CL0053/62621.html.
[2]王艳,沈佳炎.静脉滴注环磷腺苷葡胺注射液致不良反应3例[J].心脑血管病防治,2015,15(3):256-257.
[3]鲍隆梅,刘俊.注射用环磷腺苷葡胺致过敏反应1例[J].山西医药杂志,2015,44(4):487.
[4]王萍,沈洁,孔飞飞,等.静脉滴注环磷腺苷葡胺注射液致过敏1例[J].药学实践杂志,2015,33(6):575.
[5]韦又嘉.注射用环磷腺苷葡胺致严重过敏反应1例[J].中国药物警戒,2013,10(8):511.
[6]宋爱丽,刘君.环磷腺苷葡氨致过敏性休克1例[J].药物流行病学杂志,2012,21(10):487.
[7]陈春枚,费燕.注射用环磷腺苷葡胺致过敏性休克1例[J].中国医院药学杂志,2011,31(18):1 566.
[8]石壬伟.环磷腺苷葡甲胺致1例速发型过敏型休克[J].药学与临床研究,2011,19(4):365.
[9]洪文英.静脉滴注环磷腺苷葡胺注射液致寒战1例[J].中国药物警戒,2016,13(4):247-248.
[10]孔飞飞,郭良君,谭兴起,等.静滴环磷腺苷葡胺注射液致寒战1例[J].药物流行病学杂志,2011,20(11):612.
[11]王井玲,徐锦龙,陈武,等.环磷腺苷葡胺致急性荨麻疹1例[J].中国药物应用与监测,2015,12(3):195.
[12]张峻.临床静脉用药调配方法与配伍禁忌速查手册[M].北京:人民卫生出版社,2012:56.
[13]洪文英,王述蓉.环磷腺苷葡胺致不良反应文献分析[J].中国药房,2016,27(32):4518-4521.
[14]杨燕妮,冯雪梅,楚莉辉,等.85例右旋糖酐40注射剂致严重不良反应报道分析[J].临床合理用药杂志,2016,9(18):175-177.
[15]魏定基.临床使用甘露醇的不良反应分析[J].临床合理用药杂志,2010,3(1):29-30.
[2]王艳,沈佳炎.静脉滴注环磷腺苷葡胺注射液致不良反应3例[J].心脑血管病防治,2015,15(3):256-257.
[3]鲍隆梅,刘俊.注射用环磷腺苷葡胺致过敏反应1例[J].山西医药杂志,2015,44(4):487.
[4]王萍,沈洁,孔飞飞,等.静脉滴注环磷腺苷葡胺注射液致过敏1例[J].药学实践杂志,2015,33(6):575.
[5]韦又嘉.注射用环磷腺苷葡胺致严重过敏反应1例[J].中国药物警戒,2013,10(8):511.
[6]宋爱丽,刘君.环磷腺苷葡氨致过敏性休克1例[J].药物流行病学杂志,2012,21(10):487.
[7]陈春枚,费燕.注射用环磷腺苷葡胺致过敏性休克1例[J].中国医院药学杂志,2011,31(18):1 566.
[8]石壬伟.环磷腺苷葡甲胺致1例速发型过敏型休克[J].药学与临床研究,2011,19(4):365.
[9]洪文英.静脉滴注环磷腺苷葡胺注射液致寒战1例[J].中国药物警戒,2016,13(4):247-248.
[10]孔飞飞,郭良君,谭兴起,等.静滴环磷腺苷葡胺注射液致寒战1例[J].药物流行病学杂志,2011,20(11):612.
[11]王井玲,徐锦龙,陈武,等.环磷腺苷葡胺致急性荨麻疹1例[J].中国药物应用与监测,2015,12(3):195.
[12]张峻.临床静脉用药调配方法与配伍禁忌速查手册[M].北京:人民卫生出版社,2012:56.
[13]洪文英,王述蓉.环磷腺苷葡胺致不良反应文献分析[J].中国药房,2016,27(32):4518-4521.
[14]杨燕妮,冯雪梅,楚莉辉,等.85例右旋糖酐40注射剂致严重不良反应报道分析[J].临床合理用药杂志,2016,9(18):175-177.
[15]魏定基.临床使用甘露醇的不良反应分析[J].临床合理用药杂志,2010,3(1):29-30.