盐酸溴己新注射剂安全性风险的分析及思考
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摘要
目的分析盐酸溴己新注射剂的安全性风险,为临床合理用药提供参考。方法对世界卫生组织药品不良反应监测数据库、我国药品不良反应监测数据库、国内文献数据库中的不良反应报告及国内外风险控制措施等相关资料进行整理与分析。结果应关注盐酸溴己新注射剂严重过敏反应及儿童用药等相关风险。结论须加强盐酸溴己新注射剂的临床应用监测,及时完善产品说明书,促进药品的合理使用。
Obje ctive To analyze the risk of bromhexine hydrochloride injections in China, so as to provide reference for clinical rational drug use. Me thods The individual adverse drug reaction cases in WHO Vigilyze and China Adverse Drug Reaction Database, domestic literatures, and the domestic and foreign risk management measures were analyzed. Results The risk of serious allergic reaction and use of medicines in children should be concerned. Conclusion We should strengthen the clinical application monitoring of bromhexine hydrochloride injections, timely update the drug labeling and promote the rational application of medicine.
Obje ctive To analyze the risk of bromhexine hydrochloride injections in China, so as to provide reference for clinical rational drug use. Me thods The individual adverse drug reaction cases in WHO Vigilyze and China Adverse Drug Reaction Database, domestic literatures, and the domestic and foreign risk management measures were analyzed. Results The risk of serious allergic reaction and use of medicines in children should be concerned. Conclusion We should strengthen the clinical application monitoring of bromhexine hydrochloride injections, timely update the drug labeling and promote the rational application of medicine.
引文
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[2]李桂芳.盐酸溴己新葡萄糖注射液治疗小儿肺炎的疗效分析[J].临床医学研究与实践,2017, 2(19):75-76.
[3]赵慧娟.探讨溴己新联合头孢呋辛钠治疗小儿肺炎的临床疗效[J].中国医学工程, 2017, 25(11):51-52.
[4]李文刚,冯丽芳.盐酸溴己新葡萄糖注射液治疗小儿肺炎疗效观察[J].临床合理用药杂志, 2012, 5(14):68.
[5]张爱荣,杨军录.盐酸氨溴索注射液联合溴己新治疗慢性支气管炎患者的临床疗效[J].实用临床医药杂志, 2018, 22(22):14-16.
[6]张晶,刘潇,郭易苗.探讨溴己新联合头孢呋辛钠治疗小儿肺炎的临床疗效[J].继续医学教育, 2016, 30(12):157-159.
[7]王兰萍,张仁敏,宋建玲.盐酸溴己新葡萄糖注射液致皮肤过敏1例[J].中国临床药学杂志, 2010, 19(6):383.
[8]杨艳芳,侯周武.盐酸溴己新葡萄糖注射液致过敏性休克1例[J].临床合理用药杂志, 2011, 4(4):134,140.
[9]李忻,邵丹,严明兰.盐酸溴己新葡萄糖注射液致严重不良反应1例[J].中国实验诊断学, 2016, 20(11):1954-1955.
[10]白万军,孙晓利,董占军.盐酸溴己新葡萄糖注射液致全身肌肉震颤1例[J].中国医院药学杂志, 2018, 38(15):1669-1670.
[11]毕晶,王冬萌,张亚芳.注射用盐酸溴己新致儿童严重过敏反应1例[J].儿科药学杂志,2018,24(8):66.
[12]国家药品不良反应监测中心.药物警戒快讯[J].中国药物警戒, 2015, 12(4):254-256.
[13] NMPA.关于修订盐酸溴己新注射剂说明书的公告(2018年第89号)[EB/OL].(2018-11-20)[2019-02-28].http://www.nmpa.gov.cn/WS04/CL2115/332324.htmL.
[14]彭丽丽,刘巍,汤韧,等.甲巯咪唑药品不良反应/事件文献分析[J].中国药物警戒, 2018, 15(7):404-410.
[2]李桂芳.盐酸溴己新葡萄糖注射液治疗小儿肺炎的疗效分析[J].临床医学研究与实践,2017, 2(19):75-76.
[3]赵慧娟.探讨溴己新联合头孢呋辛钠治疗小儿肺炎的临床疗效[J].中国医学工程, 2017, 25(11):51-52.
[4]李文刚,冯丽芳.盐酸溴己新葡萄糖注射液治疗小儿肺炎疗效观察[J].临床合理用药杂志, 2012, 5(14):68.
[5]张爱荣,杨军录.盐酸氨溴索注射液联合溴己新治疗慢性支气管炎患者的临床疗效[J].实用临床医药杂志, 2018, 22(22):14-16.
[6]张晶,刘潇,郭易苗.探讨溴己新联合头孢呋辛钠治疗小儿肺炎的临床疗效[J].继续医学教育, 2016, 30(12):157-159.
[7]王兰萍,张仁敏,宋建玲.盐酸溴己新葡萄糖注射液致皮肤过敏1例[J].中国临床药学杂志, 2010, 19(6):383.
[8]杨艳芳,侯周武.盐酸溴己新葡萄糖注射液致过敏性休克1例[J].临床合理用药杂志, 2011, 4(4):134,140.
[9]李忻,邵丹,严明兰.盐酸溴己新葡萄糖注射液致严重不良反应1例[J].中国实验诊断学, 2016, 20(11):1954-1955.
[10]白万军,孙晓利,董占军.盐酸溴己新葡萄糖注射液致全身肌肉震颤1例[J].中国医院药学杂志, 2018, 38(15):1669-1670.
[11]毕晶,王冬萌,张亚芳.注射用盐酸溴己新致儿童严重过敏反应1例[J].儿科药学杂志,2018,24(8):66.
[12]国家药品不良反应监测中心.药物警戒快讯[J].中国药物警戒, 2015, 12(4):254-256.
[13] NMPA.关于修订盐酸溴己新注射剂说明书的公告(2018年第89号)[EB/OL].(2018-11-20)[2019-02-28].http://www.nmpa.gov.cn/WS04/CL2115/332324.htmL.
[14]彭丽丽,刘巍,汤韧,等.甲巯咪唑药品不良反应/事件文献分析[J].中国药物警戒, 2018, 15(7):404-410.