摘要
目的探讨医院制剂相关药品不良反应报告的发生特点、规律和影响因素。方法采用回顾性研究方法,提取解放军ADR监测中心数据库中2009—2014年间医院制剂相关的ADR报告数据并统计分析。结果 313例ADR报告中严重ADR占比少,仅为10例;涉及医院制剂品种较分散,为117种;其中注射剂31种(26.50%),相关ADR为121例(38.66%);中药注射剂导致ADR为45例,占14.38%;口服和静脉给药途径引起ADR分别占43.13%和36.42%。按ADR分类排序的前3名分别为皮肤及附件损害(26.75%)、全身性损害(25.51%)、消化系统损害(20.58%)。结论医院制剂的ADR表现与其用量较小、效期较短、供应范畴局限等自身特色密切相关。对ADR发生较多且较严重的品种应实施主动监测,开展用药再评价,以保障其临床应用有效安全。
Objective To explore the regularity,characteristics and influence factors of adverse drug reaction( ADR)occurrence related to hospital preparations. Methods A retrospective analysis was conducted of ADR report data related to hospital preparations from the PLA ADR monitoring center between 2009 and 2014. Results Only 10 of the 313 cases of ADR were serious. 117 kinds of hospital preparations were involved and 31 kinds of injections( 26. 50%) accounted for 38. 66% of the ADR reports. Traditional Chinese Medicine injections led to 45 ADR cases( 14. 38%). Oral and intravenous drugs accounted for 43. 13% and 36. 42% of all the ADR cases. The top three types of ADR were skin damage( 26. 75%),systemic damage( 25. 51%) and digestive damage( 20. 58%). Conclusion The ADR performance of hospital preparations was influenced by the small usage,short period and limited supply. In order to ensure clinical safety and efficacy,hospital preparations with frequent and serious ADRs should be subjected to active surveillance and drug revaluation.
出处
《解放军药学学报》
CAS
CSCD
2015年第5期452-454,共4页
Pharmaceutical Journal of Chinese People's Liberation Army
基金
2014全军后勤科研计划重点项目
No.BWS14R039
关键词
医院制剂
药品不良反应
分析
hospital preparations
adverse drug reaction
analysis
