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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 investigate the characteristics, rules and influencing factors of adverse drug reaction reports in hospital preparations. Methods A retrospective study was conducted to collect and statistically analyze hospital preparation-related ADR data from 2009 to 2014 in the People’s Liberation Army ADR Monitoring Center database. Results A total of 117 ADRs were reported in 313 ADR cases, accounting for only 117 cases (31%). Among them, 31 cases (26.50%) had ADR, 121 cases (38.66%) had ADR. ADR was 45 cases, accounting for 14.38%; oral and intravenous routes of administration caused ADR accounted for 43.13% and 36.42%. The top 3 ranked by ADR were skin and accessory damage (26.75%), generalized injury (25.51%) and digestive system damage (20.58%), respectively. Conclusion The ADR performance of hospital preparations is closely related to its own characteristics, such as smaller dosage, shorter period of validity and limited scope of supply. For more and more serious varieties of ADR, active monitoring should be implemented to re-evaluate the use of drugs in order to protect their clinical application of effective and safe.