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我院不同质量标准药品与其不良反应的相关性分析

     

摘要

OBJECTIVE:To compare and analyze the ADR in Chinese Pharmacopoeia(2010 edition)(ChPD)and non-phar-macopoeia quality standard drugs(NChPD)and its standard. METHODS:In respective study,ADR reports and drug utilization da-ta in our hospital from 2012 to 2014 were collected and divided into ChPD group and NChPD group,the index differences were an-alyzed. RESULTS:The percentages of reported ADR to product regulation [(0.27 ± 0.10)%] and to drug use frequency [(0.15 ± 0.06)%] in ChPD group were significantly lower than NChPD group [(0.62 ± 0.08)%、(0.32 ± 0.07)%],with statistical signifi-cance (P<0.05). Compared with the percentage of general reported ADR to drug use frequency in NChPD group [(0.44 ± 0.12)%],there was no significant difference in ChPD group [(0.23±0.09)%](P>0.05);the percentage of new severe reported ADR to drug use frequency in ChPD group [(0.04 ± 0.01)%] was significantly lower than NChPD group [(0.27 ± 0.05)%],with statistical significance (P<0.05). And there were no significant differences in indexes in different years (P>0.05). CONCLU-SIONS:Drug quality standards should be payed more attention,from the perspective of which to reduce the incidence of adverse drug reactions. While the drugs introduced to hospital should be strictly controlled and timely adjust the drug structure;the pharma-copoeia standard drugs should be generalized among doctors to reduce ChPD drug reactions and ensure the drug safety.%目的:探讨我院2010年版《中国药典》质量标准(ChPD)药物和非药典质量标准(NChPD)药品与其不良反应(ADR)的相关性。方法:采用回顾性分析方法,收集我院2012-2014年的ADR报告和药物使用数据,并依据其药品质量标准分为ChPD组和NChPD组,分析两组间各项指标的差异性。结果:ChPD组ADR上报例数占药品品规数百分比[(0.27±0.10)%]、ADR上报例数占药品使用频次百分比[(0.15±0.06)%]均显著低于NChPD组[(0.62±0.08)%、(0.32±0.07)%],差异有统计学意义(P<0.05)。ChPD组一般的ADR上报例数占药品使用频次百分比[(0.23±0.09)%]与NChPD组[(0.44±0.12)%]比较,差异无统计学意义(P>0.05);ChPD组新的严重的ADR上报例数占药品使用频次百分比[(0.04±0.01)%]显著低于NChPD组[(0.27±0.05)%],差异有统计学意义(P<0.05)。不同年度间各指标比较,差异均无统计学意义(P>0.05)。结论:国家应重视对药品质量标准的严格把控,从药品质量标准的角度降低ADR发生率。医院对引进的药品要进行严格的论证,及时调整药品结构,并在药品使用过程中积极鼓励、引导医师使用ChPD药物,从而降低ADR发生率,保障公众用药的安全性。

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