CFDA和FDA标准下我院精神专科药物超适应证使用比较分析

发布时间：2018-03-03 20:22

本文选题：精神专科药物　切入点：超适应证用药　出处：《中国药房》2017年14期 　论文类型：期刊论文

【摘要】：目的:了解精神专科医院住院患者在我国食品药品监督管理总局(CFDA)和FDA标准下口服化学药医嘱超适应证用药情况,比较两种标准的差异性,分析原因和用药合理性,为医院制订超适应证用药管理制度提供参考。方法:统计并分析我院2016年1-6月住院患者的口服化学药医嘱,分别以CFDA和FDA批准的适应证为标准,判断超适应证用药情况。结果:共收集到符合本研究要求的口服化学药医嘱507条,CFDA和FDA标准下的超适应证医嘱比例都相对较高,分别为58.58%和55.82%。CFDA标准下,喹硫平和阿立哌唑的超适应证发生率都明显高于FDA标准下的结果,差异均有统计学意义(P0.05);构成比居前3位者分别为丙戊酸镁(54.03%)、草酸艾司西酞普兰(10.45%)和喹硫平(10.15%);超适应证医嘱中没有循证医学依据的有7条,占超适应证医嘱总数的2.36%。结论:我院多数超适应证医嘱能提供相关依据及文献支持,但仍有少部分超适应证用药证据不够充分。医院应建立相应的管理制度,以保证患者的用药安全和医师的合法权益。
[Abstract]:Objective: to investigate the overindication of oral chemical medicine in psychiatric hospital under CFDAA and FDA standards, to compare the difference between the two standards, and to analyze the reasons and rationality of drug use. Methods: statistics and analysis of oral chemotherapeutic orders of inpatients in our hospital from January to June, 2016, were made according to the indications approved by CFDA and FDA, respectively. Results: according to the requirements of this study, the proportion of overindications was higher than that of FDA, which was 58.58% and 55.82.CFDA, respectively. The overindications of quinolipine and aripiprazole were significantly higher than those of FDA. The difference was statistically significant (P 0.05), the composition of magnesium valproate was 54.03, oxalic acid estalopram 10.45) and quinolipin 10. 155.There were 7 cases with no evidence based medical evidence. Conclusion: most of the overindications in our hospital can provide relevant evidence and literature support, but there is still a small part of the evidence of overindications is not enough. The hospital should establish the corresponding management system. In order to ensure the safety of patients and the legitimate rights and interests of doctors.
【作者单位】：西安市精神卫生中心药剂科;西安市精神卫生中心人事科;
【分类号】：R95

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