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CFDA和FDA標準下我院精神專科藥物超適應(yīng)證使用比較分析

發(fā)布時間:2018-03-03 20:22

  本文選題:精神?扑幬 切入點:超適應(yīng)證用藥 出處:《中國藥房》2017年14期  論文類型:期刊論文


【摘要】:目的:了解精神?漆t(yī)院住院患者在我國食品藥品監(jiān)督管理總局(CFDA)和FDA標準下口服化學(xué)藥醫(yī)囑超適應(yīng)證用藥情況,比較兩種標準的差異性,分析原因和用藥合理性,為醫(yī)院制訂超適應(yīng)證用藥管理制度提供參考。方法:統(tǒng)計并分析我院2016年1-6月住院患者的口服化學(xué)藥醫(yī)囑,分別以CFDA和FDA批準的適應(yīng)證為標準,判斷超適應(yīng)證用藥情況。結(jié)果:共收集到符合本研究要求的口服化學(xué)藥醫(yī)囑507條,CFDA和FDA標準下的超適應(yīng)證醫(yī)囑比例都相對較高,分別為58.58%和55.82%。CFDA標準下,喹硫平和阿立哌唑的超適應(yīng)證發(fā)生率都明顯高于FDA標準下的結(jié)果,差異均有統(tǒng)計學(xué)意義(P0.05);構(gòu)成比居前3位者分別為丙戊酸鎂(54.03%)、草酸艾司西酞普蘭(10.45%)和喹硫平(10.15%);超適應(yīng)證醫(yī)囑中沒有循證醫(yī)學(xué)依據(jù)的有7條,占超適應(yīng)證醫(yī)囑總數(shù)的2.36%。結(jié)論:我院多數(shù)超適應(yīng)證醫(yī)囑能提供相關(guān)依據(jù)及文獻支持,但仍有少部分超適應(yīng)證用藥證據(jù)不夠充分。醫(yī)院應(yīng)建立相應(yīng)的管理制度,以保證患者的用藥安全和醫(yī)師的合法權(quán)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.
【作者單位】: 西安市精神衛(wèi)生中心藥劑科;西安市精神衛(wèi)生中心人事科;
【分類號】:R95

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1 記者 李瑤;CFDA努力提升藥品安監(jiān)水平[N];醫(yī)藥經(jīng)濟報;2013年

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