广东省人民医院2012年住院患者盐酸氨溴索注射剂超说明书用药情况调查  

Survey on Off-label Drug Use of Ambroxol Hydrochloride Injection among Inpatients in Guangdong General Hospital in 2012

作　　者：周婧[1,2] 陈文颖[1] 劳海燕[1] 黄碧瑜[1] 刘晓琦[1] 李幼平[3] 黄民[2] 杨敏[1,4] 

机构地区：[1]广东省人民医院(广东省医学科学院)药学部,广州510080 [2]中山大学药学院,广州510006 [3]四川大学华西医院中国循证医学中心,成都610041 [4]广东省心血管病研究所,广州510080

出　　处：《中国循证医学杂志》2014年第9期1030-1037,共8页Chinese Journal of Evidence-based Medicine

摘　　要：目的回顾性调查广东省人民医院2012年住院患者盐酸氨溴索注射剂超说明书用药情况，为其超说明书使用提供参考。方法纳入2012年广东省人民医院使用盐酸氨溴索注射剂住院患者的用药医嘱，按照药品说明书判断其超说明书用药情况。对各科室用药情况进行统计，分析各科室超途径用药与超剂量用药发生率，计算各科室处方日剂量（PDD）和药物利用指数（DUI），评估超剂量用药程度。结果①共纳入使用盐酸氨溴索注射剂的住院患者138227人天。全院各科室均存在超说明书用药情况，总发生率为67．06％。②全院71．43％（25／35）科室存在超剂量用药，总发生率为29．53％，前4位科室依次为心脏外科重症监护病房（CICU）（97．74％）、心外科（97．51％）、心儿科（72．30％）和儿童重症监护病房（PICU）（70．28％）。⑧PDD超出说明书规定的有CICU、心外科、PICU、心儿科、肿瘤外科、神经外科和重症监护病房（ICU）；其中CICU、心外科、PICU和心儿科的DUI／cDUI明显高出正常值l～3倍。④2012年医院未接到任何与盐酸氨溴索注射剂使用相关的不良反应／不良事件（ADR／AE）报告。结论盐酸氨溴索注射剂在广东省人民医院普遍使用，超说明书用药情况常见，应进一步分析其超剂量使用的影响因素，评价其使用的合理性。Objective To retrospectively analyze off-label drug use （OLDU） situation of ambroxol hydrochloride injection （AHI） among inpatients in the Guangdong General Hospital in 2012, so as to provide references for AHI OLDU. Methods All medical orders of AHI for inpatients in the Guangdong General Hospital in 2012 were included, and OLDU was judged according to drug labels. We summarized situation of drug use in all departments, analyzed OLDU incidence in administration path and in dose, calculated prescribed daily dose （PDD） and utilization index （DUI） in each department to evaluate the degree of OLDU in dose. Results a） A total of inpatients 138 227 patient-days who used AHI were included. OLDU occurred in all departments in this hospital and the total OLDU incidence was 67.06%. b） OLDU in dose occurred in 71.43% of the departments （25/35） with an incidence of 29.53%; the top 4 departments were cardiac surgery intensive care unit department （CICU） （97.74%）, cardiac surgery department （97.51%）, pediatric cardiac surgery department （72.30%） and pediatric intensive care unit department （PICU） （70.28%） in order, c） Re PDDs in CICU department, cardiac surgery department, PICU departments, pediatric cardiac surgery department, oncological surgery ward, neurosurgery ward and intensive care unit （ICU） were higher than the defined daily dose （DDD）, of which, the DUI/cDUI in CICU, cardiac surgery department, PICU and pediatric cardiac surgery department were 1 to 3 times higher than normal level, d） No relevant ad- verse drug reaction/adverse event （ADR/AE） reports were received in this hospital in 2012. Conclusion AHI is widely used in the Guangdong General Hospital, and AHI OLDU is commonly-seen. Further studies should be conducted to analyze the influence factors ofAHI OLDU in dose and to evaluate the rationality of its application.

关 键 词：盐酸氨溴索注射剂 超说明书用药 药物利用指数 住院患者 广东省人民医院 

分 类 号：R95[医药卫生—药学]