盐酸氨溴索注射剂超说明书用药的多中心调查研究  

Multi-center Survey on Off-label Drug Use of Ambroxol Hydrochloride Injection

作　　者：曾英彤[1] 林璐[1] 赖莎 温预关 钱文璟[4] 陈峦峦 蒋大义 蔡庆群[7] 高翔[8] 郑丹微 何志超[10] 杨敏[1] ZENG Yingtong LIN Lu LAI Sha WEN Yuguan QIAN Wenjing CHEN Luanluan JIANG Dayi CAI Qin- gqun GAO Xiang ZHENG Danwei HE Zhichao YANG Min(Dept. of Pharmacy, Guangdong Provincial People＇ s Hospital/Guangdong Academy of Medical Sciences, Guangzhou 510080, China Dept. of Pharma- cy, the First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou 510080, China Dept. of Pharmacy, Guangzhou Hui＇ai Hospital, Guangzhou 510370, China Dept. of Pharmacy, Shenzhen Sec- ond People＇s Hospital, Guangdong Shenzhen 518035, China Dept. of Pharmacy, the Third Affiliated Hospi- tal of Guangzhou Medical University, Guangzhou 510150, China Dept. of Pharmacy, Shenzhen People＇ s Hospital, Guangdong Shenzhen 518020, China Dept. of Pharmacy, the First Affiliated Hospital of Guang- zhou University of TCM, Guangzhou 510405, China Dept. of Pharmacy, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China Dept. of Pharmacy, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou 510630, China Dept. of Pharmacy, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou 510235, China)

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]广东药科大学附属第一医院药学部,广州510080 [3]广州市惠爱医院药学部,广州510370 [4]深圳市第二人民医院药学部,广东深圳518035 [5]广州医科大学附属第三医院药学部,广州510150 [6]深圳市人民医院药学部,广东深圳518020 [7]广州中医药大学第一附属医院药学部,广州510405 [8]中山大学附属第一医院药学部,广州510080 [9]中山大学附属第三医院药剂科,广州510630 [10]中山大学附属孙逸仙纪念医院药学部,广州510235

出　　处：《中国药房》2017年第29期4060-4065,共6页China Pharmacy

基　　金：广州市科技计划项目(No.201509010012)

摘　　要：目的:了解盐酸氨溴索注射剂超说明书用药总体情况,为进一步循证评价临床超说明书用药的合理性和规范化管理提供参考。方法:纳入广东省10家医院2014年4月-2015年3月使用盐酸氨溴索注射剂的住院患者的用药医嘱,以药品说明书为标准,统计各类科室用药情况,分析超途径与超剂量用药的发生率,计算各类科室处方日剂量(PDD)和药物利用指数(DUI),评估超剂量用药程度。结果:共纳入使用盐酸氨溴索注射剂的患者761 821人·天,各类科室均存在超说明书用药现象,超说明书用药发生率为62.10%。其中,超途经用药的发生率为40.51%,主要为雾化吸入给药,发生率最高的科室为妇产科(92.70%);超剂量用药的发生率为36.30%,发生率最高的科室为心胸外科(85.36%)。PDD超出说明书规定的有心胸外科、重症监护病房、外科、心血管内科、急诊科、内科和儿科。结论:盐酸氨溴索注射剂超说明书用药现象普遍,有效性、安全性和必要性仍存在争议,需要设计多中心随机对照前瞻试验进行论证。OBJECTIVE： To investigate off-label drug use of Ambroxol hydrochloride injection, and to provide reference for further evidence-based evaluation on rationality and standardized management of off-label drug use. METHODS ： All medical orders for inpatients receiving Ambroxol hydrochloride injection were selected from 10 hospitals of Guangdong province during Apr. 2014 to Mar. 2015. Situation of drug use in different categories of departments was summarized, the incidence of off-label administation route and off-label dosage were analyzed; according to drug package inserts, prescription daily dose （PDD） and drug utilization in- dex （DUI） were calculated for each category of department, and the degree of off-label dosage was evaluated. RESULTS： A total of 761 821 person, day who used Ambroxol hydrochloride injection was included. Off-label drug use occurred in each category of departments, and the incidence of off-label drug use was 62.10%. The incidence of off-label administration route was 40.51%,mainly atomization inhalation; the incidence of it was the high- est in gynecology and obstetrics department （92.70%）. The in- cidence of off-label dosage was 36.30%, and the incidence of it was the highest in cardiothoracic surgery department （85.36%）. Departments whose PDDs were higher than the drug package inserts were cardiothoracic surgery department, ICU, surgical department, cardiovascular medicine department, emer- gency department, department of internal medicine and pediatrics department. CONCLUSIONS： Off-label drug use of Ambroxol hy- drochloride injection is common, and the effectiveness, safety and necessity remain controversial, which need to be proved by multi-center randomized controlled prospective trial.

关 键 词：氨溴索 超说明书用药 多中心 调查研究 

分 类 号：R974[医药卫生—药品] R969.3[医药卫生—药学]