我院生殖中心不孕不育患者的超说明书用药分析  

Off-label Drug Use in the Treatment of Infertility in Reproductive Medicine Unit

作　　者：林芸[1] 李庆南[1] 林沛鸿[1] 陈浩浩[2] LIN Yun LI Qingnan LIN Peihong CHEN Haohao(Shantou Central Hospital Affiliated Shantou Hospital of Sun Yat-Sen University,Shantou, Guangdong 515000, China The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong 515000, China)

机构地区：[1]汕头市中心医院,广东汕头515000 [2]汕头大学医学院第一附属医院,广东汕头515000

出　　处：《今日药学》2017年第1期48-51,共4页Pharmacy Today

摘　　要：目的了解我院生殖中心不孕不育患者的超说明书用药的发生率及特点,为临床合理用药提供参考。方法采用回顾性分析,抽取我院2015年10月1日至12月31日生殖中心的所有门诊患者处方,记录患者的基本信息、临床诊断和用药信息等内容,筛选出临床诊断包含不孕或不育,年龄≤45 a的病例,根据药品说明书,由两名药师共同判断超说明书用药类型,并进行统计分析。结果共筛选出处方4 437张,含6 889条用药医嘱,其中含有超说明书用药的处方1 221张,占27.5%;有1689条超说明书用药医嘱,占24.5%;类型为超适应症1 045条(61.9%),超用法用量461条(27.3%),超给药途径22条(1.3%),超适应症同时超用法用量161条(9.5%)。超说明书用药使用频率高的药品主要为激素类和影响代谢类等药物。结论我院生殖中心不孕不育患者超说明书用药现象普遍,药事管理部门应规范其使用,临床医生和药师应收集循证医学证据,提高合理用药水平。OBJECTIVE To determine the prevalence and characteristic of off-label drug use in our hospital ＇s infertility outpatients,and to provide a reference for clinical rational drug use. METHODS Retrospective analysis was used for this study.Infertility outpatient prescriptions（ October 1,2015 to December 31,2015） were included. The basic information,clinical diagnosis and treatment information of each prescription was recorded,and prescriptions with diagnosis containing infertility and age below 45 years old were screened out for this study. According to the summary of product characteristics,natures of off-label drug use were distinguished by two pharmacists. RESULTS 4 437 infertility outpatient prescriptions were enrolled,which included 6889 medication orders. 1 221prescriptions（ 27.5% of the total prescriptions） contained at least one off-label drug use,. 1689 medication orders（ 24. 5% of total）were used off label. The categories were indication（ 1045 / 1689,61. 9%）,dose（ 461 / 1689,27. 3%）,administration route（ 22 / 1689,1.3%） and indication with dose（ 161 / 1689,9.5%）,which were not recommended in the summary of product characteristics. Hormones and affect metabolism drugs were the most common off- label use. CONCLUSION Off-label drug use is very common in infertility outpatients. In order to promote rational drug use,pharmacy departments should regulate their use,and clinicians and pharmacists should collect evidence based medicine.

关 键 词：超说明书用药 生殖医学 不孕不育 合理用药 

分 类 号：R95[医药卫生—药学]