风湿免疫科门诊超说明书用药调查与分析  

Investigation and analysis of the off-label drug use in outpatient department of rheumatic immunology

作　　者：沈斌[1] 张斌[2] 徐亮[1] 杨艳英[2] 

机构地区：[1]嘉兴市第一医院药学部 [2]嘉兴市第一医院风湿免疫科

出　　处：《中国临床药理学与治疗学》2017年第3期337-341,共5页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：浙江省医药卫生计划(2015KYB386)

摘　　要：目的:了解风湿免疫科超说明书用药情况,为建立超说明书用药评价标准及规范化管理超说明书用药提供参考。方法:以药品说明书为依据,从适应证、适应人群、给药剂量、给药频次、给药途径和禁忌证等方面对本院2016年4~6月风湿免疫科门诊处方的超说明书用药情况进行统计分析,参考循证医学、文献资料、临床指南或专家共识等评价其合理性。结果:研究纳入风湿免疫科门诊处方3 501张,涉及用药记录9 889条。按处方、用药记录计,超说明用药发生率分别为47.50%和27.69%。超说明书用药类型包括超适应证(87.73%)、超剂量(6.54%)、超给药频次(5.08%)、未提及儿童用药信息(0.55%)和超年龄(0.11%)。超适应证用药记录居前3位的为硫酸羟氯喹片(1 091条)、甲氨蝶呤片(713条)和沙利度胺片(147条)。超适应证用药多有循证医学证据支持或指南文献推荐,但证据质量存在差异。结论:风湿免疫科超说明书用药较常见,一方面说明了风湿免疫性疾病新药研发及药品说明书信息更新严重滞后于医学发展,另一方面也提示国家应出台相关法律法规或指南共识,以规范日趋严重的超说明书用药行为,保障患者用药安全和规避医师职业风险。AIM：To investigate the application of the off-label drug in rheumatic immunology department so as to provide reference for establishing the standard for evaluation and management.METHODS：Statistical data of the surrogate prescriptions of rheumatic immunology department in our hospital from April to June in 2016 were collected and were analyzed from the indications,the intended group,the dosage,the frequency,the route of administration and contraindication according to the instructions of the drug.Guideline of evidencebased medicine,relevant literature,clinical guidance and expert consensus were referred to evaluate their rationality.RESULTS：3 501 prescriptions from the outpatient clinic of the department of rheumatic immunology were included,9 889 records involved.According to the prescription and medication record,the incidence rates were 47.50% and 27.69%,respectively.The specific drug use types included over-indication （87.73%）,over-dosage （6.54%）,over frequencies （5.08%）,no usage information for children （0.55%） and usage exceed certain age （0.11%）.Hydroxychloroquine sulfate tablets （1 091 records）,methotrexate tablets （713 records） and thalidomide tablets （147 records） ranked the top 3 of the over-indications.Guideline of evidence-based medicine,and relevant literature could be selected to support the over-indication,but the quality of evidence remains difference.CONCLUSION：Off-label drug use in rheumatic immunology is common,which on one hand shows the development and information update of drug for rheumatic immune disease lags behind the development of medicine,on the other hand suggests that relevant laws,regulations or guidelines for off-label drug use should be formulate to regulate such behavior so as to protect the safety of patients as well as to avoid physician occupation risk.

关 键 词：风湿免疫科 超说明书用药 处方分析 风险 

分 类 号：R457[医药卫生—治疗学]