利用循证医学方法对前列地尔注射液超说明书用药的评估探讨  

Assessment of off-label use of alprostadil injection by evidence-based medical approach

作　　者：张文[1] 汪琳[1] 赵咏莉[1] 陈月平[1] 夏礼斌 栾家杰[1] 

机构地区：[1]皖南医学院第一附属医院,安徽芜湖241001

出　　处：《中国医院药学杂志》2017年第2期177-180,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:通过对前列地尔注射液专科超说明书用药进行循证评估,为临床处方点评及医嘱审核中超说明书用药的合理性判断提供技术参考。方法:收集某院2015年内分泌科医嘱审核中发现的前列地尔注射液超说明书用药情况,按照Cochrane手册5.1及GRADE系统要求建立超说明书用药的循证评价流程,判断其超说明书用药有无循证依据。结果:医嘱审核汇总后有4项前列地尔注射液超说明书用药现象,其中应用于糖尿病周围神经病变和糖尿病足有指南和(或)权威医学专著记录,评估为有循证证据;应用于糖尿病肾病根据CDSR和DARE结论评估为无循证证据;应用于糖尿病视网膜病变根据对临床试验进行GRADE评级后评估为无循证证据。结论:利用循证评价方法和流程对超说明书用药进行评估,不仅有助于临床药师开展日常工作,更为促进临床合理用药提供了技术支持。OBJECTIVE To providing a practical reference for assessing the rationality of off-label use of alprostadil injection during prescription grading and revision of medical advices by an evidence-based medical approach. METHODS All cases of off- label use of alprostadil injection found in medical advice revision in 2015 were collected and their evidence based proofs were as- sessed following an evidence-base evaluation procedure developed based on Cochrane Handbook 5. 1 and GRADE system. RE- SULTS The summarized data showed that off-label use of alprostadil injection could be categorized into four groups： off-label use for the therapy of diabetic peripheral neuropathy and diabetic foot was backed up by certain medical guidelines and（or） au- thentic medical monographs, and was graded as evidence-based; off-label use for diabetic nephropathy was graded as non-evi- dence-based according to CDSR and DARE conclusions; the assessment on the off-label use for diabetic retinopathy was conduc- ted by assessing related clinical trials by GRADE scoring and the result was non evidence-based. CONCLUSION Assessment of off-label use of alprostadil injection by evidence-based approach is helpful to the pharmacists for their clinical practice. In the meantime, technical support can be provided for the rational use of medicines.

关 键 词：医嘱审核 超说明书用药 循证医学 前列地尔 糖尿病 

分 类 号：R969.3[医药卫生—药理学]