基于循证医学方法评价贝前列素钠超适应证用药情况  

Assessment of off-indication drug use of beraprost sodium by evidence-based medical approach

作　　者：崔佳[1] 司福国 曹迪[1] 程军[1] 王海坤[2] CUI Jia;SI Fu-guo;CAO Di;CHENG Jun;WANG Hai-kun(Department of Pharmaceutical Affairs,the third People's Hospital of Bengbu,Bengbu ANHUI 233000,China;Department of Pharmacy,People's Hospital of Bozhou City,Bozhou ANHUI 236800,China)

机构地区：[1]安徽省蚌埠市第三人民医院药学部,安徽蚌埠233000 [2]亳州市人民医院药学部,安徽亳州236800

出　　处：《中国新药与临床杂志》2022年第7期431-437,共7页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的基于循证医学方法对贝前列素钠超适应证用药情况进行评价,提出分级管理建议。方法收集本院2020年门诊使用贝前列素钠的处方,按药品说明书筛选出超适应证用药处方。按照GRADE分级系统要求建立循证医学评价流程,检索超适应证相关的循证证据,对其证据质量进行评估和分级,判断超适应证有无循证证据并提出分级管理建议。结果贝前列素钠超适应证用药涉及肺动脉高压、糖尿病周围神经病变、糖尿病足、雷诺综合征、脑梗死、偏头痛、冠心病、硬皮病及神经性耳聋9种诊断;根据国外药品说明书及权威医学专著,判定肺动脉高压有循证证据,建议A级管理,同意使用;根据指南,判定糖尿病足与糖尿病周围神经病变有循证证据,建议B级管理,限制使用;其余诊断均无循证证据,建议D级管理,禁止使用。结论经循证医学证据评价,贝前列素钠治疗肺动脉高压、糖尿病周围神经病变、糖尿病足三种超适应证用药为合理用药,其余超适应证用药为不合理用药,建议禁用。AIM To evaluate the off-indication drug use of beraprost sodium based on evidence-based medicin e,and provide a recommendations for hierarchical management.METHODS All cases of off-indication drug use for outpatient use of beraprost sodium in our hospital in 2020 were collected,these super-indication prescriptions were selected according to the drug instructions.According to the requirements of the GRADE grading system,an evidence based medicine evaluation process was established.The evidences related to off-indication were searched.These qualities of the evidences were evaluated and graded to judge whether there was evidence-based evidence for off-indication,and these classification management suggestions were proposed.RESULTS The off-indication drug use of beraprost sodium involved 9 diagnoses of pulmonary hypertension,diabetic peripheral neuropathy,diabetic foot disease,Raynaud’s syndrome,cerebral infarction,migraine,coronary heart disease,scleroderma and sensorineural hearing loss.Evidence of pulmonary hypertension was found by drug instructions and authoritative medical monographs abroad,the level of recommendation management was‘A’and agreed to use.Evidences of diabetic foot and diabetic peripheral were found by guidelines,levels of recommendation management were‘B’and limited to use.No evidence for other off-indication drug use,levels of recommendation management were‘D’and prohibited to use.CONCLUSION Based on the evidence-based medicine,there is evidencebased medicine for beraprost sodium in the treatment of pulmonary hypertension,diabetic peripheral neuropathy,and diabetic foot.There is no evidence-based medicine for other off-indication drug use,and needed to prohibit to use.

关 键 词：贝前列素钠 循证医学 药品标示外使用 肺动脉高压 

分 类 号：R969[医药卫生—药理学]