某院门诊甲氨蝶呤片超说明书使用的循证医学分析与管理

Evidence-based Medical Analysis and Management of Off-label Use of Methotrexate in A Hospital’s Outpatients

目的通过循证医学的方法评价和规范甲氨蝶呤片的合理用药。方法回顾性调取河北省人民医院2018年1月—2019年6月甲氨蝶呤片门诊处方1 011张,对超说明书用药的处方进行分类统计,并通过Micromedex的Thomson分级系统进行评价,根据评价结果给出超说明书用药的推荐意见及干预措施。结果甲氨蝶呤片超说明书使用的主要类型为超适应证用药,占比90.7%,其次为超单次剂量,占比37.4%,发生率最高的科室为风湿免疫科;发生率排名前3的临床诊断为类风湿性关节炎,其次为原发性干燥综合征、皮肌炎。据超说明书用药的循证分析结果及笔者所在医院超说明书管理制度,超适应证用药的临床诊断共4种,同意使用的有3种,限制使用的1种;超适应证同时超单次剂量用药的临床诊断有6种,同意使用的6种;超单次剂量用药的临床诊断有1种,评价结果为同意使用。结论甲氨蝶呤片超说明书用药现象普遍存在,须严格执行超说明书用药管理制度,促进临床合理用药。

OBJECTIVE To evaluate the clinical use and standardize rational drug use of methotrexate through evidenced-based medicine. METHODS A retrospective survey of 1 011 prescription for methotrexate tablets from outpatient of Hebei People’s Hospital from January 2018 to June 2019 was conducted. The prescription in which methotrexate was used off-label were categorized and evaluated by Thomson grading system of Micromedex. According to the results of evaluation, the recommendations and intervention measures of off-label use were given out. RESULTS The main type of off-label use of methotrexate tablets was super indication, accounting for 90.7%, followed by super single dose, accounting for 37.4%, the highest incidence department was rheumatology. The top three clinical diagnoses were rheumatoid arthritis, Sj?gren’s, dermatomyositis. According to the hospital’s off-label management system, analyzing evidence-based medical evidence, there were 4 types of extra-indication which 3 types were agreed to use, and one type was limited use. Six types of extra-indication and over single use at the same time were agreed to use. A type of over single was agreed to use. CONCLUSION It is a widespread phenomenon of the off-label use of methotrexate tablets. It must be strictly implement off label management system to promote safe medication.