基于循证药学的血液科药品说明书外用药情况分析与评价  

Analysis and evaluation of off-label uses of hematological drugs based on evidence-based pharmacy

作　　者：韩芙蓉[1] 张弨 李彤[2] 宋智慧[1] 徐姗姗[1] 王昕[1] HAN Fu-rong;ZHANG Chao;LI Tong;SONG Zhi-hui;XU Shan-shan;WANG Xin(Department of Pharmacy,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China;Intensive Care Unit,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China)

机构地区：[1]首都医科大学附属北京同仁医院药学部,北京100730 [2]首都医科大学附属北京同仁医院重症医学科,北京100730

出　　处：《临床药物治疗杂志》2023年第7期60-64,共5页Clinical Medication Journal

摘　　要：目的 分析首都医科大学附属北京同仁医院血液科药品说明书外用药情况,并进行循证评价。方法 收集2013年1月至2023年4月血液科处方和医嘱中药品说明书外用法情况,并运用Thomson Micromedex循证药学数据库的DrugDex分级系统进行分析和评价。结果 血液科共有49项药品说明书外用药,包括45项说明书外适应证用药(91.8%)和4项说明书外用法用量用药(8.2%);说明书外用法涉及19个药品品种,其中18种药品为说明书外适应证用药,3种为说明书外用法用量用药,占全院药品品种的1.2%(19/1462),主要为抗肿瘤类药物(78.9%,15/19)。49项说明书外用药中,9项(12.3%)已被FDA批准,20项(27.4%)在国际指南中推荐,15项(20.5%)在国内指南中推荐,27项(37.1%)符合专著。19项(38.8%)药品说明书外用药在Micromedex循证药学数据库收录,有效性等级Ⅰ级和Ⅱa级分别占10.5%和89.5%;推荐级别Ⅰ级、Ⅱa级和Ⅱb级分别占10.5%、31.6%和57.9%;证据等级均为B级。结论 血液科处方和医嘱中说明书外用药比较常见,均有循证药学证据支持,但个别用法证据质量较低,需进一步规范化管理以减少潜在风险。Objective To analyze the off-label uses of drugs in the Department of Hematology,Beijing Tongren Hospital,Capital Medical University and conduct evidence-based evaluation.Methods The off-label uses of drugs in hematological prescriptions and medical orders from January 2013 to March 2023 were collected,and analyzed and evaluated using the DrugDex grading system of Thomson Micromedex evidence-based pharmacy database.Results There were 49 off-label uses in the Department of Hematology,including 45 off-label indications(91.8%) and 4 off-label dosages(8.2%).The off-label uses involved 19 drug varieties.Among them,eighteen drugs were used outside of the instruction manual and drug was used outside of the instruction manval in terms of usage and dosage,accounting for 1.2%(19/1462) of the total drug varieties in the hospital,mainly antitumor drugs(78.9%,15/19).Of the 49 off-label uses,9(12.3%) were approved by the U.S.FDA,20(27.4%) were recommended in international guidelines,15(20.5%) were recommended in domestic guidelines,and 27(37.1%) were consistent with monographs.Nineteen(38.8%) off-label uses were included in the Micromedex evidencebased pharmacy database,with efficacy grades I and IIa accounting for 10.5% and 89.5%,respectively.Recommendation level Ⅰ,Ⅱa and Ⅱb accounted for 10.5%,31.6% and 57.9% respectively;The evidence was classified as B.Conclusion Off-label uses commonly exist in hematological prescriptions and medical orders,all supported by evidence,but the evidence level of a small number of uses is low,and further standardized management is needed to reduce potential risks.

关 键 词：药品说明书 说明书外用药 血液科 循证药学 

分 类 号：R969.3[医药卫生—药理学]