肿瘤患儿化疗辅助用药超说明书及循证医学分析  

Analysis of Off-label Uses and Evidence-based Medicine on the Orders of Chemotherapy Adjuvant Medications for Children with Solid Tumor

作　　者：徐姗姗[1] 宋智慧[1] 张弨 XU Shanshan;SONG Zhihui;ZHANG Chao(Department of Pharmacy,Beijing Tongren Hospital of 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

出　　处：《医药导报》2022年第7期1033-1038,共6页Herald of Medicine

摘　　要：目的调查实体肿瘤患儿化学治疗(化疗)辅助用药医嘱的超说明书用药情况,并对其进行循证医学分析,为患儿辅助化疗合理用药提供参考。方法回顾性统计2019年第4季度首都医科大学附属北京同仁医院儿科实体肿瘤患儿的化疗辅助用药医嘱,参照国家食品药品监督管理总局批准的最新药品说明书,对化疗辅助用药的超说明书用药情况进行统计,并进行循证医学分析。结果共收集该院恶性实体肿瘤患儿564例,涉及医嘱9978条,其中辅助用药医嘱4821条,涉及辅助用药23种,其中存在超说明用药的辅助用药18种,涉及医嘱4032条,占全部医嘱的40.41%,占全部辅助用药医嘱的83.63%,包括超适应证用药医嘱1863条(占46.21%),超适用人群用药医嘱1209条(占29.99%),超剂量用药798条(占19.79%),超给药频次用药162条(占4.02%)。未发现超禁忌证用药和超给药途径给药。18种药物共涉及19项超说明书用药情况,其中8种药物的有效性等级为Ⅱa,7种为Ⅱb,4种为Ⅲ;5种药物的推荐等级为Ⅱa,9种为Ⅱb,5种为Ⅲ;5种药物的证据等级为B,10种为C,4种为无证据。结论该院实体肿瘤患儿化疗辅助用药的超说明书用药发生率高,循证医学证据级别较低,应加强儿童化疗辅助用药超说明书用药管理,严格限制无依据超说明书用药行为,保障患儿用药安全。Objective To investigate and analyze the situation and evidence-based medicine of off-label uses for chemotherapy adjuvant medications in children with a solid tumor,to provide references for rational clinical use for chemotherapy adjuvant medications in children.Methods Medical orders of chemotherapy adjuvant medications in children with the solid tumor in the fourth quarter of 2019 in the department of pharmacy of Beijing Tongren Hospital of Capital Medical University were retrospectively investigated.The medical orders of off-label medication were analyzed by reference to the latest dispensatory approved by the China Food and Drug Administration and were analyzed according to the evidence-based medicine.Results A total of 564 children with the solid tumor in the department of pediatrics in Beijing Tongren Hospital were collected,including 9978 medical orders,of which 4821 were orders of chemotherapy adjuvant medications with 23 medications.There were 18 off-label medications with 4032 orders,accounting for 40.41%of all the orders and 83.63%of all the orders of chemotherapy adjuvant medications.In the 4032 medical orders,1863(46.21%)were over-indications,1209(29.99%)were inappropriate patients,798(19.79%)were overdose medications and 162(4.02%)were over-frequency medications.There were no under contra indications and improper administration route medication.In the 18 off-label medications with 19 off-label situations,8 were with ClassⅡa of effectiveness level,7 with ClassⅡb and 4 withⅢ,5 were with ClassⅡa of recommended level,9 with ClassⅡb and 4 withⅢ,5 were with Class B of evidence level,10 with Class C,and 4 with no category.Conclusion The incidence of off-label medication for chemotherapy adjuvant medications in children with solid tumors is relatively high;and the evidence level of many off-label medications is relatively low.The administration on off-label medication for chemotherapy adjuvant medications in children needs to be strengthened,and unreasonable off-label medication should be sever

关 键 词：化疗辅助用药 超说明书用药 循证医学 实体肿瘤 

分 类 号：R95[医药卫生—药学] R969