医院抗肿瘤药物超说明书使用调查分析

Investigation on Off-Label Use of Antineoplastic Drugs in a Hospital

目的探讨医院抗肿瘤药物超说明书使用情况及合理性。方法提取医院2017年住院患者在院期间使用抗肿瘤药物的用药医嘱,根据药品说明书判定是否超说明书,并记录超说明书患者的基本信息、临床诊断、用药情况及超说明书类型等。结果医院现有抗肿瘤药物27种,其中超说明书使用的抗肿瘤药物有22种(81.48%);超说明书类型包括超适应证(86.36%)、超剂量(27.27%)、超溶剂量(31.82%)、超途径(22.73%)、超溶剂品种(18.18%)、超频次用药(18.18%);各类超说明书抗肿瘤药物分别为烷化剂(7.41%)、抗代谢药(18.52%)、抗肿瘤抗生素(14.82%)、植物来源的抗肿瘤药及其衍生物(22.22%)、抗肿瘤激素类(0)、其他(18.52%);用药次数排序前5位的超说明书使用的抗肿瘤药物分别为丝裂霉素(21.74%)、氟尿嘧啶(6.32%)、环磷酰胺(4.31%)、紫杉醇(2.30%)和顺铂(0.43%)。结论医院大部分抗肿瘤药物存在超说明书使用现象,但大部分都有较强的科学用药依据,少部分为不合理用药。

Objective To investigate the situation and rationality of off-label use of antineoplastic drugs.Methods Medical orders of antineoplastic drugs for inpatients in the hospital in 2017 were extracted,and whether or not the off-label drug use was judged based on the drug instruction.The patients'essential information,clinical diagnosis,using situation of drugs,and types of off-label drug use were recorded.Results There are 22 kinds of off-label drugs(81.48%)in all 27 kinds of antineoplastic drugs in our hospital.The main types of off-label drug use were off-label indication(86.36%),off-label dosage(27.27%),off-label drug solvent(31.82%),off-label drug administration route(22.73%),off-label drug solvent variety(18.18%),and off-label drug frequency medication(18.18%).All kinds of off-label use of antineoplastic drugs were alkylating agents(7.41%),antimetabolites(18.52%),antineoplastic antibiotics(14.82%),plant-derived antineoplastic drugs and their derivatives(22.22%),antineoplastic hormones(0)and others(18.52%).The off-label incident rates of the top 5 administration frequency of antineoplastic drugs were mitomycin(21.74%),fluorouracil(6.32%),cyclophosphamide(4.31%),paclitaxel(2.30%)and cisplatin(0.43%).Conclusion Most of the antineoplastic drugs used in our hospital are off-label,but most of them have strong scientific basis for drug use,only a few are irrational.