我国23家医疗机构妇产科超说明书用药现状调查

Survey on off-label use of drugs in departments of gynecology and obstetrics of 23 hospitals in China

目的 调查我国23家医疗机构的妇产科超说明书用药现状,为相关决策提供依据。方法 将收集到的妇产科相关超说明书用药目录,统一药品名称,参考《新编药物学》(第17版)的药品分类,结合医疗机构性质、给药途径、超说明书用药类型、科室及依据进行分析。结果 23家医疗机构共涉及130种药品的687条妇产科超说明书用药信息。与综合医院比较,专科医院备案了更多的超说明书用药(χ^(2)=15.936,P=0.043)。排名前3位的科室分别是生殖科(23.3%)、产科(22.7%)、妇科(21.1%)。共涉及一级药物分类14种,二级药物分类39种,数量最多的3种药物分别是激素及其有关药物(33.8%)、抗肿瘤药物(24.5%)、主要作用于泌尿和生殖系统的药物(14.1%)。超说明书用药类型为超适应证(93.2%)、超剂量/频率(18.3%)、超适用人群(13.0%)及超给药途径(10.0%)。各类药物的超说明书用药类型间差异均有统计学意义(P<0.001)。687条超说明书用药的用药依据中有582条证据级别较高,占比84.7%。结论 妇产科常见超说明书用药的品种具有鲜明的特色,在用药依据方面还存在很多不足。

Objective To investigate the off-label use of drugs in departments of gynecology and obstetrics of 23 hospitals,so as to provide baseline for policy-making.Methods Off-label drug use in obstetrics and gynecology classification were collected to unify the names of drugs.All drugs were classified according to New Pharmacology(17th Edition),and analyzed in combination with the nature of medical institutions,route of administration,types of off-label drugs,departments and basis.Results A total of 687 information of 130 drugs was involved.Specialized hospitals provided significantly more information than comprehensive hospitals(χ^(2)=15.936,P=0.043).The top 3 departments were reproductive department(23.3%),obstetrics department(22.7%)and gynecology department(21.1%).There were 14 first-class drugs and 39 second-class drugs.The top 3 class were hormones and related drugs(33.8%),anti-tumor drugs(24.5%)and drugs mainly acting on urinary and reproductive systems(14.1%).The main types of off-label were over indication(93.2%),over dose/frequency(18.3%),over applicable population(13.0%)and over route of administration(10.0%).There was a significant difference in the distribution of off label types in all kinds of drugs(P<0.001).About 84.7%of off-label use of drugs had high level of evidences.Conclusion The common varieties of drugs beyond the instructions in gynecology and obstetrics have distinctive characteristics,and there are still many deficiencies in the evidence of off-label drug use.