生殖中心超说明书用药调查

Survey and analysis on off-label Drug Use in the Outpatient Reproductive Center

关键词:  超说明书用药  生殖中心  不孕症  体外授精

Key words:  off-label drug use  reproductive center  infertility  in vitro fertilization

摘要:

目的 回顾性调查并分析2015年宁波市妇女儿童医院门诊生殖中心超说明书用药现状，为我国制定超说明书用药政策提供依据和参考。方法 采用回顾性调查法，抽取该院2015年门诊生殖中心所有处方，依据药品说明书，判断其用药医嘱是否超说明书，分析各超说明书类型、各类药品超说明书用药情况以及比较不同等级循证医学或文献证据支持的超说明书用药记录在超说明书用药总量中的构成比；另外采用χ²检验比较不同年龄段人群超说明书用药发生率的差异。结果 共抽取门诊生殖中心处方46 621张，分析处方用药医嘱90 951条，按处方或用药医嘱计，超说明书用药发生率分别为58.76%、35.70%。超说明书用药类型主要包括超适应证（56.25%）和超剂量（39.55%）2种，两者之和占所有类型超说明书用药发生率总量的95%以上。不同年龄段女性的超说明书用药发生率不同，≤29岁女性组、30~39岁女性组与≥40岁女性组的超说明书用药发生率分别两两比较，无论按处方或按医嘱计均为P<0.01，差异有显著统计学意义。超适应证用药发生率居前两位的是甾体性激素类药物（45.11%）和生长激素（31.26%）。比较3类不同循证医学证据的超说明书用药记录在超说明书用药总量中的构成比，权威性较高证据支持的超说明书用药医嘱占超说明书用药医嘱总量的比例越高。结论 2015年宁波市妇女儿童医院门诊生殖中心超说明书用药情况普遍，合理评价门诊生殖中心超说明书用药，认为超说明书用药比较合理。为保护合理的超说明书用药，需要国家出台相应的法律法规。

Abstract:

OBJECTIVE To supply basises and references for the formulation of the policy by analyzing the applications of off-label prescriptions in the reproductive center of Ningbo Women and Children's Hospital in 2015 retrospectively. METHODS By a retrospective survey method, all prescriptions were selected from fertility clinics center of the hospital in 2015. Firstly, all prescriptions were judged whether off-label or not according to drug instructions and were classified to which type it belonged to and were analyzed to study how many kinds of drugs they involved. Then, to compare constituent ratio of off-label prescriptions with different grades evidence support in the total prescriptions. At last, compared of off label drugs uses in different age group using Chi-square test to detect if there was significant difference. RESULTE A total of 46 621 prescriptions were extracted from the outpatient reproductive center, and they contained 90 951 medication orders. The incidences of the off-label drug uses stood at 58.76% or 35.70% of them. The types of off-label drug uses mainly included two kinds, which were super adaptation (56.25%) and super dosage (39.55%) and they sumed up to 95% of all off-label drug uses. Steroid hormone drugs (45.11%) and growth hormone (31.26%) were in the top two of the super adaptation. The difference was significant in each two groups of the three groups of the age group 30-39 and below age 29 and elder age 40 (P<0.01). Comparisons of the three kinds of different medical evidence of off label uses, the off-label prescriptions with higher authority evidence support were of higher proportion in the total prescriptions. CONCLUSION It was generally of off-label drugs in the reproductive center of Ningbo Women and Children's Hospital in 2015. Through reasonable evaluation of prescriptions, the study provides the basis for the rational use of drugs in the clinics. Corresponding laws and regulations should be introduced by the relevant national institutions to protect reasonable off-label use behavisis in clinical practice.