某院不孕症超说明书用药分析

Analysis of off-label drug use in infertility

目的分析某院不孕症超说明书用药的合理性,为临床用药提供科学依据,对某院规范超说明书用药提出建议。方法选取某院2016年12月至2017年1月生殖助孕中心的门诊处方1 141张,列出所有超说明书药品;通过查阅相关指南、文献等对其用药合理性进行分析评价。结果超适应证用药中盐酸二甲双胍片、来曲唑片、阿司匹林肠溶片、黄体酮注射液等均有相关国内外指南推荐,循证医学证据级别较高,可归为合理用药,羟乙基淀粉130/0.4氯化钠注射液未查到相关资料支持,属医师经验用药;超剂量用药中黄体酮注射液有国内指南推荐,归为合理用药,戊酸雌二醇片无相关资料支持,属医师经验用药;超给药途径用药中雌二醇片/雌二醇地屈孕酮片复合装2/10有国内指南推荐,归于合理用药。结论某院不孕症超说明书用药的现象广泛存在,用药情况大部分合理,临床医师应当谨慎用药;某院需对有较高循证医学证据的超说明书用药行为进一步规范化管理,尽早实施《药品超说明书用药临床应用管理规定》。

Objective To analyze the rationality of off-label use of drugs in infertility of a hospital,to provide the scientific basis for the clinical medications,and to provide suggestion for standardizing the management of off-label use of drugs in the hospital.Methods A total of 1 141 outpatient prescriptions were selected from the reproductive center in clinical department from December 2016 to January 2017.All the off-label drugs were listed.The rationality of the medication was analyzed and evaluated by referring to the relevant guidelines and literature.Results Those off-label use of drugs were evidence-based medicine recommended by domestic and foreign guidelines,including metformin hydrochloride tablets,letrozol tablets,aspirin enteric-coated tablets,progesterone injection,etc.and could be classified as rational use.No information of hydroxyethy base starch 130/0.4 sodium chloride injection was found,it could be classified as a physician-experienced use.Overdose in the progesterone injection was guide-recommended at domestic and classified as a reasonable use.Valeric acid estradiol tablets was without any relevant information supported,which was classified as physician-experienced drugs.Estradiol tablets/estradiol triclosan tablets composite package 2/10 were guide-recommended at domestic and classified as reasonable drugs.Conclusion The phenomenon of off-label use of drugs is widespread in infertility in the hospital;most of the medications are reasonable;clinicians should be carefully using drugs.The hospital should further standardize the management of off-label use of drugs,so as to improve the level of clinical rational medications and a reasonable rate of prescription.