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目的:为临床雌二醇(E2)制剂的合理应用提供参考。方法:收集2016年1月-2017年3月于某院生殖医学中心接受辅助生殖助孕技术(ART)且使用E2制剂[包括戊酸雌二醇片(EV)、雌二醇片/雌二醇地屈孕酮片复合包装(EP)、雌二醇凝胶(EG)]的门诊患者的病历资料,以药品说明书为标准,从适应证、用药途径、禁忌证、用法用量、疗程等方面对其合理性进行评价;同时通过电话或门诊等方式对上述患者进行随访,对其妊娠结局和不良反应发生情况进行汇总。结果:共收集处方12 646张,使用EV、EP、EG、EV+EP的处方分别为7 222、3 912、181、1 331张;涉及超说明书用药的类型包括超适应证、超用药途径、超禁忌证,其超说明书用药率分别为100%、11.73%、43.60%。共涉及ART患者5 868例,新鲜胚胎移植和冻融胚胎移植者分别为439、5 429例,分别涉及处方720、11 926张,其上述E2制剂超说明书用药率均为100%(使用EG的新鲜胚胎移植者除外)。截至2018年2月,使用EV、EP、EG、EV+EP的ART患者的抱婴率分别为85.29%、85.37%、86.36%、85.45%,且未见相关不良反应和出生缺陷的发生。结论:该院生殖医学中心E2制剂超说明书用药现象普遍,虽未提示相关安全风险,但临床仍需扩大样本量进行循证评价,并谨慎使用。
OBJECTIVE: To provide reference for rational use of estradiol (E2) preparation in clinic. METHODS: The medical records of outpatients receiving assisted reproductive technology (ART) and E2 preparation [Estradiol valerate tablets (EV), Complex packing estradiol tablets/estradiol and dydrogesterone tablets (EP), Estradiol gel (EG)] were collected from the reproductive medicine center of a hospital during Jan. 2016-Mar. 2017. Taking drug instruction as standard, the rationality of medical records was evaluated from aspects of indication, route of administration, contraindication, usage and dosage, treatment course, etc. At the same time, these patients were followed up by telephone or outpatient service, and their pregnancy outcomes and ADR were summarized. RESULTS: A total of 12 646 prescriptions were collected, and 7 222, 3 912, 181 and 1 331 prescriptions used EV, EP, EG and EV+EP, respectively. The types of off-label use included over-indication, over-route and over-contraindication, and the rates of off-label use rates were 100%, 11.73% and 43.60%, respectively. A total of 5 868 ART patients were involved; 439 patients received fresh embryo transplantation, and 5 429 patients received frozen-thawed embryo transplantation, involving 720 and 11 926 prescriptions, respectively. The rates of off-label use of above E2 preparations were 100% (except for fresh embryo transplantation patients using EG). As of Feb. 2018, the infant-holding rates of ART patients using EV, EP, EG and EV+EP were 85.29%, 85.37%, 86.36% and 85.45%, respectively. No relevant ADR and neonatal birth defect was found. CONCLUSIONS: The phenomenon of off-label use of E2 preparations is widespread in the reproductive medicine center of the hospital. Although there is no indication of related safety risks, evidence-based evaluation should be carried out by enlarging the sample size in clinical practice, and careful use.
雌二醇制剂辅助生殖助孕技术超说明书用药调查分析
Estradiol preparationAssisted reproductive technologyOff-label useInvestigationAnalysis
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