某院ART患者雌二醇制剂超说明书用药情况调查与分析
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摘要
目的:为临床雌二醇(E_2)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E_2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E_2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E_2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(E_2)preparation in clinic. METHODS:The medical records of outpatients receiving assisted reproductive technology(ART) and E_2 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 E_2 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 E_2 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.
OBJECTIVE:To provide reference for rational use of estradiol(E_2)preparation in clinic. METHODS:The medical records of outpatients receiving assisted reproductive technology(ART) and E_2 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 E_2 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 E_2 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.
引文
[1]罗丽兰.不孕与不育[M].2版.北京:人民卫生出版社,2009:217-227.
[2]中华医学会.临床诊疗指南:辅助生殖技术与精子库分册[M].北京:人民卫生出版社,2012:21-70.
[3]孙赟,刘平,叶虹,等.黄体支持与孕激素补充共识[J].中华生殖与避孕杂志,2015,35(1):1-8.
[4]胡嘉,刘丝荪,张静,等.芬吗通在冻融胚胎移植周期中的应用效果[J].中国妇幼保健,2016,31(1):119-121.
[5] ISMAIL MADKOUR WA,NOAH B,ABDEL HAMID AM,et al. Luteal phase support with estradiol and progesterone versus progesterone alone in GnRH antagonist ICSI cycles:a randomized controlled study[J]. Hum Fertil:Camb,2016,19(2):142-149.
[6]广东省药学会.关于印发《药品未注册用法专家共识》的通知[S].2010-03-18.
[7]司徒冰,罗慕华,刘见桥,等.辅助生殖患者在黄体支持中的超说明书用药调查[J].中国医院药学杂志,2015,35(17):1587-1591.
[8]赵诗艺,刘英,杨晓葵,等.薄型子宫内膜冻融胚胎移植周期中应用雌二醇/雌二醇地屈孕酮的疗效观察[J].实用妇产科杂志,2015,31(4):270-273.
[9] LIN H,LI Y,LI L,et al. Oral oestradiol supplementation as luteal support in IVF/ICSI cycles:a prospective,randomized controlled study[J]. Eur J Obstet Gynecol Reprod Biol,2013,167(2):171-175.
[10]国家药典委员会.中华人民共和国药典:临床用药须知:化学药和生物制品卷[S].2015年版.北京:中国医药科技出版社,2015:548-1445.
[11]董悦.妊娠期和哺乳期用药[M].7版.北京:人民卫生出版社,2009:447-448.
[12] HERBST AL,POSKANZER DC,ROBBOY SJ,et al. Prenatal exposure to stilbestrol:a prospective comparison of exposed female offspring with unexposed controls[J]. N Engl J Med,1975,292(7):334-339.
[13] BIBBO M,GILL WB. Screening of adolescents exposed to diethylstilbestrol in utero[J]. Pediatr Clin North Am,1981,28(2):379-388.
[14] HENDRICKX AG,KORTE R,LEUSOHNER F,et al.Embryotoxicity of sex steroidal hormones in nonhuman primates:Ⅱ:hydroxyprogesterone caproate,estradiol valerate[J]. Teratology,1987,35(1):129-136.
[15]朱坤贤.我院药物剂型临床不合理使用现象分析[J].北方药学,2012,9(3):79-80.
[16]中华医学会生殖医学分会.促性腺激素释放激素拮抗剂方案在辅助生殖领域中使用的专家共识[J].中华妇产科杂志,2015,50(11):805-809.
[17]杨硕,李蓉.GnRH拮抗剂在控制性促排卵中的方案和疗效[J].实用妇产科杂志,2016,32(10):721-723.
[18]全国人民代表大会.中华人民共和国执业医师法[S].北京:中国法制出版社,2001:9-10.
[19]王颖,谭湘萍,司徒冰.我院超说明书用药的分级管理研究[J].中国药房,2017,28(10):1306-1309.
[2]中华医学会.临床诊疗指南:辅助生殖技术与精子库分册[M].北京:人民卫生出版社,2012:21-70.
[3]孙赟,刘平,叶虹,等.黄体支持与孕激素补充共识[J].中华生殖与避孕杂志,2015,35(1):1-8.
[4]胡嘉,刘丝荪,张静,等.芬吗通在冻融胚胎移植周期中的应用效果[J].中国妇幼保健,2016,31(1):119-121.
[5] ISMAIL MADKOUR WA,NOAH B,ABDEL HAMID AM,et al. Luteal phase support with estradiol and progesterone versus progesterone alone in GnRH antagonist ICSI cycles:a randomized controlled study[J]. Hum Fertil:Camb,2016,19(2):142-149.
[6]广东省药学会.关于印发《药品未注册用法专家共识》的通知[S].2010-03-18.
[7]司徒冰,罗慕华,刘见桥,等.辅助生殖患者在黄体支持中的超说明书用药调查[J].中国医院药学杂志,2015,35(17):1587-1591.
[8]赵诗艺,刘英,杨晓葵,等.薄型子宫内膜冻融胚胎移植周期中应用雌二醇/雌二醇地屈孕酮的疗效观察[J].实用妇产科杂志,2015,31(4):270-273.
[9] LIN H,LI Y,LI L,et al. Oral oestradiol supplementation as luteal support in IVF/ICSI cycles:a prospective,randomized controlled study[J]. Eur J Obstet Gynecol Reprod Biol,2013,167(2):171-175.
[10]国家药典委员会.中华人民共和国药典:临床用药须知:化学药和生物制品卷[S].2015年版.北京:中国医药科技出版社,2015:548-1445.
[11]董悦.妊娠期和哺乳期用药[M].7版.北京:人民卫生出版社,2009:447-448.
[12] HERBST AL,POSKANZER DC,ROBBOY SJ,et al. Prenatal exposure to stilbestrol:a prospective comparison of exposed female offspring with unexposed controls[J]. N Engl J Med,1975,292(7):334-339.
[13] BIBBO M,GILL WB. Screening of adolescents exposed to diethylstilbestrol in utero[J]. Pediatr Clin North Am,1981,28(2):379-388.
[14] HENDRICKX AG,KORTE R,LEUSOHNER F,et al.Embryotoxicity of sex steroidal hormones in nonhuman primates:Ⅱ:hydroxyprogesterone caproate,estradiol valerate[J]. Teratology,1987,35(1):129-136.
[15]朱坤贤.我院药物剂型临床不合理使用现象分析[J].北方药学,2012,9(3):79-80.
[16]中华医学会生殖医学分会.促性腺激素释放激素拮抗剂方案在辅助生殖领域中使用的专家共识[J].中华妇产科杂志,2015,50(11):805-809.
[17]杨硕,李蓉.GnRH拮抗剂在控制性促排卵中的方案和疗效[J].实用妇产科杂志,2016,32(10):721-723.
[18]全国人民代表大会.中华人民共和国执业医师法[S].北京:中国法制出版社,2001:9-10.
[19]王颖,谭湘萍,司徒冰.我院超说明书用药的分级管理研究[J].中国药房,2017,28(10):1306-1309.
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