尿源性卵泡刺激素用于促排卵治疗的临床疗效、安全性与经济性:基于102 061个体外受精周期的多中心回顾性队列研究  

Effectiveness,safety and cost of urinary follicle stimulating hormone in controlled ovarian stimulation in China:multi-center retrospective cohort study of 102061 in vitro fertilization cycles

作　　者：朱依敏[1] 高悦 乃东红 胡琳莉[4] 靳镭 钟影 武泽 郝桂敏[8] 伍琼芳[9] 管一春[10] 姜宏 张翠莲[12] 刘敏利[13] 王晓红 滕晓明 段金良 李理然 张玥[2] 叶虹[17] Yimin Zhu;Yue Gao;Donghong Nai;Linli Hu;Lei Jin;Ying Zhong;Ze Wu;Guimin Hao;Qiongfang Wu;Yichun Guan;Hong Jiang;Cuilian Zhang;Minli Liu;Xiaohong Wang;Xiaoming Teng;Jinliang Duan;Liran Li;Yue Zhang;Hong Ye(Department of Reproductive Endocrinology,Women′s Hospital,Zhejiang University School of Medicine,Hangzhou 310006,China;Health Economic Research Institute,Sun Yat-sen University,Guangzhou 510006,China;Department of Reproductive Medicine,The Reproductive Hospital of Guangxi Zhuang Autonomous Region,Nanning 530021,China;Center for Reproductive Medicine,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Reproductive Medicine Center,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China;Department of Reproduction,Chengdu Xi′nan Gynecological Hospital,Chengdu 610023,China;Department of Reproductive Medicine,the First People′s Hospital of Yunnan Province,Kunming 650034,China;Department of Reproductive Medicine,the Second Hospital of Hebei Medical University,Shijiazhuang 050000,China;Reproductive Medicine Center,Jiangxi Maternal and Child Health Hospital,Nanchang 330006,China;Center for Reproductive Medicine,the Third Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Reproductive Medicine Center,the 901st Hospital of the Joint Logistics Support Force of People′s Liberation Army,Hefei 230031,China;Institute of Reproductive Medicine,Henan Provincial People′s Hospital,Zhengzhou 450003,China;Reproductive Medicine Center,Guiyang Maternal and Child Health Care Hospital,Guiyang 550003,China;Center for Reproductive Medicine,Tangdu Hospital,Air Force Medical University,Xi′an 710038,China;Center for Reproductive Medicine,Shanghai First Maternity and Infant Hospital,Tongji University School of Medicine,Shanghai 201204,China;Reproductive Medicine Center,the 924th Hospital of the Joint Logistics Support Force of People′s Liberation Army,Guilin 541002,China;Chongqing Health Center for Women and Children,Chongqing Reproduction and

机构地区：[1]浙江大学医学院附属妇产科医院生殖内分泌科,杭州310006 [2]中山大学医药经济研究所,广州510006 [3]广西壮族自治区生殖医院生殖医学科,南宁530021 [4]郑州大学第一附属医院生殖医学中心,郑州450052 [5]华中科技大学同济医学院附属同济医院生殖医学中心,武汉430030 [6]成都西囡妇科医院生殖专科,成都610023 [7]昆明理工大学附属医院云南省第一人民医院生殖医学科,昆明650034 [8]河北医科大学第二医院生殖医学科,石家庄050000 [9]江西省妇幼保健院辅助生殖中心,南昌330006 [10]郑州大学第三附属医院河南省妇女儿童医院生殖医学中心,郑州450052 [11]解放军联勤保障部队第九〇一医院生殖医学中心,合肥230031 [12]河南省人民医院生殖医学中心,郑州450003 [13]贵阳市妇幼保健院生殖医学中心,贵阳550003 [14]空军军医大学第二附属医院生殖医学中心,西安710038 [15]同济大学附属第一妇婴保健院生殖医学中心,上海201204 [16]解放军联勤保障部队第九二四医院生殖中心,桂林541002 [17]重庆市妇幼保健院遗传与生殖研究所,重庆400013

出　　处：《中华妇产科杂志》2022年第7期510-518,共9页Chinese Journal of Obstetrics and Gynecology

摘　　要：目的:探讨尿源性卵泡刺激素(uFSH)与重组卵泡刺激素(rFSH)在控制性促排卵中的有效性、安全性和费用差异。方法:本研究是一项回顾性队列研究。数据来自全国16家生殖中心,所收集周期的取卵时间为2015年5月1日至2018年6月30日,使用uFSH(uFSH组)或rFSH(rFSH组)作为起始促性腺激素(Gn)进行控制性促排卵,并使用体外受精(IVF)和(或)卵母细胞胞质内单精子注射进行受精的新鲜周期。由于同一患者可多次接受IVF周期治疗且在同一中心内进行的周期间不独立,故使用广义估计方程进行多因素分析,纳入调整的变量包括年龄、体质指数、抗苗勒管激素水平、不孕原因、促排卵方案、受精方式、移植胚胎数、Gn使用天数。结果:本研究共纳入102 061个新鲜周期进行分析。在有效性方面,当控制不平衡的基线特征后,与rFSH组相比,uFSH组的高获卵数(定义为获卵数>15个)率显著降低(促性腺激素释放激素激动剂方案: OR=0.642, P<0.01;促性腺激素释放激素拮抗剂方案: OR=0.556, P=0.001)。对比于rFSH组,无论激动剂方案还是拮抗剂方案,uFSH组每移植周期的临床妊娠率和每移植周期的活产率均显著增加( OR=1.179、1.169, P均<0.01)。在安全性方面,多因素分析结果显示,在激动剂方案中,与rFSH组相比,uFSH组中重度卵巢过度刺激综合征(OHSS)的发生率显著降低( OR=0.644, P=0.002);在所有方案中,uFSH组与rFSH组的异位妊娠率和多胎妊娠率差异均不显著( P=0.890、0.470)。在费用方面,与rFSH组相比,uFSH组的人均Gn总花费降低( P<0.01),rFSH组的预计成本为6 734元,uFSH组为3 880元。 结论:对于接受控制性促排卵的患者,uFSH相对于rFSH在安全性和经济性方面更有优势。Objective To explore the effectiveness,safety and cost between urinary follicle stimulating hormone(uFSH)and recombinant follicle stimulating hormone(rFSH)in controlled ovarian stimulation(COS)in China.Methods Data were collected from 16 reproductive centers in China covering oocytes collection time from May 1,2015 to June 30,2018.Eligible patients were over 18 years old,adopting COS with uFSH(uFSH group)or rFSH(rFSH group)as start gonadotropins(Gn),and using in vitro fertilization(IVF)and(or)intracytoplasmic sperm injection for fertilisation,excluding frozen embryo recovery cycle.Generalised estimating equation was used to address the violation of independency assumption between cycles due to multiple IVF cycles for one person and clustering nature of cycles carried out within one center.Controlling variables included age,body mass index,anti-Müllerian hormone level,cause of infertility,ovulation protocol,type of fertilisation,number of embryos transferred,number of days of Gn use.Results Totally 102061 cycles met eligibility criteria and were included in the analyses.In terms of effectiveness,after controlling relevant unbalanced baseline characteristics,compared with rFSH group,the high oocyte retrieval(>15 oocytes was considered high retrieval)rate of uFSH group significantly decreased in gonadotropin-releasing hormone agonist protocol(OR=0.642,P<0.01)and in gonadotropin-releasing hormone antagonist protocol(OR=0.556,P=0.001),but the clinical pregnancy rate per transfer cycle and the live birth rate per transfer cycle significantly increased(OR=1.179,OR=1.169,both P<0.01)in both agonist and antagonist protocols.For safety,multiple analysis result demonstrated that in the agonist protocol,compared with rFSH group,the incidence of moderate to severe ovarian hyperstimulation syndrome of uFSH group significantly decreased(OR=0.644,P=0.002).The differences in ectopic pregnancy rate and multiple pregnancy rate between the uFSH and rFSH groups were not significant(P=0.890,P=0.470)in all patients.In terms of cost,co

关 键 词：卵泡刺激素 妊娠率 超排卵 治疗结果 卵巢过度刺激综合征 经济学 医学 

分 类 号：R714.8[医药卫生—妇产科学]