尿源性卵泡刺激素与重组卵泡刺激素α、β在早卵泡期长方案中的疗效、安全性与经济性比较  

Comparison of the efficacy,safety,and cost-effectiveness of u-FSH,r-FSH alpha and beta in the long protocol of early follicular phase

作　　者：刘兰兰[1] 张俊韦 任炳楠 郭华[1] 黄春芝 孙楠[1] 任艳丽[1] 管一春[2] Liu Lanlan;Zhang Junwei;Ren Bingnan;Guo Hua;Huang Chunzhi;Sun Nan;Ren Yanli;Guan Yichun(Department of Pharmacy,the Third Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Reproductive Health Hospital,the Third Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第三附属医院药学部,郑州450052 [2]郑州大学第三附属医院生殖健康医院,郑州450052

出　　处：《中华生殖与避孕杂志》2025年第2期154-161,共8页Chinese Journal of Reproduction and Contraception

基　　金：河南省医学科技攻关联合共建项目(LHGJ20200455)。

摘　　要：目的探讨尿源性卵泡刺激素(urinary follicle-stimulating hormone,u-FSH)、重组卵泡刺激素(recombinant follicle-stimulating hormone,r-FSH)α和r-FSHβ在年龄<35岁卵巢储备正常患者中行早卵泡期长方案的有效性、安全性和经济性。方法本研究是一项回顾性队列研究。纳入2018年1月至2023年12月期间在郑州大学第三附属医院生殖健康医院就诊的年龄<35岁卵巢储备正常患者中行早卵泡期长方案促排卵,并使用体外受精或卵胞质内单精子注射助孕的新鲜周期和冻胚移植周期。根据使用促排卵药物的不同分为u-FSH组、r-FSHα组和r-FSHβ组。卵巢刺激周期共纳入1048个,3组分别为150个周期、490个周期、408个周期。新鲜周期取消移植的冻胚移植周期共纳入710个,3组分别为95个周期、320个周期、295个周期。比较3组人群的基线数据、妊娠结局、安全性、费用差异。主要观察指标为累积妊娠率和累积活产率(cumulative live birth rate,CLBR)。通过二元logistic回归模型校正混杂因素,分析3种促排卵药物与CLBR的关系。结果在有效性和安全性方面,u-FSH组、r-FSHα组、r-FSHβ组3组间获卵数[13.0(10.0,16.0)枚、14.0(11.0,18.0)枚、15.0(11.0,19.0)枚,P=0.012]和双原核胚胎数[9.0(6.0,12.0)枚、10.0(7.0,13.0)枚、10.0(7.0,13.0)枚,P=0.046]差异均具有统计学意义。3组间可利用胚胎数、可利用胚胎率、优质胚胎数、优质胚胎率、可利用囊胚形成率、新鲜周期临床妊娠率、新鲜周期活产率、新鲜周期取消移植者冻胚累积妊娠率、新鲜周期取消移植者冻胚CLBR、累积临床妊娠率、CLBR、中重度卵巢过度刺激综合征发生率、异位妊娠率、多胎妊娠率、新生儿畸形率差异均无统计学意义(均P>0.05)。在经济性方面,u-FSH组人均促性腺激素使用总费用最低,为4429.08(3198.78,5044.23)元,r-FSHα组最高,为6023.72(5433.75,7529.65)元,r-FSHβ组为5480.00(4550.90,6437.86)元,3组间比较�ObjectiveTo explore the effectiveness,safety,and cost among urinary follicle-stimulating hormone(u-FSH),recombinant FSH(r-FSH)α,and r-FSHβin the early follicular phase prolonged protocol for patients under 35 years old with normal ovarian function.MethodsIt was a retrospective cohort study.Patients under 35 years old with normal ovarian function who underwent early follicular phase prolonged protocol for ovulation stimulation and using in vitro fertilization(IVF)or intracytoplasmic sperm injection(ICSI)for fertilization in Reproductive Health Hospital of the Third Affiliated Hospital of Zhengzhou University from January 2018 to December 2023 were recruited,including the fresh and frozen-thawed embryo transfer(FET)cycles.Patients were divided into u-FSH group,r-FSHαgroup,and r-FSHβgroup.A total of 1048 ovarian stimulation cycles were included,with 150 cycles,490 cycles and 408 cycles in the three groups respectively.A total of 710 FET cycles with fresh cycle cancellation were included,with 95 cycles,320 cycles and 295 cycles in the three groups respectively.The baseline data,pregnancy outcomes,safety,and cost were compared among the three groups.The main observation indicators were cumulative pregnancy rate and cumulative live birth rate(CLBR).A binary logistic regression model was used to control confounding factors,and to analyze the relationship between three ovulation inducing medicine and CLBR.ResultsThe difference in the number of oocytes retrieved among the u-FSH group,r-FSHαgroup,and r-FSHβgroup was statistically significant[13.0(10.0,16.0),14.0(11.0,18.0),15.0(11.0,19.0),respectively,P=0.012],and the difference in the number of 2PN embryos was statistically significant[9.0(6.0,12.0),10.0(7.0,13.0),10.0(7.0,13.0),respectively,P=0.046].There were no statistically significant differences in the number of available embryos,available embryo rate,the number of high-quality embryos,high-quality embryo rate,available blastocyst formation rate,fresh cycle clinical pregnancy rate,live birth rate in fresh cycl

关 键 词：卵泡刺激素 妊娠率 活产 有效性研究 安全性 经济性 

分 类 号：R711.6[医药卫生—妇产科学]