药学角度探讨和分析不同来源卵泡刺激素对体外受精-胚胎移植结局的影响

Influence of Follicle Stimulating Hormone from Different Sources on the Outcome of Vitro Fertilization-embryo Transfer:from an Pharmacy Point of View

目的:比较基因重组卵泡刺激素(r-FSH)及高纯度尿源性卵泡刺激素(HP-u FSH)对体外受精-胚胎移植(IVF-ET)妊娠结局的影响,结合临床表现从药学角度探讨和分析。方法:回顾分析具IVF/单精子卵细胞浆内显微注射授精(ICSI)指诊并首次接受IVF/ICSI助孕的不孕症患者235例,以给予的FSH药物种类不同分为2组:HP-u FSH组(n=135)和r-FSH组(n=100)。主要研究指标为出生率,次要研究指标为临床妊娠率,流产率及着床率。结果:HP-u FSH组外源性促性腺激素(Gn)总量和FSH量均多于r-FSH组(P<0.01),获卵数和可移植胚胎数较r-FSH组少(P<0.01),受精率较r-FSH组低(P<0.05)。两组平均Gn刺激天数,妊娠结局及中重度卵巢过度刺激综合征(OHSS)发生率均无统计学差异(P>0.05)。对患者年龄<35岁和≥35岁分别进行分组发现,年龄<35岁患者中的HP-u FSH组较r-FSH组平均年龄更大,不孕年限更长,基础窦卵泡数(AFC)更少(P<0.01),≥35岁患者中的HP-u FSH组与r-FSH组的基本特征(年龄,不孕年限,AFC)无统计学差异(P>0.05);无论年龄<35岁或年龄≥35岁,HP-u FSH组的Gn量和FSH量较r-FSH组均更大,获卵数及可移植胚胎数更少(P<0.01)。结论:在IVF/ICSI周期治疗中,国产HP-u FSH与r-FSH进行COS具有等同的IVF临床妊娠率及出生率。

Objective： To compared the influence of recombinant follicle stimulating hormones（r-FSH）and high pure urine derived FSH（HP-uFSH） on the outcome of vitro fertilization-embryo transfer（IVF-ET）, and combined the clinical manifestation to investigate and analyze their effect fxom an pharmacy point of view. Methods： Retrospectively analyzed 235 cases of infertility who were accepted assisted reproduction first time by IVF/intracytoplasmic sperm injection （ICSI）. They were divided into HP-uFSH group （n=135） and r-FSH group （n=100） according to the corresponding FSH.Birth rate was the main research index, and clinical pregnancy rate, abortion rate and implantation rate were the secondary ones. Results： Total exogenous gonadotropin （Gn） and FSH amount of HP-uFSH group were significantly higher than r-FSH group（P〈0.01）, however, oocytes amount and transferable embryos amount of HP-uFSH group were significantly less than r-FSH group （P〈0.01）, and the fertility rate was significantly lower than r-FSH group （P〈0.05）. Average Gn stimulation days, pregnancy outcomes and incidence of ovarian hyperstimulation syndrome （OHSS） of two groups had no significant difference（P〉0.05）. Regarding to the patients〈35 and --〉 35 years old, we found the average age was older, infertility years was longer and basic antral follicle （AFC） was lower in HP-uFSH group compared with r-FSH group in patients〈35 years old （P〈0.01）, while above indexes were no significant differences in patients~ 35 years old（P〉0.05）, total Gn and FSH amount were higher and oocytes amount and transferable embryos amount were less in HP-uFSH group compared with r-FSH group both in patients〈35 and ≥ 35 years old（P〈0.01）. Conclusion： Domestic HP-uFSH and r-FSH implement COS has the similar clinical pregnancy rate and birth rate oflVF in the treatment of IVF/ICSI.