尿卵泡刺激素和基因重组卵泡刺激素在体外受精-胚胎移植临床疗效及安全性的比较

A comparison of clinical efficacy and safety between urinary follicle-stimulating hormone and recombinant follicle-stimulating hormone in IVF/ICSI treatment

目的比较国产尿卵泡刺激素(uFSH)和基因重组卵泡刺激素(rFSH)在体外受精-胚胎移植(IVF-ET)/卵胞浆内单精子显微注射(ICSI)中控制性超排卵(COH)的临床疗效及安全性。方法 293例行IVF-ET/ICSI助孕的不育患者按不同用药分为uFSH组(96例)和rFSH组(197例),比较两组促性腺激素(Gn)用量、Gn天数、费用、人绒毛膜促性腺激素(hCG)注射日雌二醇(E_2)水平、取卵数、优胚数、冷冻数、受精率、妊娠率、流产率及卵巢过度刺激综合征(OHSS)发生率。结果 uFSH组患者的Gn用量(27.49±7.79)支显著多于rFSH组(25.50±7.84)支,但费用uFSH组(4,110.21±1,164.88)元显著少于rFSH组(7,839.22±2,480.75)元(P<0.05);两组患者Gn天数、hCG注射日E_2水平、取卵数、优胚数、冷冻数、受精率、妊娠率、流产率及OHSS发生率均无显著性差异(P>0.05)。结论 uFSH与rFSH相比,对IVF-ET/ICSI促排卵结局无明显影响,同样安全有效,且uFSH存在明显的价格优势。

Objective： To compare the clinical efficacy and safety between domestic urinary FSH （uFSH） and recombinant FSH （rFSH） in controlled ovarian hyperstimulation in IVF/ICSI cycles. Methods： Two hundred and ninety-three patients undergoing IVF/ICSI-ET cycles were divided into domestic uFSH group （96 cases） and rFSH group （197 cases） according to the type of FSH used. The clinical outcomes were compared between these two groups. Results： The ampoules of gonadotropin （Gn） used in uFSH group were significantly more than those in rFSH group （P〈0.05）, but the overall cost of Gn in uFSH group was significantly less than that in rFSH group （P〈0.05）. There were no significant differences in days of Gn treatment, serum estradiol （E2） levels on hCG day, the number of oocytes retrieved, quality of embryos, number of frozen embryos, fertilization rate, pregnancy rate, abortion rate or incidence of ovarian hyperstimulation syndrome between two groups （P〉0.05）. Conclusions： Domestic uFSH is as effective and safe as rFSH for induction of ovulation in IVF/ICSI treatment, and offers an obvious price advantage over rFSH.