国产尿卵泡刺激素在体外受精-胚胎移植促排卵治疗中有效性的Meta分析

Effectiveness of domestic highly purified urinary FSH on outcome of IVF-ET in controlled ovarian stimulation:a Meta-analysis

目的系统评价国产尿卵泡刺激素(uFSH)在体外受精-胚胎移植(IVF-ET)控制性促排卵治疗中的有效性。方法计算机检索VIP、CNKI和WanFang Data等数据库,查找比较uFSH与进口重组卵泡刺激素(rFSH)在IVF-ET促排卵治疗中半随机或随机对照试验(RCT)文献,并进行系统评价,采用RevMan 5.3软件进行Meta分析。结果 5篇RCT 903例患者满足纳入标准。结果显示:uFSH在促性腺激素(Gn)刺激天数[MD=0.45,95%CI(-0.42,1.31),P=0.31]、Gn用量[MD=3.37,95%CI(-0.19,6.93),P=0.06]、平均获卵数[MD=0.17,95%CI(-0.31,0.65),P=0.49]、HCG日雌二醇(E2)值[MD=-862.40,95%CI(-1858.03,133.23),P=0.09]、临床妊娠率[OR=1.02,95%CI(0.77,1.35),P=0.90]、流产率[OR=1.10,95%CI(0.54,2.26),P=0.79]、卵巢过度刺激综合征(OHSS)发生率[OR=1.03,95%CI(0.42,2.54),P=0.95]等方面与rFSH无明显差异,仅平均Gn费用[MD=-2.98,95%CI(-4.19,-1.77),P<0.000 01]显著低于rFSH。结论 uFSH与rFSH相比,在Gn用量、平均获卵数、临床妊娠率等方面相当,但采用uFSH可减少促排卵治疗费用。

Objective： To systematically review the effectiveness of domestic highly purified urinary FSH（uFSH） on outcomes of IVF-ET in controlled ovarian stimulation. Methods. The databases as VIP, CNKI and WanFang Data were electronically searched for comprehensively collecting randomized controlled trials（RCTs）or quasi-RCTs on the effectiveness of uFSH versus recombinant FSH（rFSH）in IVF-ET. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality. Then, Meta- analysis was performed using RevMan 5.3 software. Results： Five studies involving 903 patients were finally included. The results of meta-analysis showed that there was no significant difference in the stimulation duration（MD= 0.45,95% CI--0. 42 to 1.31,P=0.31） ,dose of gonadotrophins（Gn）used（MD=3.37,95%CI--0, 19 to 6.93,P=0.06）,number of oocytes retrieved（MD= 0. 17,95 % CI -- 0.31 to 0.65, P = 0.49）, serum E2 value on the day of HCG administration（MD = -- 862.40,95% CI-- 1858.03 to 133.23, P = 0.09）, clinical pregnancy rate（OR = 1.02,95% CI 0. 77 to 1.35,P=0. 90）,miscarriage rate（OR= 1.10,95% CI 0. 54 to 2.26,P=0.79）and ovarian hyperstimulation syndrome uFSH and rFSH groups. The overa 95% CI--4.19 to--1.77,P〈0. 00001）. Conclusions： uFSH is effective as rFSH for induction of ovulation in IVF-ET treatment. There is no significance in dose of Gn used,number of oocytes retrieved and clinical pregnancy rate between uFSH and rFSH groups,but an obvious price advantage is offered by uFSH.