高纯度尿促性素和普通尿促性素促排卵效果

Efficacy of highly purified hMG and ordinary hMG among Chinese women undergoing ovarian induction

目的比较高纯度尿促性素(humanmenopausalgonadotropin,hMG)和国产普通hMG在接受诱发排卵后行宫腔内人工授精或指导同房治疗的患者中的效果和安全性。方法2004年7月至2005年3月在3个生殖中心选择符合条件的219例不育妇女进行随机分组促排卵治疗,高纯度hMG组108例,普通hMG组111例。观察主要疗效指标排卵率;次要疗效指标临床妊娠率、破裂卵泡数目、注射hMG日血清E2峰浓度、药物应用时间和药物总剂量;安全性评价指标不良事件发生率。结果普通hMG和高纯度hMG排卵率分别为93.0%(93/100)和91.0%(91/100),临床妊娠率为12.4%(12/100)和20.0%(20/100),破裂卵泡数目为(1.5±1.4)个和(1.2±0.9)个,血E2峰浓度为(896.5±911.9)pmol/L和(699.0±618.5)pmol/L,用药时间为(11.6±3.7)d和(11.6±4.1)d,用药剂量为(1147.5±46.8)IU和(1280.6±646.0)IU,两者疗效及安全性评价指标的比较,差异无显著性(P>0.05)。结论高纯度hMG的促排卵治疗和国产普通hMG一样有效而安全。

Objective To compare the efficacy and safety ot highly puritied hMG and ordinary hMG among Chinese women undergoing ovarian induction in intrauterine insemination （IUI） or timed intercourse （TI）. Methods Between July 2004 and March 2005, infertile female subjects were recruited at 3 Reproductive Medical Centers in China. A total of 219 women were randomized into two groups （108 in highly purified hMG, 111 in ordinary hMG） for ovarian induction. The primary efficacy variable was the ovulation rate and the secondary efficacy variables included the clinical pregnancy rate, the number of ovulated follicles, serum concentration of estradiol on the day of hCG injection, the duration of stimulation and the total dose of ordinary hMG used. The main safety parameters were the incidence of adverse events （AE）. Results No significant differences were found between the ordinary hMG and highly purified hMG group in the ovulation rate （93.0 % versus 91.0 %）, the clinical pregnancy rate （12.0%versus 20.0 %）, the number of ovulated follicles （1.5±1.4 versus 1.2±0.9）, serum concentration of estradiol on the day of hCG injection （816.5±911.9 pmol/L versus 699. 0±618.5 pmol/L ）, the duration of stimulation （11.6±3.7 versus 11.6±4.1 d） and the total dose of ordinary hMG used （1147.5±468.3 versus 1280. 6±646.0 IU）. No differences were seen in the main safety parameters （P〉0.05）. Conclusion highly purified hMG is as effective and safe as ordinary hMG in ovarian induction.