尿促卵泡素诱发排卵的多中心随机对照试验

目的:验证国产尿促卵泡素(uFSH)对不孕症病人诱发排卵治疗的临床有效性与安全性。方法:对144例WHOⅡ类无排卵或黄体功能不全的不孕症病人进行多中心、随机、阳性对照研究。试验组使用国产uFSH,对照组使用进口uFSH,月经d 3～5始,每日肌内注射uFSH 75 IU,监测卵泡发育、宫颈黏液、有无排卵及妊娠,并观察不良反应。结果:试验组9对照组均入选72例,完成试验分别为66例和69例。试验组和对照组的有效率、排卵率、妊娠率、不良反应的发生率分别为96％(63／66)和99％(68／69),97％(61／63)和94％(64／68),14％(9／63)和15％(10／68),2％(1／68)和1％(1／70),2组比较无显著差异(P>0．05)。结论:国产uFSH用于不孕症病人诱发排卵是有效和安全的,效果与进口制剂相当。

Urofollitropin for ovulation induction in infertile patients: a prospective, multicenter, randomized and controlled clinical trial

AIM: To investigate the clinical efficacy and safety of domestic urofollitropin (uFSH) for ovulation induction in infertile patients. METHODS: A multicenter, randomized, and parallel controlled study was carried out in 144 patients with WHO groupⅡanovulation or luteal function deficiency. Subjects were randomized to receive either domestic or imported uFSH. Ovarian stimulation was undertaken by giving uFSH 75 IU·d-1 beginning from menstruation d 3 - 5. Growth of follicles, cervix mucus, ovulation and pregnancy rates, together with adverse reactions were observed. RESULTS: Total 144 patients were enrolled. Sixty-six and 69 patients accomplished the trial in the domestic uFSH group and imported uFSH group respectively. Efficiency rate, ovulation rate, and pregnancy rate were 96 % (63/66) vs 99 % (68/69) , 97 % (61/63) vs 94 % (64/ 68), and 14 % (9/63) vs 15 % (10/68) respectively for the domestic uFSH group and imported uFSH group. There were no significant statistical differences between the two groups (P > 0.05). The occurrence rate of adverse reaction was similar, 2% (1/68) vs 1 % (1/70) for the two groups. CONCLUSION: Domestic uFSH is as well efficient and safe for inducing ovulation as imported uFSH.