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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。
Objective: To verify the clinical efficacy and safety of domestic ursolic follicle stimulating hormone (uFSH) induced ovulation induction in infertility patients. Methods: A multicenter, randomized, positive control study was conducted on 144 infertile patients with WHO class Ⅱ anovulatory or corpus luteum dysfunction. The experimental group used domestic uFSH, the control group imported uFSH, menstruation d 3 ~ 5 before intramuscular injection of uFSH 75 IU, monitoring follicular development, cervical mucus, with or without ovulation and pregnancy, and observed adverse reactions. Results: The control group of experimental group 9 were enrolled in 72 cases, the completion of the trial were 66 cases and 69 cases. The incidence of ovulation, pregnancy and adverse reactions in the experimental and control groups were 96% (63/66) and 99% (68/69), 97% (61/63) and 94% (64%) respectively / 68), 14% (9/63) and 15% (10/68), 2% (1/68) and 1% (1/70) respectively. There was no significant difference between the two groups (P> 0.05). Conclusion: It is effective and safe to use domestic uFSH to induce ovulation in infertility patients with the same effect as imported preparations.