尿促卵泡素诱发排卵的多中心随机对照试验  

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

作　　者：杨冬梓[1] 李予[1] 张清学[1] 左约维[2] 康佳丽[3] 于丛一[1] 谢梅青[1] 洪淡华[2] 蒋洲梅[2] 夏薇[3] 

机构地区：[1]中山大学附属第二医院妇产科,广东广州510120 [2]广东省人民医院妇产科,广东广州510080 [3]广州市第一人民医院妇产科,广东广州510180

出　　处：《中国新药与临床杂志》2006年第11期826-829,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：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。AIM： To investigate the clinical efficacy and safety of domestic urofollitropin （uFSH） for ovulation induction in infertile patients. METHODS： A muhicenter, randomized, and parallel controlled study was carried out in 144 patients with WHO group Ⅱ anovulation 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 uFStt is as well efficient and safe for inducing ovulation as imported uFSH.

关 键 词：促卵泡素 排卵诱导 不育 随机对照试验 多中心研究 尿促卵泡素 

分 类 号：R711.6[医药卫生—妇产科学] R977.1[医药卫生—临床医学]