Coelingh Bennink H J, Fauser B C, Out H J
NV Organon, Oss, The Netherlands.
Fertil Steril. 1998 Jan;69(1):19-25. doi: 10.1016/s0015-0282(97)00423-8.
To compare the safety and efficacy of recombinant FSH (follitropin beta, Puregon; NV Organon, Oss, the Netherlands) and urinary FSH (urofollitropin, Metrodin; Ares-Serono, Geneva, Switzerland).
A prospective, multicenter, assessor-blind, randomized, clinical trial.
Twelve European infertility clinics.
PATIENT(S): One hundred seventy-two women (recombinant FSH: n = 105; urinary FSH: n = 67) with clomiphene citrate-resistant normogonadotropic chronic anovulation (World Health Organization group II).
INTERVENTION(S): Eligible subjects were randomized (ratio of recombinant to urinary FSH, 3:2) and treated for a maximum of three cycles. A low-dose step-up regimen was used, with 75 IU of FSH given IM daily for a maximum of 14 days and, if needed, weekly increments of half an ampule given thereafter until the threshold dose for follicular development was achieved.
MAIN OUTCOME MEASURE(S): Cumulative ovulation rate after three cycles, total FSH dose, and treatment period needed to achieve ovulation.
RESULT(S): The cumulative ovulation rates after three treatment cycles were 95% and 96% for the recombinant and urinary FSH groups, respectively. Overall, ovulation was seen in 155 of 223 treatment cycles (69.5%) in the recombinant FSH group, compared with 92 of 138 treatment cycles (66.7%) in the urinary FSH group. In the first cycle, a statistically significantly lower total dose (750 versus 1,035 IU) and a shorter treatment period (10 versus 13 days) were needed in the recombinant FSH group to reach ovulation. Only one case of ovarian hyperstimulation syndrome led to hospitalization. Two sets of twins (one in each treatment group) and one set of triplets (in the recombinant FSH group) were born.
CONCLUSION(S): Recombinant FSH (Puregon) is more efficient than urinary FSH (Metrodin) in inducing follicular development.
比较重组促卵泡素（卵泡刺激素β，普丽康；荷兰欧加农公司，奥斯）和尿促卵泡素（尿促性素，美诺孕；瑞士雪兰诺公司，日内瓦）的安全性和有效性。
一项前瞻性、多中心、评估者盲法、随机临床试验。
12家欧洲不孕不育诊所。
172名患有枸橼酸氯米芬抵抗性正常促性腺激素性慢性无排卵（世界卫生组织II组）的女性（重组促卵泡素组：n = 105；尿促卵泡素组：n = 67）。
符合条件的受试者被随机分组（重组促卵泡素与尿促卵泡素的比例为3:2），并接受最多三个周期的治疗。采用低剂量递增方案，每天肌肉注射75 IU促卵泡素，最多14天，如有需要，此后每周增加半支，直至达到卵泡发育的阈值剂量。
三个周期后的累积排卵率、促卵泡素总剂量以及实现排卵所需的治疗时间。
重组促卵泡素组和尿促卵泡素组三个治疗周期后的累积排卵率分别为95%和96%。总体而言，重组促卵泡素组223个治疗周期中有155个出现排卵（69.5%），尿促卵泡素组138个治疗周期中有92个出现排卵（66.7%）。在第一个周期中，重组促卵泡素组达到排卵所需的总剂量在统计学上显著较低（750 IU对1035 IU），治疗时间较短（10天对13天）。仅1例卵巢过度刺激综合征导致住院。出生了两对双胞胎（每个治疗组各1对）和一组三胞胎（在重组促卵泡素组）。
重组促卵泡素（普丽康）在诱导卵泡发育方面比尿促卵泡素（美诺孕）更有效。
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