Anasti J N, Kimzey L M, Defensor R A, White B, Nelson L M
Section on Gynecologic Research, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892-0010.
Fertil Steril. 1994 Oct;62(4):726-30. doi: 10.1016/s0015-0282(16)56996-9.
To determine if the immunomodulatory and gonadotropin-suppressing properties of danazol would improve follicle function or ovulation rates in patients with karyotypically normal spontaneous premature ovarian failure.
Prospective, double-blind, crossover trial.
Tertiary care research institution.
Two intervention phases lasting 4 months each: one phase during which patients received a standardized estrogen and progestin replacement regimen and one phase during which each patient received a twice daily 400 mg oral dose of danazol.
Fifty-two patients with karyotypically normal spontaneous premature ovarian failure ranging in age from 21 to 39 years.
We measured serum E2 and P levels weekly during the 2 months after each intervention. We defined a serum E2 > 50 pg/mL (184 pmol/L) as evidence of ovarian follicle function and a P > 3.0 ng/mL (9.5 nmol/L) as evidence for ovulation.
Of the 46 patients who completed the study, danazol did not significantly enhance ovarian follicle function or the chance of ovulation. Eight patients ovulated after danazol and four patients ovulated after estrogen and progestin. The power to detect a 30% and a 5% ovulation success rate with therapy was 0.80 and 0.90, respectively. Overall, 30 of 46 women (65%) demonstrated ovarian follicle function and 10 women (21%) ovulated.
We were unable to demonstrate a statistically significant benefit from the immunomodulatory and gonadotropin-suppressing effects of danazol in patients with karyotypically normal spontaneous premature ovarian failure. These patients often have spontaneous remission. Thus, controlled studies are required to determine the effectiveness of treatments for this condition.
确定达那唑的免疫调节和促性腺激素抑制特性是否能改善核型正常的特发性卵巢早衰患者的卵泡功能或排卵率。
前瞻性、双盲、交叉试验。
三级医疗研究机构。
两个干预阶段，各持续4个月：一个阶段患者接受标准化雌激素和孕激素替代方案，另一个阶段患者每日口服两次400mg达那唑。
52例核型正常的特发性卵巢早衰患者，年龄在21至39岁之间。
在每次干预后的2个月内，每周测量血清E2和P水平。我们将血清E2>50 pg/mL（184 pmol/L）定义为卵巢卵泡功能的证据，将P>3.0 ng/mL（9.5 nmol/L）定义为排卵的证据。
在完成研究的46例患者中，达那唑并未显著增强卵巢卵泡功能或排卵几率。8例患者在使用达那唑后排卵，4例患者在使用雌激素和孕激素后排卵。检测治疗后30%和5%排卵成功率的检验效能分别为0.80和0.90。总体而言，46例女性中有30例（65%）表现出卵巢卵泡功能，10例女性（21%）排卵。
我们未能证明达那唑的免疫调节和促性腺激素抑制作用对核型正常的特发性卵巢早衰患者有统计学意义上的显著益处。这些患者常出现自发缓解。因此，需要进行对照研究以确定针对这种情况的治疗效果。
