Rock J A, Truglia J A, Caplan R J
Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, Georgia.
Obstet Gynecol. 1993 Aug;82(2):198-205.
To compare the efficacy, endocrine effects, and safety of Zoladex (goserelin acetate) and danazol in the treatment of premenopausal women with endometriosis in a multicenter, randomized, open study.
Three hundred fifteen patients with stages I-IV endometriosis (revised American Fertility Society [AFS] classification) were treated with Zoladex, 3.6 mg every 28 days by subcutaneous injection, or danazol, 400 mg orally twice daily for 24 weeks. Efficacy was assessed by determination of pelvic signs and symptoms scores and revised AFS endometriosis scores. Endocrine effects were determined by measurements of hormone levels. Safety was evaluated by physical examination, laboratory indices, occurrence of adverse events, and bone mineral density changes.
Both treatments significantly (P < .0001) reduced mean subjective signs and symptoms scores both during and after therapy. The mean percent reduction in the revised AFS endometriosis score after 24 weeks of treatment was 53% for Zoladex and 33% for danazol, and reduction in the endometrial implants score was 56% for Zoladex and 46% for danazol. Serum estradiol levels decreased to the postmenopausal range in the Zoladex group and to the early follicular phase range in the danazol group. Hypoestrogenic effects occurred more frequently with Zoladex, whereas androgenic side effects were more common with danazol. There was a higher percentage of withdrawals due to adverse events with danazol than with Zoladex. Mean bone mineral density decreased from baseline by 5.4% in the Zoladex group and increased by 1.0% in the danazol group at the end of treatment.
Zoladex is as well tolerated and as effective as danazol in the treatment of premenopausal women with endometriosis.
在一项多中心、随机、开放性研究中，比较诺雷德（醋酸戈舍瑞林）和达那唑治疗绝经前子宫内膜异位症女性的疗效、内分泌影响及安全性。
315例I-IV期子宫内膜异位症患者（根据美国生殖医学学会[AFS]修订分类），接受诺雷德治疗，每28天皮下注射3.6 mg，或达那唑治疗，口服400 mg，每日两次，共24周。通过测定盆腔体征和症状评分以及修订的AFS子宫内膜异位症评分评估疗效。通过测量激素水平确定内分泌影响。通过体格检查、实验室指标、不良事件的发生情况以及骨密度变化评估安全性。
两种治疗方法在治疗期间及治疗后均显著（P <.0001）降低了平均主观体征和症状评分。治疗24周后，诺雷德组修订的AFS子宫内膜异位症评分平均降低百分比为53%，达那唑组为33%；子宫内膜种植灶评分降低，诺雷德组为56%，达那唑组为46%。诺雷德组血清雌二醇水平降至绝经后范围，达那唑组降至卵泡早期范围。诺雷德组低雌激素效应更常见，而达那唑组雄激素副作用更常见。因不良事件导致的停药率，达那唑组高于诺雷德组。治疗结束时，诺雷德组平均骨密度较基线下降5.4%，达那唑组增加1.0%。
在治疗绝经前子宫内膜异位症女性方面，诺雷德的耐受性和疗效与达那唑相当。
