Henzl M R, Kwei L
Department of Reproductive Medicine, Syntex Research, Palo Alto, CA 94304.
Am J Obstet Gynecol. 1990 Feb;162(2):570-4. doi: 10.1016/0002-9378(90)90432-7.
The efficacy and safety of the gonadotropin-releasing hormone agonist nafarelin for treatment of endometriosis were compared with those of danazol in two large-scale, double-blind trials. Assessments of severity of symptoms, laparoscopic scores before and after therapy, and pregnancy rates showed that nafarelin, 400 and 800 micrograms administered intranasally, was as efficacious as oral danazol, 600 and 800 mg. The adverse effects seen with nafarelin, mainly hot flashes, were related to its mode of action, namely hypoestrogenemia induced by reversible inhibition of ovarian hormone production. Hypoestrogenemia was associated with a decrease of bone density in the lumbar vertebrae, but these changes were partially or completely reversible after treatment was discontinued. No significant changes in bone mass occurred in the distal radius. Danazol was associated with androgenic and metabolic adverse effects, including weight gain, negative effects on the lipid profile, and elevated liver enzyme levels. Nafarelin was found to be as effective as danazol for the management of endometriosis, with a different and more favorable safety profile.
在两项大规模双盲试验中，对促性腺激素释放激素激动剂那法瑞林与达那唑治疗子宫内膜异位症的疗效和安全性进行了比较。对症状严重程度、治疗前后的腹腔镜评分以及妊娠率的评估表明，经鼻给予400微克和800微克的那法瑞林与口服600毫克和800毫克的达那唑疗效相当。那法瑞林的不良反应主要为潮热，与其作用方式有关，即通过可逆性抑制卵巢激素产生而导致低雌激素血症。低雌激素血症与腰椎骨密度降低有关，但在停药后这些变化部分或完全可逆。桡骨远端骨量无显著变化。达那唑会引起雄激素样和代谢方面的不良反应，包括体重增加、对血脂的负面影响以及肝酶水平升高。结果发现，那法瑞林在治疗子宫内膜异位症方面与达那唑效果相当，但具有不同且更有利的安全性。
