Vercellini P, Trespidi L, Panazza S, Bramante T, Mauro F, Crosignani P G
Clinica Ostetrica e Ginecologica L. Mangiagalli, University of Milan, Italy.
Fertil Steril. 1994 Dec;62(6):1136-42.
To evaluate the efficacy and safety of very low dose danazol in improving pelvic pain in women with endometriosis, the benefit of preceding the treatment by a short course of a GnRH agonist, symptoms recurrence after drug withdrawal, and variations in menstrual pattern.
Open-label, randomized study.
University hospital endometriosis center.
Forty-two women with moderate or severe pelvic pain and laparoscopically diagnosed endometriosis.
Treatment with oral danazol, 50 mg/d, for 9 months (group I, n = 21) or leuprolide depot for 3 months followed by oral danazol, 50 mg/d, for 6 months (group II, n = 21), and a 6-month follow-up.
Variations in severity of symptoms during treatment and at the end of follow-up as shown by a linear analog scale and a verbal rating scale; menstrual blood loss as assessed by a pictorial chart.
Four patients withdrew from the study, one in each group at the fifth month of treatment (for persistent pain) and one in each group during follow-up (they requested additional therapy); one woman in group I was lost to follow-up. Significant improvements were obtained in dysmenorrhea, deep dyspareunia, and nonmenstrual pain in both treatment schedules without differences between the groups. Also menstrual blood loss was significantly reduced in both groups. A temporary fall in high and rise in low density lipoprotein cholesterol was observed in the study population. At the end of follow-up symptoms recurred without significant differences in median pain scores with respect to baseline.
Very low dose danazol may be an alternative for temporary relief of endometriosis-associated pain. Ovulation is not always inhibited and barrier contraception is needed. Side effects occur but are rarely severe. Further data are required to evaluate the influence of long-term administration on the lipid profile.
评估极低剂量达那唑改善子宫内膜异位症女性盆腔疼痛的疗效和安全性、GnRH激动剂短疗程预处理的益处、停药后症状复发情况以及月经模式的变化。
开放标签随机研究。
大学医院子宫内膜异位症中心。
42名有中度或重度盆腔疼痛且经腹腔镜诊断为子宫内膜异位症的女性。
口服达那唑，50毫克/天，持续9个月（I组，n = 21），或亮丙瑞林缓释剂治疗3个月，随后口服达那唑，50毫克/天，持续6个月（II组，n = 21），并进行6个月的随访。
治疗期间及随访结束时症状严重程度的变化，通过线性模拟量表和语言评定量表显示；月经失血情况通过图片图表评估。
4名患者退出研究，每组各有1名在治疗第5个月退出（因持续疼痛），每组各有1名在随访期间退出（她们要求额外治疗）；I组有1名女性失访。两种治疗方案在痛经、深部性交痛和非经期疼痛方面均有显著改善，两组之间无差异。两组的月经失血也均显著减少。研究人群中观察到高密度脂蛋白胆固醇暂时下降，低密度脂蛋白胆固醇暂时上升。随访结束时症状复发，中位疼痛评分与基线相比无显著差异。
极低剂量达那唑可能是暂时缓解子宫内膜异位症相关疼痛的一种选择。排卵并非总是受到抑制，需要采取屏障避孕措施。有副作用发生，但很少严重。需要更多数据来评估长期给药对血脂的影响。
