Yang Y, Zheng S, Li K
First Affiliated Hospital of Beijing Medical University.
Zhonghua Fu Chan Ke Za Zhi. 1996 Oct;31(10):624-6.
To study the response of uterine leiomyoma to two different daily dosages of mifepristone.
Prospective nonrandomized clinical trial on women with symptomatic uterine leiomyoma was conducted. Twenty-eight patients were treated with 10mg of mifepristone daily and fifteen patients with 20mg daily for 12 weeks, beginning on day 1 to 3 of the menstrual cycle. Volume changes of leiomyoma and uterus were measured with ultrasonography before treatment (as baseline) and monthly during the course of therapy. Blood samples for hemoglobin, liver and renal function were obtained monthly.
Ovarian acyclicity was induced in both groups of patients given different daily doses of mifepristone and dysmenorrhea and low abdominal pain disappeared. All symptoms and signs of anemia were resolved. The average hemoglobin level elevated 14-16g/L monthly. After 12 weeks of mifepristone treatment, the leiomyoma volume decreased to 41.4% of baseline in the 10mg daily dose group and 43.0% in the 20mg daily dose group. There was no significant difference between the two treatment groups; the side effects were similar.
Mifepristone of 10mg daily is considered to be a more ideal dosage for treatment. Mifepristone therapy is indicated in larger fibroids, and/or as preoperative medication for severely anemic patients and in perimenopausal patients with symptomatic fibroids.
研究子宫平滑肌瘤对两种不同每日剂量米非司酮的反应。
对有症状的子宫平滑肌瘤女性进行前瞻性非随机临床试验。28例患者每日服用10mg米非司酮,15例患者每日服用20mg米非司酮,疗程为12周,从月经周期的第1至3天开始。在治疗前(作为基线)以及治疗过程中每月用超声测量平滑肌瘤和子宫的体积变化。每月采集血样检测血红蛋白、肝肾功能。
给予不同每日剂量米非司酮的两组患者均出现卵巢无周期性变化,痛经和下腹部疼痛消失。所有贫血症状和体征均得到缓解。血红蛋白平均水平每月升高14 - 16g/L。米非司酮治疗12周后,每日10mg剂量组平滑肌瘤体积降至基线的41.4%,每日20mg剂量组降至43.0%。两个治疗组之间无显著差异;副作用相似。
每日10mg米非司酮被认为是更理想的治疗剂量。米非司酮疗法适用于较大的肌瘤,和/或作为重度贫血患者的术前用药以及有症状肌瘤的围绝经期患者的治疗。