Department of Obstetrics & Gynaecology, All India Institute of Medical Sciences, New Delhi, India.
Indian J Med Res. 2013 Jun;137(6):1154-62.
BACKGROUND & OBJECTIVES: Uterine myoma is a common indication for hysterectomy in India. An effective medical treatment option may reduce hysterectomy associated morbidity. This study was undertaken to evaluate efficacy and safety of low dose mifepristone in medical management of myoma and to compare two doses - 10 vs. 25 mg/day.
In this randomized clinical trial, women with symptomatic myoma or myoma>5 cm were included. Uterine size >20 wk, fibroids >15 cm were excluded. Pictorial blood loss assessment chart (PBAC) score was used to assess menstrual-blood-loss and visual analog scale (VAS) for other symptoms. Haemogram, liver function test, ultrasound with doppler and endometrial histology was performed. Patients were randomized and were given oral mifepristone as 25 mg/day in group 1 and 10 mg/day in group 2 for 3 months. Patients were followed at 1, 3 and 6 months.
Seventy patients in group 1 and 73 in group 2 completed treatment. Mean PBAC score reduced from 253 to 19.8 and from 289.2 to 10.4 at 1 and 3 months in groups 1 and 2, respectively. At 3 months, 67 of 70 (95.7%) patients of group 1 and 66 of 73 (90.4%) of group 2 developed amenorrhoea which reverted after median 34 (range 4-85) days. Mean myoma volume decreased by 35.7 per cent (from 176.8 to 113.7 cm 3 ) and 22.5 per cent (from 147.6 to 114.4 cm 3 ) at 3 months in groups 1 and 2, respectively. Side effects seen were leg cramps in 7 of 70 (10%) and 5 of 73 (6.8%) and hot-flushes in 5 of 70 (7.1%) and 5 of 73 (6.8%) in groups 1 and 2, respectively. Repeat endometrial-histopathology did not reveal any complex hyperplasia or atypia in either group.
INTERPRETATION & CONCLUSIONS: Mifepristone (10 and 25 mg) caused symptomatic relief with more than 90 per cent reduction in menstrual blood. Greater myoma size reduction occured with 25 mg dose. Amenorrhoea was developed in 90-95 per cent patients which was reversible. It can be a reasonable choice for management of uterine leiomyoma as it is administered orally, cost-effective and has mild side effects.
子宫肌瘤是印度子宫切除术的常见指征。有效的医学治疗选择可能会降低与子宫切除术相关的发病率。本研究旨在评估低剂量米非司酮在子宫肌瘤的药物治疗中的疗效和安全性，并比较两种剂量-10 毫克/天与 25 毫克/天。
在这项随机临床试验中，纳入了有症状的子宫肌瘤或肌瘤>5 厘米的女性。排除子宫大小>20 周、肌瘤>15 厘米。使用图片出血评估图表（PBAC）评分评估月经失血，使用视觉模拟量表（VAS）评估其他症状。进行全血细胞计数、肝功能检查、超声检查和子宫内膜组织学检查。患者随机分为两组，一组给予米非司酮 25 毫克/天（第 1 组），另一组给予米非司酮 10 毫克/天（第 2 组），治疗 3 个月。患者在 1、3 和 6 个月时进行随访。
第 1 组 70 例患者和第 2 组 73 例患者完成了治疗。第 1 组和第 2 组的 PBAC 评分分别从治疗前的 253 分降至 1 个月时的 19.8 分和 3 个月时的 10.4 分，从 289.2 分降至 1 个月时的 10.4 分和 3 个月时的 6.4 分。第 3 个月时，第 1 组 70 例患者中有 67 例（95.7%）和第 2 组 73 例患者中有 66 例（90.4%）出现闭经，中位时间为 34 天（范围为 4-85 天）后恢复月经。第 1 组和第 2 组的平均肌瘤体积分别减少了 35.7%（从 176.8 厘米 3 降至 113.7 厘米 3 ）和 22.5%（从 147.6 厘米 3 降至 114.4 厘米 3 ）。第 1 组和第 2 组分别有 7 例（10%）和 5 例（6.8%）出现腿部痉挛，5 例（7.1%）和 5 例（6.8%）出现热潮红。两组均未见子宫内膜组织病理学检查出现复杂增生或不典型增生。
米非司酮（10 毫克和 25 毫克）可缓解症状，使月经出血量减少 90%以上。25 毫克剂量可使肌瘤更大程度地缩小。90-95%的患者出现闭经，闭经是可逆的。米非司酮是一种合理的治疗选择，因为它是口服给药的，具有成本效益，并且副作用轻微。
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