Carbonell Josep Lluis, Acosta Rita, Pérez Yasmirian, Garcés Roberto, Sánchez Carlos, Tomasi Giuseppe
Mediterránea Médica Clinic, C/Salvador Guinot 14, 46017 Valencia, Spain.
ISRN Obstet Gynecol. 2013 Jul 29;2013:649030. doi: 10.1155/2013/649030. eCollection 2013.
Objectives. To evaluate the efficacy, safety, and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9-month followup period. Design. Randomized clinical trial. Place. "Eusebio Hernández" Hospital, Havana, Cuba. Subjects. 220 women with symptomatic uterine fibroids. Treatment. One-half (2.5 mg) or one-whole 5 mg mifepristone tablet. Variables to Evaluate Efficacy. Changes in fibroid and uterine volumes, in symptomatic prevalence and intensity, and in quality of life. Results. After 3-month treatment, fibroid volume decreased by 27.9% (CI 95% 20-35) and 45.5% (CI 95% 37-62), in the 2.5 and 5 mg groups, respectively, P = 0.003. There was no difference in the prevalence of symptoms at the end of treatment, unlike after 6- and 9-month followup when there was a difference. Amenorrhea was significantly higher in the 5 mg group, P = 0.001. There were no significant differences in mifepristone side effects between the groups. Both groups displayed a similar improvement in quality of life. Conclusions. The 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose. This trial is registered with ClinicalTrials.gov NCT01786226.
目的。评估每日使用2.5毫克和5毫克米非司酮治疗子宫肌瘤3个月并随访9个月期间的疗效、安全性及生活质量。设计。随机临床试验。地点。古巴哈瓦那“尤西比奥·埃尔南德斯”医院。受试者。220名有症状的子宫肌瘤女性。治疗。一半（2.5毫克）或整片5毫克米非司酮片。评估疗效的变量。肌瘤和子宫体积的变化、症状发生率和严重程度的变化以及生活质量的变化。结果。治疗3个月后，2.5毫克组和5毫克组的肌瘤体积分别减少了27.9%（95%置信区间20 - 35）和45.5%（95%置信区间37 - 62），P = 0.003。治疗结束时症状发生率无差异，但在6个月和9个月随访时有差异。5毫克组闭经发生率显著更高，P = 0.001。两组米非司酮副作用无显著差异。两组生活质量改善相似。结论。与5毫克剂量相比，2.5毫克剂量导致肌瘤大小减小程度较小，但生活质量改善相似。本试验已在ClinicalTrials.gov注册，注册号为NCT01786226。
