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首页> 外文期刊>International Journal of Women s Health >Safety and effectiveness of different dosage of mifepristone for the treatment of uterine fibroids: a double-blind randomized clinical trial
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Safety and effectiveness of different dosage of mifepristone for the treatment of uterine fibroids: a double-blind randomized clinical trial

机译：米非司酮不同剂量治疗子宫肌瘤的安全性和有效性：双盲随机临床试验

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Objectives: The aim of this study was to evaluate the safety and improvement in quality of life using 10 mg and 5 mg daily doses of mifepristone for the treatment of uterine fibroids.Design: The research was a randomized double-blind clinical study undertaken at the Eusebio Hernández Hospital in Havana, Cuba.Subjects and methods: Seventy subjects with symptomatic uterine fibroids took one daily capsule of 10 mg or 5 mg mifepristone orally for 9 months. One to three endometrial biopsies were performed. In evaluating safety, the variables studied were endometrial changes associated with mifepristone, elevation of hepatic transaminases, side effects of mifepristone, and instances and duration of irregular bleeding.Results: There were 30/49 (61.2%) and 13/24 (54.2%) diagnoses of endometrial changes associated with mifepristone in the 10 mg and 5 mg groups, respectively (P = 0.282). At every evaluation visit the average endometrial thickness was significantly greater in the 10 mg group than in the 5 mg group (P = 0.013, P = 0.002, and P = 0.013, respectively). Only five subjects had slight elevations in their hepatic transaminases after 9 months' treatment. Sixteen of 35 (45.7%) and eight of 33 (24.2%) subjects had the occasional hot flush in the 10 mg and 5 mg groups, respectively (P = 0.032). In total, there were 12.9 ± 4.6 (n = 21) and 9.1 ± 3.9 (n = 18) days of irregular bleeding in the 10 mg and 5 mg groups, respectively (P = 0.009).Conclusion: According to the study findings, a 5 mg daily dose over 9 months has a relatively better safety profile than the 10 mg dose.
机译：目的：本研究旨在评估每日服用10毫克和5毫克米非司酮治疗子宫肌瘤的安全性和生活质量的改善。设计：该研究是在该实验室进行的一项随机双盲临床研究。古巴哈瓦那市尤西比奥·埃尔南德斯医院（EusebioHernándezHospital）受试者与方法：70名有症状子宫肌瘤的受试者口服1粒每日口服10毫克或5毫克米非司酮胶囊，历时9个月。进行了1-3次子宫内膜活检。在评估安全性时，所研究的变量是与米非司酮相关的子宫内膜变化，肝转氨酶升高，米非司酮的副作用以及不规则出血的情况和持续时间。结果：分别为30/49（61.2％）和13/24（54.2％） ）分别在10 mg和5 mg组中诊断与米非司酮相关的子宫内膜变化（P = 0.282）。在每次评估访视时，10 mg组的平均子宫内膜厚度显着大于5 mg组（分别为P = 0.013，P = 0.002和P = 0.013）。治疗9个月后，只有5名受试者的肝转氨酶轻度升高。 35例受试者中有16例（45.7％）和33例受试者中有8例（24.2％）分别在10 mg和5 mg组中偶尔出现潮热（P = 0.032）。在10 mg和5 mg组中，总共有12.9±4.6（n = 21）天和9.1±3.9（n = 18）天不规则出血（P = 0.009）。结论：根据研究结果，在9个月内每天5 mg的剂量比10 mg的剂量具有相对更好的安全性。

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