Palmara Vittorio, Sturlese Emanuele, Villari Daniela, Giacobbe Valentina, Retto Annalisa, Santoro Giuseppe
Department of Gynecology, Obstetrics and Pathophysiology of Human Reproduction, University of Messina, Messina, Italy.
Aust N Z J Obstet Gynaecol. 2013 Aug;53(4):381-5. doi: 10.1111/ajo.12097. Epub 2013 May 24.
Abnormal uterine bleeding is defined as any alteration in the pattern or volume of menstrual blood flow, and it is preferably treated using hysterectomy, endometrial destruction or the levonorgestrel-releasing intrauterine system (Mirena(®) ). Recently, it has been demonstrated that studies of Mirena(®) were generally small and consequently imprecise.
Our study was aimed at assessing the effects of a slow-release levonorgestrel (20 μg/day) intrauterine device in fertile and postmenopausal women experiencing abnormal uterine bleeding that did not respond to traditional medical management.
A total of 40 women, of whom 24 were of reproductive capacity and 16 were postmenopausal, were enrolled in the trial. Removal of the intrauterine device was required for only 2 of the 24 fertile women and for only 3 of the 16 postmenopausal women. After 6 and 12 months of treatment, the remaining women were clinically evaluated and underwent ultrasound and hysteroscopy using biopsy specimens as a control. The EuroQol Group EQ-5D questionnaire was used for evaluation of quality of life.
The device showed good tolerability and efficacy. It resulted in a reduction in the endometrial mucosal thickness with a regression of bleeding and collateral effects, which were more evident after 12 months of treatment. A positive effect of the device on the woman's quality of life was demonstrated.
The slow-release levonorgestrel intrauterine device may be a valid therapeutic tool for treating basic symptomatology and increasing quality of life in women with abnormal uterine bleeding.
异常子宫出血被定义为月经血流模式或血量的任何改变,其首选治疗方法为子宫切除术、子宫内膜破坏术或左炔诺孕酮宫内节育系统(曼月乐®)。最近有研究表明,关于曼月乐®的研究通常规模较小,因此不够精确。
我们的研究旨在评估一种缓释左炔诺孕酮(20微克/天)宫内节育器对患有异常子宫出血且对传统药物治疗无效的育龄期和绝经后女性的影响。
共有40名女性参与该试验,其中24名具有生育能力,16名已绝经。24名育龄期女性中只有2人需要取出宫内节育器,16名绝经后女性中只有3人需要取出。治疗6个月和12个月后,对其余女性进行临床评估,并进行超声和宫腔镜检查,同时取活检标本作为对照。使用欧洲生活质量五维度量表(EQ-5D)问卷评估生活质量。
该节育器显示出良好的耐受性和疗效。它使子宫内膜黏膜厚度减小,出血及副作用消退,在治疗12个月后更为明显。该节育器对女性生活质量有积极影响。
缓释左炔诺孕酮宫内节育器可能是治疗异常子宫出血女性的基本症状及提高其生活质量的有效治疗工具。