Yazbeck C, Omnes S, Vacher-Lavenu M-C, Madelenat P
Service de gynécologie-obstétrique, groupe hospitalier Bichat-Claude-Bernard, APHP, 46, rue Henri-Huchard, 75018 Paris, France.
Gynecol Obstet Fertil. 2006 Oct;34(10):906-13. doi: 10.1016/j.gyobfe.2006.06.019. Epub 2006 Sep 20.
To evaluate the levonorgestrel-releasing intra-uterine system as an alternative to surgical treatment in patients presenting with menorrhagia.
In the set of a prospective multicenter study, 49 patients with menorrhagia resistant to medical treatment and/or referred for hysterectomy or endometrial ablation were included. Medical visits were organized 3, 6, 12, 24 and 36 months after insertion of the levonorgestrel-releasing intra-uterine system. Visual score of menstrual bleeding and satisfaction index were noted on each visit. Transvaginal ultrasound, pap smear, endometrial biopsy, and clinical data were retrieved one month before and 12 months after inclusion for tolerance evaluation.
Renouncement rate was 90.0% (95% CI = 80.7-96.6%). After a twelve months follow-up, 86.1% of patients were satisfied or very satisfied with their clinical state. We found a significant increase of hemoglobin rates from baseline (14,0 versus 12,9 g/dl; P < 10(-4)). Similar increases were also found in serum iron and ferritin.
This study confirms the efficacy of the levonorgestrel-releasing intra-uterine system in the control and reduction of menstrual blood loss in patients with dysfunctional uterine bleeding. The high rate of surgery cancellation is a proof of the potential role of the levonorgestrel-releasing intra-uterine system as an alternative treatment in these patients.
评估左炔诺孕酮宫内节育系统作为月经过多患者手术治疗替代方法的效果。
在一项前瞻性多中心研究中,纳入了49例对药物治疗耐药和/或被转诊接受子宫切除术或子宫内膜切除术的月经过多患者。在放置左炔诺孕酮宫内节育系统后的3、6、12、24和36个月安排就诊。每次就诊时记录月经出血的视觉评分和满意度指数。在纳入前1个月和纳入后12个月获取经阴道超声、巴氏涂片、子宫内膜活检及临床数据以进行耐受性评估。
放弃率为90.0%(95%可信区间 = 80.7 - 96.6%)。经过12个月的随访,86.1%的患者对其临床状况感到满意或非常满意。我们发现血红蛋白水平较基线有显著升高(14.0对12.9 g/dl;P < 10⁻⁴)。血清铁和铁蛋白也有类似升高。
本研究证实了左炔诺孕酮宫内节育系统在控制和减少功能失调性子宫出血患者月经失血方面的疗效。高手术取消率证明了左炔诺孕酮宫内节育系统作为这些患者替代治疗方法的潜在作用。