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首页> 外文期刊>Clinical Medicine Insights: Reproductive Health >Femilis? 60 Levonorgestrel-Releasing Intrauterine System–-A Review of 10 Years of Clinical Experience
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Femilis? 60 Levonorgestrel-Releasing Intrauterine System–-A Review of 10 Years of Clinical Experience

机译：Femilis？ 60左炔诺孕酮释放子宫内系统-十年临床经验回顾

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Objective The aim of this study was to update the clinical experience with the Femilis? 60 levonorgestrel-releasing intrauterine system (LNG-IUS), now up to 10 years in parous and nulliparous women, particularly with regard to ease and safety of insertion, contraceptive performance, retention, acceptability, continuation of use, impact on menstrual blood loss (MBL), and duration of action.Study Design Using the Femilis? 60 LNG-IUS releasing 20 μg of levonorgestrel/day, the following studies were conducted: an open, prospective noncomparative contraceptive study, an MBL study, a perimenopausal study, a study for the treatment of endometrial hyperplasia, and early cancer of the uterus, a residue study.Results A total of 599 Femilis LNG-IUS were inserted in various clinical trials, the majority for contraceptive purposes. The total exposure in the first and second contraceptive studies, covering 558 parous and nulliparous women, was 32,717 woman-months. Femilis has high contraceptive effectiveness as only one pregnancy occurred. Expulsion of the LNG-IUS was rare with only two total and no partial expulsions (stem protruding through the cervical canal) occurred. Femilis was well tolerated, with continuation rates remaining high. Several MBL studies were conducted, totaling 80 heavy and normal menstrual bleeders, using the pictorial bleeding assessment chart method or the quantitative alkaline hematin technique. Virtually all women responded well with strongly reduced menstrual bleeding. Amenorrhea rates were high, up to 80% after three months, and ferritin levels simultaneously increased significantly. The Femilis LNG-IUS was tested in 104 symptomatic perimenopausal women for seamless transition to and through menopause, adding estrogen therapy when required. Patient tolerability appeared high as >80% requested a second and a third LNG-IUS. Twenty women presenting with nonatypical and atypical hyperplasia and one woman presenting with early endometrial carcinoma were treated with Femilis LNG-IUS. All histology specimens showed full regression, and patients remained in remission without signs of hyperplasia or cancer at yearly and ongoing follow-up examinations up to 10 years. Residual content of LNG was measured in 37 women having the Femilis LNG-IUS for up to 10 years. In 10 of the 102 women who had the Femilis 60 in situ for 10 years between 20% and 30% of the original 60 mg was recovered confirming the long duration of action of the Femilis 60 LNG-IUS.Conclusion These studies suggest that the Femilis 60 LNG-IUS releasing 20 μg of LNG/day is an effective, well-tolerated, and well-retained contraceptive both in parous and in nulliparous women. The design of the LNG-IUS, with flexible transverse arm(s) length of 28 mm, allows for a simplification of the insertion technique and training requirements facilitating the use by nonspecialist providers in either developed or developing countries. For nulliparous women, additional evaluation of devices with a 24 mm transverse arm(s), as it relates to tolerability, retention, and continuation of use, still needs to be undertaken.
机译：目的这项研究的目的是更新Femilis的临床经验。 60个左炔诺孕酮释放子宫内系统（LNG-IUS），目前在产妇和未产妇中长达10年，尤其是在插入的容易性和安全性，避孕性能，保留率，可接受性，继续使用，对月经失血的影响方面MBL）和动作持续时间。使用Femilis进行研究设计？ 60 LNG-IUS每天释放20μg左炔诺孕酮，进行了以下研究：一项开放性，前瞻性非对比避孕研究，MBL研究，围绝经期研究，子宫内膜增生的治疗研究以及子宫早期癌，结果在各种临床试验中总共插入了599枚Femilis LNG-IUS，其中大多数用于避孕目的。第一次和第二次避孕研究的总接触量为558名产妇和未产妇，为32,717个妇女月。 Femilis具有很高的避孕效果，因为仅发生了一次妊娠。 LNG-IUS的排出很少，只有两个总量，并且没有发生部分排出（穿过颈管的茎突出）。 Femilis的耐受性良好，持续率很高。使用绘画式出血评估图法或定量碱性血红素技术，进行了几次MBL研究，总共80例正常月经量大的出血。几乎所有妇女对月经出血的减少都反应良好。闭经率很高，三个月后高达80％，同时铁蛋白水平也显着增加。 Femilis LNG-IUS已在104位有症状围绝经期妇女中进行了测试，可以无缝过渡到绝经和通过绝经，并在需要时添加雌激素治疗。由于> 80％要求第二次和第三次LNG-IUS，患者的耐受性似乎很高。 Femilis LNG-IUS治疗了20例非典型和非典型增生的女性和1例患有早期子宫内膜癌的女性。所有组织学标本均显示完全消退，并且在长达10年的年度和持续随访检查中，患者仍处于缓解状态，没有增生或癌症的迹象。测量了37名患有Femilis LNG-IUS长达10年的女性的LNG残留量。在102位原位服用Femilis 60的女性中，有102位女性中有10位恢复了最初60 mg的20％至30％，这证实了Femilis 60 LNG-IUS的作用时间长。结论这些研究表明Femilis 60 LNG-IUS的作用时间长。 60液化天然气-IUS每天释放20微克液化天然气是一种有效的，耐受性良好且保留良好的避孕药，无论是在产妇还是未产妇中。 LNG-IUS的设计具有可弯曲的横向臂，长度为28毫米，可简化插入技术和培训要求，从而有利于发达国家或发展中国家的非专业人员使用。对于未生育的妇女，仍然需要对带有24毫米横臂的器械进行额外的评估，因为它涉及耐受性，保留性和继续使用。

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