■子宫腺肌病的医学管理是现代妇科的一个新兴观点。虽然左炔诺孕酮宫内系统(LNG-IUS)和地鼠(DNG)有效缓解子宫腺肌病的症状,两者都没有被批准用于相同的适应症。我们的研究旨在比较这些孕激素治疗子宫腺肌病的疗效和安全性。
■研究LNG-IUS与DNG在有症状的子宫腺肌病患者中的疗效和安全性。
■开放标签,平行,单中心,随机临床试验。
■子宫腺肌病相关疼痛伴或不伴异常子宫出血的患者随机分为LNG-IUS组和DNG组。主要结果是通过视觉模拟量表(VAS)评分测量的治疗12周后疼痛症状的减少。月经失血(MBL)的变化,生活质量(QoL)的改善,并对药物不良反应进行分析。
■两组的VAS评分均较基线显著降低。LNG-IUS组的基线和治疗后VAS评分分别为6.41±1.07和3.41±1.04(p=<0.001),DNG组,分别为6.41±0.95和3.12±1.40(p=<0.001),分别。与DNG组相比,LNG-IUS组中明显更大比例的患者经历了较轻的MBL[LNG-IUS组中的27/30(90%)对DNG组中的17/22(77.2%)(p=0.006)]。根据世界卫生组织QOL量表(WHOQOLBREF)问卷计算,两组的QOL得分均有改善;然而,在DNG组中更为明显[(LNG-IUS组28.76±30.47vsDNG组48.26±44.91(p=0.04)].两种药物都是安全的,因为没有报告重大的药物不良反应。
■DNG可以是LNG-IUS的有效且安全的替代品,用于子宫腺肌病的医疗管理。
■该试验在临床试验注册处进行了前瞻性注册-印度(CTRI),CTRI编号为CTRI/2020/05/025186。
比较曼月乐(LNG-IUS)与地鼠治疗子宫腺肌病的有效性和安全性子宫腺肌病是一种影响女性的疾病,通常年龄在40-50岁,但其发病率在年轻女性中上升,影响生育能力。它会引起痛经等痛苦症状,性交困难,慢性盆腔疼痛,大量月经出血。管理症状至关重要,和医疗方法包括左炔诺孕酮宫内节育器系统(LNG-IUS)和地鼠(DNG)。LNG-IUS是可逆避孕,批准了八年,有效治疗症状。DNG,一种新的孕激素,对子宫内膜异位症有效,但子宫腺肌病的证据有限.这个单一中心,开放标签随机临床试验比较了LNG-IUS和DNG治疗子宫腺肌病的疗效.使用超声诊断20岁以上患有盆腔疼痛的女性,并符合特定标准。知情同意后,参与者被随机分配到LNG-IUS或DNG组.治疗结果,包括骨盆疼痛,生活质量(QoL),和不利影响,评估超过12周。在84个评估中,招募了74名妇女,每组34人进行分析。12周后,两组均显示骨盆疼痛(VAS评分)显着降低,但两组间无显著差异。LNG-IUS导致月经大出血(HMB)的显著减少,而DNG在整体生活质量方面表现出更好的改善。两组的不良反应相似,DNG组中报告的潮热。本研究是为数不多的比较LNG-IUS和DNG治疗子宫腺肌病的研究之一,发现两者都有效缓解症状。尽管LNG-IUS在降低HMB方面具有优势,DNG在QoL方面表现出更好的整体改善。安全性相似。先前的研究支持DNG在减轻子宫腺肌病症状方面的功效。最后,LNG-IUS和DNG均能有效缓解子宫腺肌病症状,LNG-IUS在减少大量月经出血方面优于DNG,在生活质量方面表现出更好的整体改善。DNG是LNG-IUS的可行且有效的替代方案。
UNASSIGNED: Medical management of adenomyosis is an emerging perspective in modern gynecology. Though levonorgestrel intrauterine system (LNG-IUS) and dienogest (DNG) effectively relieve symptoms in adenomyosis, neither has been approved for the same indication. Our study aims to compare the efficacy and safety of these progestins in treating adenomyosis.
UNASSIGNED: To study the efficacy and safety of LNG-IUS versus DNG in patients with symptomatic adenomyosis.
UNASSIGNED: Open-labeled, parallel, single-centered, randomized clinical trial.
UNASSIGNED: Patients with adenomyosis-associated pain with or without abnormal uterine bleeding were randomly allocated to either LNG-IUS group or DNG group. The primary outcome was a reduction in painful symptoms after 12 weeks of treatment measured by visual analog scale (VAS) score. Changes in menstrual blood loss (MBL), improvement in quality of life (QoL), and adverse drug reactions were also analyzed.
UNASSIGNED: The VAS score significantly decreased from baseline in both groups. The baseline and post-treatment VAS scores in the LNG-IUS group were 6.41 ± 1.07 and 3.41 ± 1.04 (p = <0.001) and in the DNG group, were 6.41 ± 0.95 and 3.12 ± 1.40 (p = <0.001), respectively. A significantly greater proportion of patients in the LNG-IUS group experienced lighter MBL as compared to the DNG group [27/30 (90%) in the LNG-IUS group versus 17/22 (77.2%) in the DNG group (p = 0.006)]. Both the groups had improvement in QOL scores calculated by the World Heath Organisation QOL scale (WHOQOL BREF) questionnaire; however, it was more pronounced in the DNG group [(28.76 ± 30.47 in the LNG-IUS group versus 48.26 ± 44.91 in the DNG group (p = 0.04)]. Both the agents were safe as there were no reported major adverse drug reactions.
UNASSIGNED: DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis.
UNASSIGNED: The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.
Comparison of effectiveness and safety of Mirena (LNG-IUS) with dienogest for treatment of adenomyosis Adenomyosis is a condition affecting women, typically aged 40–50, but its incidence is rising in younger women, impacting fertility. It causes painful symptoms like dysmenorrhea, dyspareunia, chronic pelvic pain, and heavy menstrual bleeding. Managing symptoms is crucial, and medical approaches include levonorgestrel intrauterine system (LNG-IUS) and dienogest (DNG). LNG-IUS is reversible contraception, approved for eight years, effectively treating symptoms. DNG, a newer progestin, is effective for endometriosis, but evidence for adenomyosis is limited. This single-center, open-label randomized clinical trial compared LNG-IUS and DNG in treating adenomyosis. Women over 20 with pelvic pain were diagnosed using ultrasound and met specific criteria. After informed consent, participants were assigned randomly to LNG-IUS or DNG groups. Treatment outcomes, including pelvic pain, quality of life (QoL), and adverse effects, were assessed over 12 weeks. Out of 84 assessed, 74 women were recruited, with 34 in each group analyzed. After 12 weeks, both groups showed significantly reduced pelvic pain (VAS scores), but no significant difference was found between the groups. LNG-IUS resulted in a significantly greater reduction in heavy menstrual bleeding (HMB), whereas DNG showed better improvement in overall QOL. Adverse effects were similar in both groups, with hot flushes reported in the DNG group. This study is one of the few comparing LNG-IUS and DNG for adenomyosis, finding both effective for symptom relief. Although LNG-IUS was superior in reducing HMB, DNG showed better overall improvement in QoL. Safety profiles were similar. Previous studies support the efficacy of DNG in reducing adenomyosis symptoms. To conclude, both LNG-IUS and DNG effectively alleviate adenomyosis symptoms, with LNG-IUS superior in reducing heavy menstrual bleeding and DNG showing better overall improvement in QOL. DNG is a viable and effective alternative to LNG-IUS.