Choudhury Satish, Jena Saubhagya Kumar, Mitra Subarna, Padhy Biswa Mohan, Mohakud Sudipta
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, MIG 08, Housing Board Colony, Athgarh, Cuttack, Bhubaneswar, Odisha 754029, India.
Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Ther Adv Reprod Health. 2024 Jan 25;18:26334941241227401. doi: 10.1177/26334941241227401. eCollection 2024 Jan-Dec.
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.
To study the efficacy and safety of LNG-IUS DNG in patients with symptomatic adenomyosis.
Open-labeled, parallel, single-centered, randomized clinical trial.
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.
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 ( = <0.001) and in the DNG group, were 6.41 ± 0.95 and 3.12 ± 1.40 ( = <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 17/22 (77.2%) in the DNG group ( = 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 48.26 ± 44.91 in the DNG group ( = 0.04)]. Both the agents were safe as there were no reported major adverse drug reactions.
DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis.
The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.
子宫腺肌病的药物治疗是现代妇科领域中一个新兴的研究方向。尽管左炔诺孕酮宫内节育系统（LNG-IUS）和地诺孕素（DNG）能有效缓解子宫腺肌病的症状，但二者均未被批准用于该适应症。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和DNG治疗有症状子宫腺肌病患者的疗效和安全性。
开放标签、平行、单中心随机临床试验。
有或无异常子宫出血的子宫腺肌病相关性疼痛患者被随机分配至LNG-IUS组或DNG组。主要结局指标为治疗12周后通过视觉模拟量表（VAS）评分测量的疼痛症状减轻情况。还分析了月经出血量（MBL）的变化、生活质量（QoL）的改善情况以及药物不良反应。
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）。与DNG组相比，LNG-IUS组有显著更高比例的患者月经出血量减少[LNG-IUS组27/30（90%），DNG组17/22（77.2%）（P=0.006）]。两组通过世界卫生组织生活质量量表（WHOQOL BREF）问卷计算的生活质量评分均有改善；然而，DNG组更为明显[LNG-IUS组为28.76±30.47，DNG组为48.26±44.91（P=0.04）]。两种药物均安全，未报告重大药物不良反应。
对于子宫腺肌病的药物治疗，DNG可以是LNG-IUS一种有效且安全的替代药物。
该试验已在印度临床试验注册中心（CTRI）进行前瞻性注册，注册号为CTRI/2020/05/025186。
