{"title":"左炔诺孕酮宫内避孕系统与双炔诺孕酮对子宫腺肌症的疗效比较：随机临床试验。","authors":"Satish Choudhury, Saubhagya Kumar Jena, Subarna Mitra, Biswa Mohan Padhy, Sudipta Mohakud","doi":"10.1177/26334941241227401","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To study the efficacy and safety of LNG-IUS <i>versus</i> DNG in patients with symptomatic adenomyosis.</p><p><strong>Design: </strong>Open-labeled, parallel, single-centered, randomized clinical trial.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> = <0.001) and in the DNG group, were 6.41 ± 0.95 and 3.12 ± 1.40 (<i>p</i> = <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 <i>versus</i> 17/22 (77.2%) in the DNG group (<i>p</i> = 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 <i>versus</i> 48.26 ± 44.91 in the DNG group (<i>p</i> = 0.04)]. Both the agents were safe as there were no reported major adverse drug reactions.</p><p><strong>Conclusion: </strong>DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis.</p><p><strong>Trial registration: </strong>The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.</p>","PeriodicalId":75219,"journal":{"name":"Therapeutic advances in reproductive health","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10812097/pdf/","citationCount":"0","resultStr":"{\"title\":\"Comparison of efficacy between levonorgestrel intrauterine system and dienogest in adenomyosis: a randomized clinical trial.\",\"authors\":\"Satish Choudhury, Saubhagya Kumar Jena, Subarna Mitra, Biswa Mohan Padhy, Sudipta Mohakud\",\"doi\":\"10.1177/26334941241227401\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>To study the efficacy and safety of LNG-IUS <i>versus</i> DNG in patients with symptomatic adenomyosis.</p><p><strong>Design: </strong>Open-labeled, parallel, single-centered, randomized clinical trial.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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 (<i>p</i> = <0.001) and in the DNG group, were 6.41 ± 0.95 and 3.12 ± 1.40 (<i>p</i> = <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 <i>versus</i> 17/22 (77.2%) in the DNG group (<i>p</i> = 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 <i>versus</i> 48.26 ± 44.91 in the DNG group (<i>p</i> = 0.04)]. Both the agents were safe as there were no reported major adverse drug reactions.</p><p><strong>Conclusion: </strong>DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis.</p><p><strong>Trial registration: </strong>The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.</p>\",\"PeriodicalId\":75219,\"journal\":{\"name\":\"Therapeutic advances in reproductive health\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2024-01-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10812097/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic advances in reproductive health\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/26334941241227401\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic advances in reproductive health","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/26334941241227401","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：子宫腺肌症的药物治疗是现代妇科的一个新观点。尽管左炔诺孕酮宫腔内注射系统（LNG-IUS）和双炔诺孕酮（DNG）能有效缓解子宫腺肌症的症状，但这两种药物均未被批准用于相同的适应症。我们的研究旨在比较这两种孕激素治疗子宫腺肌症的有效性和安全性：研究 LNG-IUS 与 DNG 对有症状子宫腺肌症患者的疗效和安全性：设计：开放标签、平行、单中心、随机临床试验：方法：将伴有或不伴有异常子宫出血的子宫腺肌症相关疼痛患者随机分配到 LNG-IUS 组或 DNG 组。主要结果是治疗 12 周后疼痛症状减轻，以视觉模拟量表（VAS）评分来衡量。此外，还分析了月经失血量（MBL）的变化、生活质量（QoL）的改善以及药物不良反应：结果：两组患者的 VAS 评分均较基线明显下降。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 = P =，而DNG组为17/22（77.2%）（P = 0.006）]。根据世界卫生组织 QOL 量表（WHOQOL BREF）调查问卷计算，两组患者的 QOL 评分均有所提高，但 DNG 组的提高更为明显[（LNG-IUS 组为 28.76 ± 30.47，DNG 组为 48.26 ± 44.91（P = 0.04）]。两种药物都是安全的，没有重大药物不良反应的报告：试验登记：该试验在印度临床试验注册中心（CTRI）进行了前瞻性注册，注册号为 CTRI/2020/05/025186。
Comparison of efficacy between levonorgestrel intrauterine system and dienogest in adenomyosis: a randomized clinical trial.
Background: 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.
Objective: To study the efficacy and safety of LNG-IUS versus DNG in patients with symptomatic adenomyosis.
Methods: 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.
Results: 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.
Conclusion: DNG can be an effective and safe alternative to LNG-IUS for the medical management of adenomyosis.
Trial registration: The trial was prospectively registered at the clinical trial registry - India (CTRI) vide CTRI number CTRI/2020/05/025186.
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