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  1. 学部学科区分一覧
  2. 医学部・医学系研究科・医学部附属病院
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  2. 学術雑誌論文

Real-world outcomes of the levonorgestrel-releasing intrauterine system for heavy menstrual bleeding or dysmenorrhea in Japanese patients: A prospective observational study (J-MIRAI)

https://repository.lib.tottori-u.ac.jp/records/2001557
https://repository.lib.tottori-u.ac.jp/records/2001557
c5748f09-b1d8-4ffd-b3c7-e7fb6307b4b1
名前 / ファイル ライセンス アクション
contraception116_22.pdf contraception116_22.pdf (763 KB)
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Item type デフォルトアイテムタイプ(フル)(1)
公開日 2024-12-12
タイトル
タイトル Real-world outcomes of the levonorgestrel-releasing intrauterine system for heavy menstrual bleeding or dysmenorrhea in Japanese patients: A prospective observational study (J-MIRAI)
言語 en
作成者 原田,省

× 原田,省

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研究者総覧鳥取大学 100000223
e-Rad_Researcher 40218649

ja 原田,省
kakenhi 鳥取大学 15101

en Harada,Tasuku
Tottori University

ja-Kana ハラダ,タスク

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Ota,Ikuko

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en Ota,Ikuko

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Kitawaki,Jo

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en Kitawaki,Jo

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Momoeda,Mikio

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en Momoeda,Mikio

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Maeda,Nagamasa

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en Maeda,Nagamasa

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Akira,Shigeo

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en Akira,Shigeo

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Umeyama,Mikiko

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en Umeyama,Mikiko

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Sunaya,Toshiyuki

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Hirano,Kazufumi

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en Hirano,Kazufumi

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主題
言語 en
主題Scheme Other
主題 Chronic pelvic pain
主題
言語 en
主題Scheme Other
主題 Dysmenorrhea
主題
言語 en
主題Scheme Other
主題 Expulsion
主題
言語 en
主題Scheme Other
主題 Heavy menstrual bleeding
主題
言語 en
主題Scheme Other
主題 Levonorgestrel-releasing intrauterine system
内容記述
内容記述タイプ Other
内容記述 Objectives: We collected real-world data on the safety and clinical outcomes of the levonorgestrel-releasing intrauterine system (LNG-IUS) for heavy menstrual bleeding and dysmenorrhea. Study Design: This was a prospective, multicenter, single-cohort, open-label, post-authorization 12-month follow-up study of Japanese patients initiating the LNG-IUS for heavy menstrual bleeding and/or dysmenorrhea. The primary endpoint was the safety profile based on adverse events and adverse drug reactions (ADRs), including expulsions and abnormal bleeding, within 12 months of LNG-IUS insertion. Secondary endpoints included changes from baseline in menstrual blood loss based on bleeding days and dysmenorrhea graded on a visual analog scale (VAS). Results: Of the 595 patients included, many had underlying conditions such as adenomyosis (39.5%), uterine leiomyoma (30.8%), or endometriosis (12.9%). The incidences of ADRs and serious ADRs were 59.7% and 0.3%, respectively. Frequently reported ADRs were metrorrhagia (48.9%), procedural pain (14.1%), and ovarian cyst (6.2%). The cumulative incidence of expulsions at 12 months was 8.7%. Risk factors for expulsion were obesity (body mass index ≥25 kg/m2), adenomyosis, and uterine cavity length ≥8 cm. The median [interquartile range] VAS score for dysmenorrhea improved from 46.5 [13.0–68.0] at insertion to 1.0 [0.0–13.0] at 12 months, and improvements were also observed in chronic pelvic pain and painful defecation. Conclusions: The LNG-IUS safely and effectively reduced dysmenorrhea, chronic pelvic pain, and painful defecation. Risk factors for expulsion suggest that patients with underlying organic disease should be monitored carefully when using the LNG-IUS. Implications: The LNG-IUS is an effective treatment for secondary dysmenorrhea with organic disease, and for the reduction of chronic pelvic pain; however, physicians should be aware of the increased risk of expulsion in patients with organic conditions.
言語 en
出版者
出版者 Elsevier BV
言語 en
日付
日付 2022-11-18
日付タイプ Issued
言語
言語 eng
資源タイプ
資源タイプ識別子 http://purl.org/coar/resource_type/c_6501
資源タイプ journal article
出版タイプ
出版タイプ VoR
出版タイプResource http://purl.org/coar/version/c_970fb48d4fbd8a85
関連情報
関連タイプ isIdenticalTo
識別子タイプ DOI
関連識別子 https://doi.org/10.1016/j.contraception.2022.08.006
収録物識別子
収録物識別子タイプ PISSN
収録物識別子 00107824
収録物名
収録物名 Contraception
言語 en
巻
巻 116
開始ページ
開始ページ 22
終了ページ
終了ページ 28
書誌情報 en : Contraception

巻 116, p. 22-28, 発行日 2022-11-18
アクセス権
アクセス権 open access
アクセス権URI http://purl.org/coar/access_right/c_abf2
権利情報
言語 en
権利情報 (C) 2022 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ )
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