[Pharmacological and clinical profile of dienogest (DINAGEST Tab. 1 mg)].

Sasagawa S, Shimizu Y, Imada K, Mizuguchi K
Nihon yakurigaku zasshi. Folia pharmacologica Japonica · 2009 · doi:10.1254/fpj.133.32 · PMID:19145049
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Dienogest, a fourth-generation progestin, inhibits ovarian function and endometriotic cell proliferation in preclinical models, while clinical trials demonstrate its efficacy in improving symptoms and signs of endometriosis with sustained long-term use.

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Dienogest is identified as a fourth-generation progestin that selectively agonizes progesterone receptors without exhibiting androgenic, glucocorticoid, or mineralocorticoid activities. Preclinical studies demonstrate its ability to suppress ovarian function by lowering estradiol levels and inhibiting the proliferation of stromal cells derived from both normal endometrium and endometriosis tissue. Clinical trials in patients with endometriosis confirmed that a daily dose of 2 mg significantly improved subjective symptoms and objective findings while maintaining efficacy during long-term administration without cumulative bone density loss. This paper is centrally about endometriosis, specifically detailing the pharmacological mechanisms and clinical efficacy of dienogest for treating the condition.

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抄録 ジエノゲスト（販売名：ディナゲスト錠1 mg）は，プロゲステロン受容体に対して選択的なアゴニスト活性を示す第4世代のプロゲスチンである．ジエノゲストは，ラットおよびウサギに経口投与することによりプロゲステロン作用を示し，一方，アンドロゲン作用，グルココルチコイド作用およびミネラルコルチコイド作用は示さなかった．ジエノゲストは，カニクイザルに反復経口投与することにより月経周期の停止，月経周期に伴う血中エストラジオール濃度の上昇および黄体形成ホルモン濃度の上昇を抑制し，卵巣機能抑制作用を示した．ジエノゲストは，カニクイザルに単回経口投与することにより，血中卵胞刺激ホルモン濃度の基礎値に影響することなく血中エストラジオール濃度を低下させ，このとき，主席卵胞の閉鎖を示唆する所見が観察された．また，ジエノゲストは，ヒト正常子宮内膜および子宮内膜症組織由来の間質細胞の増殖を抑制した．以上の結果から，ジエノゲストは，子宮内膜症患者において，卵巣機能抑制作用および直接的な子宮内膜症細胞の増殖抑制により，疼痛の軽減および病巣の縮小・萎縮を示すと考えられる．子宮内膜症患者を対象とした国内臨床試験において，ジエノゲストの2 mg/日により，自覚症状の改善および他覚所見の改善が認められた．また，本剤の長期投与試験において，投与期間の延長による骨密度の累積的な減少がみられることなく有効性を示したことから，長期投与による有用性が期待される． © 2009 公益社団法人 日本薬理学会

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