JP2021536454A - ハイリスクヒトパピローマウイルス感染症の治療 - Google Patents
ハイリスクヒトパピローマウイルス感染症の治療 Download PDFInfo
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Abstract
Description
−本明細書で定義される医薬組成物を得ること;および
−有効量の組成物を患者に投与すること(ここで、組成物は膣内に適用される)を含む方法にも関する。
組成物は、以下の成分(ゲル5ml当たり)を有する水溶液膣ゲルである:
高分散二酸化ケイ素 10.00 mg
クエン酸 24.80 mg
亜セレン酸ナトリウム 0.83 mg
(セレン当量0.25mg相当)
安息香酸ナトリウム 2.50 mg
ソルビン酸カリウム 5.00 mg
ヒドロキシエチルセルロース 100.00 mg
水 (最大 5ml)。
本試験は、症例1(女性患者116例、年齢25〜60歳、慢性ウイルス性疾患、癌および免疫抑制治療なし)の構成で1日1回3×28日間の治療を行う対照群多施設共同無作為化プロスペクティブ非盲検試験であった。毎日の用量は、膣内に適用された組成物5mlであった。
評価したデータから、活動群の患者では、測定したすべてのパラメータで明らかに結果が改善したことが実証されている。わずかな有害事象が報告されたのみであった。
Claims (15)
- HPV16、HPV18、HPV31、HPV33およびHPV58から選択される少なくとも1つのヒトパピローマウイルス(HPV)による女性患者の内部生殖器官の感染の予防または治療に使用するための、セレン酸含有化合物およびクエン酸、酢酸、リンゴ酸、炭酸、硫酸、硝酸、塩酸、果実酸およびそれらの混合物から選択される薬学的に許容される酸を含有する医薬組成物であって、膣内に適用される医薬組成物。
- 患者が少なくとも内部生殖器官の領域においてp16陽性、好ましくはp16陽性およびKi−67陽性であり、好ましくは患者が該領域においてp16陰性、好ましくはp16陰性およびKi−67陰性になるまで適用される、請求項1に記載の使用のための医薬組成物。
- 全セレン含量が、組成物5ml当たり0.01mg〜1.25mg、好ましくは0.025mg〜1.00mg、より好ましくは0.05mg〜0.75mg、さらにより好ましくは0.10mg〜0.50mg、さらにより好ましくは0.15mg〜0.40mg、特に0.20mg〜0.30mgである請求項1または2に記載の使用のための医薬組成物。
- 全セレン用量が、適用当たり0.01mg〜1.25mg、好ましくは0.025mg〜1.00mg、より好ましくは0.05mg〜0.75mg、さらにより好ましくは0.10mg〜0.50mg、さらにより好ましくは0.15mg〜0.40mg、特に0.20mg〜0.30mgである請求項1〜3のいずれか1項に記載の使用のための医薬組成物。
- 組成物が1日に少なくとも1回、好ましくは少なくとも30日間、より好ましくは少なくとも60日間、さらにより好ましくは少なくとも90日間適用され、任意選択で、該適用は患者の月経中に中止される、請求項1〜4のいずれか1項に記載の使用のための医薬組成物。
- 前記組成物が1日1回適用され、任意選択で、該適用は、患者の月経中に中止される、請求項1〜5のいずれか1項に記載の使用のための医薬組成物。
- 前記適用が患者の月経中に中止される、請求項1〜6のいずれか1項に記載の使用のための医薬組成物。
- 前記組成物が、前記内部生殖器の感染がもはや検出されなくなるまで適用される、請求項1〜7のいずれか1項に記載の使用のための医薬組成物。
- 前記組成物が、ゲル、懸濁液、エマルジョン、ゼラチンカプセル若しくはゼラチンを含まないカプセルなどの坐剤、噴霧または粉末の形態で存在する、請求項1〜8のいずれか1項に記載の使用のための医薬組成物。
- 前記組成物が、二酸化ケイ素、好ましくは高分散二酸化ケイ素をさらに含有する、請求項1〜9のいずれか1項に記載の使用のための医薬組成物。
- 7.0未満、好ましくは5.0未満、特に4.0〜2.5のpHを有する、請求項1〜10のいずれか1項に記載の使用のための医薬組成物。
- 薬学的に許容される酸がクエン酸である請求項1〜11のいずれか1項に記載の使用のための医薬組成物。
- 前記亜セレン酸塩含有化合物が、亜セレン酸ナトリウムである請求項1〜12のいずれか1項に記載の使用のための医薬組成物。
- 内部生殖器官が患者の膣または子宮頸部である請求項1〜13のいずれか1項に記載の使用のための医薬組成物。
- 患者がHPV感染以外の癌および/または慢性ウイルス疾患を有さず、および/または患者が免疫抑制されていない、請求項1〜14のいずれか1項に記載の使用のための医薬組成物。
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EP18191289.0A EP3616693A1 (en) | 2018-08-28 | 2018-08-28 | Therapy of high-risk human papillomavirus infections |
PCT/EP2019/072926 WO2020043762A1 (en) | 2018-08-28 | 2019-08-28 | Therapy of high-risk human papillomavirus infections |
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JP2004518758A (ja) * | 2001-02-13 | 2004-06-24 | オーコファーム フォーシュンクス−ウント エントウィックルングス−ゲゼルシャフト ミット ベシュレンクテル ハフトング | 亜セレン酸塩またはセレン酸塩を含有する製剤の使用 |
US20130323328A1 (en) * | 2011-02-16 | 2013-12-05 | Selo Medical Gmbh | Pharmaceutical Preparation Containing Selenite or Selenite-Containing Compounds for Treating Cervical Dysplasia or Carcinomas |
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AT412758B (de) | 2000-06-05 | 2005-07-25 | Vis Vitalis Lizenz & Handels | Verwendung einer selenithältigen lösung zur behandlung viraler erkrankungen |
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JP2004518758A (ja) * | 2001-02-13 | 2004-06-24 | オーコファーム フォーシュンクス−ウント エントウィックルングス−ゲゼルシャフト ミット ベシュレンクテル ハフトング | 亜セレン酸塩またはセレン酸塩を含有する製剤の使用 |
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MA53482A (fr) | 2021-07-07 |
ES2958808T3 (es) | 2024-02-15 |
TWI827652B (zh) | 2024-01-01 |
EP3843715B1 (en) | 2023-09-13 |
MA53482B1 (fr) | 2023-11-30 |
JP7420791B2 (ja) | 2024-01-23 |
UA127632C2 (uk) | 2023-11-08 |
CL2021000197A1 (es) | 2021-09-20 |
AU2019332079A1 (en) | 2021-02-11 |
GEP20227432B (en) | 2022-10-25 |
EP3843715A1 (en) | 2021-07-07 |
AR116027A1 (es) | 2021-03-25 |
MD3843715T2 (ro) | 2023-12-31 |
BR112021003360A2 (pt) | 2021-05-11 |
MX2021002310A (es) | 2021-04-28 |
RS64916B1 (sr) | 2023-12-29 |
EP3843715C0 (en) | 2023-09-13 |
HUE064691T2 (hu) | 2024-04-28 |
TW202023534A (zh) | 2020-07-01 |
IL281080A (en) | 2021-04-29 |
HRP20231470T1 (hr) | 2024-03-01 |
CN112584828A (zh) | 2021-03-30 |
PL3843715T3 (pl) | 2024-02-19 |
EA202190441A1 (ru) | 2021-06-15 |
CA3107691A1 (en) | 2020-03-05 |
WO2020043762A1 (en) | 2020-03-05 |
US20210299163A1 (en) | 2021-09-30 |
EP3616693A1 (en) | 2020-03-04 |
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