JP2012046483A - 線維筋痛症候群または慢性疲労症候群の処置のための経皮的組成物および方法 - Google Patents
線維筋痛症候群または慢性疲労症候群の処置のための経皮的組成物および方法 Download PDFInfo
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Abstract
【解決手段】アンドロゲンが、テストステロン、テストステロン誘導体またはテストステロンとテストステロン誘導体との組合せを含む約1%の濃度のアンドロゲンと、薬学的に許容できるゲルとを含む、血中アンドロゲンレベルを増加させるための組成物。血中の成長ホルモンまたはIGF−1レベルを増加させる化合物をさらに含む組成物。
【選択図】なし
Description
エストロゲンおよび酢酸メドロキシプロゲステロンを用いた、健康女性への併用ホルモン補充療法のリスクと利益をプロスペクティブに評価することを目的とした女性健康イニシアティブ(WHI)臨床試験が、最近中止された(Fletcher, S. W. et al., 2002, J. Amer. Med. Assoc., 288:366-368)。冠状動脈性心臓病、乳癌、卒中および肺塞栓におけるリスクの増加が、結腸直腸癌、子宮内膜癌、股関節の骨折および他の原因による死における利益の増加を上回り、これにより、これらのホルモンを摂取している女性における危険率の総合指標に対して、わずかだが統計的に有意に増加したリスクがもたらされた。しかし、著者らは、これらの研究がホルモン不足の症状を有する者ではなく、健康な女性のみを評価したことを指摘している。さらに、たとえば、経皮システムなどの他の送達経路は、経皮送達が、これらの患者の利益を増加させおよび/またはリスクを減少させ得る可能性があるので、研究の必要がある。ホルモン補充療法が、ほてりなどの閉経周辺期症状を軽減するために効果的であると依然考えられていることが、WHI研究の著者らにより言及された。
本発明の1つの目的は、約1%の濃度のアンドロゲンと、薬学的に許容できるゲルとを含む、血液中のアンドロゲンレベルを増加させる組成物である。本発明のアンドロゲン組成物は、テストステロンおよびその誘導体を含みうる。
本発明の他の目的は、血液中の成長ホルモンのレベルを増加させる化合物または成長ホルモン自体に加え、アンドロゲンゲル製剤を投与することである。
本発明の他の目的は、線維筋痛症候群および慢性疲労症候群に罹患した患者に、症状を緩和するアンドロゲンゲル製剤の有効量を投与することを含む、線維筋痛症候群および慢性疲労症候群の症状を緩和する方法である。該方法の他の態様において、投与される製品は、アンドロゲンホルモンならびに血液中の成長ホルモンレベルを増加させる化合物の組合せを含むゲルでありうる。さらに、本発明の方法は、患者へのアンドロゲンゲルの投与および別個の成長ホルモンの注射を意図する。
慢性疲労の症状は、近年多くの注目を受けた。慢性疲労症候群の診断の確認に用いることができる身体所見または臨床検査は存在しない。しかし、この症候群は、一般に、以下の症状の少なくとも4種またはそれ以上の症状が同時に起こる、6ヶ月より長く存続または再発する疲労により特徴づけられる:減じられた記憶または集中、のどの痛み、圧痛のある頸部または腋窩リンパ節、筋痛、多関節痛、新たな頭痛、爽快でない睡眠、労作後の不快感。初期の研究は、慢性疲労症候群の病態生理学について、伝染性または免疫異常調節のメカニズムを示唆した。より最近の研究では、神経学的、感情的および認知的症状もまたしばしば起こることが示された。
アンドロゲンなどのホルモンの経皮投与が、FMSまたはCFS罹患患者の症状を緩和しうることが、今回見いだされた。「アンドロゲン療法」とは、アンドロゲン単独またはアンドロゲンの組合せの投与を含むものである。「緩和」とは、FMSまたはCFSの患者の症状を軽くし、減少もしくは低減させ、または軽減させもしくは取り除くことを意味する。FMSまたはCFSの「症状」とは、FMSまたはCFSによってもたらされる筋の痛みおよび萎縮、慢性疲労、回復睡眠の欠如、感染への増加した感受性および頭痛を含む。
この研究用の送達ビークルは、ゲル製剤であった。その使用を選択したのは、アンドロゲン治療の副作用を減じる方法として、有効レベルの血中ホルモンをもたらすホルモン用の経皮送達システムを特定することが研究の目的であったからである。本研究に使用されたゲルは、USPグレードの1%w/wのテストステロンゲルであった。1日に適用されるゲル用量は、0.75グラムであり、10%の生物学的利用能が期待できるため、24時間あたり0.75mgのテストステロンが送達される。このゲルは、Bently Pharmaceuticals Inc.(ノースハンプトン、NH)により、適正製造基準を用いて女性用に製剤されたもので、無色であり、皮膚に快適であり、汚れをつけることもない。
この開示で当業者に明白であるように、他の薬学的に許容できるアンドロゲン療法が使用されうる。本発明でアンドロゲンまたはアンドロゲンの組合せが投与されうる、効果的な量および経路は、アンドロゲン療法の他の使用に従って、当業者により日常的に決定されうる。
いくつかある用語の中でも特にGHの視床下部−下垂体−肝臓軸として知られるこの系に影響を与える他の化合物が知られている。このホルモン調節系に関与する他の化合物が、間接的または直接的にGH、IGF-1またはIGF-2のレベルに影響を与えおよび増加させる役割を果たしえ、本発明と関連して、そのような処置による成長/抗老化の最大限の効果を得るために、アンドロゲン補給と共に投与されうることが予想される。線維筋痛症の他に処置されうる他の適応症は、これに限定されるものではないが、下垂体性小人症、または内分泌学、成長および老化の分野の医師によく知られた状態または症候群を含む、個体の成長に影響を与える症候群でありうる。
Claims (14)
- 約1%の濃度のアンドロゲンと、薬学的に許容できるゲルとを含む、血中アンドロゲンレベルを増加させるための組成物。
- アンドロゲンが、テストステロン、テストステロン誘導体またはテストステロンとテストステロン誘導体との組合せを含む、請求項1に記載の組成物。
- 血中の成長ホルモンまたはIGF−1レベルを増加させる化合物をさらに含む、請求項1に記載の組成物。
- 線維筋痛症候群または慢性疲労症候群罹患患者に、症状を緩和する請求項1に記載の組成物の有効量を投与することを含む、線維筋痛症候群および慢性疲労症候群の症状を緩和する方法。
- 患者が、閉経周辺期/閉経後の年齢の女性である、請求項4に記載の方法。
- アンドロゲンが、テストステロン誘導体を含む、請求項4に記載の方法。
- アンドロゲンの組合せが患者に投与される、請求項4に記載の方法。
- アンドロゲンの組合せが、テストステロンまたはテストステロン誘導体と、デヒドロエピアンドロステロンとを含む、請求項7に記載の方法。
- アンドロゲンと成長ホルモンとの組合せが、患者に投与される、請求項4に記載の方法。
- アンドロゲンと、血中の成長ホルモンレベルを増加させる化合物との組合せが、患者に投与される、請求項4に記載の方法。
- 化合物が、成長ホルモン放出ペプチド、成長ホルモン放出ホルモン、IGF−1およびIGF−2からなる群から選択される、請求項10に記載の方法。
- 化合物が、成長ホルモンおよびその誘導体、IGF−1およびIGF−2、またはそれらの誘導体からなる群から選択される、請求項10に記載の方法 。
- 化合物が、2〜20アミノ酸長であり、成長ホルモンを放出することが既知の成長ホルモン放出ペプチド模倣化合物である、請求項10に記載の方法。
- 成長ホルモン放出ペプチド模倣薬がヘキサレリンである、請求項13に記載の方法。
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Also Published As
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US20040259852A1 (en) | 2004-12-23 |
US20110009318A1 (en) | 2011-01-13 |
AU2011200914B2 (en) | 2014-07-03 |
JP5651540B2 (ja) | 2015-01-14 |
WO2005000236A2 (en) | 2005-01-06 |
CA2529575A1 (en) | 2005-01-06 |
WO2005000236A3 (en) | 2005-08-04 |
EP2000143B1 (en) | 2014-07-23 |
JP5717312B2 (ja) | 2015-05-13 |
JP2007523856A (ja) | 2007-08-23 |
EP2000143A3 (en) | 2009-09-30 |
AU2004251075A1 (en) | 2005-01-06 |
EP1638575A4 (en) | 2007-07-25 |
AU2011200914A1 (en) | 2011-03-24 |
US8999963B2 (en) | 2015-04-07 |
US7799769B2 (en) | 2010-09-21 |
US20060100186A1 (en) | 2006-05-11 |
EP1638575A2 (en) | 2006-03-29 |
EP2000143A2 (en) | 2008-12-10 |
AU2004251075B2 (en) | 2010-12-02 |
CA2529575C (en) | 2012-04-10 |
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