JP5717312B2 - 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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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。
図1は、1日目(円で示す)および28日目(四角で示す)における、患者の血液中の経時的な総テストステロン量のグループ平均を示す。
図2は、処置前(0日目)および試験終了時(28日目)の圧痛点(tender point)評価の結果を示す。記録した結果は、0(無痛)〜10(最も高い痛みレベル)のスケールでの痛みレベルである。
図3は、処置前(0日目)および試験終了時(28日目)の圧痛点における痛みの痛覚計による測定評価の結果を示す。
図4は、試験の1日目と28日目との1〜10のスケールでの(10が最も高いレベル)、線維筋痛症および慢性疲労に関連する症状/状態の重篤性の対比を示す。評価した症状/状態は、リビドー、筋痛、倦怠感、頭痛の重篤性、頭痛の頻度、凝り、不眠、覚醒時の疲労、不安、憂鬱を含んだ。
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 (2)
- 線維筋痛症、慢性疲労症候群および減少した性的欲求からなる群から選択される状態を有し、酵素結合免疫測定により決定された場合に適した閉経前の基準範囲またはそれと同等のテストステロン濃度決定法を使用した場合の対応する範囲の下半分のテストステロン濃度を有する女性ヒト患者の処置に使用するための医薬組成物であって、
該医薬組成物が、テストステロンと薬学的に許容し得るゲルとからなる経皮ゲルであり、
テストステロンが、重量ベースで1%の量で存在し、
該ゲルの1日に適用される用量として、前記女性患者の状態を緩和し、かつ、テストステロンによる有害な副作用を惹起することなく、該女性患者の血清テストステロンの定常状態総テストステロンレベルに、ならびに遊離テストステロン血清レベルを閉経前の基準範囲および閉経後基準範囲の上部に上昇させ、維持し、血清総テストステロン濃度平均を閉経前女性の基準範囲の上限を超えないのに有効な0.75gの量を投与するものである、前記組成物。 - 線維筋痛症、慢性疲労症候群および減少した性的欲求からなる群から選択される状態を有し、酵素結合免疫測定により決定された場合に適した閉経前の基準範囲またはそれと同等のテストステロン濃度決定法を使用した場合の対応する範囲の下半分のテストステロン濃度を有する女性ヒト患者の処置に使用するための医薬組成物であって、
該医薬組成物が、テストステロンと薬学的に許容し得るゲルとからなる経皮ゲルであり、
テストステロンが、重量ベースで1%の量で存在し、
該ゲルの1日に適用される用量として、前記女性患者の状態を緩和し、かつ、テストステロンによる有害な副作用を惹起することなく、該女性患者の血清テストステロンの定常状態総テストステロンレベルに、ならびに遊離テストステロン血清レベルを閉経前の基準範囲および閉経後基準範囲の上部に上昇させ、維持し、血清総テストステロン濃度平均を閉経前女性の基準範囲の上限を超えないのに有効な0.75gの量を投与するものであり、
遊離テストステロンのCmaxの平均を約4.69pg/mLまで増加させ、遊離テストステロンのAUCの24時間の平均を約71.38pg−h/mLまで増加させる、前記組成物。
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US20060100186A1 (en) | 2006-05-11 |
AU2011200914A1 (en) | 2011-03-24 |
AU2004251075B2 (en) | 2010-12-02 |
CA2529575A1 (en) | 2005-01-06 |
EP1638575A2 (en) | 2006-03-29 |
EP2000143A2 (en) | 2008-12-10 |
AU2004251075A1 (en) | 2005-01-06 |
US8999963B2 (en) | 2015-04-07 |
JP5651540B2 (ja) | 2015-01-14 |
WO2005000236A2 (en) | 2005-01-06 |
AU2011200914B2 (en) | 2014-07-03 |
EP1638575A4 (en) | 2007-07-25 |
JP2007523856A (ja) | 2007-08-23 |
US7799769B2 (en) | 2010-09-21 |
JP2012046483A (ja) | 2012-03-08 |
US20110009318A1 (en) | 2011-01-13 |
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