JP2017149760A - 慢性疲労の治療用の組成物および方法 - Google Patents
慢性疲労の治療用の組成物および方法 Download PDFInfo
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- JP2017149760A JP2017149760A JP2017084218A JP2017084218A JP2017149760A JP 2017149760 A JP2017149760 A JP 2017149760A JP 2017084218 A JP2017084218 A JP 2017084218A JP 2017084218 A JP2017084218 A JP 2017084218A JP 2017149760 A JP2017149760 A JP 2017149760A
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Abstract
Description
者および医療従事者が彼らの治療戦略を常にチェックして見直すことが概して求められる。CFSを治療するための現在の治療法は、最も衰弱させる症状(即ち、痛み、不眠症および憂うつ)を緩和しようとすることに主眼を置いている。これまでのところ、CFSを著しく改善または治療するアメリカ合衆国食品医薬品局(「FDA」)承認の治療法または一般に認められている治療法はない。
称されることもある)、痛みを伴う月経期ならびにその他の疼痛症候群が挙げられる。アメリカ合衆国における線維筋痛の有病率は2%と推定されており、2005年では500万人の成人に及んでいる。有病率は男性より女性がはるかに高い(3.4%対0.5%)(女性:男性比7:1)。
えられる。
ことができ、または同時に投与することができる。
経系、免疫系および内分泌系の更なる消耗または崩壊をもたらすことなく神経系、免疫系および内分泌系の機能を補助し、および慢性疲労の症状に対して薬がその肯定的な臨床効果を呈することができるレベルに前記機能を高める。
系、内分泌系および免疫系の再統合を誘発し、疲労症状を著しく緩和し、または軽減し、少なくとも相当数の患者のサブセットが機能的に動く状態に復帰することができ、および/または機能的に動く状態を維持することができると考えられる。
S剤は、アトモキセチン約20〜50mg/日、アトモキセチン約20〜25mg/日もしくはアトモキセチン約22.5〜25mg/日、またはカフェイン約50〜500mg/日、カフェイン100〜400mg/日もしくはカフェイン約100〜300mg/日の量で投与される。2種以上のCNS剤を同じ組成物または方法に含めることもでき、開示した微量栄養素との組み合わせで治療上有効な、全体として低いCNS用量を得るために、本明細書の教示内容を考慮して各々の量は、比例的に減少し得る。
ウム、鉄、ヨウ素、銅、マンガン、カリウム、クロム、モリブデンおよび/またはホウ素が挙げられる。
00mg〜1500mgの量のL−チロシン、約500mg〜750mgの量のN−アセチルシステインおよび約300mg〜450mgの量のアルファ−リポ酸が挙げられる。
あることができる任意のビタミン微量栄養素の具体例として、ビタミンA、B、C、DおよびEが挙げられる。
日としての服用で1日当たり4錠の丸剤であることができ、各丸剤は表2に示す栄養素成分および1日当たり同様に低投与量の表1に示すCNS剤を有する。しかしながら、処方薬または栄養サプリメントの服用に対して極度に敏感である患者では、有効な投与量を1日当たり1錠の丸剤まで少なくすることができる。1〜2週間以内に初期投与量に反応しない患者に関しては、次いで、治療における投与量を1日当たり6錠の丸剤(3錠の丸剤×2回/日として服用)に増加させることができ、必要な場合には、1日当たり8錠の丸剤(4錠の丸剤×2回/日として服用、各丸剤は表2に示す成分を有する)に増加させることができる。そのため、表2に示す1つまたはそれ以上の栄養素の経口投与量に関する治療上有効な量は、例えば表2に示す量の30、40、50、60、70、80、90、110、120、130、140、150、160、170、180、190または200%超であることができる。本明細書に記載の教示内容および指針を考慮して、当業者は前記に例示したもの以外の有効な量を求めることができる。
コンドリアの機能およびエネルギー生成を高める。アセチル−L−カルニチンはまた、嫌気条件下でミトコンドリアのエネルギー生成能力を高める燃料源をミトコンドリアに供給するように機能する。ミトコンドリアDNAの枯渇に起因して電子伝達鎖が制御されていない場合、例えば嫌気的代謝が生じる可能性がある。
ミノ酸、炭水化物および脂肪の代謝で起こる多くの種類のアミノ基転移反応(アミノ酸代謝)および脱カルボキシル化反応に関わる補酵素である。ビタミンB6はまた、免疫系機能における補助因子である。抗酸化物質であるとは一般に考えられていないが、ビタミンB6は抗酸化特性を示す。
シウム、鉄、ヨウ素、銅、マンガン、カリウム、クロム、モリブデンもしくはホウ素等の付加的なミネラルが挙げられる。例えば、ビタミンのカテゴリーから1つまたはそれ以上の栄養素を付加的に含めることができる。同様に、ミネラルのカテゴリーから1つまたはそれ以上の栄養素を付加的に含めることができる。また、ビタミンおよびミネラルの両方のカテゴリーから1つまたはそれ以上の栄養素を、開示した実施形態の微量栄養素成分に付加的に含めることができる。そのため、開示した実施形態の微量栄養素成分は、以下のビタミンまたはミネラルの様々な組み合わせのうちのいずれか1つまたはそれ以上だけでなく、前記組み合わせの全ても含むことができる:ベータカロテン、ビタミンC、ビタミンE、ビタミンB6、ビタミンB12、亜鉛、セレン、混合トコフェロール、ビタミンB1(チアミン)、ビタミンB2(リボフラビン)、ナイアシンアミド、パントテン酸カルシウム、コリン(酒石酸水素塩)、イノシトール、葉酸(フォラシン)、ビオチン、ビタミンD3(コレカルシフェロール(cholicalciferol))、カルシウム、マグネシウム、
鉄、ヨウ素、銅、マンガン、カリウム、クロム、モリブデンおよび/またはホウ素。
神経細胞の機能に必要である。カルシウムはまた、神経系を補助するとともにその神経系のバランスを取るミネラルであり、そのため本明細書に開示した組成物および方法のいくつかの態様で特に有益である。
応に基づいて例えば1日当たり2回で2錠の錠剤(表2)であることができるが、投与量を例えば1日当たり2回で4錠の丸剤または1日当たり2回で1錠の丸剤に変更することもできる。任意の特定の対象のために、個々の要求および組成物の投与を管理している専門家の専門的な判断に基づいて、具体的な投与レジメンを経時的に調整しなくてはならないことを理解すべきである。したがって、患者は1つの用量で開始され得るが、患者の状態が変化するとともにその用量を変更することができる。
た、当業者に既知の方法を用いて栄養素を生化学的に精製することまたは化学的に合成することができる。
)は、20〜140に順位付けした、前2週間にわたる疲労の重症度を評価する自己申告式質問票である。本研究の目的のため、臨床的に有意な応答を、疲労スコアでの33%低下、または従事者での推定疲労に関するカットオフ・ポイントとして事前に定義している76%以下のCISスコアと定義した。これらの基準を満たしている患者を応答者と見なした。(2)第2の手段として、主観的疲労を測定する視覚的アナログ・スケール(VAS)を用いた(範囲0〜10)。
疲労:4週目での中間解析では、CISの総スコアにおいて33%以上の低下で判断する疲労の臨床的に有意な減少が、疲労症状が平均して33%低減している参加者の66%[15例中10例が有意に応答した]で見られた。12週目での中間解析では、CISの総スコアにおいて33%以上の低下で判断する疲労の臨床的に有意な減少が、疲労症状が平均して41%減少している(図1参照)参加者の100%[7例の患者中7例が有意に応答した]で見られた。視覚的アナログ・スケール(VAS)でも同様の結果が見られ、この結果は、12週目において疲労症状が平均して54%低減している(図2参照)本研究の患者の66%[15例中10例が有意に応答した]での疲労症状の臨床的に有意な減少と一致した。
Claims (57)
- 治療上有効な低投与量の中枢神経系刺激薬;
L−カルニチンおよびL−チロシンを含む、治療上有効な量の微量栄養素刺激成分;ならびに
N−アセチルシステインおよびアルファ−リポ酸を含む、治療上有効な量の微量栄養素抗酸化成分
を含む、慢性疲労の治療用の経口投与組成物。 - アセチル−L−カルニチンは60〜250mgの範囲で存在する、請求項1に記載の組成物。
- アセチル−L−カルニチンは100〜150mgの範囲で存在する、請求項1に記載の組成物。
- L−チロシンは50〜200mgの範囲で存在する、請求項1に記載の組成物。
- L−チロシンは80〜100mgの範囲で存在する、請求項1に記載の組成物。
- N−アセチルシステインは60〜250mgの範囲で存在する、請求項1に記載の組成物。
- N−アセチルシステインは100〜150mgの範囲で存在する、請求項1に記載の組成物。
- アルファ−リポ酸は25〜100mgの範囲で存在する、請求項1に記載の組成物。
- アルファ−リポ酸は40〜60mgの範囲で存在する、請求項1に記載の組成物。
- L−タウリン約25〜100mgを更に含む、請求項1に記載の組成物。
- L−タウリンは35〜75mgの範囲で存在する、請求項10に記載の組成物。
- 中枢神経系刺激薬は約2mg〜20mgの量のアトモキセチンHClである、請求項1に記載の組成物。
- 中枢神経系刺激薬は約0.75mg〜7.5mgの量のメチルフェニデートHClである、請求項1に記載の組成物。
- 中枢神経系刺激薬は約0.5mg〜5mgの量のデクスメチルフェニデートHClである、請求項1に記載の組成物。
- 中枢神経系刺激薬は約4mg〜40mgの量のモダフィニルである、請求項1に記載の組成物。
- 中枢神経系刺激薬は約4mg〜40mgの量のアルモダフィニルである、請求項1に記載の組成物。
- 中枢神経系刺激薬は約1mg〜10mgの量のアンフェタミンである、請求項1に記載の組成物。
- ビタミンB6(ピリドキシン)およびビタミンB12のうちの1つまたはそれ以上を更に含む、請求項1に記載の組成物。
- ビタミンC、ビタミンE、ベータカロテン、亜鉛およびセレンのうちの1つまたはそれ以上を更に含む、請求項1に記載の組成物。
- アセチル−L−カルニチン、L−チロシン、ビタミンB6(ピリドキシン)、ビタミンB12、N−アセチルシステイン、アルファ−リポ酸、L−タウリン、ビタミンC、ビタミンEおよびベータカロテンを含む、請求項1に記載の組成物。
- 亜鉛、セレン、混合トコフェロール、ビタミンB1(チアミン)、ビタミンB2(リボフラビン)、ナイアシンアミド、パントテン酸カルシウム、コリン(酒石酸水素塩)、イノシトール、葉酸(ホラシン)、ビオチン、ビタミンD3(コレカルシフェロール(cholicalciferol))、カルシウム、マグネシウム、鉄、ヨウ素、銅、マンガン、カリウム、
クロム、モリブデンおよびホウ素から成る群から選択される1つまたはそれ以上の付加的なビタミンまたはミネラルを更に含む、請求項20に記載の組成物。 - 刺激薬およびそれらの微量栄養素成分は、一緒に配合されて、丸剤、錠剤、カプセル剤または液状の剤形とされる、請求項1に記載の組成物。
- 1日当たり低投与量の中枢神経系刺激薬を投与するステップ、ならびに
1日当たり治療上有効な投与量の、アセチル−L−カルニチン、
L−チロシン、
N−アセチルシステイン、および
アルファ−リポ酸
を投与するステップ、
を含む、ヒト患者における慢性疲労の治療方法。 - 約100〜2000mg/日の範囲でアセチル−L−カルニチンを投与する、請求項23に記載の方法。
- 約400〜1600mg/日の範囲でアセチル−L−カルニチンを投与する、請求項23に記載の方法。
- 約100〜2000mg/日の範囲でL−チロシンを投与する、請求項23に記載の方法。
- 350〜1400mg/日の範囲でL−チロシンを投与する、請求項23に記載の方法。
- 100〜2000mg/日の範囲でN−アセチルシステインを投与する、請求項23に記載の方法。
- 250〜1250mg/日の範囲でN−アセチルシステインを投与する、請求項23に記載の方法。
- 50〜1000mg/日の範囲でアルファ−リポ酸を投与する、請求項23に記載の方法。
- 150〜600mg/日の範囲でアルファ−リポ酸を投与する、請求項23に記載の方法。
- 前記投与を少なくとも12週にわたって継続的に行なう、請求項23に記載の方法。
- 慢性疲労は慢性疲労症候群に関連する、請求項23に記載の方法。
- 慢性疲労は線維筋痛症に関連する、請求項23に記載の方法。
- 慢性疲労は、癌、HIV/AIDS、B型およびC型慢性肝炎、自己免疫疾患、ライム病、パーキンソン病、アルツハイマー病、精神的疾患(うつ病、ADDおよびADHDを含む)、多発性硬化症、鎌状赤血球貧血ならびにうっ血性心不全の群から選択される状態に関連する、請求項23に記載の方法。
- CNS刺激薬、アセチル−L−カルニチン、L−チロシン、N−アセチルシステインおよびアルファ−リポ酸を、配合剤形で、一緒に経口投与する、請求項23に記載の方法。
- CNS刺激薬はメチルフェニデートを含む、請求項23に記載の方法。
- 2.5〜40mg/日の量でメチルフェニデートを投与する、請求項37に記載の方法。
- 20mg/日未満の量でメチルフェニデートを投与する、請求項38に記載の方法。
- CNS刺激薬はモダフィニルを含む、請求項23に記載の方法。
- 30〜100mg/日の量でモダフィニルを投与する、請求項37に記載の方法。
- 30〜50mg/日の量でモダフィニルを投与する、請求項38に記載の方法。
- CNS刺激薬はアルモダフィニルを含む、請求項23に記載の方法。
- 20〜80mg/日の量でアルモダフィニルを投与する、請求項37に記載の方法。
- 20〜40mg/日の量でアルモダフィニルを投与する、請求項38に記載の方法。
- CNS刺激薬はデクスメチルフェニデートを含む、請求項23に記載の方法。
- 2.5〜10mg/日の量でデクスメチルフェニデートを投与する、請求項37に記載の方法。
- 2.5〜5mg/日の量でデクスメチルフェニデートを投与する、請求項38に記載の方法。
- CNS刺激薬はアンフェタミンを含む、請求項23に記載の方法。
- 2.5〜20mg/日の量でアンフェタミンを投与する、請求項37に記載の方法。
- 2.5〜10mg/日の量でアンフェタミンを投与する、請求項38に記載の方法。
- CNS刺激薬はアトモキセチンを含む、請求項23に記載の方法。
- 20〜50mg/日の量でアトモキセチンを投与する、請求項37に記載の方法。
- 20〜25mg/日の量でアトモキセチンを投与する、請求項38に記載の方法。
- CNS刺激薬はカフェインを含む、請求項23に記載の方法。
- 15〜200mg/日の量でカフェインを投与する、請求項55に記載の方法。
- 30〜125mg/日の量でカフェインを投与する、請求項55に記載の方法。
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JP2021524495A (ja) * | 2018-07-10 | 2021-09-13 | ヌチド リミテッド | 酸化的ストレスおよびミトコンドリアストレスから,細胞を保護する組成物 |
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CN107106540A (zh) * | 2015-10-13 | 2017-08-29 | 财团法人峨山社会福利财团 | 包含α‑硫辛酸及N‑乙酰半胱氨酸作为有效成分的肥胖的预防或治疗用组合物 |
RU2709501C1 (ru) * | 2019-10-15 | 2019-12-18 | Виктор Александрович Сисев | Фармацевтическая композиция для парентерального капельного введения |
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