JP2014502617A - 虚弱防止および治療用の成分の組み合わせ - Google Patents
虚弱防止および治療用の成分の組み合わせ Download PDFInfo
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Abstract
【選択図】図1
Description
(i)ヌクレオシド均等物、
(ii)DHA、DPAおよびEPAからなる群より選ばれるω−3ポリ不飽和脂肪酸、
(iii)ビタミンB、
(iv)ホスホリピッド、
(v)抗酸化剤、および
(vi)コリン
から選ばれる少なくとも2種の、好ましくは3種、さらに好ましくは4種の成分を(活性成分として)を含む組成物−ただし、少なくとも成分(i)または(iii)が存在する−を哺乳動物における(病理的)虚弱の予防または治療に使用するための、とりわけ人間、特にお年寄りの人間において体重、肥満度指数および除脂肪体質量の1つ以上を増加するための組成物に関する。
(i)ヌクレオシド均等物、
(ii)ドコサヘキサエン酸(DHA)、ドコサペンタエン酸(DPA)およびエイコサペンタエン(EPA)からなる群より選ばれるω−3ポリ不飽和脂肪酸、
(iii)好ましくはビタミンB6、ビタミンB9およびビタミンB12からなる群から選ばれるビタミンB、
(iv)ホスホリピッド、
(v)好ましくはビタミンC、ビタミンEおよびセレン(セレン化合物を含む)からなる群から選ばれる抗酸化剤、および
(vi)コリン
から選ばれる少なくとも2種の、好ましくは3種、さらに好ましくは4種の成分を(活性成分として)含む組成物−ただし、少なくとも成分(i)または(iii)が存在する−であって、下記:体重、肥満度指数および除脂肪体質量の1つ以上を、とりわけ人間、とくにお年寄りの人間において増加させるのに使用するための組成物に関する。
(i)ヌクレオシド均等物類、
(ii)DHA、DPAおよびEPAからなる群より選ばれるn−3ポリ不飽和脂肪酸類、
(iii)ビタミンB類、
(iv)ホスホリピッド類、
(v)抗酸化剤類、および
(vi)コリン類
から選ばれる少なくとも2つの成分−ただし、少なくとも1種の(i)ヌクレオシド、または少なくとも1種の(iii)ビタミンBが存在する−を哺乳動物の日常生活の活動を行う能力を改善するため、哺乳動物の日常生活の活動を行う能力を維持するため、または哺乳動物の日常生活の活動(ADL)を行う能力の低下を減少させるために使用される。
(i)ウリジン均等物、
(ii)DHA、DPAおよびEPAからなる群より選ばれるω−3ポリ不飽和脂肪酸、
(iii)ビタミンB、
(iv)ホスホリピッド、
(v)好ましくはビタミンC、ビタミンEおよびセレン(セレン化合物を含む)からなる群から選ばれる抗酸化剤、および
(vi)コリン
を含み、(病理的)虚弱の予防または治療に使用するための組成物であって、哺乳動物は認知症、特にアルツハイマー病に罹った患者であり、この患者のBMIは26未満、さらに好ましくは23.5未満であるものに関する。
(i)ウリジン均等物、
(ii)DHA、DPAおよびEPAからなる群より選ばれるω−3ポリ不飽和脂肪酸、
(iii)ビタミンB、
(iv)ホスホリピッド、
(v)好ましくはビタミンC、ビタミンEおよびセレン(セレン化合物を含む)からなる群から選ばれる抗酸化剤、および
(vi)コリン
を含み、哺乳動物における(病理的)虚弱、および/または生活の質、および/または日常活動(ADL)を改善するための組成物であって、哺乳動物は認知症、特にアルツハイマー病に罹った患者であり、この患者のBMIは26未満、さらに好ましくは23.5未満であるものに関する。
1.筋肉の弱さ
2.過度の消耗または疲労感,
3.異常に低い身体活動
4.遅いまたは不安定な歩行
5.体重喪失
6.神経系の機能障害
a)腕の筋肉について:ハンドグリップ強度または四頭筋強度
b)脚について:Boersheim et al.(2008)Clin Nutr.27,189−195に記載されている方法;またはPijnappels et al.(2008)Eur J Appl Physiol.102(5):585−592に記載されている方法。
年齢と性別の一致する群の下位20%に属する人々がこの虚弱基準を満たした。
a)精神的疲労、
b)標準化された運動計画、筋肉能力または筋力の認識、または
c)肺活量。
好ましくは、方法a)は、従来技術において知られている質問表、例えば、Roberts(1980)Psychiatr Res,2,125−134に記載されているCES−Dスケールを利用し、「私は出かけられない。」または「私は何をするにも努力感を伴う。」のような陳述について採点することにより行われる。この測定は、個体のスタミナの度合に強く関連している。
方法b)は身体的消耗の測定であり、例えば感じられた労作を測定するためのBorgスケール(Borg(1998)Human kinetics,Champaign,Ill;Nybo(2003)Med Sci Sports Exerc,35,589−594)を利用することにより行うことができる。
方法c)は、身体に十分な酸素(空気)を提供する人間の能力の測定である。
それを適用する好適な方法は、努力性呼気1秒量(FEV1)を測定している。努力性呼気1秒量は、基準を満たすには、同様の年齢と性別の個体の正常値の30%未満でなければならない。
a)日常生活の間に適用された基礎活動の量の決定(上記の通り)、および
b)日常生活の際に適用される手段的活動の量の決定
とりわけ、手段的活動の測定は有益な尺度である。
これを行うための信頼性のある方法は、「お年寄りのための身体活動スケールの評価」(PASE)であり、Washburn et al.(1999)J Clin Epidemiol 52,643−651;「お年寄りのための身体活動スケール;有効性の証拠」に記載されている。男性については、スコアが30未満であり、下位20%に属する部分がこの虚弱基準を満たした。女性については、この閾値は<27.5であった(Graham et al.(2009)Gerontol,55,644−651)。
b)5〜15メートル歩く時間と方法、または
c)椅子から立ち上がる時間と方法、のように行われる。
例えば、方法b)について、虚弱の基準は、その人が必要時間に関して人々の20%に属したときに満たされた。Graham et al.(2009)Gerontol,55,644−651において言及されている性別毎の閾値を好適に適用することができる。
a)歩行能力を測定するのに適用された平行および動作テストとは異なる振戦または運動の機能障害の確定、
b)認知機能の測定(悪化)、
c)発話流ちょう性の決定、
d)電気信号の神経伝達速度の測定
e)感覚機能の分析による、聴覚、視覚、味覚、嗅覚および触覚に関連する問題の確定、
f)きわだった鬱状態、情緒異常、不安異常の存在を確立するような感情または生理状態の測定、
g)失禁または日常的に生じる顕著な尿沮喪の決定、および
h)慢性不眠症または睡眠無呼吸症のようなきわだった睡眠異常の存在
神経系機能障害を評価する方法は、従来技術において記載されている。これらの方法は、DSM IV方法と、慣用の虚弱評価方法の対応する分野において記載されている測定法を含む。これらの測定法には、Groningen虚弱指標(Schuurmans et al.(2004)J Gerontol,Biol Sci,Med Sci,59,M962−5)、総合的老人病評価(FI−SGA:Goggins et al.(2005)60,1046;Jones et al.(2004)J Am Geriatr Soc,52,1929−33)または身体的虚弱の変化の全体的印象(CGIC−PF:Studenski et al.(2004)J AM Geriatr Soc,52,1560−6)のような方法がある。尿失禁は10ml/日を超えると顕著であるとみなされる。
1−哺乳動物の栄養状態の評価および
2−本発明による栄養または医薬組成物を用いた介入
a)虚弱の診断、虚弱の存在を評価するための上記6つの基準の評価を用いる。
b)本発明による組成物を用いる介入、および
c)少なくとも再び工程a)においてなされたのと同じ症状クラスを評価することにより進行を測定
1)運動プログラム、
2)社会的交流を改善するプログラム、
3)日光と新鮮な空気にもっとさらされるようにするプログラム
4)患者の食餌または一般の食物摂取プラクティスの適合
5)医薬を用いた介入
好ましくは、治療的管理は少なくとも日光と新鮮な空気にもっとさらされるようにするプログラムまたは運動プログラムを患者の状態の治療的管理における第4および第5の工程として含む。
−全τ 350ng/リットルより高い濃度の脳脊髄液(CSF)
−CSF中のabeta−42/Phospho−τ−181の重量比が6.5未満、
−内側側頭葉(MTL)萎縮の存在、磁気共鳴映像法(MRI)上で証明された海馬、内嗅皮質、または扁桃体の体積喪失の存在、視覚による採点法を用いた定性的格付け(平均年齢を用いてよく特徴づけられた集団を参照した)または関心のある領域の定量的体積測定(平均年齢を用いてよく特徴づけられた集団を参照した)のいずれかを用いたもの
−MRI上で証明された前側頭葉(FTL)萎縮の存在、定性的格付けまたは定量的体積測定のいずれかを用いたもの
−F2−イソプロスタン(F2−IsoP,イソプロスタン8,12−イソ−iPF2α−VI) 25pg/mLCSFを超える濃度。
−脳の両側性側頭頭頂領域におけるグルコース代謝の低下、陽電子放出断面撮影法(PET)により検知可能、
−後帯状回皮質におけるグルコース代謝の低下、PETにより検知可能、
−脳における血流傷害、単光子放出コンピュータ断層撮影(SPECT)の適用、例えば、ラジオアイソトープ99mTc−HMPAOを利用することにより測定可能、
−脳におけるグルコース代謝傷害、SPECTを利用することにより測定可能、
−内側側頭葉または下側側頭葉の組織構造における異常、MRIにより決定可能、またはグルコース利用率における異常、
−側頭頭頂皮質または後帯状回皮質における組織構造またはグルコース利用の異常。
Claims (20)
- 哺乳動物の虚弱を予防または治療するために使用する組成物であって、
(i)ヌクレオシド均等物、
(ii)DHA、DPAおよびEPAからなる群から選ばれるω−3ポリ不飽和脂肪酸、
(iii)ビタミンB、
(iv)ホスホリピッド、
(v)抗酸化剤、および
(vi)コリン、
からなる群から選ばれる少なくとも2種の成分を含み、少なくとも成分(i)、または(iii)が存在する組成物。 - 哺乳動物における虚弱の予防または治療のために使用する組成物であって、
(i)ヌクレオシド均等物、
(ii)DHA、DPAおよびEPAからなる群から選ばれるω−3ポリ不飽和脂肪酸、
(iii)ビタミンB、
(iv)ホスホリピッド、
(v)抗酸化剤、および
(vi)コリン、
からなる群から選ばれる少なくとも3種の成分を含み、少なくとも成分(i)または(iii)が存在する組成物。 - 哺乳動物における虚弱の予防または治療のために使用する組成物であって、(i)ヌクレオシド均等物、
(ii)DHA、DPAおよびEPAからなる群から選ばれるω−3ポリ不飽和脂肪酸、
(iii)ビタミンB、
(iv)ホスホリピッド、
(v)抗酸化剤、および
(vi)コリン、
からなる群から選ばれる少なくとも4種の成分を含み、少なくとも成分(i)または(iii)が存在する組成物。 - 請求項1〜3のいずれか一項に記載の組成物であって、
虚弱は、筋肉の弱さ、過度の消耗または疲労感、異常に低い身体活動、遅いまたは不安定な歩行、体重喪失および神経障害からなる群から選ばれる少なくとも2つの基準、好ましくは3つの基準に一致することにより決定される組成物。 - 請求項1〜4のいずれか一項に記載の組成物であって、
体重、体容積指数、除脂肪体質量、筋肉質量、筋肉強度または筋機能の1種以上を、特にお年寄りの人間において増加するのに用いられる組成物。 - 請求項1〜4のいずれか一項に記載の組成物であって、
体重、体容積指数、除脂肪体質量、筋肉質量、筋肉強度または筋機能の1種以上を増加するとともに、日常生活活動を改善するのに用いられる組成物。 - 請求項1〜6のいずれか一項に記載の組成物であって、
認知低下または認知症、特に老年性認知症、さらにアルツハイマー病の傾向があるか、または罹っている人間に投与される組成物。 - 請求項1〜7のいずれか一項に記載の組成物であって、
前記哺乳動物は認知症の前駆症状に罹っている組成物。 - 請求項1〜8のいずれか一項に記載の組成物であって、
前記哺乳動物はBMIが26kg/m2未満、好ましくは23.5kg/m2未満である組成物。 - 請求項1〜9のいずれか一項に記載の組成物であって、
前記組成物は、栄養または医薬組成物である組成物。 - 請求項1〜10のいずれか一項に記載の組成物であって、
UMPを含む組成物。 - 請求項1〜11のいずれか一項に記載の組成物であって、
DHAおよびEPAを含む組成物。 - 請求項1〜12のいずれか一項に記載の組成物であって、
ビタミンB6、ビタミンB12およびビタミンB9を含む組成物。 - 請求項1〜13のいずれか一項に記載の組成物であって、
ホスファチジル・セリン、ホスファチジル・イノシトール、ホスファチジル・コリンおよびホスファチジル・エタノールアミンからなる群から選ばれる少なくとも2種の異なるホスホリピッドを含む組成物。 - 請求項1〜14のいずれか一項に記載の組成物であって、
ビタミンC、ビタミンEおよびセレンを含む組成物。 - 請求項1〜15に記載の組成物であって、
塩化コリンを含む組成物。 - 請求項1〜16のいずれか一項に記載の組成物であって、
(i)UMP、
(ii)DHAおよびEPA、
(iii)ビタミンB6、ビタミンB12およびビタミンB9、
(iv)ホスファチジル・セリン、ホスファチジル・イノシトール、ホスファチジル・コリンおよびホスファチジル・エタノールアミンからなる群から選ばれる少なくとも2種の異なるホスホリピッド、
(v)ビタミンC、ビタミンEおよびセレン、および
(vi)塩化コリン、
を含む組成物。 - 哺乳動物の虚弱を予防または治療するために使用する組成物であって、
(i)ヌクレオシド均等物、
(ii)DHA、DPAおよびEPAからなる群から選ばれるω−3ポリ不飽和脂肪酸、
(iii)ビタミンB、
(iv)ホスホリピッド、
(v)好ましくは、ビタミンC、ビタミンEおよびセレンからなる群から選ばれる抗酸化剤、および
(vi)コリン
を少なくとも含み、
前記哺乳動物はアルツハイマー病または認知症に罹っている患者であり、前記患者はBMIが26kg/m2未満、好ましくは23.5kg/m2未満である組成物。 - 栄養組成物であって、
請求項1〜18のいずれか一項に記載の組成物を含み、
前記栄養組成物は少なくとも乳清タンパク質、好ましくは血清アルブミンおよび任意に植物タンパク質を補強した乳清タンパク質である栄養組成物。 - 請求項19に記載の栄養組成物であって、
前記栄養組成物は、組成物100ml当たり栄養価が少なくとも50kcal、特に100〜300kcalである栄養組成物。
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