JP5221094B2 - 褥瘡患部の皮下筋層の再生剤 - Google Patents
褥瘡患部の皮下筋層の再生剤 Download PDFInfo
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Description
褥瘡治療に関する基準として,「褥瘡の予防・治療ガイドライン」がある.褥瘡の治療としては,保存的治療と外科的治療があるが,このガイドラインは保存的治療を主体としている.褥瘡は,多方面からの治療が必要で,定時の***変換や清拭,体圧分散用具,栄養管理など看護・介護の占める割合は大きい.なかでも,栄養管理は褥瘡予防・治療に不可欠な組織の耐久性を高め,創傷治癒を促進するために重要である.褥瘡は一旦発症すると完治させることは難しく予防が大切とされてきたが,近年総合的なアセスメントにより適切なケアプランを立てれば治癒も可能となってきた.
栄養組成物による褥瘡の予防・治療を目的とした技術としては,特定組成のアミノ酸を含有する褥瘡予防治療用アミノ酸栄養剤が特開平11-130669号公報(特許文献1)に開示されているが,これはアミノ酸の混合物であることから,味が粗悪で継続摂取は困難と考えられる.
特開2004-284972号公報(特許文献3)には,小麦グルテン,小麦グルテン加水分解物を含有する経腸創傷治療剤が開示されている.これは,小麦グルテン,小麦グルテン加水分解物及び/又は当該加水分解物に相当するポリペプチドを含有する経腸創傷治療剤であるが,その効果は,皮膚表皮の創面積(創面の長径×短径)の減少にとどまっている.圧負荷による循環障害は,皮内の細静脈,筋肉内静脈,筋肉内動脈,皮内細動脈の順に起こることから,表皮,真皮よりも皮下筋層の方が傷害されやすく,表皮のみの創面積の減少では治癒効果とは言い難い.また,褥瘡が浅層にとどまるものは創縁及び創面内からの基底細胞の遊走,進展という過程で治癒するが,深層に及ぶものは肉芽組織の増殖が必要である(臨床看護,31:1456,2005、非特許文献2).
そのため,事前及び/または継続摂取すると褥瘡になりにくく,また褥瘡が発生しても患部皮下組織の筋層再生を促進し,褥瘡を早期治癒させることのできる栄養剤が望まれていた.
(1)乳清蛋白質を有効成分として含有する褥瘡の治癒及び/または発生予防剤.
(2)乳清蛋白質として一日あたり1.25〜2.0g/kg(体重)を経消化管的に投与されるものである上記(1)に記載の褥瘡の治癒及び/または発生予防剤。
(3)上記(1)に記載の褥瘡の治癒及び/または発生予防剤を蛋白質成分として配合した乳清蛋白質配合栄養剤。
(4)糖質,脂質,ビタミン,およびミネラルを配合した上記(2)に記載の乳清蛋白質栄養剤.
(5)前記ビタミンが,少なくともビタミンA及びビタミンCを含有する上記(4)に記載の乳清蛋白質栄養剤.
(6)ミネラルが,少なくともカルシウム,鉄,亜鉛,及び銅を含有する上記(4)または(5)に記載の乳清蛋白質栄養剤.
(7)乳清蛋白質の含有量が,100kcalあたり2〜13.5gである上記(3)〜(6)のいずれかに記載の乳清蛋白質栄養剤。
(8)液状である上記(3)〜(7)のいずれかに記載の乳清蛋白質栄養剤。
(9)高圧蒸気滅菌されてなる上記(8)に記載の乳清蛋白質栄養剤。
本発明の褥瘡の治癒及び/または発生予防剤は、消化管に吸収されるような投与形態であれば、常用されるいずれの投与形態でも,褥瘡の予防・治療効果がある.具体的には、剤形としては液状,固形状,ゲル状,または粉末であってもよく、投与方法としては,経口投与、あるいは経鼻,胃ろう,腸ろうによる経管投与が可能である.
また、原料となる乳清は、チーズホエイ(酸ホエイ)、スイートホエイ、脱乳糖ホエイ、脱塩ホエイ、などから適宜選択することができる。
また、乳清蛋白濃縮物(WPC)、乳清蛋白単離物(WPI)を用いることができる。
本発明の乳清蛋白質栄養剤中の乳清蛋白質含有量は,2〜13.5g/100kcalが好ましい.2g/100kcal以下では,褥瘡の予防・治療効果が十分に発揮できないほかにも、一般的な栄養剤の蛋白質含有量としては少なく,高齢者や低栄養状態の患者への投与に適していない.また,13.5g/100kcal以上では,蛋白質含有量が過剰となり、配合量に対する効果が相対的に小さくなるばかりでなく、他の栄養成分の摂取も考慮した場合、好ましい栄養バランスから外れがちになる.
本発明の乳清蛋白質栄養剤の投与量は,1日当たり750〜2000kcalが好ましい.乳清蛋白質の投与量としては,1日当たり37.5〜100gが好ましい.
(比較例1) 実施例1において乳清蛋白質の代わりにカゼインナトリウムを配合した以外は実施例1と同様の方法で栄養組成物を調製した.この栄養組成物中に含有されるカゼインは100kcal当たり5.36gである.
(試験例1) 実施例1及び比較例1で調整した栄養組成物を用いて動物実験を行った.ラットを二群に群分けし,一群には実施例1,もう一群には比較例1の栄養組成物を2週間自由摂取させた.これらのラットを用いて,Skalakらの方法(Wound Rep Reg 8:68-76,2000)により褥瘡モデルを作製した.さらに1週間,栄養組成物の摂取を継続し,褥瘡形成部の皮膚を採取した.
(評価例2) 病理標本の強拡大の一視野における再生筋細胞について,画像解析ソフト(Scion Image)を用いて数と面積を計測した.具体的には,多核でH.E.染色で濃染する細胞を再生筋細胞とみなし,選択した.Threshold機能により閾値を設定し2値化処理を行い,細胞数と面積を計測した.一視野全体の面積を計測し,{(再生筋細胞の面積)/(視野全体の面積)}×100(%)の式により面積割合を算出した.その結果,比較例1では細胞数20,面積割合4.50%であったのに対して,実施例1では細胞数32,面積割合6.73%であり,実施例1による皮下筋層の再生促進効果が明らかになった.
Skalakらの褥瘡モデルは,組織学的に皮下筋層に壊死の認められる,臨床の病態をよく反映したモデルである.圧負荷により循環障害を起こし壊死した筋細胞はマクロファージの侵入が起こり,その後,筋衛星細胞の活性化,分化増殖,融合の過程を経て成熟した筋線維となる.乳清蛋白質は,これらの過程のうち筋衛星細胞の活性化,分化増殖促進効果があると考えられる.
(比較例2) 実施例2において乳清蛋白質の代わりに卵白蛋白質を配合した以外は実施例2と同様の方法で卵白蛋白質栄養剤を調製した.得られた卵白蛋白質栄養剤は,チューブに詰まり継続投与不可能であった.また,風味が悪く経口摂取が困難であった.
(比較例3) 実施例2において乳清蛋白質の代わりに大豆蛋白質を配合した以外は実施例2と同様の方法で大豆蛋白質栄養剤を調製した.得られた大豆蛋白質栄養剤は,チューブに詰まり継続投与不可能であった.また,風味が悪く経口摂取が困難であった.
Claims (2)
- 乳清蛋白質を有効成分として含有することを特徴とする褥瘡患部の皮下筋層の再生剤。
- 乳清蛋白質として一日あたり1.25〜2.0g/kg(体重)を経消化管的に投与されるものである請求項1に記載の褥瘡患部の皮下筋層の再生剤。
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