JPWO2019246225A5 - - Google Patents

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JPWO2019246225A5
JPWO2019246225A5 JP2020570746A JP2020570746A JPWO2019246225A5 JP WO2019246225 A5 JPWO2019246225 A5 JP WO2019246225A5 JP 2020570746 A JP2020570746 A JP 2020570746A JP 2020570746 A JP2020570746 A JP 2020570746A JP WO2019246225 A5 JPWO2019246225 A5 JP WO2019246225A5
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amino acid
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muscle
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JP2021527670A (en
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Priority claimed from PCT/US2019/037936 external-priority patent/WO2019246225A1/en
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本発明の明細書本文において引用された参考文献、発行された特許、及び特許出願はすべて、あらゆる目的においてそれらの全体が参照によって組み込まれる。

以下に、本願の当初の特許請求の範囲に記載の発明を列挙する。
［発明１］
筋肉中の脂肪浸潤を低下させるための方法であって、筋肉中に脂肪浸潤のリスクのある対象に、
ａ）ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体；
ｂ）Ｎ－アセチルシステイン（ＮＡＣ）実体；並びに
ｃ）ヒスチジンアミノ酸実体、リシンアミノ酸実体、フェニルアラニンアミノ酸実体、及びトレオニンアミノ酸実体から選ばれる必須アミノ酸（ＥＡＡ）実体又は２、３、若しくは４つのＥＡＡの組み合わせ
を含む組成物を投与することを含む方法。
［発明２］
筋肉中に脂肪浸潤のリスクのある前記対象は、肩腱板損傷を有する、発明１に記載の方法。
［発明３］
前記組成物の投与は、肩腱板損傷のための手術の前に行われる、発明２に記載の方法。
［発明４］
手術の前に前記肩腱板損傷によって冒された肩筋肉中の脂肪浸潤のレベルを決定することをさらに含む、発明２に記載の方法。
［発明５］
手術の後に前記肩腱板損傷によって冒された肩筋肉中の脂肪浸潤のレベルを決定することをさらに含む、発明２に記載の方法。
［発明６］
前記対象は、高齢の対象である、発明２に記載の方法。
［発明７］
筋肉中に脂肪浸潤のリスクのある前記対象は、慢性背部痛（傍脊柱筋群中の脂肪浸潤）；ＨＩＶ患者（運動に関係する筋肉中の脂肪浸潤）；脊髄損傷；脳卒中；ＣＯＰＤ；末期肝疾患（ＥＳＬＤ）、たとえば肝性脳症、静脈瘤出血、門脈圧亢進症、腹水症、感染リスク、敗血症、総入院率、並びに総死亡率及び肝臓関連死亡率；並びに老化に関連する筋力低下を有する、発明１に記載の方法。
［発明８］
筋肉中に脂肪浸潤のリスクのある前記対象への組成物の投与は、グルコースを捕捉する筋機能を改善する、発明１に記載の方法。
［発明９］
筋肉中に脂肪浸潤のリスクがある前記対象は、糖尿病又は代謝性疾患を有する、発明８に記載の方法。
［発明１０］
筋肉中に脂肪浸潤のリスクのある前記対象は、癌を有する、発明１に記載の方法。
［発明１１］
前記癌は、結腸直腸癌又は乳頭部周囲癌である、発明１０に記載の方法。
［発明１２］
筋肉中に脂肪浸潤のリスクがある前記対象は、ＢＭＩの著しい増加、サルコペニア、又は他の明白な状態を有していない、発明１に記載の方法。
［発明１３］
筋肉中に脂肪浸潤のリスクがある前記対象は、サルコペニアを伴わない肝硬変に罹患している、発明１に記載の方法。
［発明１４］
筋肉中に脂肪浸潤のリスクがある前記対象は、ＥＳＬＤ、たとえば肝性脳症、静脈瘤出血、門脈圧亢進症、腹水症、感染リスク、敗血症、総入院率、並びに総死亡率及び肝臓関連死亡率を有する、発明１に記載の方法。
［発明１５］
筋肉中の脂肪浸潤の程度は、磁気共鳴画像法（ＭＲＩ）によって決定される、発明１に記載の方法。
［発明１６］
メチオニン（Ｍ）、トリプトファン（Ｗ）、バリン（Ｖ）、若しくはシステイン（Ｃ）の少なくとも１つは、不在であるか又は存在する場合、１重量（ｗｔ．）％未満で存在する、発明１に記載の方法。
［発明１７］
（ａ）～（ｃ）の総ｗｔ．％は、前記組成物中の任意の他のアミノ酸実体の総ｗｔ．％よりも多い、発明１に記載の組成物。
［発明１８］
前記組成物は、イソロイシンアミノ酸実体、バリンアミノ酸実体、又はイソロイシンアミノ酸実体及びバリンアミノ酸実体の両方をさらに含む、発明１～１７のいずれか一つに記載の方法。
［発明１９］
前記ロイシンアミノ酸実体、前記アルギニンアミノ酸実体、前記グルタミンアミノ酸実体、又は１、２、３、若しくはすべての前記ＥＡＡアミノ酸実体の少なくとも１つは、遊離アミノ酸であり、前記組成物の総乾燥ｗｔ．の少なくとも５０ｗｔ．％は、遊離形態をした１つ又はそれ以上のアミノ酸実体である、発明１～１８のいずれか一つに記載の方法。
［発明２０］
前記ロイシンアミノ酸実体、前記アルギニンアミノ酸実体、前記グルタミンアミノ酸実体、又は１、２、３、若しくはすべての前記ＥＡＡアミノ酸実体の少なくとも１つは、塩形態をしており、前記組成物の総乾燥ｗｔ．の少なくとも５０ｗｔ．％は、塩形態をした１つ又はそれ以上のアミノ酸実体である、発明１～１９のいずれか一つに記載の方法。
［発明２１］
前記組成物は、約０．５ｇ～約１５ｇのロイシンアミノ酸実体、約０．２５ｇ～約１０ｇのイソロイシンアミノ酸実体、約０．２５ｇ～約１０ｇのバリンアミノ酸実体、約０．５～約２５ｇのアルギニンアミノ酸実体、約０．５ｇ～約２０ｇのグルタミンアミノ酸実体、約０．１～約５ｇのＮＡＣ又はその塩、約０．０５ｇ～約３ｇのＬ－ヒスチジン又はその塩、約０．０５～約６ｇのＬ－リシン又はその塩、約０．０４～約２ｇのＬ－フェニルアラニン又はその塩、及び約０．０８～約４ｇのＬ－トレオニン又はその塩の実体；たとえば、約１ｇのロイシンアミノ酸実体、約０．５ｇのイソロイシンアミノ酸実体、約０．５ｇのバリンアミノ酸実体、約１．５ｇ又は約１．８１ｇのアルギニンアミノ酸実体、約１．３３ｇのグルタミンアミノ酸実体、約０．１５ｇ又は約０．３ｇのＮＡＣ又はその塩、約０．０８ｇのＬ－ヒスチジン又はその塩、約０．３５ｇのＬ－リシン又はその塩、約０．０８ｇのＬ－フェニルアラニン又はその塩、及び約０．１７ｇのＬ－トレオニン又はその塩を含む、発明１～２０のいずれか一つに記載の方法。
［発明２２］
前記組成物は、医薬組成物であり、薬学的に許容され得る賦形剤をさらに含む、発明１～２１のいずれか一つに記載の方法。
［発明２３］
脂肪浸潤を低下させることによって、移動性が低下したか又は固定された筋肉における筋機能を改善するための方法であって、前記方法は、少なくとも４つのアミノ酸を含む組成物の有効量をその必要のある対象に投与することを含み、前記組成物は、筋肉中の脂肪浸潤を低下させる方法。
［発明２４］
脂肪浸潤は、移動性が低下したか又は固定された筋肉中で低下する、発明２３に記載の方法。
［発明２５］
筋肉中の脂肪浸潤の程度を決定することをさらに含む、発明２３に記載の方法。
［発明２６］
前記組成物は、
ａ）ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体；
ｂ）Ｎ－アセチルシステイン（ＮＡＣ）実体、たとえばＮＡＣ；並びに
ｃ）ヒスチジンアミノ酸実体、リシンアミノ酸実体、フェニルアラニンアミノ酸実体、及びトレオニンアミノ酸実体から選ばれる必須アミノ酸（ＥＡＡ）実体又は２、３、若しくは４つのＥＡＡの組み合わせ
を含み、ただし
ｄ）少なくとも１つのアミノ酸実体は、長さが２０アミノ酸残基を超えるペプチドとして提供されないことを条件とし、
（ｉ）（ａ）のアミノ酸実体は、表１から選択され；且つ
（ｉｉ）前記アルギニンアミノ酸実体及び前記グルタミンアミノ酸実体の一方又は両方は、前記ロイシンアミノ酸実体よりも多い量（ｗｔ．％）で存在する、発明２３に記載の方法。
［発明２７］
前記対象は、まれな筋疾患、筋萎縮、サルコペニア、筋肉の劣化、筋肉の衰弱、悪液質、医薬誘発性のミオパチー、筋ジストロフィー、ミオペニア、筋力低下、知覚された筋力低下、ＩＣＵ関連ミオパチー、熱傷関連ミオパチー、神経筋障害、人工呼吸器誘発性の横隔膜ジストロフィー、低ナトリウム血症、低カリウム血症、カルシウム欠乏症、高カルシウム血症、筋萎縮性側索硬化症、骨低下症からなる群から選択される疾患若しくは障害を有し；又は前記対象は、加齢、損傷、筋萎縮、感染、疾患、脳卒中、又は骨折若しくは他の外傷による筋機能の減少を有し又は有するとして確認され、前記骨折又は他の外傷は、肩腱板の手術、膝の手術、腰の手術、関節置換術、損傷修復手術から選択されるか又はギブスを着用している、発明２３～２６のいずれか一つに記載の方法。
［発明２８］
前記疾患若しくは前記障害、筋機能の減少、又は骨折若しくは他の外傷を治療する際の前記組成物の投与の有効性を判定するために、前記対象において筋肉中の脂肪浸潤を判定することを含む、発明２３～２７のいずれか一つに記載の方法。
［発明２９］
少なくとも４つのアミノ酸を含む組成物が筋機能に関連する疾患又は障害を治療する際に有効であるかどうかを決定するための方法であって、少なくとも４つのアミノ酸を含む組成物を前記対象に投与すること及び前記対象において筋肉中の脂肪浸潤の低下があるかどうかを決定することを含む方法。
［発明３０］
脂肪浸潤は、筋機能に関連する前記疾患又は障害によって冒された筋組織中のものである、発明２９に記載の方法。 All references, issued patents, and patent applications cited in the present specification are incorporated by reference in their entirety for all purposes.

Listed below are the inventions originally claimed in this application.
[Invention 1]
A method for reducing fat infiltration in muscle, comprising:
a) a leucine amino acid entity, an arginine amino acid entity, and a glutamine amino acid entity;
b) an N-acetylcysteine (NAC) entity; and
c) an essential amino acid (EAA) entity selected from a histidine amino acid entity, a lysine amino acid entity, a phenylalanine amino acid entity, and a threonine amino acid entity or a combination of two, three, or four EAAs;
A method comprising administering a composition comprising
[Invention 2]
The method of claim 1, wherein the subject at risk of fat infiltration in muscle has a rotator cuff injury.
[Invention 3]
3. The method of claim 2, wherein administration of the composition is performed prior to surgery for a shoulder rotator cuff injury.
[Invention 4]
3. The method of claim 2, further comprising determining the level of fat infiltration in the shoulder muscle affected by said rotator cuff injury prior to surgery.
[Invention 5]
3. The method of claim 2, further comprising determining the level of fat infiltration in the shoulder muscle affected by said rotator cuff injury after surgery.
[Invention 6]
The method according to invention 2, wherein the subject is an elderly subject.
[Invention 7]
The subjects at risk for fatty infiltrates in muscles include chronic back pain (fatty infiltrates in paraspinal muscles); HIV patients (fatty infiltrates in exercise-related muscles); spinal cord injuries; stroke; COPD; disease (ESLD) such as hepatic encephalopathy, variceal hemorrhage, portal hypertension, ascites, infection risk, sepsis, total hospitalization and total and liver-related mortality; and age-related muscle weakness. The method according to Invention 1, comprising:
[Invention 8]
The method of claim 1, wherein administration of the composition to said subject at risk of fat infiltration in muscle improves muscle function to sequester glucose.
[Invention 9]
9. The method of claim 8, wherein said subject at risk of fat infiltration in muscle has diabetes or a metabolic disease.
[Invention 10]
The method of claim 1, wherein said subject at risk of fat infiltration in muscle has cancer.
[Invention 11]
11. The method of claim 10, wherein the cancer is colorectal cancer or periampullary cancer.
[Invention 12]
The method of claim 1, wherein said subject at risk of fat infiltration in muscle does not have a significant increase in BMI, sarcopenia, or other overt condition.
[Invention 13]
The method of claim 1, wherein said subject at risk of fat infiltration in muscle suffers from cirrhosis without sarcopenia.
[Invention 14]
Said subjects at risk of fat infiltration in muscle have ESLD such as hepatic encephalopathy, variceal hemorrhage, portal hypertension, ascites, infection risk, sepsis, total hospitalization and total and liver-related mortality. The method of claim 1, wherein the method has a rate of
[Invention 15]
The method of invention 1, wherein the degree of fat infiltration in muscle is determined by magnetic resonance imaging (MRI).
[Invention 16]
At least one of methionine (M), tryptophan (W), valine (V), or cysteine (C) is absent or, if present, is present in less than 1% by weight (wt.). described method.
[Invention 17]
Total wt. of (a) to (c). % is the total wt. of any other amino acid entity in the composition. % of the composition according to invention 1.
[Invention 18]
18. The method of any one of inventions 1-17, wherein the composition further comprises an isoleucine amino acid entity, a valine amino acid entity, or both isoleucine and valine amino acid entities.
[Invention 19]
At least one of said leucine amino acid entity, said arginine amino acid entity, said glutamine amino acid entity, or 1, 2, 3, or all of said EAA amino acid entities is a free amino acid, and the total dry wt. of at least 50 wt. 19. The method of any one of inventions 1-18, wherein % is one or more amino acid entities in free form.
[Invention 20]
At least one of said leucine amino acid entity, said arginine amino acid entity, said glutamine amino acid entity, or 1, 2, 3, or all of said EAA amino acid entities is in salt form, and the total dry wt. of at least 50 wt. 20. The method of any one of inventions 1-19, wherein % is one or more amino acid entities in salt form.
[Invention 21]
The composition comprises from about 0.5 g to about 15 g of leucine amino acid entity, from about 0.25 g to about 10 g of isoleucine amino acid entity, from about 0.25 g to about 10 g of valine amino acid entity, from about 0.5 to about 25 g of arginine. Amino acid entity, about 0.5 g to about 20 g glutamine amino acid entity, about 0.1 to about 5 g NAC or salt thereof, about 0.05 g to about 3 g L-histidine or salt thereof, about 0.05 to about 6 g of L-lysine or a salt thereof, about 0.04 to about 2 g of L-phenylalanine or a salt thereof, and about 0.08 to about 4 g of L-threonine or a salt thereof entity; for example, about 1 g of leucine amino acid entity; about 0.5 g isoleucine amino acid entity, about 0.5 g valine amino acid entity, about 1.5 g or about 1.81 g arginine amino acid entity, about 1.33 g glutamine amino acid entity, about 0.15 g or about 0.3 g of NAC or a salt thereof, about 0.08 g of L-histidine or a salt thereof, about 0.35 g of L-lysine or a salt thereof, about 0.08 g of L-phenylalanine or a salt thereof, and about 0.17 g of L- 21. The method according to any one of inventions 1 to 20, comprising threonine or a salt thereof.
[Invention 22]
The method according to any one of inventions 1 to 21, wherein said composition is a pharmaceutical composition and further comprises a pharmaceutically acceptable excipient.
[Invention 23]
A method for improving muscle function in reduced mobility or immobilized muscle by reducing fat infiltration, said method comprising administering an effective amount of a composition comprising at least four amino acids in need thereof. wherein said composition reduces fat infiltration in muscle.
[Invention 24]
24. A method according to invention 23, wherein fat infiltration is reduced in reduced mobility or immobilized muscle.
[Invention 25]
24. The method of invention 23, further comprising determining the extent of fat infiltration in muscle.
[Invention 26]
The composition comprises
a) a leucine amino acid entity, an arginine amino acid entity, and a glutamine amino acid entity;
b) N-acetylcysteine (NAC) entities such as NAC; and
c) an essential amino acid (EAA) entity selected from a histidine amino acid entity, a lysine amino acid entity, a phenylalanine amino acid entity, and a threonine amino acid entity or a combination of two, three, or four EAAs;
including, but
d) provided that at least one amino acid entity is not provided as a peptide exceeding 20 amino acid residues in length;
(i) the amino acid entity of (a) is selected from Table 1; and
(ii) one or both of said arginine amino acid entity and said glutamine amino acid entity are present in a greater amount (wt.%) than said leucine amino acid entity.
[Invention 27]
The subject has rare muscle disease, muscle atrophy, sarcopenia, muscle deterioration, muscle wasting, cachexia, drug-induced myopathy, muscular dystrophy, myopenia, muscle weakness, perceived muscle weakness, ICU-associated myopathy, burn injury selected from the group consisting of associated myopathy, neuromuscular disorder, ventilator-induced diaphragmatic dystrophy, hyponatremia, hypokalemia, calcium deficiency, hypercalcemia, amyotrophic lateral sclerosis, osteopenia or said subject has or is confirmed to have decreased muscle function due to aging, injury, muscle wasting, infection, disease, stroke, or fracture or other trauma, said fracture or other trauma is selected from rotator cuff surgery, knee surgery, hip surgery, joint replacement surgery, injury repair surgery, or wearing a cast, according to any one of inventions 23-26 described method.
[Invention 28]
determining fat infiltration in muscle in said subject to determine efficacy of administration of said composition in treating said disease or said disorder, loss of muscle function, or fracture or other trauma. , the method according to any one of inventions 23 to 27.
[Invention 29]
A method for determining whether a composition comprising at least four amino acids is effective in treating a disease or disorder associated with muscle function, comprising administering a composition comprising at least four amino acids to said subject and determining whether there is reduced fat infiltration in muscle in said subject.
[Invention 30]
30. A method according to invention 29, wherein the fat infiltration is in muscle tissue affected by said disease or disorder related to muscle function.

Claims (14)

筋肉中に脂肪浸潤のリスクのある対象における筋肉中の脂肪浸潤を低下させるための薬剤の製造における組成物の使用であって、前記組成物が、
ａ）ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体；
ｂ）Ｎ－アセチルシステイン（ＮＡＣ）実体；並びに
ｃ）ヒスチジンアミノ酸実体、リシンアミノ酸実体、フェニルアラニンアミノ酸実体、及びトレオニンアミノ酸実体から選ばれる必須アミノ酸（ＥＡＡ）実体又は２、３、若しくは４つのＥＡＡの組み合わせ
を含む、前記使用。 Use of a composition in the manufacture of a medicament for reducing muscle fat infiltration in a subject at risk of muscle fat infiltration, said composition comprising
a) a leucine amino acid entity, an arginine amino acid entity, and a glutamine amino acid entity;
b) an N-acetylcysteine (NAC) entity; and
c) an essential amino acid (EAA) entity selected from a histidine amino acid entity, a lysine amino acid entity, a phenylalanine amino acid entity, and a threonine amino acid entity or a combination of two, three, or four EAAs;
the above uses, including 筋肉中に脂肪浸潤のリスクのある対象における筋肉中の脂肪浸潤を低下させるために使用される組成物であって、前記組成物が、 A composition for use in reducing muscle fat infiltration in a subject at risk for muscle fat infiltration, said composition comprising:
ａ）ロイシンアミノ酸実体、アルギニンアミノ酸実体、及びグルタミンアミノ酸実体；a) a leucine amino acid entity, an arginine amino acid entity, and a glutamine amino acid entity;
ｂ）Ｎ－アセチルシステイン（ＮＡＣ）実体；並びにb) an N-acetylcysteine (NAC) entity; and
ｃ）ヒスチジンアミノ酸実体、リシンアミノ酸実体、フェニルアラニンアミノ酸実体、及びトレオニンアミノ酸実体から選ばれる必須アミノ酸（ＥＡＡ）実体又は２、３、若しくは４つのＥＡＡの組み合わせc) an essential amino acid (EAA) entity selected from a histidine amino acid entity, a lysine amino acid entity, a phenylalanine amino acid entity, and a threonine amino acid entity or a combination of two, three, or four EAAs;
を含む、前記組成物。The composition, comprising: 筋肉中に脂肪浸潤のリスクのある前記対象は、肩腱板損傷を有し、任意選択により、前記対象は高齢の対象である、請求項１に記載の使用又は請求項２に記載の組成物。 3. The use according to claim 1 or the composition according to claim 2, wherein said subject at risk of fat infiltration in muscle has a rotator cuff injury and optionally said subject is an elderly subject. . 前記組成物は、肩腱板損傷のための手術の前に投与されるものである、請求項１若しくは３に記載の使用又は請求項２若しくは３に記載の組成物。 4. Use according to claim 1 or 3 or composition according to claim 2 or 3, wherein the composition is administered prior to surgery for shoulder rotator cuff injuries. 前記組成物はさらに、 The composition further comprises:
（ｉ）手術の前に前記肩腱板損傷によって冒された肩筋肉中の脂肪浸潤のレベルを決定すること、及び／又は (i) determining the level of fat infiltration in the shoulder muscle affected by said rotator cuff injury prior to surgery; and/or
（ｉｉ）手術の後に前記肩腱板損傷によって冒された肩筋肉中の脂肪浸潤のレベルを決定すること (ii) determining the level of fat infiltration in the shoulder muscle affected by said rotator cuff injury after surgery;
のために使用されるものである、請求項１、３若しくは４に記載の使用又は請求項２～４のいずれか一項に記載の組成物。The use according to claim 1, 3 or 4 or the composition according to any one of claims 2-4, which is used for 筋肉中に脂肪浸潤のリスクのある前記対象は、慢性背部痛（傍脊柱筋群中の脂肪浸潤）；ＨＩＶ（運動に関係する筋肉中の脂肪浸潤）；脊髄損傷；脳卒中；ＣＯＰＤ；末期肝疾患（ＥＳＬＤ）、たとえば肝性脳症、静脈瘤出血、門脈圧亢進症、腹水症、感染リスク、敗血症、総入院率、並びに総死亡率及び肝臓関連死亡率；並びに老化に関連する筋力低下を有する、請求項１及び３～５のいずれか一項に記載の使用又は請求項２～５のいずれか一項に記載の組成物。 The subjects at risk for fatty infiltrates in muscles include chronic back pain (fatty infiltrates in paraspinal muscles); HIV (fatty infiltrates in exercise-related muscles); spinal cord injury; stroke; COPD; (ESLD) such as hepatic encephalopathy, variceal hemorrhage, portal hypertension, ascites, infection risk, sepsis, total hospitalization, and total and liver-related mortality; and age-related muscle weakness , the use according to any one of claims 1 and 3-5 or the composition according to any one of claims 2-5. 前記組成物は、グルコースを捕捉する筋機能を改善するために筋肉中に脂肪浸潤のリスクのある前記対象に投与されるものであり、任意選択により、筋肉中に脂肪浸潤のリスクがある前記対象は、糖尿病又は代謝性疾患を有する、請求項１及び３～６のいずれか一項に記載の使用又は請求項２～６のいずれか一項に記載の組成物。 wherein said composition is administered to said subject at risk of fat infiltration in muscle to improve muscle function to sequester glucose; optionally said subject at risk of fat infiltration in muscle has diabetes or a metabolic disorder. 筋肉中に脂肪浸潤のリスクのある前記対象は、下記（ｉ）～（ｉｖ）： Said subject at risk of fat infiltration in muscle has the following (i)-(iv):
（ｉ）癌を有し、任意選択により、前記癌は、結腸直腸癌又は乳頭部周囲癌である、 (i) has cancer, optionally said cancer is colorectal cancer or periampullary cancer;
（ｉｉ）ＢＭＩの著しい増加、サルコペニア、又は他の明白な状態を有していない、 (ii) have no significant increase in BMI, sarcopenia, or other overt condition;
（ｉｉｉ）サルコペニアを伴わない肝硬変に罹患している、及び (iii) suffers from cirrhosis without sarcopenia, and
（ｉｖ）ＥＳＬＤ、たとえば肝性脳症、静脈瘤出血、門脈圧亢進症、腹水症、感染リスク、敗血症、総入院率、並びに総死亡率及び肝臓関連死亡率を有する、 (iv) having ESLD such as hepatic encephalopathy, variceal hemorrhage, portal hypertension, ascites, infection risk, sepsis, total hospitalization, and total and liver-related mortality;
の１つ以上である、請求項１及び３～７のいずれか一項に記載の使用又は請求項２～７のいずれか一項に記載の組成物。The use according to any one of claims 1 and 3-7 or the composition according to any one of claims 2-7, which is one or more of 筋肉中の脂肪浸潤の程度は、磁気共鳴画像法（ＭＲＩ）によって決定される、請求項１及び３～８のいずれか一項に記載の使用又は請求項２～８のいずれか一項に記載の組成物。 The use according to any one of claims 1 and 3-8 or according to any one of claims 2-8, wherein the degree of fat infiltration in the muscle is determined by magnetic resonance imaging (MRI). composition. （ｉ）メチオニン（Ｍ）、トリプトファン（Ｗ）、バリン（Ｖ）、若しくはシステイン（Ｃ）の少なくとも１つは、不在であるか又は存在する場合、１重量（ｗｔ．）％未満で存在する、及び／又は (i) at least one of methionine (M), tryptophan (W), valine (V), or cysteine (C) is absent or, if present, is present at less than 1% by weight (wt.); and/or
（ｉｉ）（ａ）～（ｃ）の総ｗｔ．％は、前記組成物中の任意の他のアミノ酸実体の総ｗｔ．％よりも多い、 (ii) total wt. % is the total wt. of any other amino acid entity in the composition. more than %,
請求項１及び３～９のいずれか一項に記載の使用又は請求項２～９のいずれか一項に記載の組成物。The use according to any one of claims 1 and 3-9 or the composition according to any one of claims 2-9. 前記組成物は、イソロイシンアミノ酸実体、バリンアミノ酸実体、又はイソロイシンアミノ酸実体及びバリンアミノ酸実体の両方をさらに含む、請求項１及び３～１０のいずれか一項に記載の使用又は請求項２～１０のいずれか一項に記載の組成物。 The use of any one of claims 1 and 3-10 or claims 2-10, wherein the composition further comprises an isoleucine amino acid entity, a valine amino acid entity, or both isoleucine and valine amino acid entities. A composition according to any one of the preceding claims. 前記ロイシンアミノ酸実体、前記アルギニンアミノ酸実体、前記グルタミンアミノ酸実体、又は１、２、３、若しくはすべての前記ＥＡＡアミノ酸実体の少なくとも１つは、遊離アミノ酸であり、前記組成物の総乾燥ｗｔ．の少なくとも５０ｗｔ．％は、遊離形態をした１つ又はそれ以上のアミノ酸実体である、又は、 At least one of said leucine amino acid entity, said arginine amino acid entity, said glutamine amino acid entity, or 1, 2, 3, or all of said EAA amino acid entities is a free amino acid, and the total dry wt. of at least 50 wt. % is one or more amino acid entities in free form, or
前記ロイシンアミノ酸実体、前記アルギニンアミノ酸実体、前記グルタミンアミノ酸実体、又は１、２、３、若しくはすべての前記ＥＡＡアミノ酸実体の少なくとも１つは、塩形態をしており、前記組成物の総乾燥ｗｔ．の少なくとも５０ｗｔ．％は、塩形態をした１つ又はそれ以上のアミノ酸実体である、 At least one of said leucine amino acid entity, said arginine amino acid entity, said glutamine amino acid entity, or 1, 2, 3, or all of said EAA amino acid entities is in salt form, and the total dry wt. of at least 50 wt. % is one or more amino acid entities in salt form;
請求項１及び３～１１のいずれか一項に記載の使用又は請求項２～１１のいずれか一項に記載の組成物。The use according to any one of claims 1 and 3-11 or the composition according to any one of claims 2-11. 前記組成物は、約０．５ｇ～約１５ｇのロイシンアミノ酸実体、約０．２５ｇ～約１０ｇのイソロイシンアミノ酸実体、約０．２５ｇ～約１０ｇのバリンアミノ酸実体、約０．５～約２５ｇのアルギニンアミノ酸実体、約０．５ｇ～約２０ｇのグルタミンアミノ酸実体、約０．１～約５ｇのＮＡＣ又はその塩、約０．０５ｇ～約３ｇのＬ－ヒスチジン又はその塩、約０．０５～約６ｇのＬ－リシン又はその塩、約０．０４～約２ｇのＬ－フェニルアラニン又はその塩、及び約０．０８～約４ｇのＬ－トレオニン又はその塩の実体；たとえば、約１ｇのロイシンアミノ酸実体、約０．５ｇのイソロイシンアミノ酸実体、約０．５ｇのバリンアミノ酸実体、約１．５ｇ又は約１．８１ｇのアルギニンアミノ酸実体、約１．３３ｇのグルタミンアミノ酸実体、約０．１５ｇ又は約０．３ｇのＮＡＣ又はその塩、約０．０８ｇのＬ－ヒスチジン又はその塩、約０．３５ｇのＬ－リシン又はその塩、約０．０８ｇのＬ－フェニルアラニン又はその塩、及び約０．１７ｇのＬ－トレオニン又はその塩を含む、請求項１及び３～１２のいずれか一項に記載の使用又は請求項２～１２のいずれか一項に記載の組成物。 The composition comprises from about 0.5 g to about 15 g of leucine amino acid entity, from about 0.25 g to about 10 g of isoleucine amino acid entity, from about 0.25 g to about 10 g of valine amino acid entity, from about 0.5 to about 25 g of arginine. Amino acid entity, about 0.5 g to about 20 g glutamine amino acid entity, about 0.1 to about 5 g NAC or salt thereof, about 0.05 g to about 3 g L-histidine or salt thereof, about 0.05 to about 6 g of L-lysine or a salt thereof, about 0.04 to about 2 g of L-phenylalanine or a salt thereof, and about 0.08 to about 4 g of L-threonine or a salt thereof entity; for example, about 1 g of leucine amino acid entity; about 0.5 g isoleucine amino acid entity, about 0.5 g valine amino acid entity, about 1.5 g or about 1.81 g arginine amino acid entity, about 1.33 g glutamine amino acid entity, about 0.15 g or about 0.3 g of NAC or a salt thereof, about 0.08 g of L-histidine or a salt thereof, about 0.35 g of L-lysine or a salt thereof, about 0.08 g of L-phenylalanine or a salt thereof, and about 0.17 g of L- The use according to any one of claims 1 and 3-12 or the composition according to any one of claims 2-12, comprising threonine or a salt thereof. 前記組成物は、医薬組成物であり、薬学的に許容され得る賦形剤をさらに含む、請求項１及び３～１３のいずれか一項に記載の使用又は請求項２～１３のいずれか一項に記載の組成物。 The use according to any one of claims 1 and 3-13 or any one of claims 2-13, wherein said composition is a pharmaceutical composition and further comprises a pharmaceutically acceptable excipient. 13. The composition of claim 1.
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