JP5484704B2 - Fever symptom suppressant for the elderly - Google Patents
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- JP5484704B2 JP5484704B2 JP2008250766A JP2008250766A JP5484704B2 JP 5484704 B2 JP5484704 B2 JP 5484704B2 JP 2008250766 A JP2008250766 A JP 2008250766A JP 2008250766 A JP2008250766 A JP 2008250766A JP 5484704 B2 JP5484704 B2 JP 5484704B2
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Description
本発明は、高齢者向けの機能食品および高齢者向けの医薬組成物の技術に関する。より詳細には、本発明は、胃瘻栄養法により栄養摂取している高齢者の発熱症状抑制用の機能食品および医薬組成物の技術に関する。 The present invention relates to a technology for functional foods for elderly people and pharmaceutical compositions for elderly people. More specifically, the present invention relates to a technique of a functional food and a pharmaceutical composition for suppressing fever symptoms in elderly people who are ingested by gastrostomy.
介護を必要とする高齢者の４０％以上および寝たきりの高齢者の半数以上は、タンパク質・エネルギー低栄養状態（ＰＥＭ：protein energy malnutirition）に陥っており、このＰＥＭは種々の疾患の併発および疲労回復の遅れをもたらし、高齢者における疾患症状の慢性化の要因となっている。一方、このように介護を要する高齢者では、通常の食餌による栄養状態の改善が難しく、経皮内視鏡的胃瘻(いろう)造設術（Percutaneous Endoscopic Gastrostomy、本明細書においては以後「ＰＥＧ」という）によって、外部から栄養物を直接腸に投与することで栄養状態の改善が行われている。 More than 40% of the elderly who need care and more than half of the bedridden elderly are suffering from protein energy malnutirition (PEM), which is associated with various diseases and recovery from fatigue. This is a cause of chronic disease symptoms in the elderly. On the other hand, it is difficult to improve the nutritional state by normal diet in such elderly people who need care, and percutaneous endoscopic gastrostomy (hereinafter referred to as “PEG”). ”), The nutritional state is improved by administering the nutrient directly from the outside to the intestines.
ＰＥＧは栄養物を直接腸へ投与できることから、食道機能の低下など、摂食障害を伴うことが多い要介護高齢者の栄養状態を効率よく改善できるが、一方で施術後に慢性的な発熱症状を伴うという問題がある。 Since PEG can administer nutrients directly to the intestines, it can effectively improve the nutritional status of elderly people requiring care, often accompanied by eating disorders such as reduced esophageal function. There is a problem with it.
さらに、発熱の原因がウイルスや一般細菌などの感染性疾患によるもの、アレルギー、自己免疫疾患、腫瘍熱などの非−感染性炎症性疾患によるもの、熱中症、脱水症状、甲状腺機能亢進症などの非−炎症性発熱疾患によるものなど多岐にわたるため、症状の主訴自体が的確に行えない要介護高齢者や寝たきりの高齢者では、従来常套的に行われる個々の病因に応じた解熱剤や抗生剤の点滴治療などでは、薬物相互作用による副作用被害や、長期連続投与による薬物耐性獲得などへの懸念もあり、治療効果と安全性を両立した投薬治療が難しいという問題もある。 Furthermore, the cause of fever is caused by infectious diseases such as viruses and general bacteria, allergies, autoimmune diseases, non-infectious inflammatory diseases such as tumor fever, heat stroke, dehydration, hyperthyroidism, etc. For patients with long-term care and bedridden elderly who are unable to accurately present the chief complaint of symptoms due to a variety of non-inflammatory fever diseases, conventional antipyretic drugs and antibiotics depending on the individual etiology conventionally used In the case of infusion therapy, there are also concerns about side effects caused by drug interactions and the acquisition of drug resistance due to long-term continuous administration, and there is a problem that it is difficult to administer medication that achieves both therapeutic effect and safety.
従って、本発明の目的は、高齢者向けの発熱症状抑制用の機能食品および高齢者向けの医薬組成物、特に、ＰＥＧ施術高齢患者の発熱症状抑制用の機能食品および医薬組成物を提供することにある。 Accordingly, an object of the present invention is to provide a functional food for suppressing fever symptoms for the elderly and a pharmaceutical composition for the elderly, in particular, a functional food and a pharmaceutical composition for suppressing fever symptoms in PEG-treated elderly patients. It is in.
一方で、特許文献１には、発熱性消耗性疾患における栄養補給を目的とした、桂皮、芍薬、甘草、大棗及び生姜からなる生薬群より選ばれる１種又は２種以上、ビタミン及びアミノ酸を含有する疲労改善内服薬が開示されている。
当該特許文献１には、発熱性消耗性疾患のほか、期待される効能・効果として、肉体疲労、病中病後、食欲不振、栄養障害、妊娠授乳期や貧血、冷え性などの場合の栄養補給、滋養強壮、虚弱体質が記載されているが、その明細書には健常な実験動物（マウス）を用いた自発運動量の増加結果のみが示され、発熱性疾患に対する実質的な効果は何ら示されていない。
In Patent Document 1, in addition to febrile debilitating diseases, as expected effects and effects, physical fatigue, post-disease, anorexia, malnutrition, pregnancy lactation, anemia, cooling, etc. The description of nutritional tonic and frail constitution is described, but the specification shows only the result of increased locomotor activity using a healthy experimental animal (mouse), and shows no substantial effect on febrile disease. Absent.
本発明者らは、かかる課題に鑑み鋭意検討した結果、特定のアミノ酸を組み合わせて含有する組成物が、従来の点滴などによる侵襲的な投与を行うことなく治療計画的にも高齢者患者に大きな負担を課することなく、経口摂取または胃瘻を介して経腸摂取することにより発熱症状を抑制できることを見出し、本発明を完成するに至った。 As a result of intensive investigations in view of such problems, the present inventors have found that a composition containing a combination of specific amino acids is great for elderly patients in terms of treatment plan without performing invasive administration such as conventional infusion. It has been found that fever symptoms can be suppressed by ingestion or enteral administration via gastrostomy without imposing a burden, and the present invention has been completed.
すなわち、本発明は、
［１］Ｌ−ロイシン、Ｌ−グルタミンおよびＬ−アルギニンまたはそれらの医薬上許容し得る塩よりなるアミノ酸と医薬上許容し得る担体または賦形剤とを含有する高齢者の発熱症状抑制用の機能食品または医薬組成物；
［２］高齢者が経皮内視鏡的胃瘻造設術を施した高齢者である前記［１］に記載の機能食品または医薬組成物；
［３］経口摂取する前記［１］または［２］に記載の機能食品または医薬組成物；および
［４］胃瘻を介して経腸摂取する前記［１］または［２］に記載の機能食品または医薬組成物
を提供する。
That is, the present invention
[1] Function for suppressing fever symptom in elderly people containing amino acid comprising L-leucine, L-glutamine and L-arginine or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier or excipient Food or pharmaceutical composition;
[2] The functional food or pharmaceutical composition according to the above [1], wherein the elderly is an elderly who has undergone percutaneous endoscopic gastrostomy;
[3] The functional food or pharmaceutical composition according to [1] or [2] to be taken orally; and [4] the functional food according to [1] or [2] to be taken enterally via a gastrostoma. Alternatively, a pharmaceutical composition is provided.
本願の［１］〜［４］に係る発明によれば、有効成分がアミノ酸であって、タンパク質やポリペプチド製剤とは異なり消化を必要としないため、代謝活性が低下した高齢者でも迅速に体内に吸収し得て、高齢者の慢性的な発熱症状を安全に改善し得る機能食品および医薬組成物を提供することができる。また、過剰投与による副作用のリスクが著しく低く、他の薬剤との薬物相互作用のリスクが非常に低く、長期連続投与しても抗生剤のように薬物耐性の獲得による二次的な院内感染の心配がなく、また、ＰＥＧ施術患者においては点滴などの新たな侵襲的手法を用いることなく栄養物を投与できる点で、患者に対する負担が少ないなど高齢者患者に対して安全かつ効果的に投与することができる。 According to the inventions according to [1] to [4] of the present application, the active ingredient is an amino acid, and unlike a protein or polypeptide preparation, digestion is not required. It is possible to provide a functional food and a pharmaceutical composition that can be absorbed into the body and can safely improve chronic fever symptoms in the elderly. In addition, the risk of side effects due to overdose is remarkably low, the risk of drug interaction with other drugs is very low, and secondary nosocomial infections due to acquisition of drug resistance like antibiotics even after long-term administration. It is safe and effective for elderly patients because there is no worry and the burden on patients is low because PEG-treated patients can administer nutrition without using new invasive techniques such as infusion. be able to.
本発明は、高齢者向けの機能食品および医薬組成物に関する。また、特には、本発明は、経口剤または胃瘻を介した経腸栄養剤として有効な医薬組成物に関する。
本発明の機能食品および医薬組成物に含まれるアミノ酸は、アミノ酸がＬ−ロイシン、Ｌ−グルタミンおよびＬ−アルギニンまたはそれらの医薬上許容し得る塩である。これらのアミノ酸の含有量はアミノ酸の合計量として700〜1600ｍｇ／用量で機能食品および医薬組成物に含有することができる。より具体的には、Ｌ−ロイシンは450〜750ｍｇ／用量が好ましく、500〜700ｍｇ／用量がより好ましく、550〜650ｍｇ／用量が最も好ましい。また、Ｌ−グルタミンは150〜450ｍｇ／用量が好ましく、200〜400ｍｇ／用量がより好ましく、250〜350ｍｇ／用量が最も好ましい。さらに、Ｌ−アルギニンは100〜400ｍｇ／用量が好ましく、150〜350ｍｇ／用量がより好ましく、200〜300ｍｇ／用量が最も好ましい。
The present invention relates to a functional food and a pharmaceutical composition for elderly people. In particular, the present invention relates to a pharmaceutical composition effective as an oral preparation or enteral nutrition via gastrostomy.
The amino acid contained in the functional food and the pharmaceutical composition of the present invention is L-leucine, L-glutamine and L-arginine or a pharmaceutically acceptable salt thereof. The content of these amino acids can be contained in the functional food and the pharmaceutical composition at a total amount of amino acids of 700 to 1600 mg / dose. More specifically, L-leucine is preferably 450 to 750 mg / dose, more preferably 500 to 700 mg / dose, and most preferably 550 to 650 mg / dose. L-glutamine is preferably 150 to 450 mg / dose, more preferably 200 to 400 mg / dose, most preferably 250 to 350 mg / dose. Further, L-arginine is preferably 100 to 400 mg / dose, more preferably 150 to 350 mg / dose, most preferably 200 to 300 mg / dose.
本発明の機能食品または医薬組成物には、有効成分としての上記アミノ酸の他に賦形剤、抗酸化剤、着色剤、矯味矯臭剤、香料、界面活性剤、可塑剤などを含有して、液剤、錠剤、顆粒剤、散剤、カプセル剤、チュアブル剤などの経口または経腸剤として製剤化することができる。 In addition to the above amino acids as active ingredients, the functional food or pharmaceutical composition of the present invention contains excipients, antioxidants, coloring agents, flavoring agents, fragrances, surfactants, plasticizers, etc. It can be formulated as oral or enteral preparations such as liquids, tablets, granules, powders, capsules, chewables and the like.
本発明の機能食品または医薬組成物を高齢者が長期摂取した場合の効果について検討した。 The effect when the elderly person ingested the functional food or pharmaceutical composition of the present invention for a long time was examined.
試験対象
主病に加えて医師が低栄養または貧血傾向と診断したＰＥＧ施術患者１１名（平均年齢８０.８歳、うち男性６名および女性５名）を対象とした。
Study subjects In addition to the main disease, 11 PEG-treated patients (average age: 80.8 years, of which 6 were men and 5 were women) diagnosed by doctors as undernourished or anemic.
試験方法および結果
一日当たりＬ−ロイシン600mg、Ｌ−グルタミン300mg、Ｌ−アルギニン250mgを含むアミノ酸顆粒製剤（モル組成比：Ｌ−ロイシン 57：Ｌ−アルギニン 18：Ｌ−グルタミン 25）を、そのまま経口でまたは経腸栄養剤（アイソカル２Ｋ／ネスレニュートリション株式会社製）に溶解して２ヶ月間摂取した。摂取前、摂取開始４週間後および摂取開始８週間後に摂取患者と非−摂取患者の体温データを比較したところ、発熱（３７℃以上）の頻度に差違が認められた。具体的には、摂取１ヶ月目（2008年2月1日〜2月28日）では非−摂取群と摂取群の間に差違は認められなかったが、摂取２ヶ月目（2008年3月1日〜3月31日）では非−摂取群において有意な増加が認められたのに対し、摂取群では増加が認められなかった。
従って、本発明の機能食品または医薬組成物には、高齢者における発熱症状の改善効果が認められた。
Test Method and Results An amino acid granule preparation containing L-leucine 600 mg, L-glutamine 300 mg, and L-arginine 250 mg per day (molar composition ratio: L-leucine 57: L-arginine 18: L-glutamine 25) is orally administered as it is. Or it melt | dissolved in enteral nutrient (Isocal 2K / made by Nestlé Nutrition Co., Ltd.) and ingested for 2 months. When the body temperature data of the ingested patient and the non-ingested patient were compared before ingestion, 4 weeks after ingestion and 8 weeks after ingestion, a difference was observed in the frequency of fever (above 37 ° C.). Specifically, in the first month of intake (February 1 to February 28, 2008), there was no difference between the non-intake group and the intake group, but the second month of intake (March 2008). From 1st to March 31), a significant increase was observed in the non-intake group, whereas no increase was observed in the intake group.
Therefore, the functional food or pharmaceutical composition of the present invention was found to improve fever symptoms in the elderly.
次に、本発明の機能食品または医薬組成物を経腸栄養剤（アイソカル２Ｋ／ネスレニュートリション株式会社製）に溶解し、ＰＥＧを介して経腸投与した投与した場合の効果についても検討した。
その結果を表１に示す。
Next, the function food or pharmaceutical composition of the present invention was dissolved in an enteral nutrient (Isocal 2K / manufactured by Nestlé Nutrition Co., Ltd.) and the effect when administered enterally via PEG was also examined.
The results are shown in Table 1.
その結果、ＰＥＧ施術後の本発明品非−摂取群においては、全ての患者で１ヶ月目に比べて摂取２ヶ月目に発熱日数の増加が見られたのに対して、摂取群では、１ヶ月目に比べて摂取２ヶ月目に発熱日数の減少が見られた。またこのとき、長期連続投与による何らの副作用的症状も確認されなかった。
As a result, in the non-ingestion group of the present invention after PEG treatment, the number of days of fever was increased in the
本発明の機能食品および医薬組成物は、高齢者、特に経皮内視鏡的胃瘻造設術を施した高齢者の発熱症状の抑制に有効であり、経口摂取または胃瘻を介した経腸摂取する発熱症状抑制用の機能食品または医薬組成物として、食品、医薬品の分野において利用することができる。また、本発明の機能食品および医薬組成物は、有効成分がアミノ酸であるため、薬物相互作用のリスクが非常に低く、長期連続投与しても抗生剤のように薬剤耐性の獲得による二次的な院内感染の心配がなく、また、ＰＥＧ施術患者においては点滴などの新たな侵襲的手法を用いることなく栄養物を投与できる点で患者に対する負担が小さい。
従って、本発明の機能食品および医薬組成物は、到来する高齢者社会において患者のクオリティー・オブ・ライフをも考慮した機能食品および医薬組成物として、非常に安全かつ有効に高齢者に使用することができる。
The functional food and pharmaceutical composition of the present invention are effective in suppressing fever symptoms in elderly people, particularly elderly people who have undergone percutaneous endoscopic gastrostomy, and are taken orally or enterally via gastrostoma As a functional food or pharmaceutical composition for suppressing fever symptoms, it can be used in the fields of food and medicine. In addition, since the active ingredient is an amino acid in the functional food and pharmaceutical composition of the present invention, the risk of drug interaction is very low, and even after long-term continuous administration, secondary effects due to acquisition of drug resistance like antibiotics are obtained. There is no worry about nosocomial infection, and the burden on the patient is small in that PEG-treated patients can administer nutrients without using a new invasive technique such as infusion.
Therefore, the functional food and the pharmaceutical composition of the present invention should be used for the elderly very safely and effectively as the functional food and the pharmaceutical composition considering the quality of life of the patient in the coming elderly society. Can do.
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