JP5596779B2 - 急性心筋梗塞に対する初期対応におけるリボースの使用 - Google Patents
急性心筋梗塞に対する初期対応におけるリボースの使用 Download PDFInfo
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
- A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Cardiology (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Hospice & Palliative Care (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
発酵により生産される製品は多くの場合発熱物質、すなわち静脈内投与した時点で発熱を誘発し得る物質の残渣を幾分か有する。最も頻度の高い発熱性汚染物質は細菌内毒素である。したがって、物質が本質的に発熱物質を含むか含まないかを決定するために、内毒素分析が用いられる。さらに、同族体、すなわち発酵中に産生される所望されない副産物、そして重金属が、発酵産物を通して運ばれ、その中に存在するかもしれない。
A.Foker(米国特許4,719,201号)は、健康なイヌの心臓が、正常体温における20分間の大域的心筋虚血の後に正常なベースラインATPレベルを再度確立するために最高9日間を必要とする、ということを発見した。再かん流時に直ちにD−リボースを投与し少なくとも4日間続行することで、ATPの回復が増強された。弁手術と冠動脈バイパス移植(CABG)、またはCABG単独のいずれかを受けている、心臓機能の低下したヒト被験者が、Fokerの研究の健康なイヌと同様に心臓手術後のリボースの投与からメリットを受けるか否かをテストするために、プロトコルが考案された。
FDAおよび治験審査委員会の承認の後、心臓外科的処置中に大域的に誘発された虚血の結果発症した心筋機能不全を治療するためのD−リボースの効能を評価するように設計された、プロスペクティブ単一施設、二重盲検プラセボ対照試験への登録のために、49名の患者からインフォームドコンセントを得た。
・ 18才以上の男性または女性、
・ 冠動脈疾患が確認され、外科手術後8週間以内に行われた、心エコー検査、放射性核種イメージングまたは心臓カテーテル法に基づく駆出率(EF)が35%でCABGを受けている患者。(この期間にEFを評価するために2つ以上の方法が使用された場合は、各種の方法の平均値が35%であった)。
・ 冠動脈疾患が確認され、一弁交換または二弁交換と同様にCABGも受けている患者;あるいはCABG無しで一弁交換または二弁交換を受けている患者。
・ 血清クレアチニンが2.35mg/dl未満。
・ 妊娠可能年令の女性については、妊娠テスト陰性。
・ 同意書署名済み。
実施例2に記述された初期研究の後、ひき続き、OPCABGを受けている41才〜88才までの年令の366名の患者を登録した。そのうち89名は最近MIを患い、7名が1〜7日以内にMIを提示していた、予め収集したデータには、併存疾患、血液動態および転帰が含まれていた。全ての患者は、正常血糖、正常体温および炎症の削減を強調するプロトコルを用いて管理された。グループ1(n=308)は、外科手術の前後にD−リボースの経口用量(5グラム/用量)を多数回受けた。グループ2(n=58)は、同じ代謝プロトコルで管理されたが、D−リボースを受けなかった。グループ2は、緊急のOPCABGを受けた確率が比較的高い(9%対1%、P<0.001)が、グループ1は、比較的低い平均術前心係数(CI、表1参照)を有していた。その他の点では、両グループ共、駆出率(EJ)および胸部手術(STS)リスク指標を含めた類似の術前特性を有し、グループにおける併存疾患の増大傾向は有意なものではなかった。
A.これらの研究は有望なものであるが、いずれも、時間が最も重要である初期対応において急性心筋梗塞的を呈している患者の臨床的状況を再現していない。大部分の症例においてMIは自然発生的事象であるが、MIは、血管造影図、血管形成術、またはドブタミン心エコー検査などの処置の間に誘発される可能性がある。このような患者は一般に心臓機能が損なわれる過程にある。表IIは、D−リボースでプレコンディショニングされた308名の患者(以下で表1の全患者として記述)に対する7名の急性初期対応MI患者の比較を示す。
Claims (5)
- 有効量のD−リボースを含む、急性心筋梗塞を患う患者において心臓の危険を予防するための初期対応治療用組成物であって、急性心筋梗塞を患う患者の心係数が維持または改善される、組成物。
- 食物および水を摂取できる患者に対しては経口で、そして食物および水を摂取できない患者に対しては静脈内で投与される、請求項1に記載の組成物。
- 経口投与される組成物中のD−リボースの有効量が、2〜5グラムであり、一日に1回〜4回投与される、請求項2に記載の組成物。
- 静脈内投与される組成物中のD−リボースの有効量が、50〜300mg/kg/時であり、D−リボースが発熱物質を含まない、請求項2に記載の組成物。
物。 - アスピリン、舌下硝酸塩および吸入酸素と一緒に投与される、請求項1に記載の組成物。
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ATE487485T1 (de) * | 2007-01-23 | 2010-11-15 | Bioenergy Inc | Verwendung von d-ribose zur behandlung von vorhofflimmern |
JP7082258B2 (ja) | 2016-02-01 | 2022-06-08 | バイオエナジー ライフ サイエンス,インコーポレイティド | うっ血性心不全に罹っている対象を治療するためのリボースの使用 |
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US4605644A (en) * | 1985-02-07 | 1986-08-12 | Regents Of The University Of Minnesota | Method for stimulating recovery from ischemia employing ribose and adenine |
US4719201A (en) * | 1985-02-07 | 1988-01-12 | Regents Of The University Of Minnesota | Method for stimulating recovery from ischemia |
US4824660A (en) * | 1985-06-06 | 1989-04-25 | Paul S. Angello | Method of determining the viability of tissue in an organism |
US6159942A (en) * | 1998-06-19 | 2000-12-12 | Bioenergy, Inc. | Compositions for increasing energy in vivo |
US6218366B1 (en) * | 1998-06-19 | 2001-04-17 | Bioenergy, Inc. | Method for raising the hypoxic threshold |
GB9814039D0 (en) * | 1998-06-29 | 1998-08-26 | Univ London | Materials and methods relating to the prevention or treatment of ischaemia-reperfusion injury |
US6429198B1 (en) * | 1999-04-12 | 2002-08-06 | Bioenergy Inc. | Compositions for increasing athletic performance in mammals |
US20020119933A1 (en) * | 2000-07-28 | 2002-08-29 | Butler Terri L. | Compositions and methods for improving cardiovascular function |
US6534480B2 (en) * | 1999-06-17 | 2003-03-18 | Bioenergy Inc. | Compositions for increasing energy in vivo |
US6159943A (en) * | 1999-09-24 | 2000-12-12 | Bioenergy, Inc. | Use of ribose to prevent cramping and soreness in muscles |
US6339716B1 (en) * | 1999-09-24 | 2002-01-15 | Bioenergy Inc. | Method for determining viability of a myocardial segment |
US6511964B2 (en) * | 1999-09-24 | 2003-01-28 | Bioenergy, Inc. | Method for treating acute mountain sickness |
US6703370B1 (en) * | 1999-10-27 | 2004-03-09 | Bioenergy, Inc. | Use of ribose to treat fibromyalgia |
GB2364642B (en) * | 2000-01-07 | 2004-10-27 | Bioenergy Inc | Compositions for enhancing the immune response |
US6525027B2 (en) * | 2000-01-20 | 2003-02-25 | Bioenergy Inc. | Use of ribose supplementation for increasing muscle mass and decreasing body fat in humans |
US6420342B1 (en) * | 2000-05-08 | 2002-07-16 | N.V. Nutricia | Nutritional preparation comprising ribose and medical use thereof |
AU2001278197A1 (en) * | 2000-07-28 | 2002-02-13 | Bioenergy Inc. | Compositions and methods for improving cardiovascular function |
US20030212006A1 (en) * | 2002-05-13 | 2003-11-13 | Seifert John G. | Method for reducing free radical formation in healthy individuals undergoing hypoxic exercise and medical conditions with increased oxygen free radicals |
EP1703913B1 (en) * | 2004-01-14 | 2012-08-01 | RiboCor, Inc. | Use of ribose in recovery from anaesthesia |
EP1786436B1 (en) * | 2004-04-29 | 2012-11-14 | RiboCor, Inc. | Method for improving ventilatory efficiency |
US20060105972A1 (en) * | 2004-11-17 | 2006-05-18 | Nagasawa Herbert T | Method to enhance delivery of glutathione and ATP levels in cells |
US8835396B2 (en) * | 2006-12-15 | 2014-09-16 | Bioenergy, Inc. | Method and compositions for improving pulmonary hypertension |
ATE487485T1 (de) * | 2007-01-23 | 2010-11-15 | Bioenergy Inc | Verwendung von d-ribose zur behandlung von vorhofflimmern |
US20080312169A1 (en) * | 2007-03-20 | 2008-12-18 | Clarence Albert Johnson | Cosmetic use of D-ribose |
WO2009094593A1 (en) * | 2008-01-25 | 2009-07-30 | Foker John E | Methods and compositions for inhibiting progression to chronic cardiac failure |
US20090286750A1 (en) * | 2008-05-16 | 2009-11-19 | Kasubick Robert V | Use of ribose in lessening the clinical symptoms of aberrant firing of neurons |
CA2734769A1 (en) * | 2008-08-20 | 2010-02-25 | Bioenergy, Inc. | Use of d-ribose for fatigued subjects |
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CN106138071A (zh) | 2016-11-23 |
CN102387805A (zh) | 2012-03-21 |
WO2009123742A1 (en) | 2009-10-08 |
CA2757442A1 (en) | 2009-10-08 |
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