JP2020164507A - 分子状水素を含む腎臓疾患の腎機能改善のための組成物 - Google Patents
分子状水素を含む腎臓疾患の腎機能改善のための組成物 Download PDFInfo
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Abstract
Description
(1)分子状水素を有効成分として含む、ヒトの腎臓疾患を改善するための組成物。
(2)上記腎臓疾患の改善が、急性または慢性の腎炎の改善、腎不全の改善、および/または、ネフローゼ症候群の改善である、上記(1)に記載の組成物。
(3)上記急性または慢性の腎炎が、糸球体腎炎、間質性腎炎、腎盂腎炎、急性進行性糸球体腎炎、抗糸球体基底膜抗体腎炎、膜性増殖性糸球体腎炎、管内増殖性糸球体腎炎、半月性糸球体腎炎、および、糖尿病性腎炎からなる群から選択される、上記(2)に記載の組成物。
(4)上記急性または慢性の腎炎の改善が、尿蛋白および尿蛋白/尿クレアチニン比を正常範囲に改善すること、あるいは浮腫を改善することを含む、上記(2)または(3)に記載の組成物。
(5)尿蛋白の正常範囲が0.2g/日未満であり、尿蛋白/尿クレアチニン比の正常範囲が、0.3g/gCr未満である、上記(4)に記載の組成物。
(6)組成物が分子状水素をゼロ(0)より大きく、かつ18.5体積%以下の濃度で含む気体である、上記(1)〜(5)のいずれかに記載の組成物。
(7)組成物が有効量の分子状水素を含む生体適用液である、上記(1)〜(5)のいずれかに記載の組成物。
(8)生体適用液が、水、飲料、生理食塩水もしくは輸液である、上記(7)に記載の組成物。
(9)生体適用液中に溶存する分子状水素の濃度が1〜10ppmである、上記(7)又は(8)に記載の組成物。
(11)上記腎臓疾患の改善が、急性または慢性の腎炎の改善、腎不全の改善、および/または、ネフローゼ症候群の改善である、上記(10)に記載の方法。
(12)上記急性または慢性の腎炎が、糸球体腎炎、間質性腎炎、腎盂腎炎、急性進行性糸球体腎炎、抗糸球体基底膜抗体腎炎、膜性増殖性糸球体腎炎、管内増殖性糸球体腎炎、半月性糸球体腎炎、および、糖尿病性腎炎からなる群から選択される、上記(11)に記載の方法。
(13)上記急性または慢性の腎炎の改善が、尿蛋白及び尿蛋白/尿クレアチニン比を正常範囲に改善すること、あるいは浮腫を改善することを含む、上記(11)または(12)に記載の方法。
1.腎臓疾患
本発明における腎臓疾患は、例えば、腎炎(原発性糸球体疾患、続発性糸球体疾患)、ネフローゼ症候群、急性腎障害、慢性腎臓病、(慢性)腎不全、腎腫瘍、遺伝性腎障害、腎・尿路結石、後腹膜線維症、腎アミロイド―シス、腎梗塞、血清ナトリウム調節異常(高ナトリウム血症、低ナトリウム血症)、抗利尿ホルモン不適切分泌症候群、血清カリウム調節異常(高カリウム血症、低カリウム血症)、血清カルシウム調節異常(高カルシウム血症、低カルシウム血症)、血症リン調節異常(高リン血症、低リン血症)、酸塩基平衡調節異常、尿毒症、またはこれに関連する疾患を含む。
原発性腎臓疾患の代表的なものが腎炎であり、炎症の起こる部位によって例えば糸球体腎炎、間質性腎炎、腎盂腎炎、急性進行性糸球体腎炎、抗糸球体基底膜抗体腎炎、膜性増殖性糸球体腎炎、管内増殖性糸球体腎炎、半月性糸球体腎炎、糖尿病性腎炎などが知られており、本明細書中の「腎炎」は上記例示の疾患を包含する。また、腎炎は、症状の進行度合いによって急性と慢性の疾患に分けられており、症状が急激に進行する場合が急性であり、症状が徐々に進行する場合が慢性である。
(a)尿、画像診断、血液、及び病理検査を通して腎障害の存在が明らかであり、特に尿異常、すなわち0.15g/gCr以上の蛋白尿(30mg/gCr以上のアルブミン尿)が認められる。
(b)GFR<60ml/分/1.73m2である。ここで、GFRは、血清クレアチニン(Cr)値、性別、年齢から日本人の下記のGFR推算式(ここでeGFRは推算GFRである。):
eGFR(ml/分/1.73m2)=194×血清Cr(mg/dl)−1.094×年齢(歳)−0.287
(ただし、女性の場合には、0.739を掛ける。)
を用いて算出される。
本発明の組成物は、分子状水素を有効成分として含み、腎臓疾患をもつヒト患者において腎臓疾患を改善する、例えば尿蛋白及び尿蛋白/尿クレアチニン比を正常範囲に改善するために使用される。
上記急性または慢性の腎炎は、非限定的に、例えば糸球体腎炎、間質性腎炎、腎盂腎炎、急性進行性糸球体腎炎、抗糸球体基底膜抗体腎炎、膜性増殖性糸球体腎炎、管内増殖性糸球体腎炎、半月性糸球体腎炎、および、糖尿病性腎炎からなる群から選択されうる。
<分子状水素吸入による慢性腎炎ヒト患者の尿蛋白及び尿蛋白/尿クレアチニン比の改善>
慢性腎炎に罹患した60代の女性は、尿中の蛋白が1+から3+まで、一時5+のときもあり、透析が必要になるかもしれないと医師から言われていた。この患者は、初診時の尿蛋白3+、尿蛋白定量286.5mg/dl、尿クレアチニン56.7mg/dl、尿蛋白/尿クレアチニン比5.0g/gCr、推算糸球体ろ過量(eGFR)57.6、尿素窒素(BUN)15.5mg/dl、血清クレアチニン0.79mg/dlであり、また血糖値156mg/dl、HbA1c8.0%、グリコアルブミン19.8%であり糖尿病性であると診断され、血糖を下げる薬剤、インスリン分泌促進薬、血圧降下剤、抗凝固薬を服用した。
<分子状水素吸入による腎不全患者の症状改善>
65歳の女性は、糖尿病から腎不全になり、2006年から血液透析を受けている。20数種類の薬剤を使用してきたが症状の改善は認められず、歩行困難の症状もあった。
Claims (13)
- 分子状水素を有効成分として含む、ヒトの腎臓疾患を改善するための組成物。
- 前記腎臓疾患の改善が、急性または慢性の腎炎の改善、腎不全の改善、および/または、ネフローゼ症候群の改善である、請求項1に記載の組成物。
- 前記急性または慢性の腎炎が、糸球体腎炎、間質性腎炎、腎盂腎炎、急性進行性糸球体腎炎、抗糸球体基底膜抗体腎炎、膜性増殖性糸球体腎炎、管内増殖性糸球体腎炎、半月性糸球体腎炎、および、糖尿病性腎炎からなる群から選択される、請求項2に記載の組成物。
- 前記急性または慢性の腎炎の改善が、尿蛋白および尿蛋白/尿クレアチニン比を正常範囲に改善すること、あるいは浮腫を改善することを含む、請求項2または3に記載の組成物。
- 尿蛋白の正常範囲が0.2g/日未満であり、尿蛋白/尿クレアチニン比の正常範囲が、0.3g/gCr未満である、請求項4に記載の組成物。
- 組成物が分子状水素をゼロ(0)より大きく、かつ18.5体積%以下の濃度で含む気体である、請求項1〜5のいずれか1項に記載の組成物。
- 組成物が有効量の分子状水素を含む生体適用液である、請求項1〜5のいずれか1項に記載の組成物。
- 生体適用液が、水、飲料、生理食塩水もしくは輸液である、請求項7に記載の組成物。
- 生体適用液中に溶存する分子状水素の濃度が1〜10ppmである、請求項7又は8に記載の組成物。
- 請求項1〜9のいずれか1項に記載の組成物を、腎臓疾患をもつヒト患者に投与し、該患者において腎臓疾患を改善することを含む、腎臓疾患を改善する方法。
- 前記腎臓疾患の改善が、急性または慢性の腎炎の改善、腎不全の改善、および/または、ネフローゼ症候群の改善である、請求項10に記載の方法。
- 前記急性または慢性の腎炎が、糸球体腎炎、間質性腎炎、腎盂腎炎、急性進行性糸球体腎炎、抗糸球体基底膜抗体腎炎、膜性増殖性糸球体腎炎、管内増殖性糸球体腎炎、半月性糸球体腎炎、および、糖尿病性腎炎からなる群から選択される、請求項11に記載の方法。
- 前記急性または慢性の腎炎の改善が、尿蛋白及び尿蛋白/尿クレアチニン比を正常範囲に改善すること、あるいは浮腫を改善することを含む、請求項11または12に記載の方法。
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