JP5677294B2 - 腎疾患の検査方法 - Google Patents
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/78—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/34—Genitourinary disorders
- G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
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Description
1.尿中ポドカリキシンと、1つ以上の他のマーカーとを組み合わせて使用することを特徴とする、腎疾患の検査方法。
2.他のマーカーが腎機能マーカーであることを特徴とする前項1に記載の腎疾患の検査方法。
3.腎機能マーカーが推算糸球体濾過量および/または尿蛋白である、前項1または2に記載の腎疾患の検査方法。
4.尿中ポドカリキシン値と他のマーカーの値とを用いてポドカリキシンインデックス値を算出し、ポドカリキシンインデックス値を指標として使用する、前項1〜3のいずれか1に記載の腎疾患の検査方法。
5.ポドカリキシンインデックス値が、尿中ポドカリキシン値を推算糸球体濾過量で除することにより得られる、前項4に記載の腎疾患の検査方法。
6.ポドカリキシンインデックス値が、尿中ポドカリキシン値に尿蛋白値を乗することにより得られる、前項4に記載の腎疾患の検査方法。
7.ポドカリキシンインデックス値が基準値より高い場合、腎生検が必要であると判定される、前項4〜6のいずれか1に記載の腎疾患の検査方法。
8.基準値が、IgA腎症の予後良好群および予後比較的良好群からなる被験者群から得られた値である、前項7に記載の腎疾患の検査方法。
9.他のマーカーにより予後不良群に該当しないと予め判定された被験者を対象とする、前項1〜8のいずれか1に記載の腎疾患の検査方法。
10.尿中ポドカリキシン値または1つ以上の他のマーカーの値の、いずれか1つ以上を尿中成分の値を用いて補正する、前項1〜9のいずれか1項に記載の腎疾患の検査方法。
11.尿中成分が、尿中クレアチニンである、前項10に記載の腎疾患の検査方法。
12.尿中ポドカリキシンの検出を免疫学的手法により行う、前項1〜11のいずれか1項に記載の腎疾患の検査方法。
13.尿中ポドカリキシンを検出するための抗ポドカリキシン抗体を含む、前項1〜12のいずれか1項に記載の検査方法のための検査用試薬。
14.抗ポドカリキシン抗体を用いて尿中ポドカリキシンを検出する試薬を含む、前項1〜13のいずれか1項に記載の検査方法のための検査用試薬キット。
<式> PCX/Cre:尿中ポドカリキシン排泄量(μg/g)=100×尿中ポドカリキシン濃度(ng/mL)÷尿中クレアチニン濃度(mg/dL)
GFR(男)=194×SCre(血清クレアチニン)^−1.094×age(年齢)^−0.287
GFR(女)=GRF(男)×0.739
本発明において、糸球体濾過量としては、推算糸球体濾過量(eGFR)を用いることが好ましい。尿中ポドカリキシン排泄量をeGFRで割り、インデックス値「(PCX/Cre)/eGFR」を算出する。インデックス値「(PCX/Cre)/eGFR」の算出は、ソフトウェアを用いてコンピュータにより行ってもよい。インデックス値「(PCX/Cre)/eGFR」を本発明の検査方法の指標として用いることができる。
ポドカリキシン濃度の測定には、2種類の抗ヒトポドカリキシンモノクローナル抗体を用いた。これらの2種類の抗体は、ヒトポドカリキシンの異なる2つのエピトープを各々認識し、それぞれ抗ヒトポドカリキシンモノクローナル抗体a(以下単に「抗体a」と称する)と、抗ヒトポドカリキシンモノクローナル抗体b(以下単に「抗体b」と称する)である。本実施例では、抗体a固相化マイクロタイタープレート(分割型マイクロプレートGF8高:Nunc社)と、西洋ワサビPeroxidase(以下「HRP」と略す)により標識化した抗体bを用いた。
<式> 尿中ポドカリキシン排泄量(μg/g)=100×尿中ポドカリキシン濃度(ng/mL)÷尿中クレアチニン濃度(mg/dL)
実施例1の方法により、IgA腎症患者28症例から得た尿検体について、尿中ポドカリキシン排泄量(PCX/Cre)を算出した。また、同じ尿検体から推算糸球体濾過量(eGFR:estimated glomerular filtrationrate)及び尿蛋白排泄量(尿蛋白/Cre)を測定・算出し、尿中ポドカリキシン排泄量と組み合わせてインデックス値を得、インデックス値の予後スクリーニングマーカーとしての意義を検討した。
Claims (7)
- 尿中ポドカリキシン値を推算糸球体濾過量で除することにより得られるポドカリキシンインデックス値、または、尿中ポドカリキシン値に尿蛋白値を乗することにより得られるポドカリキシンインデックス値を指標として使用することを特徴とする、腎疾患の検査方法。
- ポドカリキシンインデックス値が基準値より高い場合、腎生検が必要であると判定される、請求項1に記載の腎疾患の検査方法。
- 基準値が、IgA腎症の予後良好群および予後比較的良好群からなる被験者群から得られた値である、請求項2に記載の腎疾患の検査方法。
- 他のマーカーにより予後不良群に該当しないと予め判定された被験者を対象とする、請求項1〜3のいずれか1に記載の腎疾患の検査方法。
- 尿中ポドカリキシン値が尿中成分の値を用いて補正された値である、請求項1〜4のいずれか1項に記載の腎疾患の検査方法。
- 尿中成分が、尿中クレアチニンである、請求項5に記載の腎疾患の検査方法。
- 尿中ポドカリキシンの検出を免疫学的手法により行う、請求項1〜6のいずれか1項に記載の腎疾患の検査方法。
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US20170146553A1 (en) * | 2009-06-10 | 2017-05-25 | Masanori Hara | Test method on renal diseases |
US8673577B2 (en) | 2010-02-26 | 2014-03-18 | Masanori Hara | Method for examining acute renal disorder |
JP5988199B2 (ja) * | 2012-05-29 | 2016-09-07 | 学校法人順天堂 | IgA腎症診断法 |
WO2014060486A1 (en) * | 2012-10-18 | 2014-04-24 | Metanomics Gmbh | Means and methods for determining a clearance normalized amount of a metabolite disease biomarker in a sample |
SG10202108135VA (en) * | 2016-12-16 | 2021-09-29 | Merck Patent Gmbh | Methods for the use of galectin 3 binding protein detected in the urine for monitoring the severity and progression of lupus nephritis |
EP3665705A1 (en) | 2017-08-08 | 2020-06-17 | Fresenius Medical Care Holdings, Inc. | Systems and methods for treating and estimating progression of chronic kidney disease |
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JP2008122410A (ja) * | 2000-10-27 | 2008-05-29 | Masanori Hara | 腎障害の検査方法 |
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JP2932837B2 (ja) * | 1992-06-25 | 1999-08-09 | 富士レビオ株式会社 | ヒトポドカリキシンの測定方法 |
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JP2000241431A (ja) | 1999-02-17 | 2000-09-08 | Nissho Corp | 免疫グロブリンa−フィブロネクチン複合体の免疫学的測定試薬および測定法 |
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JP2008122410A (ja) * | 2000-10-27 | 2008-05-29 | Masanori Hara | 腎障害の検査方法 |
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JPN6010045638; 関根盛、 原正則: '腎障害の新しいマーカーについて-尿中ポドサイト,ポドカリキシンと臨床病理学的意義-' Ther.Res. Vol.29 No.11, 2008, p.1900-1904 * |
JPN7014003563; Yuji Sato: 'Urine Podocyte mRNAs Mark Progression of Renal Disease' J Am Soc Nephrol Vol. 20, 200905, pp. 1041-1052 * |
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EP2442105A1 (en) | 2012-04-18 |
JPWO2010143422A1 (ja) | 2012-11-22 |
EP2442105A4 (en) | 2012-11-28 |
EP2442105B1 (en) | 2015-01-07 |
WO2010143422A1 (ja) | 2010-12-16 |
US20120164662A1 (en) | 2012-06-28 |
ES2530054T3 (es) | 2015-02-26 |
WO2010143422A9 (ja) | 2011-04-07 |
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