JP7490677B2 - HFpEFのためのIGFBP7の比 - Google Patents
HFpEFのためのIGFBP7の比 Download PDFInfo
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- JP7490677B2 JP7490677B2 JP2021569358A JP2021569358A JP7490677B2 JP 7490677 B2 JP7490677 B2 JP 7490677B2 JP 2021569358 A JP2021569358 A JP 2021569358A JP 2021569358 A JP2021569358 A JP 2021569358A JP 7490677 B2 JP7490677 B2 JP 7490677B2
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- 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
- G01N33/74—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
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- 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
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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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- 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
- G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
- G01N2333/47—Assays involving proteins of known structure or function as defined in the subgroups
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- G01N2333/4737—C-reactive protein
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- G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
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- G01N2333/46—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans from vertebrates
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- G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
- G01N2333/575—Hormones
- G01N2333/58—Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
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Description
(a)対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、
(b)(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別する工程を含む、方法に関する。
(a)対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、
(b)(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全を診断する工程を含む、方法に関する。
(a)対象由来の試料中のIGFBP7の量、BNP型ペプチドの量およびCRPの量を決定する工程、
(b)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程。
1.IGFBP7/BNP型ペプチド(すなわち、BNP型ペプチドの量に対するIGFBP7の量の比)、または
2.(IGFBP7+CRP)/BNP型ペプチド(すなわち、BNP型ペプチドの量に対するIGFBP7の量およびCRPの量の和の比)
3.BNP型ペプチド/IGFBP7、または
4.BNP型ペプチド/(IGFBP7+CRP)
(a)処理ユニットにおいて、対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量の値、BNP型ペプチドの量の値、および任意にCRP(C反応性タンパク質)の量の値を受け取る工程、
(b)前記処理ユニットによって、(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)前記処理ユニットによって、工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別する工程を含む、方法に関する。
(a)処理ユニットにおいて、対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量の値、BNP型ペプチドの量の値、および任意にCRP(C反応性タンパク質)の量の値を受け取る工程、
(b)前記処理ユニットによって、(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)前記処理ユニットによって、工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全を診断する工程を含む、方法に関する。
(a)対象から試料を受け取る工程、
(b)試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、ならびに
(c)IGFBP7の量、BNP型ペプチドの量および任意にCRPの量の値を主治医に提供し、それにより、HFpEFとHFrEFとを鑑別することを可能にする工程を含む、方法に関する。
(a)対象から試料を受け取る工程、
(b)試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、ならびに
(c)IGFBP7の量、BNP型ペプチドの量および任意にCRPの量の値を主治医に提供し、それにより、HFpEFの診断を可能にする工程を含む、方法に関する。
本発明の以下の実施形態は、本明細書に記載の任意の他の実施形態と組み合わせて使用され得る。本明細書での上記の定義および説明を、以下に準用する。
(a)対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、
(b)(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別する工程を含む、方法。
(a)対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、
(b)(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全を診断する工程を含む、方法。
(a)処理ユニットにおいて、対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量の値、BNP型ペプチドの量の値、および任意にCRP(C反応性タンパク質)の量の値を受け取る工程、
(b)前記処理ユニットによって、(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)前記処理ユニットによって、工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別する工程を含む、方法。
(a)処理ユニットにおいて、対象由来の試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量の値、BNP型ペプチドの量の値、および任意にCRP(C反応性タンパク質)の量の値を受け取る工程、
(b)前記処理ユニットによって、(i)IGFBP7の量とBNPペプチドの量との比、または(ii)IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比を計算する工程、
(c)前記処理ユニットによって、工程(b)で計算された比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全を診断する工程を含む、方法。
(a)対象から試料を受け取る工程、
(b)試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、ならびに
(c)IGFBP7の量、BNP型ペプチドの量および任意にCRPの量の値を主治医に提供し、それにより、HFpEFとHFrEFとを鑑別することを可能にする工程を含む、方法。
(a)対象から試料を受け取る工程、
(b)試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量、および任意にCRP(C反応性タンパク質)の量を決定する工程、ならびに
(c)IGFBP7の量、BNP型ペプチドの量および任意にCRPの量の値を主治医に提供し、それにより、HFpEFの診断を可能にする工程を含む、方法。
NTproBNP、GDF-15、ST2、CRP(hs CRP)およびIGFBP-7のレベルを、駆出率の低下あり、およびなしのHF患者において決定した。
表1:HFpEF対HFrEF患者における循環バイオマーカーの力価
表1に示すように、HFpEF患者と比較して、HFrEF患者から循環NTproBNPレベルの上昇を検出することができた。対照的に、駆出率の低下を伴うまたは伴わないHF患者間の循環レベルの有意差を、CRPおよびGDF15について検出することはできなかった。
表1に示すように、HFpEF患者と比較して、HFrEF患者から循環NTproBNPレベルの上昇を検出することができた。対照的に、駆出率の低下を伴うまたは伴わないHF患者間の循環レベルの有意差を、CRPおよびIGFBP-7について検出することができなかった。HFpEFの改善された診断について、CRP+IGFBP-7(HFrEF対HFpEFで上昇していない)/NTproBNP(HFrEF対HFpEFで上昇している)の比を評価した。
高血圧を有する76歳の女性肥満患者は、息切れを呈する。NTproBNP、IGFBP-7およびCRPを、患者から得られた血清試料で(Elecsys NTproBNP、Elecsys IGFBP-7およびCobas CRPを用いて)決定する。NTproBNP値は、肥満の存在のためグレーゾーンにある可能性があるので、心不全の鑑別診断が行われる。NTproBNP値は476pg/mL、IGFBP-7値は190,8ng/mL、およびCRP値は5,8ng/mLである。計算された指標(CRP+IGFBP-7):NTproBNPは0.41であり、計算された基準比(0.09)に対して上昇している。基準比は、基準コホートにおける中央値の比として計算した。得られた比(0.41)は、駆出率が保持された心不全を示し、患者は、HFpEF改善戦略を伴う処置、例えばSGLT2阻害薬による処置からより利益を受けると同定されている。患者の治療はそれに応じて適合される。
Claims (16)
- 心不全に罹患している対象において、駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別するための指標を提供する方法であって、
(a)前記対象由来の血液試料、血清試料または血漿試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量およびCRP(C反応性タンパク質)の量を決定する工程、
(b)IGFBP7およびCRPの前記量の和とBNP型ペプチドの前記量との比を計算する工程、
(c)工程(b)で計算された前記比を基準比と比較する工程、ならびに
(d)駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別するための指標を提供する工程を含む、方法。 - 前記対象がヒトである、請求項1に記載の方法。
- 前記BNP型ペプチドがBNPまたはNT-proBNPである、請求項1または2に記載の方法。
- 前記BNP型ペプチドの量に対するIGFBP7およびCRPの前記量の和の比が計算される、請求項1から3のいずれか一項に記載の方法。
- 前記基準比を上回る比が、駆出率が保持された心不全(HFpEF)を示し、かつ/または前記基準比を下回る比が、駆出率が低下した心不全(HFrEF)を示す、請求項4に記載の方法。
- HFpEFに罹患している疑いのある対象において、駆出率が保持された心不全(HFpEF)を診断するための指標を提供する方法であって、
(a)前記対象由来の血液試料、血清試料または血漿試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量およびCRP(C反応性タンパク質)の量を決定する工程、
(b)IGFBP7およびCRPの前記量の和とBNP型ペプチドの前記量との比を計算する工程、
(c)工程(b)で計算された前記比を基準比と比較する工程、ならびに、
(d)駆出率が保持された心不全を診断するための指標を提供する工程を含む、方法。 - 心不全に罹患している対象において、駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別するためのコンピュータ実装方法であって、
(a)処理ユニットにおいて、前記対象由来の血液試料、血清試料または血漿試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量の値、BNP型ペプチドの量の値、およびCRP(C反応性タンパク質)の量の値を受け取る工程、
(b)前記処理ユニットによって、IGFBP7およびCRPの前記量の和とBNP型ペプチドの前記量との比を計算する工程、
(c)前記処理ユニットによって、工程(b)で計算された前記比を基準比と比較する工程、ならびに
(d)前記処理ユニットによって、駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別する工程を含む、方法。 - HFpEFに罹患している疑いのある対象において、駆出率が保持された心不全(HFpEF)を診断するためのコンピュータ実装方法であって、
(a)処理ユニットにおいて、前記対象由来の血液試料、血清試料または血漿試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量の値、BNP型ペプチドの量の値、およびCRP(C反応性タンパク質)の量の値を受け取る工程、
(b)前記処理ユニットによって、IGFBP7およびCRPの前記量の和とBNP型ペプチドの前記量との比を計算する工程、
(c)前記処理ユニットによって、工程(b)で計算された前記比を基準比と比較する工程、ならびに
(d)前記処理ユニットによって、駆出率が保持された心不全を診断する工程を含む、方法。 - 前記基準比がメモリから確立される、請求項8に記載の方法。
- 心不全に罹患している対象において、駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別するための方法であって、
(a)前記対象由来の血液試料、血清試料または血漿試料を受け取る工程、
(b)前記血液試料、血清試料、または血漿試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量およびCRP(C反応性タンパク質)の量を決定する工程、ならびに
(c)IGFBP7およびCRPの前記量の和とBNP型ペプチドの前記量との比の値を主治医に提供する工程を含み、それにより、HFpEFとHFrEFとを鑑別することを支援するための方法。 - HFpEFに罹患している疑いのある対象において、駆出率が保持された心不全(HFpEF)を診断するための方法であって、
(a)前記対象由来の血液試料、血清試料または血漿試料を受け取る工程、
(b)前記血液試料、血清試料、または血漿試料中のIGFBP7(インスリン様成長因子結合タンパク質7)の量、BNP型ペプチドの量およびCRP(C反応性タンパク質)の量を決定する工程、ならびに
(c)IGFBP7およびCRPの前記量の和とBNP型ペプチドの前記量との比の値を主治医に提供する工程を含み、それにより、HFpEFの診断を支援するための方法。 - 駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)とを鑑別のための指標を提供するため、またはHFpEFを診断するための指標を提供するための、対象由来の血液試料、血清試料または血漿試料中のバイオマーカーとしてのIGFBP7、BNP型ペプチドおよびCRPの使用であって、IGFBP7およびCRPの量の和とBNP型ペプチドの量との比が計算される、使用。
- 駆出率が保持された心不全(HFpEF)と駆出率が低下した心不全(HFrEF)を鑑別のための指標を提供するため、またはHFpEFを診断するための指標を提供するための、対象由来の血液試料、血清試料または血漿試料中のIGFBP7に結合する少なくとも1種の検出剤、BNP型ペプチドに結合する少なくとも1種の検出剤、およびCRPに結合する少なくとも1種の検出剤の使用であって、IGFBP7の量およびCRPの量の和とBNP型ペプチドの量との比が計算される、使用。
- 前記検出剤が、抗体またはその抗原結合断片である、請求項13に記載の使用。
- 前記対象がヒトである、請求項6から11のいずれか一項に記載の方法または請求項12から14のいずれか一項に記載の使用。
- 前記BNP型ペプチドがBNPまたはNT-proBNPである、請求項6から11のいずれか一項に記載の方法または請求項12から14のいずれか一項に記載の使用。
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