JP7362869B2 - 腎機能測定のための組成物及びシステム - Google Patents
腎機能測定のための組成物及びシステム Download PDFInfo
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- JP7362869B2 JP7362869B2 JP2022155098A JP2022155098A JP7362869B2 JP 7362869 B2 JP7362869 B2 JP 7362869B2 JP 2022155098 A JP2022155098 A JP 2022155098A JP 2022155098 A JP2022155098 A JP 2022155098A JP 7362869 B2 JP7362869 B2 JP 7362869B2
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Description
X1及びX2は、互いに独立して、-CO2R1、-CONR1R2、-CO(AA)、及び-CONH(PS)からなる群から選択され、
Y1及びY2は、互いに独立して、NR1R2、及び
Z1は、単結合、-CR1R2-、-O-、-NR1-、-NCOR1-、-S-、-SO-、及び-SO2-からなる群から選択され、
R1及びR2は、互いに独立して、H、-CH2(CHOH)aH、-CH2(CHOH)aCH3、-CH2(CHOH)aCO2H、-(CHCO2H)aCO2H、-(CH2CH2O)cH、-(CH2CH2O)cCH3、-(CH2)aSO3H、-(CH2)aSO3 -、-(CH2)aSO2H、-(CH2)aSO2 -、-(CH2)aNHSO3H、-(CH2)aNHSO3 -、-(CH2)aNHSO2H、-(CH2)aNHSO2 -、-(CH2)aPO4H3、-(CH2)aPO4H2 -、-(CH2)aPO4H2-、-(CH2)aPO4 3-、-(CH2)aPO3H2、-(CH2)aPO3H-、及び-(CH2)aPO3 2-からなる群から選択され、
AAは、ペプチド結合またはアミド結合によって互いに結合された1以上の天然または非天然のアミノ酸を含むポリペプチド鎖であり、AAの各々は、互いに同一であってもよいし異なっていてもよく、
PSは、グリコシド結合によって互いに結合された1以上の単糖単位を含む硫化多糖鎖または非硫化多糖鎖であり、
aは、1~10の範囲の数であり、
cは、1~100の範囲の数であり、
m及びnは、互いに独立して、1~3の範囲の数である。
X1及びX2は、互いに独立して、-CO2R1、-CONR1R2、-CO(AA)、及び-CONH(PS)からなる群から選択され、
Y1及びY2は、互いに独立して、NR1R2、及び
Z1は、単結合、-CR1R2-、-O-、-NR1-、-NCOR1-、-S-、-SO-、及び-SO2-からなる群から選択され、
R1及びR2は、互いに独立して、H、-CH2(CHOH)aH、-CH2(CHOH)aCH3、-CH2(CHOH)aCO2H、-(CHCO2H)aCO2H、-(CH2CH2O)cH、-(CH2CH2O)cCH3、-(CH2)aSO3H、-(CH2)aSO3 -、-(CH2)aSO2H、-(CH2)aSO2 -、-(CH2)aNHSO3H、-(CH2)aNHSO3 -、-(CH2)aNHSO2H、-(CH2)aNHSO2 -、-(CH2)aPO4H3、-(CH2)aPO4H2 -、-(CH2)aPO4H2-、-(CH2)aPO4 3-、-(CH2)aPO3H2、-(CH2)aPO3H-、及び-(CH2)aPO3 2-からなる群から選択され、
AAは、ペプチド結合またはアミド結合によって互いに結合された1以上の天然または非天然のアミノ酸を含むポリペプチド鎖であり、AAの各々は、互いに同一であってもよいし、異なっていてもよく、
PSは、グリコシド結合によって互いに結合された1以上の単糖単位を含む硫化多糖鎖または非硫化多糖鎖であり、
aは、1~10の範囲の数であり、
cは、1~100の範囲の数であり、
m及びnは、互いに独立して、1~3の範囲の数である。
X1及びX2は、互いに独立して、-CO2R1、-CONR1R2、-CO(AA)、及び-CONH(PS)からなる群から選択され、
Y1及びY2は、互いに独立して、NR1R2、及び
Z1は、単結合、-CR1R2-、-O-、-NR1-、-NCOR1-、-S-、-SO-、及び-SO2-からなる群から選択され、
R1及びR2は、互いに独立して、H、-CH2(CHOH)aH、-CH2(CHOH)aCH3、-CH2(CHOH)aCO2H、-(CHCO2H)aCO2H、-(CH2CH2O)cH、-(CH2CH2O)cCH3、-(CH2)aSO3H、-(CH2)aSO3 -、-(CH2)aSO2H、-(CH2)aSO2 -、-(CH2)aNHSO3H、-(CH2)aNHSO3 -、-(CH2)aNHSO2H、-(CH2)aNHSO2 -、-(CH2)aPO4H3、-(CH2)aPO4H2 -、-(CH2)aPO4H2-、-(CH2)aPO4 3-、-(CH2)aPO3H2、-(CH2)aPO3H-、及び-(CH2)aPO3 2-からなる群から選択され、
AAは、ペプチド結合またはアミド結合によって互いに結合された1以上の天然または非天然のアミノ酸を含むポリペプチド鎖であり、AAの各々は、互いに同一であってもよいし異なっていてもよく、
PSは、グリコシド結合によって互いに結合された1以上の単糖単位を含む硫化多糖鎖または非硫化多糖鎖であり、
aは、0~10の範囲の数であり、
cは、1~100の範囲の数であり、
m及びnは、互いに独立して、1~3の範囲の数である。
Z1は、単結合、-CR1R2-、-O-、-NR1-、-NCOR1-、-S-、-SO-、及び-SO2-からなる群から選択され、
R1及びR2は、互いに独立して、H、-CH2(CHOH)aH、-CH2(CHOH)aCH3、-CH2(CHOH)aCO2H、-(CHCO2H)aCO2H、-(CH2CH2O)cH、-(CH2CH2O)cCH3、-(CH2)aSO3H、-(CH2)aSO3 -、-(CH2)aSO2H、-(CH2)aSO2 -、-(CH2)aNHSO3H、-(CH2)aNHSO3 -、-(CH2)aNHSO2H、-(CH2)aNHSO2 -、-(CH2)aPO4H3、-(CH2)aPO4H2 -、-(CH2)aPO4H2-、-(CH2)aPO4 3-、-(CH2)aPO3H2、-(CH2)aPO3H-、及び-(CH2)aPO3 2-からなる群から選択され、a、c、m及びnは、上述した通りである。
Claims (15)
- 腎糸球体濾過率(GFR)の測定を必要とする患者のリアルタイムGFRを測定するためのシステムであって、
コンピュータ装置と、
前記患者の皮膚に動作可能に接続され、かつ前記コンピュータ装置に動作可能に接続された1以上のセンサヘッドと、
前記患者に投与され、電磁放射線に暴露されたときにスペクトルエネルギーを放出するように構成された少なくとも1つのトレーサ剤であって、前記スペクトルエネルギーは前記1以上のセンサヘッドによって検出可能である、該少なくとも1つのトレーサ剤と、を含み、
前記コンピュータ装置は、測定時間ウィンドウにわたって前記トレーサ剤から放射された光の減少を、前記患者のGFRと相関させ、かつ前記測定時間ウィンドウにわたって腎クリアランスに関連する減衰パラメータを算出することによって、前記患者のGFRを測定し、
前記減衰パラメータは、前記患者の身体サイズについて正規化された前記GFRに直接相関する減衰速度定数であり、前記減衰速度定数は、指数関数を時間の関数として前記スペクトルエネルギーにフィッティングさせるか、または、線形関数を時間の関数として前記スペクトルエネルギーの対数にフィッティングさせることによって求められ、前記フィッティングは、血管空間と血管外身体空間との間での前記トレーサ剤の平衡後に開始されることを特徴とする、システム。 - 請求項1に記載のシステムであって、
前記トレーサ剤は、下記の化学式Iの化合物であることを特徴とするシステム。
X1及びX2は、互いに独立して、-CO2R1、-CONR1R2、-CO(AA)、及び-CONH(PS)からなる群から選択され、
Y1及びY2は、互いに独立して、NR1R2、及び
Z1は、単結合、-CR1R2-、-O-、-NR1-、-NCOR1-、-S-、-SO-、及び-SO2-からなる群から選択され、
R1及びR2は、互いに独立して、H、-CH2(CHOH)aH、-CH2(CHOH)aCH3、-CH2(CHOH)aCO2H、-(CHCO2H)aCO2H、-(CH2CH2O)cH、-(CH2CH2O)cCH3、-(CH2)aSO3H、-(CH2)aSO3 -、-(CH2)aSO2H、-(CH2)aSO2 -、-(CH2)aNHSO3H、-(CH2)aNHSO3 -、-(CH2)aNHSO2H、-(CH2)aNHSO2 -、-(CH2)aPO4H3、-(CH2)aPO4H2 -、-(CH2)aPO4H2-、-(CH2)aPO4 3-、-(CH2)aPO3H2、-(CH2)aPO3H-、及び-(CH2)aPO3 2-からなる群から選択され、
AAは、ペプチド結合またはアミド結合によって互いに結合された1以上の天然または非天然のアミノ酸を含むポリペプチド鎖であり、AAの各々は、互いに同一であってもよいし異なっていてもよく、
PSは、グリコシド結合によって互いに結合された1以上の単糖単位を含む硫化多糖鎖または非硫化多糖鎖であり、
aは、1~10の範囲の数であり、
cは、1~100の範囲の数であり、
m及びnは、互いに独立して、1~3の範囲の数である。 - 請求項1に記載のシステムであって、
前記身体サイズの評価基準は、体表面積であることを特徴とするシステム。 - 請求項1に記載のシステムであって、
前記身体サイズの評価基準は、前記トレーサ剤の分布容積であることを特徴とするシステム。 - 請求項1に記載のシステムであって、
前記トレーサ剤の単回注射後に、前記減衰速度定数の複数回の測定が実施され、これにより、GFRモニタリングがリアルタイムで行われることを特徴とするシステム。 - 請求項1に記載のシステムであって、
前記減衰速度定数を算出するために使用される前記測定時間ウィンドウは、前記1以上のセンサヘッドで測定された蛍光データに基づいて算出された品質評価基準にしたがって決定されることを特徴とするシステム。 - 請求項1に記載のシステムであって、
前記フィッティングを適用する前に、前記トレーサ剤の注入前に測定されたベースライン信号が蛍光データから差し引かれることを特徴とするシステム。 - 請求項1に記載のシステムであって、
前記フィッティングを適用する前に、フィルタリングが蛍光データに適用されることを特徴とするシステム。 - 請求項7に記載のシステムであって、
前記品質評価基準は、信号及び/またはモデルフィッティング品質の評価基準、信号対ノイズ比、フィッティングの二乗平均平方根誤差、データとフィッティングとの間の相関係数、単一指数フィッティング及び二重指数フィッティングにより求められた減衰速度定数の差、同一患者の2つの異なる身体部位で求められた減衰速度定数の差、フィッティングされた減衰速度定数の推定誤差、複数の時間セグメントにわたってフィッティングさせた場合の減衰速度定数の変動係数、及びそれらの任意の組み合わせからなる群から選択されることを特徴とするシステム。 - 請求項1に記載のシステムであって、
前記指数関数または前記線形関数は、オフセット項を含むことを特徴とするシステム。 - 請求項11に記載のシステムであって、
前記オフセット項が第1のフィッティングに加えられ、前記第1のフィッティングから推定された前記減衰速度定数が予め定められた閾値を超えた場合に第2のフィッティングが実行され、これにより、前記オフセット項の変更を可能にすることを特徴とするシステム。 - 請求項1に記載のシステムであって、
信号の品質評価基準が、GFRを報告するか否かを決定するために使用されることを特徴とするシステム。 - 請求項1に記載のシステムであって、
前記コンピュータ装置は、さらに
前記測定時間ウィンドウにわたって測定された前記スペクトルエネルギーに関連する品質評価基準を決定し、
前記品質評価基準を使用して、前記減衰パラメータが十分に正確であるかどうかを評価し、前記減衰パラメータが十分に正確でないと評価された場合には、前記品質評価基準が十分に正確であると評価されるまで、前記測定時間ウィンドウの時間長さを延長するように構成された、システム。 - 請求項8に記載のシステムであって、
ベースラインの安定性を評価し、予め定められた閾値と比較し、前記ベースラインが十分に安定するまでGFR測定を行わないことを特徴とするシステム。
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KR20210102371A (ko) * | 2018-12-12 | 2021-08-19 | 메디비콘 아이엔씨. | 지속적 신장 대체 요법에서 경피 사구체 여과율 측정의 용도 |
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