中华检验医学杂志
中華檢驗醫學雜誌
중화검험의학잡지
CHINESE JOURNAL OF LABORATORY MEDICINE
2013年
4期
352-359
,共8页
杨渝伟%曾平%张林%邱玲%国秀芝%泰岩%李雪梅%刘红春%韩星敏
楊渝偉%曾平%張林%邱玲%國秀芝%泰巖%李雪梅%劉紅春%韓星敏
양투위%증평%장림%구령%국수지%태암%리설매%류홍춘%한성민
肾功能不全,慢性%肾小球滤过率%胱抑素C%肌酸酐%算法
腎功能不全,慢性%腎小毬濾過率%胱抑素C%肌痠酐%算法
신공능불전,만성%신소구려과솔%광억소C%기산항%산법
Renal insufficiency,chronic%Glomerular filtration rate%Cystatin C%Creatinine%Algorithms
目的 建立基于血清胱抑素C(CysC)和肌酐(Cr)浓度计算中国成人慢性肾病(CKD)患者肾小球滤过率(GFR)估计方程,并对其适用性进行评价.方法 由国内不同地域6家综合医院(四川省绵阳市中心医院、北京协和医院、郑州大学第一附属医院、吉林医科大学附属第一医院、四川省成都市核工业部416医院和四川省内江市第一人民医院)组成多中心非随机试验研究小组,按照K/DOQI指南及预先设定的排除标准,选取2010年10月至2011年12月门诊或住院肾病科就诊的成人CKD患者788例(男421例,女367例,年龄19 ～ 87岁),兼顾性别和疾病分期进行分层随机抽样,将受试者分成方程开发组(687例)和验证组(101例).以双血浆法检测99m Tc-DTPA肾脏清除率,作为参考GFR(rGFR),同时测定所有受试者CysC和Cr浓度.采用非线性回归拟合开发组之GFR估计方程,然后用验证组资料评估所开发方程、Cockcroft-Gault方程(eGFR1)、简化MDRD方程(eGFR2)、2个MDRD/CKD-EPI CysC方程(eGFR3、eGFR4)和2个中国eGFR协作组CysC方程(eGFR5、eGFR6)共8个GFR估算等式对中国CKD患者的适用性,并对其与rGFR的一致性进行相互比较.结果 开发组rGFR、CysC和Cr浓度分别是44.19(3.51～166.00) ml/(min·1.73 m2)、1.88(0.59 ～8.62) mg/L和1.73(0.40 ～ 19.77) mg/dl,验证组分别为47.85(10.49 ～ 148.12) ml/(min· 1.73 m2)、1.79 (0.66 ～7.22) mg/L和1.56(0.48 ～ 23.34) mg/dl,用非线性回归拟合得到2个最佳GFR估算方程:eGFR7=173.9×CysC-0.725×Cr-0.184×年龄-0.193(女性×0.89)(R2=0.734,P=0.000)和eGFR8 =78.64×CysC-0.964 (R2 =0.764,P=0.000)；8个eGFR方程估算结果与rGFR分别经Bland-Altman一致性检验、Passing&Bablok回归分析和Mountain一致性比较发现,仅eGFR7和eGFR8的一致性界限未超过事先规定的专业界值[＜60 ml/(min· 1.73 m2)],且与rGFR之间没有明显的比例误差(斜率b的95％ CI包含B=1)和恒定误差(截距a的95％ CI包含A=0),其Mountain 偏差分布曲线几乎重合,估算GFR的效果基本一致,而eGFR1、eGFR2、eGFR5和eGFR6估计GFR的偏差较eGFR7和eGFR8大,eGFR3和eGFR4整体低估了GFR.结论 用血清肌酐和(或)胱抑素C来估算GFR可得到相同精度的结果.选择文献方程估算GFR时,应首先考虑其标记物的检测方法,当检测方法与文献不一致时,不应用来估算CKD患者GFR,否则可能导致eGFR与实际水平相差较大.(中华检验医学杂志,2013,36:352-359
目的 建立基于血清胱抑素C(CysC)和肌酐(Cr)濃度計算中國成人慢性腎病(CKD)患者腎小毬濾過率(GFR)估計方程,併對其適用性進行評價.方法 由國內不同地域6傢綜閤醫院(四川省綿暘市中心醫院、北京協和醫院、鄭州大學第一附屬醫院、吉林醫科大學附屬第一醫院、四川省成都市覈工業部416醫院和四川省內江市第一人民醫院)組成多中心非隨機試驗研究小組,按照K/DOQI指南及預先設定的排除標準,選取2010年10月至2011年12月門診或住院腎病科就診的成人CKD患者788例(男421例,女367例,年齡19 ～ 87歲),兼顧性彆和疾病分期進行分層隨機抽樣,將受試者分成方程開髮組(687例)和驗證組(101例).以雙血漿法檢測99m Tc-DTPA腎髒清除率,作為參攷GFR(rGFR),同時測定所有受試者CysC和Cr濃度.採用非線性迴歸擬閤開髮組之GFR估計方程,然後用驗證組資料評估所開髮方程、Cockcroft-Gault方程(eGFR1)、簡化MDRD方程(eGFR2)、2箇MDRD/CKD-EPI CysC方程(eGFR3、eGFR4)和2箇中國eGFR協作組CysC方程(eGFR5、eGFR6)共8箇GFR估算等式對中國CKD患者的適用性,併對其與rGFR的一緻性進行相互比較.結果 開髮組rGFR、CysC和Cr濃度分彆是44.19(3.51～166.00) ml/(min·1.73 m2)、1.88(0.59 ～8.62) mg/L和1.73(0.40 ～ 19.77) mg/dl,驗證組分彆為47.85(10.49 ～ 148.12) ml/(min· 1.73 m2)、1.79 (0.66 ～7.22) mg/L和1.56(0.48 ～ 23.34) mg/dl,用非線性迴歸擬閤得到2箇最佳GFR估算方程:eGFR7=173.9×CysC-0.725×Cr-0.184×年齡-0.193(女性×0.89)(R2=0.734,P=0.000)和eGFR8 =78.64×CysC-0.964 (R2 =0.764,P=0.000)；8箇eGFR方程估算結果與rGFR分彆經Bland-Altman一緻性檢驗、Passing&Bablok迴歸分析和Mountain一緻性比較髮現,僅eGFR7和eGFR8的一緻性界限未超過事先規定的專業界值[＜60 ml/(min· 1.73 m2)],且與rGFR之間沒有明顯的比例誤差(斜率b的95％ CI包含B=1)和恆定誤差(截距a的95％ CI包含A=0),其Mountain 偏差分佈麯線幾乎重閤,估算GFR的效果基本一緻,而eGFR1、eGFR2、eGFR5和eGFR6估計GFR的偏差較eGFR7和eGFR8大,eGFR3和eGFR4整體低估瞭GFR.結論 用血清肌酐和(或)胱抑素C來估算GFR可得到相同精度的結果.選擇文獻方程估算GFR時,應首先攷慮其標記物的檢測方法,噹檢測方法與文獻不一緻時,不應用來估算CKD患者GFR,否則可能導緻eGFR與實際水平相差較大.(中華檢驗醫學雜誌,2013,36:352-359
목적 건립기우혈청광억소C(CysC)화기항(Cr)농도계산중국성인만성신병(CKD)환자신소구려과솔(GFR)고계방정,병대기괄용성진행평개.방법 유국내불동지역6가종합의원(사천성면양시중심의원、북경협화의원、정주대학제일부속의원、길림의과대학부속제일의원、사천성성도시핵공업부416의원화사천성내강시제일인민의원)조성다중심비수궤시험연구소조,안조K/DOQI지남급예선설정적배제표준,선취2010년10월지2011년12월문진혹주원신병과취진적성인CKD환자788례(남421례,녀367례,년령19 ～ 87세),겸고성별화질병분기진행분층수궤추양,장수시자분성방정개발조(687례)화험증조(101례).이쌍혈장법검측99m Tc-DTPA신장청제솔,작위삼고GFR(rGFR),동시측정소유수시자CysC화Cr농도.채용비선성회귀의합개발조지GFR고계방정,연후용험증조자료평고소개발방정、Cockcroft-Gault방정(eGFR1)、간화MDRD방정(eGFR2)、2개MDRD/CKD-EPI CysC방정(eGFR3、eGFR4)화2개중국eGFR협작조CysC방정(eGFR5、eGFR6)공8개GFR고산등식대중국CKD환자적괄용성,병대기여rGFR적일치성진행상호비교.결과 개발조rGFR、CysC화Cr농도분별시44.19(3.51～166.00) ml/(min·1.73 m2)、1.88(0.59 ～8.62) mg/L화1.73(0.40 ～ 19.77) mg/dl,험증조분별위47.85(10.49 ～ 148.12) ml/(min· 1.73 m2)、1.79 (0.66 ～7.22) mg/L화1.56(0.48 ～ 23.34) mg/dl,용비선성회귀의합득도2개최가GFR고산방정:eGFR7=173.9×CysC-0.725×Cr-0.184×년령-0.193(녀성×0.89)(R2=0.734,P=0.000)화eGFR8 =78.64×CysC-0.964 (R2 =0.764,P=0.000)；8개eGFR방정고산결과여rGFR분별경Bland-Altman일치성검험、Passing&Bablok회귀분석화Mountain일치성비교발현,부eGFR7화eGFR8적일치성계한미초과사선규정적전업계치[＜60 ml/(min· 1.73 m2)],차여rGFR지간몰유명현적비례오차(사솔b적95％ CI포함B=1)화항정오차(절거a적95％ CI포함A=0),기Mountain 편차분포곡선궤호중합,고산GFR적효과기본일치,이eGFR1、eGFR2、eGFR5화eGFR6고계GFR적편차교eGFR7화eGFR8대,eGFR3화eGFR4정체저고료GFR.결론 용혈청기항화(혹)광억소C래고산GFR가득도상동정도적결과.선택문헌방정고산GFR시,응수선고필기표기물적검측방법,당검측방법여문헌불일치시,불응용래고산CKD환자GFR,부칙가능도치eGFR여실제수평상차교대.(중화검험의학잡지,2013,36:352-359
Objective To establish equations for estimating glomerular filtration rate (GFR) based on serum Cystatin C (CysC) and creatinine (Cr) concentration in Chinese adult patients with chronic kidney disease (CKD),and evaluate their applicability.Methods Six tertiary hospitals located in different geographic regions of China formed a muhicenter nonrandom test research,composed of the Mianyang Central Hospital,the Peking Union Medical College Hospital,the First Affiliated Hospital of Zhengzhou University,the First Bethune Hospital of Jilin University,the Nuclear Industrial 416 Hospital,and the First people's Hospital of Neijiang.According to K/DOQI guidelines and pre-set exclusion criteria,788 adult patients with CKD were enrolled,from October 2010 to December 2011 (421 males,367 females,age from 19-year-old to 87-year-old),and randomly divided into development group (n =687) and validation group (n =101) with a stratified sampling take into account both gender and disease stages.Two-sample 99mTc-DTPA plasma clearance was determined as the reference GFR (rGFR),meanwhile serum CysC and Cr were also detected.The data of development group was used to fit GFR-estimating equation using nonlinear regression,and the data of validation group to evaluate the applicability of eight equations,including two developed equations,Cockcroft-Gault equation (eGFR1),MDRD equation (eGFR2),two MDRD/CKD-EPI equations (eGFR3,eGFR4) and two Chinese eGFR Investigation Collaboration equations (eGFR5,eGFR6),and compared each other in the consistency with rGFR.Results The mean rGFR,CysC and Cr of development group were 44.19 (3.51-166.00) ml/(min · 1.73 m2),1.88 (0.59-8.62) mg/L and 1.73 (0.40-19.77)mg/dl,respectively.The mean rGFR,CysC and Cr of validation group were 47.85(10.49-148.12) ml/(min · 1.73 m2),1.79(0.66-7.22) mg/L and 1.56(0.48-23.34) mg/dl,respectively.Two best-fit GFR estimation equations were established using nonlinear regression:eGFR7 =173.9 × CysC-0.725 × Cr-0.184 ×Age-0.193 (if female × 0.89) (R2 =0.734,P =0.000),and eGFR8 =78.64 × CysC-0.964 (R2 =0.764,P =0.000).With Bland-Altman plot,Passing & Bablok regression,and Mountain plot analysis,only the 95％ agreement limits of eGFR7 and eGFR8,did not exceed the prior acceptable tolerances [＜ 60 ml/(min ·1.73 m2)],and they did not show significant differences in proportional differences (the 95％ CI of slopes included B =1) and constant differences (the 95％ CI of intercepts included A =0) comparied with rGFR,and their Mountain plots almost overlapped each other that indicated their basical agreement in GFR estimating effect.As compared with rGFR,the deviation of eGFR1,eGFR2,eGFR5 or eGFR6 was larger than of eGFR7 or eGFR8,especially eGFR3 and eGFR4 underestimated GFR overall.Conclusions It can provide an equal precision to estimate GFR using serum CysC alone or in combination with serum Cr.The agreement of GFR marker's measured method must be considered adequately before a literature eGFR equation was chosen.Otherwise,the eGFR value would have a large error,which may lead to misdiagnosis and mistreatment.(Chin J Lab Med,2013,36:352-359)
