CN106456865B - 使用血液稀释的绝对血量估计 - Google Patents
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Abstract
本文描述了一种使用血液稀释法测定绝对血量的仪器。
Description
相关申请
本申请要求2014年5月20日提交的美国临时申请No.62/000,684的权益。前述申请的全部教导通过引用并入本文。
背景技术
体液超量和贫血在透析患者的发病中起到关键作用,而血量是这些病情的关键组成部分。仅举数个应用,对患者绝对血量的了解对于干重评估、透析中并发症的预防和贫血处置的不同后果是重要的。
因此,需要以不明显增加的成本,在当前临床实践过程中日常地估计透析患者的绝对血量,而没有副作用或辐射暴露并且不改变或显著干扰现有操作过程。
发明内容
在一个实施方式中,血液透析机包括用于用已知量的预充液预充透析器的装置,用于在使得所述已知量的预充液开始输注到患者的情况下开始所述患者的血液透析或超滤治疗的装置,之后所述患者的血液被透析和/或超滤或二者,用于测定所述患者的相对血量的装置,和用于在预定时间测定所述患者的经稀释血红蛋白浓度的装置,所述预定时间选择为使得通过预充液输注到所述患者体内引起全身性血液稀释,同时最小化由再循环的预充液导致的血液稀释。所述血液透析机可以进一步包括用于比较所述患者的血液稀释后血红蛋白浓度与所述患者的透析前血红蛋白浓度的装置,用于计算所述患者的透析前绝对血量的装置,和用于从所述相对血量在所述血液透析治疗期间定期地测定所述患者的绝对血量的装置。
在另一个实施方式中,测定经历血液透析治疗的患者的绝对血量的方法包括用已知量的预充液预充透析器,在使得所述已知量的预充液开始输注到患者体内的情况下开始所述患者的血液透析治疗,之后所述患者的血液被透析或超滤,测定所述患者的相对血量,和在预定时间测定所述患者的经稀释血红蛋白浓度,所述预定时间选择为使得通过预充液输注到所述患者体内引起全身性血液稀释,同时最小化由再循环的预充液导致的血液稀释。所述方法进一步包括比较所述患者的血液稀释后血红蛋白浓度与所述患者的透析前血红蛋白浓度,计算所述患者的透析前绝对血量,和从所述相对血量在所述血液透析治疗期间定期地测定所述患者的绝对血量。
本发明使得能够以不明显增加的成本,在当前临床实践过程中日常地估计透析患者中的绝对血量,而没有副作用或辐射暴露,并且不改变或显著干扰现有操作过程。
附图说明
前述内容将从下文中如随附附图所说明的本发明的示例实施方式的更加详细描述而更加明显,附图中贯穿不同视图,相似的引用字符指代相同的部件。附图不一定是按比例的,重点而是在于说明本发明的实施方式。
图1A是比较透析开始Crit-Line和透析前Spectra血红蛋白测量结果的Bland-Altman图的图解。
图1B是具有在95%置信水平给出的一致性范围(limits of agreement)(LAG)的Bland-Altman统计的图解。
图2是实验室结果(Spectra)和根据本发明的Crit-Line测量的时机的图解。
图3是静态预充液添加(240mL)对Hgb浓度的稀释作用的图解(假设完全混合,可忽略的效应,从HD开始UFR为800mL/h,和治疗中Crit-Line测量5分钟)。
图4是比较透析开始CritLine和透析前Spectra血红蛋白测量结果的Bland-Altman图的图解。上排小图:使用未修正的Crit-Line值(与图1A相同);中排小图:对血液稀释作出修正的Crit-Line Hgb(用Nadler方程获得的血量估计值);下排小图:对血液稀释作出修正的Crit-Line Hgb(用Wennesland和Brown方程分别对男性和女性获得的血量估计值)。
图5是绝对血量与透析前血红蛋白浓度估计值潜在整合到常规血液透析护理中的图解。对于可以如何利用绝对血量的描述,参见具体实施方式部分。
具体实施方式
在血液透析患者中,在透析和/或超滤前常规地抽血以进行实验室(例如,Spectra)检验(包括血红蛋白(Hgb)浓度),即在患者插管后但在患者连接到透析机前抽血。如今,利用使用照相光学技术的装置如Crit-Line监视器(Crit-Line III,FreseniusMedical Care,North America,Waltham MA),可以在血液透析和/或超滤期间获得连续的、非侵入的、实时的血细胞比容测量结果(可以从其获得Hgb浓度)。目前在透析和/或超滤治疗中大约3至5分钟时获得首次读数。这种延迟是有意的,以便确保在首次Crit-Line Hgb测定时,体外循环中没有预充液再循环。这种初始Crit-Line Hgb与透析前实验室Hgb的比较揭示了,在不同透析设备中,Crit-Line Hgb值比实验室结果系统性地平均低约0.5g/dL(参见图1A和1B),其主要归因于由在透析开始时涌入患者体内的预充液(例如,盐水溶液,如0.9重量%NaCl)引起的血液稀释。这种做法在美国的Fresenius血液透析诊所都是普遍性的(图2说明了时间过程)。体外回路中预充液的量取决于血液管道系统和血液透析器的内部容积,并且对于任何给定设置是已知的。血液管道的预充体积约为148mL,而透析器的预充体积取决于透析器型号并且将在约83至98mL的范围内变化。因此,总预充体积将在约231至246mL范围内。该体积在透析和/或超滤治疗开始的约1.5分钟时间内送入患者体内。因此,虽然初始Crit-Line Hgb测定的延迟避免了由再循环的预充液引起的任何明显血液稀释,但是将存在由预充液输注到患者体内引起的系统性血液稀释。
假设正好在治疗开始前,血浆再灌注速率和血浆过滤速率是相等的,导致血量随时间没有净变化。我们进一步假设该血浆再灌注速率在透析开始与Crit-line装置测量血红蛋白的时间之间没有变化。进一步假设完全混合以及在治疗开始与初始Crit-line Hgb测定之间的时间段内微循环与宏观循环之间的流体分布无变化,由血液稀释引起的Hgb浓度的诱导变化是透析开始时的绝对血量、透析前Hgb浓度、输注的预充液的量、输注的预充液在血浆区室(compartment)中的半衰期、治疗开始与初始Crit-Line Hgb测定之间的时间及该时间期间超滤的体积的函数。透析前Hgb浓度、初始Crit-Line测量之前的延迟、该时间期间的超滤体积和输注的预充液的量是已知的,输注的盐水溶液的血管内半衰期已经在文献中报告[1],并且Hgb浓度的变化可以计算为透析前Hgb与初始Crit-Line Hgb之间的差异。这些关系的图示参见图3。这允许根据以下方程式计算患者的透析前绝对血量,只要HgbSpectra不等于HgbCritLine:
BV是透析前血量,V盐水是患者连接到透析机时体外回路中的盐水体积,是输注的盐水溶液在血浆区室中的半衰期,是从透析开始(t0)到初次Crit-Line测量(tcrit)的间隔期间的超滤体积,HgbCritLine是通过Crit-Line监视器测量的初始Hgb浓度,以及HgbSpectra是当前透析前Hgb浓度。该方程产生与用于V盐水相同单位的透析前血量,前提是所有Hgb测量结果使用相同单位,并且tcrit和以相同单位表示。输注的盐水溶液在血浆区室中的半衰期约为半小时[1]。
在另一个实施方式中,选择最小的HgbCritLine作为优选HgbCritLine数据点以计算BV可能是期望的。
在又一个实施方式中,阻止超滤直到已经测量HgbCritLine以通过最大化血液稀释程度而获得更好的信噪比可能是期望的。
注意方程1.1反映了优选实施方式(使用Crit-Line监视器进行透析中Hgb测量,并且使用由Spectra Laboratories报告的透析前Hgb浓度),但是该方程或者方法都不依赖于利用Spectra Laboratories或Crit-Line监视器,因为任何测定Hgb的精确方法都可以用作替代。还注意可以反映血液稀释的任何物质或量(例如,血细胞比容(Hct))可以在本发明中代替Hgb。此外,预充液可以是盐水以外的流体,如5%葡萄糖溶液或者Ringer溶液。进一步注意预充液在约1至1.5分钟时间内冲入患者体内。因此,净外渗甚至略小于由上述方程估算的。而且,这代表了输注的盐水在血液透析患者(其通常是体液超量的)中的血浆半衰期可能一定程度上长于在健康对照中的理由,从而进一步减少了净外渗。最后,注意Fresenius 2008T透析机将包括Crit-Line监视器,并且在该情况下,治疗开始与初始Crit-Line测量之间的延迟不仅是已知的,而且将处于透析机的控制下并被精确管理。透析前和Crit-Line Hgb数据二者都将输入电子数据库中,如图5所示。因此,如图5所示的实施方式是可能的,其中血量估计的过程是完全自动化的,使得不管在什么时候透析前Hgb值在数据库中成为可得的,则该系统对于相应治疗提取初始Crit-Line Hgb和上文提到的所有其他必要参数并立即作出可以在数据库中获得的血量估计,以供医生或技术人员检查。为了减少由各种不同来源(患者生理、测量精密度、操作变化性,等等)导致的变异性,优选的实施方式可以采用Crit-Line Hgb值的移动平均数或顺序平均数(而非个体值)进行血量估计。
此外,使用上述方法使得能够根据以下方程式计算透析开始Crit-Line与透析前实验室参比Hgb浓度之间估计的偏离(estimated offset):
其然后可以用于根据以下方程式对血液稀释修正所测量的Crit-Line Hgb浓度:
假设用于该修正的血量估计值与该治疗开始时患者的实际血量相同,Crit-Line监视器和实验室参比二者准确地和高精度地测量Hgb,方程1.1的基本假设被满足,并且Crit-Line与参比实验室Hgb浓度之间的差异仅仅是血液稀释的影响,那么方程1.3中获得的修正Hgb浓度将与参比实验室Hgb浓度相同。
为了说明对血液稀释修正初始Crit-Line Hgb浓度的效果,图1A中使用的同一数据集扩展为包括透析治疗开始时施用的盐水溶液的量,初始Crit-Line Hgb测定时的透析经过时间,和基于已发表的人体测量方程式的两个独立的透析前血量估计值:1)Nadler方程式[2](用于男性和女性的独立方程式)和2)用于男性的Wennesland方程式[3]和用于女性的Brown方程式[4]。基于这些附加信息,对每位患者计算估计的Crit-Line Hgb偏离并相应地修正Crit-Line Hgb值。结果在图4中描述。为参照目的,上排小图示出了未修正的数据并且与图1A相同。中排小图示出了根据用Nadler方程式获得的BV估计值修正的Crit-LineHgb值的情况,下排小图分别采用Wennesland和Brown方程式。注意到,在对血液稀释的适当Crit-Line Hgb修正的情况下,Bland-Altman图中的偏倚如何变得接近零(Nadler方程式)和变为零(Wennesland和Brown方程式),意味着在这些适当的修正的情况下,修正的Crit-Line Hgb值平均与参比实验室值相同。
在另一个示例中,在2012年3月14日与2014年9月20日之间的952位RenalResearch Institute患者的5731次血液透析治疗中,使用以下参数根据方程式1.2估计ΔHgb:HgbCritLine=如Spectra Laboratories East,NJ,USA测量的每位患者的透析前血液Hgb浓度;HgbCritLine=通过Crit-Line III监视器测定的每位患者的血液Hgb浓度,在第0分钟和Crit-Line记录开始后第2分钟之间取平均;V盐水=250mL;tcrit=5min(假设血液透析开始与Crit-Line记录开始之间典型的4分钟延迟);输注的盐水的血浆半衰期=20min[通过医学判断采自文献(Evidence-based Colloid Use in the Critically Ill:AmericanThoracic Society Consensus Statement”,2004年3月)];=透析开始与tcrit之间每位患者的累计过滤量,从所记录的超滤速率计算;BV=每位患者的估计透析前血量,通过首先使用患者性别、身高和透析前体重通过Nadler方程获得绝对血量估计值[文献:Nadler SB等,“Prediction of blood volume in normal human adults”;Surgery,1962年2月;51(2):224-32],然后基于如通过Crit-Line III监视器测量的相对血量在治疗过程中的变化反算透析开始绝对血量,和然后减去250mL的V盐水而获得。然后根据方程式1.3计算二者之间的差异计算为发现Hgb偏离具有-0.068g/dL的平均值和0.59g/dL的标准差。该结果表明,修正的Crit-Line Hgb浓度与测量的透析前Spectra Hgb浓度平均来看接近相同。
该方法的优选实施方式包括在持续进行的情况下和使用预期血量值的移动测量值(moving measure)(如移动中位值或移动平均值)代替单一血量测定在多个(理想地紧密间隔的)场合估计透析前血量,以便减少与血量的生理学差异无关的估计值的变异性的影响。
更优选的实施方式可以进一步包括表征(例如,通过统计回归)估计的血量与预测变量(例如,体重、血清白蛋白浓度)之间的患者特异性关系,并且采用该关系以将修正应用到期望Crit-Line Hgb修正的各个治疗的基线预期血量。
注意到,在适当互联的IT基础结构中,本发明描述的方法可以是完全自动化的,导致修正的Crit-Line Hgb值不仅可以在数据库中立即获得,而且可以在各个透析治疗期间护理时实时获得,可以例如通过Crit-Line显示器访问。
还注意到,如果期望的话,可以随时间模拟初始盐水输注的效果,以允许Crit-Line监视器在持续进行的情况下提供适当修正的Hgb值直到血液稀释影响逐渐消逝。
绝对血量(ABV)的应用
1)初始ABV的显示:例如,HD仪屏幕、移动设备、临床客户端计算机
2)当前(瞬时)ABV和相对BV(RBV)的显示:例如,HD仪屏幕、移动设备、临床客户端计算机
3)ABV&RBV时程的显示:例如,HD仪屏幕、移动设备、临床客户端计算机
4)与ABV范围相关的(1)至(3):例如,血量正常、血量过多和血量不足
5)应用
a)体液处置
b)透析中并发症的预防
c)贫血处置
d)心血管状态评估
5a)期望的ABV可以定义为在相当的健康受试者(在年龄、性别、种族、体重、身高、身体组成的其他方面相当的)的范围内的ABV。由于正常ABV对于保持充分的重要器官灌注至关重要并且由于ABV介导体液超量对于心血管系统的大多数有害效应,ABV可以用于告知对于血液透析后目标和体液去除的决策。
5b)透析中并发症经常与血管腔室的灌注不足相关,即ABV减少到低于特定阈值。ABV的了解可以用于在逐渐接近该关键阈值时警告工作人员和/或用于自动实施对治疗和监测特性(例如,超滤速率、治疗时间、透析液温度、血压测量频率、患者体位、自动流体脉冲、透析液电导率变化)的改变,以避免透析中并发症。
5c)ABV与红细胞(RBC)量和因此与血红蛋白量密切相关。贫血处置的目的是使血红蛋白浓度进入特定目标范围内。然而,血细胞比容和血红蛋白的浓度受到稀释影响。ABV的了解允许计算“标准化的”血红蛋白浓度(和血细胞比容),且因此允许区分血液稀释与真实的血红蛋白缺乏。在另一个应用中,ABV是贫血的数学模型中的重要组成部分(参见2012年9月7日提交的PCT申请PCT/US2012/054264,2013年3月14日公布为WO 2013/036836 A2;以及2013年11月15日提交的美国申请No.14/072,506,代理人案卷号为No.:3806.1042-001)。
5d)ABV是循环系统的关键组成部分。在与其他指标如心率、血压和心输出量结合使用时,ABV的了解允许对心血管功能更加全面的评估。
参考文献(在上文方括号[#]中编号)
1.Evidence-based colloid use in the critically ill:American ThoracicSociety Consensus Statement.American journal of respiratory and critical caremedicine,2004.170(11):p.1247-59.
2.Nadler,S.B.,J.H.Hidalgo和T.Bloch,Prediction of blood volume innormal human adults.Surgery,1962.51(2):p.224-32.
3.Wennesland,R.等,Red cell,plasma and blood volume in healthy menmeasured by radiochromium(Cr51)cell tagging and hematocrit:influence of age,somatotype and habits of physical activity on the variance after regressionof volumes to height and weight combined.The Journal of clinicalinvestigation,1959.38(7):p.1065-77.
4.Brown,E.等,Red cell,plasma,and blood volume in the healthy womenmeasured by radiochromium cell-labeling and hematocrit.The Journal ofclinical investigation,1962.41:p.2182-90.
估计透析前血红蛋白(Hgb前)水平的替代性方法如下。接近治疗终点时,记录如通过Critline监视器描述的相对血量(RBV终点)和血红蛋白浓度(Hgb终点)。可以使用经验式如Nadler方程式估计治疗终点时患者的绝对血量(ABV终点)。记录治疗开始时输注到患者体内的预充液的量(V盐水)。然后,Hgb前估计如下:
Hgb前=Hgb终点*ABV终点/(100*ABV终点/RBV终点-V盐水)
该方程式以与Hgb终点所用单位相同的单位提供Hgb前,前提是ABV终点和V盐水以相同单位提供,并且RBV终点表示为%。例如:
Hgb终点=10g/dL;ABV终点=5L;RBV终点=90%;V盐水=0.25L
Hgb前=10[g/dL]*5.0[L]/(100*5.0[L]/90[%]–0.25[L])=9.42[g/dL]
该替代性方法示例如下。在2012年3月14日与2014年9月20日之间952位RenalResearch Institute患者的5853次血液透析治疗中,根据第27段的方程式使用下列参数估计Hgb前:Hgb终点=在透析结束时通过Crit-Line III监视器测定的每位患者的Hgb浓度(定义为透析治疗的最后5分钟期间的中位值);ABV终点=在透析终点时每位患者的估计绝对血量,使用Nadler方程式基于性别、身体高度和透析后体重估计[参考文献:Nadler SB等,“Prediction of blood volume in normal human adults”;Surgery,1962年2月;51(2):224-32];RBV终点=在透析结束时通过Crit-Line III监视器测量的每位患者的相对血量(表示为%)(定义为透析治疗最后5分钟期间的中位值);和V盐水=250mL。
Hgb前与所测定HgbSpectra之间的差异计算为Hgb偏离=Hgb前-HgbSpectra,并且发现具有0.11g/dL的平均值和0.6g/dL的标准差。
在一个实施方式中,治疗终点定义为透析的最后5分钟,并且Hgb终点和RBV终点作为该区间内的中位值获得。Hgb和RBV预期在该区间中不实质变化。
本文引用的所有专利、已公开申请和参考文献的相关教导都通过引用全文并入。
虽然本发明已经参照其示例实施方式而详细示出和描述,但本领域技术人员将理解可以在其中作出形式上和细节上的各种各样变化而不偏离由随附权利要求涵盖的本发明的范围。
Claims (2)
1.一种用于测定经历血液透析治疗的患者的绝对血量的系统,所述系统包括:
a)用于用已知量的预充液预充透析器的装置;
b)用于在使得所述已知量的预充液开始输注到患者体内的情况下开始所述患者的血液透析治疗的装置,之后所述患者的血液被透析或超滤;
c)用于测定所述患者的相对血量的装置;
d)用于在预定时间测定所述患者的经稀释血红蛋白浓度的装置,所述预定时间选择为使得通过预充液输注到所述患者体内引起全身性血液稀释,同时最小化由再循环的预充液导致的血液稀释;
e)用于比较所述患者的血液稀释后血红蛋白浓度与所述患者的透析前血红蛋白浓度的装置;
f)用于计算所述患者的透析前绝对血量的装置;和,任选地
g)用于基于所述相对血量在所述血液透析治疗期间定期地测定所述患者的绝对血量的装置。
2.一种血液透析机,其包括:
a)用于用已知量的预充液预充透析器的装置;
b)用于在使得所述已知量的预充液开始输注到患者体内的情况下开始所述患者的血液透析和/或超滤治疗的装置,之后所述患者的血液被透析或超滤;
c)用于测定所述患者的相对血量的装置;
d)用于在预定时间测定所述患者的经稀释血红蛋白浓度的装置,所述预定时间选择为使得通过预充液输注到所述患者体内引起全身性血液稀释,同时最小化由再循环的盐水导致的血液稀释;
e)用于比较所述患者的血液稀释后血红蛋白浓度与所述患者的透析前血红蛋白浓度的装置;
f)用于计算所述患者的透析前绝对血量的装置;和,任选地
g)用于基于所述相对血量在所述血液透析治疗期间定期地测定所述患者的绝对血量的装置。
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CA2949692C (en) | 2022-07-19 |
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EP3145393B1 (en) | 2019-11-20 |
AU2015264261A1 (en) | 2016-12-01 |
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CA2949692A1 (en) | 2015-11-26 |
AU2015264261B2 (en) | 2018-07-05 |
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