CN104812294B - 用于检测胰岛素耐受、糖尿病和心血管疾病的方法和设备 - Google Patents
用于检测胰岛素耐受、糖尿病和心血管疾病的方法和设备 Download PDFInfo
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Abstract
用于早期检测胰岛素耐受、糖尿病和/或心血管疾病的方法和设备,方法包括以下步骤:获得患者的血氧定量计体积描记器示踪;执行体积描记器示踪的总记录的第一导数的快速傅里叶变换以及计算以米每秒平方计的PTGTP、PTGi和PTGVLFi,其中PTGTP的测量值>370米每秒平方表明患者具有胰岛素耐受、PTGVLFi>33表明患者具有糖尿病和/或PTGi<40表明患者具有心血管疾病。TM‑Oxi系统硬件和软件可被用以实施所述方法。
Description
本发明涉及检测胰岛素耐受、糖尿病和糖尿病的并发症例如心血管疾病的方法和设备。更具体地,本发明涉及动脉光电体积描记术(arterial photo plethysmography)的光谱分析(spectral analysis)以检测胰岛素耐受、糖尿病和糖尿病的并发症例如心血管疾病。更具体地,本发明涉及基于血氧定量计的装置例如TM-Oxi装置检测胰岛素、糖尿病和糖尿病的并发症例如心血管疾病的用途。
2型糖尿病(T2DM)的流行在近几十年来已经提高至流行病的比例。在2000年,世界范围内约1.5亿人具有T2DM,并且预计这个数字到2025年前提高至~3亿1。因为T2DM的慢性过程和与疾病的血管并发症相关的显著的发病率和死亡率,T2DM已经不仅成为严重的公共健康威胁,也成为医疗保健系统的严重经济负担2。在美国,糖尿病护理的每年总花费估计在2007年是$1750亿,并且预计这个数字随着发病率的提高进一步提高2。
多年前,人们已经认识到肥胖症与T2DM相关,并且对于此联系的主要基础是肥胖症产生胰岛素耐受的能力。胰岛素耐受是T2DM病因学的基本方面,并且还与包括高血压、高血脂、动脉粥样硬化(即,代谢综合征或X综合征)和多囊卵巢综合症的一系列广泛的其他病理生理后遗症相关3,4。
对于发展心血管疾病,胰岛素耐受携带比吸烟、或年龄、或总/HDL胆固醇比值更高的危险5,6,7,8。
也有理由考虑除了由肥胖症引起以外,胰岛素耐受和高血脂的相关的可能性,可有助于肥胖症的发展9。
2型糖尿病可未被检测地进展许多年,引起心血管疾病10,11。到患者被诊断具有糖尿病时,达50%的患者具有心血管并发症12。
最近研究表明,早期检测糖尿病心血管并发症可以降低糖尿病死亡率13,14。但是,难以进行心血管疾病的早期检测,因为症状不经常出现在患者中14。
因此,检测胰岛素耐受、糖尿病和心血管并发症在糖尿病治疗管理和早期检测糖尿病并发症中可以是有用的。
胰岛素耐受诊断需要执行金标准正常血糖高胰岛素钳夹(euglycemichyperinsulinemic clamp,HE钳夹),其在常规临床环境(routine clinical setting)中是昂贵的、耗时的和不方便的15。
糖尿病诊断使用血液试验例如空腹血糖(fasting plasma glucose,FPG)和口服葡萄糖耐量实验(oral glucose tolerance test,OGTT)。研究展示,FPG对检测糖尿病具有非常低的灵敏度,并且OGTT是昂贵的和耗时的(检测持续时间从2至5小时)。
心血管疾病诊断使用EKG、应激测试、超声波心动描记术(echocardiography)、胸部X光片、EBCT和其他冠状动脉造影术。没有金标准并且所有这些组系(battery)检测是昂贵的和耗时的。
本发明的一个目的是改进检测胰岛素耐受、糖尿病检测和/或糖尿病的心血管并发症的能力,与标准的方法有利地相当但是不昂贵的或不耗时以执行。
根据本发明,提供了检测胰岛素耐受、糖尿病/或心血管并发症的方法,所述方法包括使用在心率60心跳每分钟(bpm)具有固定在1Hertz(Hz)的频率值的心率作为参考,分析血氧定量计波形(体积描记器(plethysmograph))的快速傅里叶变换(fast Fouriertransformation,FFT)。
使用体积描记器的总记录的第一导数的快速傅里叶变换(FFT)的光谱分析提供了3种频率:高频率(PTGHF)、低频率(PTGLF)和极低频率(PTGVLF)。
3种频率的表面的和是光谱分析的总功率(total power)(PTG TP)。
3种频率的振幅的和是光谱分析的PTG指数(PTGi)。
比率(PTGVLF/PTGi)*100是PTGVLF指数(PTGVLFi)。
根据本发明,提供了用于早期检测胰岛素耐受、糖尿病和/或心血管疾病的检验,该检验包括以下步骤:获得患者的血氧定量计体积描记器示踪;执行体积描记器示踪的总记录的第一导数的快速傅里叶变换以及以m/s2(毫秒平方)计算PTGTP、PTGi和PTGVLFi,其中PTGTP的测量值大于370m/s2表明患者具有胰岛素耐受,PTGVLFi大于33表明患者具有糖尿病和/或PTGi小于40表明患者具有心血管疾病。
本发明还提供了包括血氧定量计的硬件和安装在PC上的软件以实施检验和分析结果。
在一个特定的实施方案中,本发明进一步提供了TM-Oxi系统在检测胰岛素耐受、糖尿病和/或心血管并发症中的用途。
除了血氧定量计以外,TM-Oxi系统还包括由PC的USB口提供动力的血压装置。
本发明进一步提供了血氧定量计在检测胰岛素耐受、糖尿病和心血管并发症中的用途。
因此,本发明提供了低成本、快速执行的测试,其给出的结果与HE钳夹金标准测试和用于检测糖尿病和心血管疾病的标准的方法高度相关。
本发明由如以下在特定的实施例中描述的3个临床实验支持:
使用斯皮尔曼系数(Spearman’s coefficient)的M值和PTG总功率(PTGTP)的相关性是-0.624(P.0.001)。
PTGTP对检测M值<4.5(P.0.0001)具有90%的灵敏度和特异性(临界值#370m/s2)。
PTGi对检测动脉粥样硬化(P.0.0001)具有90.7%的灵敏度和86.6%的特异性(临界值#<40.8)。Roc曲线下面积(AUC)=0.934。
PTGVLFi对检测糖尿病(P.0.0001)具有94%的灵敏度和95%的特异性(临界值#<18)。Roc曲线下面积(AUC)=0.984。
本发明在本文参考附图描述,其中
图1阐明了PTG TP对检测胰岛素耐受M值<4.5的特异性和灵敏度(P.0.0001)。
图2阐明了PTGVLFi对检测糖尿病的特异性和灵敏度(P.0.001)。
图3阐明了PTGi对检测动脉粥样硬化的特异性和灵敏度(P.0.001)。
研究
一般设备
描述的研究的每一个使用TM-Oxi系统,其被用以测量使用血氧定量计波形(体积描记器)的快速傅里叶变换计算的新参数。TM-Oxi系统使用血氧定量计和由PC的USB口提供动力的血压设备。
放置在个体的食指上的血氧定量计具有实时展示光电体积描记术的能力,光电体积描记术表示心搏周期(cardiac cycle)期间动脉血量变化。波形的信号处理分析允许确定心率、心率变异性分析和对动脉顺应性成反比的硬度指数或老化指数。
使用体积描记器的总记录的第一导数的快速傅里叶变换(FFT)的光谱分析提供了3种频率:高频率、低频率和极低频率,3种频率的和是光谱分析的总功率,并且这被命名为体积描记器总功率(PTG TP)。
尽管研究使用TM-Oxi系统,但是来自其他装置的血氧定量计读数可以如本文描述的被推断和被分析,并且因此本发明不限于TM-Oxi装置的使用,而是涉及描述的体积描记器的分析的新颖的和创造性的方法。
研究1使用动脉体积描记术的光谱分析对正常血糖高胰岛素钳夹检查胰岛素耐受检测。这由在UNICAMP University Campinas Brazil的Aglecio L.Souza和其他人实施。
方法:为胰岛素耐受测试候选者的平均年龄32(范围在22-55)岁,且BMI为27.3(范围在19-49)Kg.m2的健康状况良好的30名患者(23名女性)被包括在本研究中,并且经历高胰岛素正常血糖钳夹(HE钳夹)测试和以TM-Oxi系统检查。TM-Oxi系统使用自动血压装置和由软件管理的血氧定量计,但是在本研究中关注于光谱分析中血氧定量计数据的信号处理分析。我们调查了胰岛素耐受(M值,使用(HE钳夹)评估)和光电的体积描记器(PTG)的总记录的光谱分析之间的代表性关联(cross-sectional association)。
进行统计分析以使用Band Altman Plot将M值和PTG总功率(PTG TP)关联。受试者工作特征曲线(receiver-operating characteristic curve)也被构建以确定PTG TP、体重指数(Body Mass Index,BMI)和血糖在检测M值<4.5方面的特异性和灵敏度。
结果:秩相关(rho)的斯皮尔斯曼系数是-0.624(P.0.001)。PTG TP对检测M值<4.5(P.0.0001)具有90%的灵敏度和90%的特异性(临界值#370m/s2)Roc曲线下面积(AUC)=0.95。BMI对检测M值<4.5(P.0.01)具有80%的灵敏度和60%的特异性(临界值#28.8Kgm2)AUC=0.752。血糖对检测M值<4.5(P.0.001)具有60%的灵敏度和95%的特异性(临界值#89.4)AUC=0.810。
结论:相比于其他现有的可得的测试对检测HE钳夹的M值<4.5,PTG TP参数具有最佳AUC(0.95)。因此,由TM-Oxi系统提供的PTG TP表示用于大范围人群的胰岛素耐受的新颖的筛查和随访参数。此参数对于T2DM和心血管疾病是危险的独立因素。这样易使用、非入侵性并且成本有效的工具对于流行的糖尿病疾病和其并发症的控制将是大有益处的。一项新的研究正在进行中以证实100名患者的结果。
研究2着眼于治疗管理中和早期检测糖尿病人群中足部神经病变的新的方法,并且由Mumbai,India的Pratiksha G Gandhi和其他人实施。
背景:新的ADA和ESDA指南显示糖尿病治疗的复杂性,并且也显示了糖尿病并发症的预防。ACCORD研究表明使用A1C<=6.5%的严格控制实际上提高了与低血糖症(hypoglycemia)相关的心血管死亡率的危险。
因此,新推荐的A1C水平升高至7%,并且仅仅基于A1C的算法处理(algorithmtreatment)是被认为有争议的。在此背景下,在糖尿病治疗管理和并发症早期检测中A1C以外(in adjunct of)的新标志将会是有用的。
材料和方法:
本研究包括164名患者。
患者分为6个组:
组1:102名患者(70名男性),平均年龄56岁(范围在26-90),BMI为29,被诊断具有糖尿病并且正在经历治疗(组1)。
组2:它是组1的亚组,包括25名患者(25名男性),平均年龄66岁(范围在56-88),被诊断具有糖尿病,正在经历治疗并且足部具有麻刺感、灼烧感或电击样痛或对触摸极其敏感的迹象和症状。
组3:它是组1的亚组,包括68名患者(42名男性),平均年龄45岁(范围在25-85),被诊断具有糖尿病,正在经历治疗并且不具有足部神经病变的迹象或症状。
组4:它是组1的亚组,包括31名患者(23名男性),平均年龄65岁(范围在47-90),被诊断具有糖尿病,正在经历治疗并且具有自主神经病变(autonomic neuropathy)的迹象或症状例如,肌无力或虚弱或发热或运动不耐或肠、膀胱或消化问题或血压改变,引起头晕或目眩。
组5:它是组1的亚组,包括71名患者(49名男性),平均年龄56岁(范围在26-85),被诊断具有糖尿病,正在经历治疗并且不具有自主神经病变的迹象或症状。
组6:62名患者,平均年龄40岁(范围在22-85),处于良好状况,没有检测出糖尿病,或足部神经病变或自主神经病变的症状或迹象。
对所有组患者以TM-Oxi系统和SudoPath系统,根据Michigan Neuropathy评估和检查进行体格检查、关于已知疾病的问卷调查、目前治疗、病史和症状。TM-Oxi系统提供了用于心血管代谢风险因素(cardiometabolic risk factor)(CMR Score)、自主神经病变风险(autonomic neuropathy risk)(ANR Score)、内皮功能紊乱(endothelialdysfunction)(EndoT Score)的评分卡(scoring card),并且也提供了光谱分析血氧定量计波形的频率(光电体积描记术或PTG频率)。
SudoPath系统使用皮肤电响应技术(galvanic skin response technology)以特定的测量过程评估催汗(sudomotor)功能。SudoPath系统允许检测皮肤微循环紊乱、汗腺密度和响应的延迟。该系统提供了基于这些3个参数的催汗响应评分(SMR Score)用于早期检测外周足部神经病变。
我们:
1.使用PTG极低频率指数(PTG VLFi)、CMR评分和EndoT评分比较组1至组6。
2.使用SMR评分比较组2和组3
3.使用SMR评分比较组2和组6
4.使用ANR评分比较组4和组5
5.使用ANR评分比较组4和组6
使用受试者工作特征(ROC)曲线执行统计分析以确定:1.PTGVLFi和CMR评分作为糖尿病的标志和EndoT评分作为糖尿病患者中微循环并发症的标志在比较糖尿病患者组和健康受试者时的特异性和灵敏度。
2.SMR评分在比较糖尿病患者组时早期检测足部神经病变迹象和症状方面的特异性和灵敏度,以及在比较糖尿病患者组和健康受试者时作为糖尿病患者中微循环并发症的标志的特异性和灵敏度。
3.ANR评分在比较糖尿病患者组时检测自主神经病变迹象和症状方面的特异性和灵敏度,以及在较糖尿病患者组和健康受试者时作为糖尿病患者中自主神经系统并发症的标志。
结果:
比较糖尿病患者组和健康受试者,PTGVLFi对检测糖尿病(P.0.0001)具有96%的灵敏度和93.6%的特异性(临界值#>26)。Roc曲线下面积(AUC)=0.989。
比较糖尿病患者组和健康受试者组,CMR评分对检测糖尿病(P.0.0001)具有91.2%的灵敏度和90%的特异性(临界值#>4)。Roc曲线下面积(AUC)=0.962。
比较糖尿病患者组和健康受试者组,EndoT评分对检测糖尿病(P.0.0001)具有88.2%的灵敏度和88.6%的特异性(临界值#>1)。Roc曲线下面积(AUC)=0.962。
比较具有足部神经病变症状的糖尿病患者组和不具有足部神经病变症状的糖尿病患者组,SMR评分对检测糖尿病患者中足部神经病变症状(P.0.0001)具有91.4%的灵敏度和79.1%的特异性(临界值#≥3)。Roc曲线下面积(AUC)=0.858。
比较具有足部神经病变症状的糖尿病患者组和健康受试者组,SMR评分对检测健康受试者中足部神经病变症状(P.0.0001)具有91.4%的灵敏度和96.8%的特异性(临界值#≥3)。Roc曲线下面积(AUC)=0.982。
比较具有自主神经病变症状的糖尿病患者组和不具有自主神经病变症状的糖尿病患者组,ANR评分对检测糖尿病患者中自主神经病变症状(P.0.0001)具有69.4%的灵敏度和86.3%的特异性(临界值#>7)。Roc曲线下面积(AUC)=0.831。
比较具有足部神经病变症状的糖尿病患者组和健康受试者组,ANR评分对检测健康受试者中自主神经病变(P.0.0001)具有87.2%的灵敏度和95.1%的特异性(临界值#>5)。Roc曲线下面积(AUC)=0.964。
结论:由TM-Oxi系统提供的PTGVLFi和CMR评分对检测糖尿病具有很高的灵敏度和特异性,并且应该被用作糖尿病患者的筛查和治疗管理中新的标志。
比较糖尿病患者和健康受试者,SMR评分、ANR评分和EndoT评分分别对检测诸如足部神经病变症状、自主神经病变症状和内皮功能紊乱的糖尿病并发症具有高度灵敏度和特异性。
比较具有和不具有足部疼痛或自主神经病变症状的糖尿病患者,SMR评分和ANR评分在糖尿病患者中这样的并发症的早期检测中将会是有用的。
总之,一方面这些结果对评估具有危险因素的患者的易感性将会是有用的工具,并且也将保证A1C百分比以外的糖尿病治疗的更好的监测,并且在另一方面评估具有糖尿病并发症的危险因素的患者的易感性,因此降低其长期的发生率。
这些发现必须由使用TM-Oxi和SudoPath系统的大规模研究确认。
研究3涉及动脉粥样硬化筛查中的光电体积描记术的光谱分析,并且由Mumbai,India的心脏病学家Dr Pratiksha G Gandhi实施。
背景:由于疾病提高的流行和危险因素例如糖尿病、肥胖症或吸烟的影响,动脉粥样硬化是心血管死亡的主要原因。心脏性猝死(sudden cardiac death)是50%男性和64%女性中冠状动脉疾病的主要结果。目前,降低危险人群死亡率的仅有的可行的策略是一级预防;目标人群必须接受动脉粥样硬化筛查。筛查亚临床动脉粥样硬化的价值是仍旧相关的,并且其在非入侵技术(无线电频率、测量内膜-中层厚度和流介导的血管舒张)出现下已经成为标准临床实践。在此项研究中,我们介绍了基于由血氧定量计提供的体积描记术的光谱分析的新的非入侵技术。
材料和方法:
本研究包括:63名患者(12名女性),平均年龄62.9岁(范围在40-80),使用CAG报告被诊断具有动脉粥样硬化(组1),和47名受试者(13名女性),平均年龄45.1岁(范围在25-85),被假定是健康的(组2)。
组1分成2个亚组。
亚组1A:未经手术例如冠状动脉旁路移植术(coronary artery bypassgrafting,CABG)或冠状动脉血管成形术(coronary angioplasty)也被称为经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的动脉粥样硬化患者。
亚组1B:经手术(CABG或PCI)的动脉粥样硬化患者。
这些患者和受试者经历以TM-Oxi系统检查。TM-Oxi系统使用血压装置和血氧定量计,并且本研究关注于血氧定量计波形(光电体积描记术或PTG)的信号处理分析和基于此分析(EndoT评分)的评分卡。我们使用PTG光谱分析指数(PTGi)和EndoT评分比较了组1和组2两个组。
我们使用PTG极低频率(PTG VLF)还比较了组1A和组2B两个亚组。
使用受试者工作特征曲线(ROC)执行统计分析以确定:
PTGi和EndoT评分在比较组1和组2时检测动脉粥样硬化方面的灵敏度和特异性。
PTGVLF在比较亚组1A和亚组1B时检测经历手术的动脉粥样硬化患者方面的灵敏度和特异性。
结果:
PTGi对检测动脉粥样硬化(P.0.0001)具有86.1%的灵敏度和87.3%的特异性(临界值#≤40.8)。Roc曲线下面积(AUC)=0.926。
EndoT评分对检测动脉粥样硬化(P.0.0001)具有相似的结果,86.2%的灵敏度和88.2%的特异性(临界值>1)。Roc曲线下面积(AUC)=0.902。
PTGVLF对检测正在经历手术例如CABG或PCI的的动脉粥样硬化患者(P.0.0001)具有82.6%的灵敏度和100%的特异性(临界值#≤69)。Roc曲线下面积(AUC)=0.952。
结论:PTGi参数和EndoT评分对检测动脉粥样硬化具有高度灵敏度和特异性,并且作为内皮功能紊乱的新标志将是有用的。
PTGVLF对检测冠状手术的益处具有良好的灵敏度和惊人的100%的特异性。TM-Oxi参数和评分对评估具有危险因素的患者的易感性是有用的工具,并且保证动脉粥样硬化和手术的更好的监测,因此,降低长期心血管事件的发生。
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Claims (3)
1.一种用于检测胰岛素耐受性、糖尿病和/或心血管并发症的设备,所述设备包括安装在PC上的软件和血氧定量计,其中所述软件能够:
a)使用体积描记器的总记录的第一导数的快速傅里叶变换执行光谱分析,由此产生基于PTG的三个组成频率:PTG高频率(PTGHF)、PTG低频率(PTGLF)和PTG极低频率(PTGVLF);
b)计算PTG总功率(PTGTP)为PTGHF、PTGLF与PTGVLF的和;
c)计算所述光谱分析的PTG指数(PTGi)为PTGHF、PTGLF和PTGVLF的振幅的和;
d)计算所述光谱分析的PTGVLF指数(PTGVLFi)为(PTGVLF/PTGi)*100;以及
e)比较PTGTP、PTGi和PTGVLFi与预定的值,其中,PTGTP大于370m/s2表明患者具有胰岛素耐受,PTGVLFi大于33表明患者具有糖尿病,和/或PTGi小于40表明患者具有心血管疾病。
2.如权利要求1所述的设备,其中所述软件根据(PTGVLF/PTGi)×100计算PTGVLF指数(PTGVLFi),用于评估动脉粥样硬化。
3.如权利要求1或权利要求2所述的设备,其中所述设备在TM-Oxi系统硬件和软件中。
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WO2014199221A2 (en) | 2013-06-14 | 2014-12-18 | Albert Maarek | Method and apparatus to assess early stages of peripheral distal neuropathy in diabetic patients |
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