全干式超声骨强度测量方法研究
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摘要
骨质疏松症是一种常见的退行性疾病。随着我国人口的快速老龄化,骨质疏松和由此引发的骨折成为危害公众健康的一个重要问题。骨强度的定量检测评估是防治骨质疏松症的先决条件和有效手段,双能x射线、定量CT等方法可实现骨密度的精确测量,但仪器昂贵、操作复杂且具有辐射性,难以满足大规模筛查、普查和长期动态跟踪测评的需求。定量超声骨强度检测方法具有测量准确、无辐射、成本低和操作简便的优点,尤其适合基层社区和家庭日常健康检测的需求。针对这种情况,开展了全干式耦合的超声骨强度测量方法的研究,具体内容包括：
1、一种全干式超声骨强度测量方法的建立
基于超声波在骨骼中传播的理论模型和目前广泛应用的定量超声检测骨强度的原理及方法,建立了一种具有自主知识产权的全干式超声骨强度测量方法。该方法研制了柔软而富有弹性的全干式耦合器,对各种不同形状跟骨有较好的适应性,全干式耦合器的使用使测试安全性、操作方便性、使用寿命和跟骨宽度测量精度均有所提高；采用高精度力敏传感器实时检测跟骨夹紧力,保证每次测量夹紧程度的一致性；使用双向导轨、换档装置等实现跟骨的精确定位；利用电子技术实现了超声波信号的激发、接收、信号调理、A/D转换、存储和上传上位机；采用五点三次平滑算法实现超声波信号的有效软件去噪；采用快速傅立叶变换和最小二乘法线性拟合实现宽带超声衰减(BUA)的获取；采用阈值加极值的判别方法提取超声波传播时间特征点,进而获取超声传播速度(SOS)。
2、环境温度对全干式超声骨强度测量结果的影响规律研究,并建立消除温度影响的方法
通过实验详细分析了环境温度对全干式耦合的超声骨强度测量精度的影响规律,认识了全干式超声骨强度测量中消除温度影响的必要性。进而提出一种基于PWM闭环控制产生恒温热风的方法,该方法产生的恒温热风保证了超声传输通道温度的恒定,减小了环境温度对超声骨强度测量精度的影响,该方法的有效性通过实验得到了初步验证。
3、全干式耦合的超声骨强度测量平台的重复性和有效性研究
重复性评估：采用两个直接测量参数(BUA和SOS)的变异系数均方根百分比(CVRMS%)来评价重复性,分别选择了11人和18人进行了短期和长期的重复性实验,SOS,BUA的短期CVRMS%分别为0.30,4.24；中期CVRMSS%分别为0.39,4.33,达到了国外同类设备的水平。有效性评估：与DEXA设备(GE Lunar Prodigy; GE, USA)的30人相关性实验表明,跟骨骨强度指数与腰椎骨密度相关系数r=0.793(p<0.01)；与韩国超声骨强度设备(SONOST-3000)的15人相关性实验表明,自制测量平台所测跟骨骨强度指数与韩国仪器所测骨质指数的相关系数r=0.860(p<0.01),这些结果表明自主研制的全干式超声骨强度测量平台具有较好的有效性。
4、初步建立了适合中国人群的成年人骨强度评价标准
基于分层抽样方法从合肥、深圳、南京抽样采集500名成年人的骨强度测量数据。利用数理统计方法和曲线回归分析初步建立成年人的骨强度评价标准,包括男、女性骨强度随年龄变化的趋势曲线,男、女性平均骨强度峰值,男、女性性骨强度的标准差等信息。并运用Bland-Altman法对初步建立的成年人骨强度评价标准进行了评估,结果表明根据该评价标准作出的评价结果与DEXA的评价结果有较好的一致性。
5、全干式超声骨强度仪的应用研究
应用一：根据日常运动量的大小,将30名青年志愿者分为运动组和不运动组,采用t检验对两组骨强度均值进行分析,结果表明运动组的骨强度峰值显著高于不运动组,说明运动对于提高骨强度峰值有着重要的作用。应用二：采用Bland-Altman法对20人的左、右脚跟骨强度进行一致性分析,结果表明左、右脚跟骨的骨强度值无显著差别,用单只脚跟骨强度可以反映骨质状况。
全干式超声骨强度测量方法具有高精度、低成本、操作简便等特点,在青少年骨骼生长发育评估、中老年人群骨质疏松症预防、骨折风险评估等方面拥有广阔应用前景。
Osteoporosis is a common degenerative disease. The increasing amount of elderly people in our country results in the high possibility of more osteoporosis and bone fractures, which becomes a significant problem in public health. The quantitative assessment of bone strength is the prerequisite and effective method of osteoporosis predicting, for example, DEXA and QCT, which can measure bone density accurately. Howerer, they can not satisfy the demand of the mass screening and long-term dynamic tracking measurement due to their high expense, complex operation and X-ray exposure. The method of quantitative ultrasound bone strength detection is especially suitable for bone status assessment in community and family as it is non-ionizing, inexpensive and simple to use. In view of this situation, the method of dry ultrasonic bone strength measurement was studied, the contents of the study are as follows:
1、Establish the method of dry ultrasonic bone strength measurement
The method of dry ultrasonic bone strength with independent intellectual property rights was established based on the theory model of ultrasonic propagation and the principle of quantitative ultrasonic bone strength assessment. A soft and elastic dry coupler was developed, which can compensate the different shape of feet, improve the security of measurement, convenience of operation, the service life and the measurement precision of heel width. A force sensor with high precision was employed to detect the clamping force of heel, which can ensure the consistency of each positioning. Meanwihle, a bidirectional guide rail and shifting device was used for accurate positioning. The electronic technology was applied to realize the ultrasonic signal excitation, receiving, signal conditioning, A/D conversion, storage and uploading PC. Five point three smoothing algorithm was used for ultrasonic signal denoising. Fast Fourier transform and the method of least square fitting were employed to obtain broadband ultrasound attenuation (BUA). The method of threshold and extereme point discrimination were applied to get the feature point of reveiving ultrasound, and then obtain the ultrasound speed (SOS).
2、The study of the influence of temperature on dry ultrasonic bone strength measuremnt, and establish the method of eliminating the influence of temperature
First, the influence rule of temperature on dry ultrasonic bone strength measuremnt was studied through the experiments. Then, a method of producing warm-air with constant temperature based on PWM loop control was proposed, which can ensure the temperature of ultrasonic transmission channel constant, reduce the influence of temperature on ultrasonic bone strength measurement. Finally, the validity of the method was proved.
3、The study of reproducibility and effectiveness of dry ultrasonic bone strength measurement
The reproducibility was evaluated by the CVRMS%of two parameters (BUA and SOS), which is defined as root-mean square average of coefficient of variation. Eleven people were recruited for short-term measurement, and eighteen for medium-term. The short-term CVRMS%were0.30for SOS and4.24for BUA, and the medium-term CVRMS%were0.39for SOS and4.33for BUA. We found that the platform of our dry ultrasonic bone strength measurement achieved the level of the similar device from abroad. The effectiveness was evaluated by correlation analysis between our platform and DEXA device (GE Lunar Prodigy; GE, USA), ultrasonic bone strength device (SONOST-3000). The Pearson correlation between STI of our system and BMD of DEXA was0.793(p<0.01). The Pearson correlation between STI of our system and QUI of SONOST-3000was0.860(p<0.01). The results of correlation analysis showed that the platform of our dry ultrasonic bone strength measurement was effective for bone assessment.
4、Preliminary build the evaluation standard of bone strength for adult Chinese people
The STIs of500adults were collected from Hefei, Shenzhen and Nanjing based on the method of stratified sampling. Then the methods of mathematical statistics and regression analysis were utilized to build the elementary evaluation standard of bone strength for adult Chinese people, including the curves of men's and women's STI with age, the averages of men's and women's STI, the standard deviations of men's and women's STI. With the method of Bland-Altman, the elementary evaluation standard was estimated; the result showed that it was consistent with the method of DEXA.
5、Application research of the system of dry ultrasonic bone strength assessment
First, t-test was used for analysing the averages of bone strength in both exercise group and non-exercise group, in which the ages of objects ranged from20-30. Then the influence of exercise on peak bone strength was obtained. The results showed that the peak bone strength of exercise group was significantly higher than that of non-exercise group, so that exercise plays an important role in improving peak bone strength. Second, the method of Bland-Altman was used for analysing the consistency of bone strength of left and right heel, in which20people were recruited. The results showed that the bone strength of left and right calcaneus bone were not significantly different. The bone status can be reflected by only one calcaneus bone.
This study has made some meaningful work in the technology of dry ultrasonic bone strength measurement, which is expected to establish a method of bone assessment with high precision, low cost, convenient operation. It has broad applicaion prospects in assessment of adolescents skeletal growth, prevention of osteoporosis in the elderly people, evaluation of fracture risk, and so on.
1、一种全干式超声骨强度测量方法的建立
基于超声波在骨骼中传播的理论模型和目前广泛应用的定量超声检测骨强度的原理及方法,建立了一种具有自主知识产权的全干式超声骨强度测量方法。该方法研制了柔软而富有弹性的全干式耦合器,对各种不同形状跟骨有较好的适应性,全干式耦合器的使用使测试安全性、操作方便性、使用寿命和跟骨宽度测量精度均有所提高；采用高精度力敏传感器实时检测跟骨夹紧力,保证每次测量夹紧程度的一致性；使用双向导轨、换档装置等实现跟骨的精确定位；利用电子技术实现了超声波信号的激发、接收、信号调理、A/D转换、存储和上传上位机；采用五点三次平滑算法实现超声波信号的有效软件去噪；采用快速傅立叶变换和最小二乘法线性拟合实现宽带超声衰减(BUA)的获取；采用阈值加极值的判别方法提取超声波传播时间特征点,进而获取超声传播速度(SOS)。
2、环境温度对全干式超声骨强度测量结果的影响规律研究,并建立消除温度影响的方法
通过实验详细分析了环境温度对全干式耦合的超声骨强度测量精度的影响规律,认识了全干式超声骨强度测量中消除温度影响的必要性。进而提出一种基于PWM闭环控制产生恒温热风的方法,该方法产生的恒温热风保证了超声传输通道温度的恒定,减小了环境温度对超声骨强度测量精度的影响,该方法的有效性通过实验得到了初步验证。
3、全干式耦合的超声骨强度测量平台的重复性和有效性研究
重复性评估：采用两个直接测量参数(BUA和SOS)的变异系数均方根百分比(CVRMS%)来评价重复性,分别选择了11人和18人进行了短期和长期的重复性实验,SOS,BUA的短期CVRMS%分别为0.30,4.24；中期CVRMSS%分别为0.39,4.33,达到了国外同类设备的水平。有效性评估：与DEXA设备(GE Lunar Prodigy; GE, USA)的30人相关性实验表明,跟骨骨强度指数与腰椎骨密度相关系数r=0.793(p<0.01)；与韩国超声骨强度设备(SONOST-3000)的15人相关性实验表明,自制测量平台所测跟骨骨强度指数与韩国仪器所测骨质指数的相关系数r=0.860(p<0.01),这些结果表明自主研制的全干式超声骨强度测量平台具有较好的有效性。
4、初步建立了适合中国人群的成年人骨强度评价标准
基于分层抽样方法从合肥、深圳、南京抽样采集500名成年人的骨强度测量数据。利用数理统计方法和曲线回归分析初步建立成年人的骨强度评价标准,包括男、女性骨强度随年龄变化的趋势曲线,男、女性平均骨强度峰值,男、女性性骨强度的标准差等信息。并运用Bland-Altman法对初步建立的成年人骨强度评价标准进行了评估,结果表明根据该评价标准作出的评价结果与DEXA的评价结果有较好的一致性。
5、全干式超声骨强度仪的应用研究
应用一：根据日常运动量的大小,将30名青年志愿者分为运动组和不运动组,采用t检验对两组骨强度均值进行分析,结果表明运动组的骨强度峰值显著高于不运动组,说明运动对于提高骨强度峰值有着重要的作用。应用二：采用Bland-Altman法对20人的左、右脚跟骨强度进行一致性分析,结果表明左、右脚跟骨的骨强度值无显著差别,用单只脚跟骨强度可以反映骨质状况。
全干式超声骨强度测量方法具有高精度、低成本、操作简便等特点,在青少年骨骼生长发育评估、中老年人群骨质疏松症预防、骨折风险评估等方面拥有广阔应用前景。
Osteoporosis is a common degenerative disease. The increasing amount of elderly people in our country results in the high possibility of more osteoporosis and bone fractures, which becomes a significant problem in public health. The quantitative assessment of bone strength is the prerequisite and effective method of osteoporosis predicting, for example, DEXA and QCT, which can measure bone density accurately. Howerer, they can not satisfy the demand of the mass screening and long-term dynamic tracking measurement due to their high expense, complex operation and X-ray exposure. The method of quantitative ultrasound bone strength detection is especially suitable for bone status assessment in community and family as it is non-ionizing, inexpensive and simple to use. In view of this situation, the method of dry ultrasonic bone strength measurement was studied, the contents of the study are as follows:
1、Establish the method of dry ultrasonic bone strength measurement
The method of dry ultrasonic bone strength with independent intellectual property rights was established based on the theory model of ultrasonic propagation and the principle of quantitative ultrasonic bone strength assessment. A soft and elastic dry coupler was developed, which can compensate the different shape of feet, improve the security of measurement, convenience of operation, the service life and the measurement precision of heel width. A force sensor with high precision was employed to detect the clamping force of heel, which can ensure the consistency of each positioning. Meanwihle, a bidirectional guide rail and shifting device was used for accurate positioning. The electronic technology was applied to realize the ultrasonic signal excitation, receiving, signal conditioning, A/D conversion, storage and uploading PC. Five point three smoothing algorithm was used for ultrasonic signal denoising. Fast Fourier transform and the method of least square fitting were employed to obtain broadband ultrasound attenuation (BUA). The method of threshold and extereme point discrimination were applied to get the feature point of reveiving ultrasound, and then obtain the ultrasound speed (SOS).
2、The study of the influence of temperature on dry ultrasonic bone strength measuremnt, and establish the method of eliminating the influence of temperature
First, the influence rule of temperature on dry ultrasonic bone strength measuremnt was studied through the experiments. Then, a method of producing warm-air with constant temperature based on PWM loop control was proposed, which can ensure the temperature of ultrasonic transmission channel constant, reduce the influence of temperature on ultrasonic bone strength measurement. Finally, the validity of the method was proved.
3、The study of reproducibility and effectiveness of dry ultrasonic bone strength measurement
The reproducibility was evaluated by the CVRMS%of two parameters (BUA and SOS), which is defined as root-mean square average of coefficient of variation. Eleven people were recruited for short-term measurement, and eighteen for medium-term. The short-term CVRMS%were0.30for SOS and4.24for BUA, and the medium-term CVRMS%were0.39for SOS and4.33for BUA. We found that the platform of our dry ultrasonic bone strength measurement achieved the level of the similar device from abroad. The effectiveness was evaluated by correlation analysis between our platform and DEXA device (GE Lunar Prodigy; GE, USA), ultrasonic bone strength device (SONOST-3000). The Pearson correlation between STI of our system and BMD of DEXA was0.793(p<0.01). The Pearson correlation between STI of our system and QUI of SONOST-3000was0.860(p<0.01). The results of correlation analysis showed that the platform of our dry ultrasonic bone strength measurement was effective for bone assessment.
4、Preliminary build the evaluation standard of bone strength for adult Chinese people
The STIs of500adults were collected from Hefei, Shenzhen and Nanjing based on the method of stratified sampling. Then the methods of mathematical statistics and regression analysis were utilized to build the elementary evaluation standard of bone strength for adult Chinese people, including the curves of men's and women's STI with age, the averages of men's and women's STI, the standard deviations of men's and women's STI. With the method of Bland-Altman, the elementary evaluation standard was estimated; the result showed that it was consistent with the method of DEXA.
5、Application research of the system of dry ultrasonic bone strength assessment
First, t-test was used for analysing the averages of bone strength in both exercise group and non-exercise group, in which the ages of objects ranged from20-30. Then the influence of exercise on peak bone strength was obtained. The results showed that the peak bone strength of exercise group was significantly higher than that of non-exercise group, so that exercise plays an important role in improving peak bone strength. Second, the method of Bland-Altman was used for analysing the consistency of bone strength of left and right heel, in which20people were recruited. The results showed that the bone strength of left and right calcaneus bone were not significantly different. The bone status can be reflected by only one calcaneus bone.
This study has made some meaningful work in the technology of dry ultrasonic bone strength measurement, which is expected to establish a method of bone assessment with high precision, low cost, convenient operation. It has broad applicaion prospects in assessment of adolescents skeletal growth, prevention of osteoporosis in the elderly people, evaluation of fracture risk, and so on.
引文
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