复合振动仪治疗原发骨质疏松症的临床疗效观察
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摘要
研究背景
骨质疏松症(Osteoporosis,OP)是中老年人群和绝经后妇女的常见病,以骨量减少,骨微结构破坏,骨强度下降,骨脆性增加,骨折风险增大为特点。骨质疏松症最主要的风险来自骨质疏松性骨折,其中以髋部骨折危害最大,不仅髋部活动功能损伤明显,而且死亡率高。随着人口老龄化和人均寿命的延长,骨质疏松性骨折发生率全球每年平均以大于1%的速度递增,因此更多有效、简便的非药物的辅助手段以满足不同人群对骨质疏松预防和治疗的需要是目前研究的重点内容之一。降低骨质疏松性骨折发生率是骨质疏松症预防和治疗的核心任务。骨质疏松性骨折发生率取决于骨质量和非暴力跌倒几率。运动是预防和治疗骨质疏松的重要方法之一,研究表明:体育锻炼和增加活动有助于老年患者和绝经后妇女维持骨矿密度,降低骨质疏松症的危险性。人们已经认识到力学因素在骨质疏松症的发生、发展过程中具有重要作用。机械振动是力学作用形式之一。研究表明:振动具有良好的促进骨形成和骨重建效应,振动应力(Vibration Stress,VS)有利于骨的成熟与改建。振动作为一种特殊的力学刺激近年来在骨质疏松防治领域内被广泛研究。众多研究已经证实,高频(≥30Hz)、低强度(＜1g,1g=9.8m/s2)和短时(＜30分钟)的振动可以调节骨代谢,抑制骨吸收和促进骨形成。同时一定的振动刺激还可以增加肌量,预防或改善肌萎缩,增强肌力,改善机体平衡能力。但目前研究大多仍处于实验阶段,而且许多研究所使用的频率及强度并不适合人体长期使用。存在的主要问题是振动强度大多相对较大,人体的不适感较强,一定程度上影响了振动的临床应用。复合振动仪防治骨质疏松相关研究由广东省自然科学基金资助,课题组拥有复合振动和复合振动仪知识产权。复合振动是在全身垂直振动的基础上复合一定平衡干扰振动而成,希翼在保留垂直振动成骨作用的同时,强化肌肉功能和平衡控制能力,通过对骨质量和平衡能力的改善以达到预防和治疗骨质疏松的作用。
目的
研究复合振动仪对原发性骨质疏松症的志愿者骨密度影响,从而评价其治疗骨质疏松症的有效性和安全性。为临床开展和推广使用复合振动仪治疗骨质疏松症提供初步的临床依据。
方法
1志愿者选择
70名志愿者来自广州市寿星大厦大原院养老院。所有志愿者治疗前经过美国Lorland公司XR—46双能X线吸收骨密度测量仪测定骨密度≤峰值骨密度2.5个标准差(T≤2.5SD),符合WHO制定的骨质疏松诊断标准。通过详细询问病史和体格检查及血尿便三大常规、肝肾功能实验室检查,排除继发性和特发性骨质疏松志愿者及其他不适合做符合振动治疗的志愿者。所有志愿者治疗前6个月未接受过抗骨质疏松药物治疗(活性维生素D、降钙素、二膦酸盐雌激素以及雌激素受体调节剂),治疗过程中亦不能服用上述药物,但允许用用其他不能中断的日常用药和治疗措施。
2材料和方法
2.1仪器:由广州市番禺区美亦丰实验设备有限公司提供,该仪器为一种复合振动治疗仪,在垂直振动基础上增加了小幅随机多轴运动装置,复合振动频率范围是0～100Hz,复合振动强度范围是0～10g,多轴偏转变换时间可以自行调节。骨密度测定采用美国Lorland公司XR—46双能X线吸收骨密度测量仪(Dual Energy X-Ray Absorptiometry,DEXA)。
2.2治疗方法:70例骨质疏松志愿者,其中女性54人,男性16人。女性平均71.5岁,平均绝经年龄48.9岁;男性平均年龄72.4岁。所有志愿者被随即分为全身复合震动治疗组(Whole body Compound vibration training group,WBCV)和对照组(Control group,CON),各35例。治疗组给予复合振动强度0.5～0.8g、频率45～55Hz全身复合振动,每周3～4次,每次30分钟,连续6个月的全身复合振动仪治疗;对照组从观察开始到结束,维持原生活规律未作任何治疗。
2.3疗效评估:骨密度测定部位为骨代谢较为活跃的区域(腰椎、髋部)。治疗组和对照组均在治疗开始前和6个月后接受前后腰椎L2-4及髋部Neck、大转部Troch、Wardps三角区骨密度变化情况。
2.4安全性评价:所有志愿者治疗前、6个月后进行常规体格检查及血、尿、便三大常规、肝肾功能实验室检查。
结果
1.腰椎L2—4平均骨密度在6个月后,对照组分别平均降低了4.7%,治疗组分别平均增长了6.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
2.髋部Neck骨密度在6个月后,对照组分别平均降低了4.8%,治疗组分别平均增长了5.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
3.大转部Troch骨密度在6个月后,对照组分别平均降低了4.9%,治疗组分别平均增长了5.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
4.Wards三角区骨密度在6个月后,对照组分别平均降低了5.1%,治疗组分别平均增长了6.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
结论
1.复合振动仪可以改善原发性骨质疏松患者的骨密度。
2.复合振动仪治疗原发性骨质疏松症是安全的。
3.复合振动仪治疗原发性骨质疏松症的远期疗效,特别是能否降低骨质疏松性骨折的危险性尚待研究。
Backgrounds
Osteoporosis(OP)is a common disease in middle-aged and old people and postmenopausal women,characterized by low bone mass and microarchitectural deterioration of bone tissue with a consequent increase in bone fragility and susceptibility to fracture.The major consequence of osteoporosisis osteoporotic fracture.Fracture of hip,which had obviously decreased activity and a high mortality, was thought as the most dangerous consequence in osteoporosis.With ageing and prolonging of life,the rate of osteoporotic fracture increased by 1%each year in the world.To deal with the problem,we had to seek more effective and convenient non-pharmacal ways for osteoporosis prevention and treatment.Bone quality and probability of non-trauma fall were the key factors of oseoporotic fracture.So the most effective way to prevention and treatment of osteoporosis was to improve bone quality or/and balance control.Movement is one of the important ways for the preventionand treatment of OP,according to correlated investigation:with regard to the elderly with OP and the postmenopausal women,physical exercise and activities can help to maintain bone mineral density and reduce the chanciness of OP.People have already recognized that mechanical factors play an important role in the process and development of OP.The mechanical vibration is one of mechanics function forms,some researches indicate that vibration is a favorable promotion to bone formation and bone remodeling,Vibration Stress(VS) is good to bone maturation and improvement.Many researches confirmed that high frequency(≥30Hz),low level (＜1g) and short time(＜30minutes) mechanical vibration could regulate bone metabolism,inhibit bone absorption and promote bone formation.On the other hand, it also could increase muscle mass,and improve muscle force and be helpful in balance control.But the current researches still stayed in laboratory,because most of the vibration level in current researches was too large to accept by people for long time using.Our research was supported by natural science found of Guangdong province.And we had the intellectual property rights of compound vibration and compound vibration machine.The compound vibration was compound by special balance interruption and vertical whole-body-vibration(WBV).We hoped it could enhance the muscle function and balance control based on the bone formation situation of WBV,and gain the improvement of both bone quality and balance control.
Objective
To study therapeutic effects of Compound Vibration Machine on primary osteoporosis volunteers and influences on bone mineral density(BMD).As well as, we made safety evaluation.Thus,this study may provide preliminary and practical evidence for the development of thetreatment on primary osteoporosis.
Methods
1 Volunteer Selection
70 volunteers of osteoporosis were selected from Da-yuan nursing home of Shouxing building in Guangzhou.All volunteers were received examination of BMD by XR-46 Dual Energy X-ray Absorptiometry(U.S.Lorland company,DEXA) and the standard peak BMD were less than or equal to 2.5 SD of standard peak BMD(T≤ 2.5SD),which correspond with International diagnostic criteria for osteoporosis. Through detailed history and physical examination and liver and kidney function, three routine laboratory,eliminate the secondary and idiopathic osteoporosis and other volunteers not suitable for treatment of Compound vibration therapy.All volunteers can neither take osteoporosis medications(active vitamin D,calcitonin, two bisphosphonates estrogen and estrogen receptor modulators) for 6 months before the treament nor take those drugs in the treatment process,but allow use other drugs and treatment measures which can not be interrupted in the daily life.
2 Materials and methods
2.1 Instrument:Provided by Meiyifeng laboratory equipmentcompany in Panyu district,Guangzhou.This instrument is a kind of compound vibration therapeutic machine,which adds random multi-axis motion device based on vertical vibration.It' s frequency range is 0～100Hz,compound vibration intensity range is 0～10g time of multiaxial deflection can adjust manually.Use U.S.Lorland company XR-46 Dual Energy X-Ray Absorptiometry(DEXA) to detect BMD.
2.2 Treatments:70 cases of osteoporosis volunteers consist of 54 female and 16male.The average age of woman is 71.5 and the average age of menopause is 48.9; the average age of men is 72.4.All volunteers were randomly assigned to a whole body Compound vibration training group(WBCV,n-35) or a control group(CON, n-35).The WBCV group intervention consisted of an 6-month whole body compound vibration(30min/day,4～5 times per week).During the 30-minute vibration program, the platform oscillated in an ascending order from 45 to 55 Hz,corresponding to estimated maximum compound accelerations from 0.5g to 0.8g.The Con group did not participate in any training,just keeping the normal life as before.
2.3 Efficacy evaluation:Take the bone metabolism active regions as determination of BMD(lumbar,hip).BMD was measured at the lumbar 2～4 spine, femoral neck,trochanter,Wards triangle region of hip using DXA at baseline and after 6-month intervention.
2.4 Safety evaluation:All volunteers were received physical examination,blood routine examination,urine routine examination,stool routine examination,liver and nephric function examination before and after treatment.
Results
1 The re-measurement of BMD in lumbar 2～4 spine(L2-4) after 6-months later showed that the average BMD was decreased by4.7%in Con group,however,it increased by 6.9%in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(＜0.01).
2 The re-measurement of BMD in femur neck after 6-months later showed that the average BMD was decreased by4.8%in Con group,however,it increased by 5.9% in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(P＜0.01).
3 The re-measurement of BMD in trochanter after 6-months later showed that the average BMD was respectively decreased by 4.9%in Con group,however,it increased by 5.9%in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(P＜0.01).
4 The re-measurement of BMD in wards triangle region after 6-months later showed that the average BMD was decreased by 5.1%in Con group,however,it increased by 6.9%in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(P＜0.01).
Conclusions
1 Compound Vibration Machine can improve the BMD of primary osteoporosis patients.
2 Treatment of Compound Vibration Machine on primary osteoporosis is safe.
3 Long-term outcome therapeutic effect of Compound Vibration Machine on primary osteoporosis,especially the risk of osteoporotic fractures need further study.
骨质疏松症(Osteoporosis,OP)是中老年人群和绝经后妇女的常见病,以骨量减少,骨微结构破坏,骨强度下降,骨脆性增加,骨折风险增大为特点。骨质疏松症最主要的风险来自骨质疏松性骨折,其中以髋部骨折危害最大,不仅髋部活动功能损伤明显,而且死亡率高。随着人口老龄化和人均寿命的延长,骨质疏松性骨折发生率全球每年平均以大于1%的速度递增,因此更多有效、简便的非药物的辅助手段以满足不同人群对骨质疏松预防和治疗的需要是目前研究的重点内容之一。降低骨质疏松性骨折发生率是骨质疏松症预防和治疗的核心任务。骨质疏松性骨折发生率取决于骨质量和非暴力跌倒几率。运动是预防和治疗骨质疏松的重要方法之一,研究表明:体育锻炼和增加活动有助于老年患者和绝经后妇女维持骨矿密度,降低骨质疏松症的危险性。人们已经认识到力学因素在骨质疏松症的发生、发展过程中具有重要作用。机械振动是力学作用形式之一。研究表明:振动具有良好的促进骨形成和骨重建效应,振动应力(Vibration Stress,VS)有利于骨的成熟与改建。振动作为一种特殊的力学刺激近年来在骨质疏松防治领域内被广泛研究。众多研究已经证实,高频(≥30Hz)、低强度(＜1g,1g=9.8m/s2)和短时(＜30分钟)的振动可以调节骨代谢,抑制骨吸收和促进骨形成。同时一定的振动刺激还可以增加肌量,预防或改善肌萎缩,增强肌力,改善机体平衡能力。但目前研究大多仍处于实验阶段,而且许多研究所使用的频率及强度并不适合人体长期使用。存在的主要问题是振动强度大多相对较大,人体的不适感较强,一定程度上影响了振动的临床应用。复合振动仪防治骨质疏松相关研究由广东省自然科学基金资助,课题组拥有复合振动和复合振动仪知识产权。复合振动是在全身垂直振动的基础上复合一定平衡干扰振动而成,希翼在保留垂直振动成骨作用的同时,强化肌肉功能和平衡控制能力,通过对骨质量和平衡能力的改善以达到预防和治疗骨质疏松的作用。
目的
研究复合振动仪对原发性骨质疏松症的志愿者骨密度影响,从而评价其治疗骨质疏松症的有效性和安全性。为临床开展和推广使用复合振动仪治疗骨质疏松症提供初步的临床依据。
方法
1志愿者选择
70名志愿者来自广州市寿星大厦大原院养老院。所有志愿者治疗前经过美国Lorland公司XR—46双能X线吸收骨密度测量仪测定骨密度≤峰值骨密度2.5个标准差(T≤2.5SD),符合WHO制定的骨质疏松诊断标准。通过详细询问病史和体格检查及血尿便三大常规、肝肾功能实验室检查,排除继发性和特发性骨质疏松志愿者及其他不适合做符合振动治疗的志愿者。所有志愿者治疗前6个月未接受过抗骨质疏松药物治疗(活性维生素D、降钙素、二膦酸盐雌激素以及雌激素受体调节剂),治疗过程中亦不能服用上述药物,但允许用用其他不能中断的日常用药和治疗措施。
2材料和方法
2.1仪器:由广州市番禺区美亦丰实验设备有限公司提供,该仪器为一种复合振动治疗仪,在垂直振动基础上增加了小幅随机多轴运动装置,复合振动频率范围是0～100Hz,复合振动强度范围是0～10g,多轴偏转变换时间可以自行调节。骨密度测定采用美国Lorland公司XR—46双能X线吸收骨密度测量仪(Dual Energy X-Ray Absorptiometry,DEXA)。
2.2治疗方法:70例骨质疏松志愿者,其中女性54人,男性16人。女性平均71.5岁,平均绝经年龄48.9岁;男性平均年龄72.4岁。所有志愿者被随即分为全身复合震动治疗组(Whole body Compound vibration training group,WBCV)和对照组(Control group,CON),各35例。治疗组给予复合振动强度0.5～0.8g、频率45～55Hz全身复合振动,每周3～4次,每次30分钟,连续6个月的全身复合振动仪治疗;对照组从观察开始到结束,维持原生活规律未作任何治疗。
2.3疗效评估:骨密度测定部位为骨代谢较为活跃的区域(腰椎、髋部)。治疗组和对照组均在治疗开始前和6个月后接受前后腰椎L2-4及髋部Neck、大转部Troch、Wardps三角区骨密度变化情况。
2.4安全性评价:所有志愿者治疗前、6个月后进行常规体格检查及血、尿、便三大常规、肝肾功能实验室检查。
结果
1.腰椎L2—4平均骨密度在6个月后,对照组分别平均降低了4.7%,治疗组分别平均增长了6.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
2.髋部Neck骨密度在6个月后,对照组分别平均降低了4.8%,治疗组分别平均增长了5.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
3.大转部Troch骨密度在6个月后,对照组分别平均降低了4.9%,治疗组分别平均增长了5.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
4.Wards三角区骨密度在6个月后,对照组分别平均降低了5.1%,治疗组分别平均增长了6.9%;两组各自治疗前后比较有显著性差异(P＜0.01),治疗组和对照组比较亦有显著性差异(P＜0.01)。
结论
1.复合振动仪可以改善原发性骨质疏松患者的骨密度。
2.复合振动仪治疗原发性骨质疏松症是安全的。
3.复合振动仪治疗原发性骨质疏松症的远期疗效,特别是能否降低骨质疏松性骨折的危险性尚待研究。
Backgrounds
Osteoporosis(OP)is a common disease in middle-aged and old people and postmenopausal women,characterized by low bone mass and microarchitectural deterioration of bone tissue with a consequent increase in bone fragility and susceptibility to fracture.The major consequence of osteoporosisis osteoporotic fracture.Fracture of hip,which had obviously decreased activity and a high mortality, was thought as the most dangerous consequence in osteoporosis.With ageing and prolonging of life,the rate of osteoporotic fracture increased by 1%each year in the world.To deal with the problem,we had to seek more effective and convenient non-pharmacal ways for osteoporosis prevention and treatment.Bone quality and probability of non-trauma fall were the key factors of oseoporotic fracture.So the most effective way to prevention and treatment of osteoporosis was to improve bone quality or/and balance control.Movement is one of the important ways for the preventionand treatment of OP,according to correlated investigation:with regard to the elderly with OP and the postmenopausal women,physical exercise and activities can help to maintain bone mineral density and reduce the chanciness of OP.People have already recognized that mechanical factors play an important role in the process and development of OP.The mechanical vibration is one of mechanics function forms,some researches indicate that vibration is a favorable promotion to bone formation and bone remodeling,Vibration Stress(VS) is good to bone maturation and improvement.Many researches confirmed that high frequency(≥30Hz),low level (＜1g) and short time(＜30minutes) mechanical vibration could regulate bone metabolism,inhibit bone absorption and promote bone formation.On the other hand, it also could increase muscle mass,and improve muscle force and be helpful in balance control.But the current researches still stayed in laboratory,because most of the vibration level in current researches was too large to accept by people for long time using.Our research was supported by natural science found of Guangdong province.And we had the intellectual property rights of compound vibration and compound vibration machine.The compound vibration was compound by special balance interruption and vertical whole-body-vibration(WBV).We hoped it could enhance the muscle function and balance control based on the bone formation situation of WBV,and gain the improvement of both bone quality and balance control.
Objective
To study therapeutic effects of Compound Vibration Machine on primary osteoporosis volunteers and influences on bone mineral density(BMD).As well as, we made safety evaluation.Thus,this study may provide preliminary and practical evidence for the development of thetreatment on primary osteoporosis.
Methods
1 Volunteer Selection
70 volunteers of osteoporosis were selected from Da-yuan nursing home of Shouxing building in Guangzhou.All volunteers were received examination of BMD by XR-46 Dual Energy X-ray Absorptiometry(U.S.Lorland company,DEXA) and the standard peak BMD were less than or equal to 2.5 SD of standard peak BMD(T≤ 2.5SD),which correspond with International diagnostic criteria for osteoporosis. Through detailed history and physical examination and liver and kidney function, three routine laboratory,eliminate the secondary and idiopathic osteoporosis and other volunteers not suitable for treatment of Compound vibration therapy.All volunteers can neither take osteoporosis medications(active vitamin D,calcitonin, two bisphosphonates estrogen and estrogen receptor modulators) for 6 months before the treament nor take those drugs in the treatment process,but allow use other drugs and treatment measures which can not be interrupted in the daily life.
2 Materials and methods
2.1 Instrument:Provided by Meiyifeng laboratory equipmentcompany in Panyu district,Guangzhou.This instrument is a kind of compound vibration therapeutic machine,which adds random multi-axis motion device based on vertical vibration.It' s frequency range is 0～100Hz,compound vibration intensity range is 0～10g time of multiaxial deflection can adjust manually.Use U.S.Lorland company XR-46 Dual Energy X-Ray Absorptiometry(DEXA) to detect BMD.
2.2 Treatments:70 cases of osteoporosis volunteers consist of 54 female and 16male.The average age of woman is 71.5 and the average age of menopause is 48.9; the average age of men is 72.4.All volunteers were randomly assigned to a whole body Compound vibration training group(WBCV,n-35) or a control group(CON, n-35).The WBCV group intervention consisted of an 6-month whole body compound vibration(30min/day,4～5 times per week).During the 30-minute vibration program, the platform oscillated in an ascending order from 45 to 55 Hz,corresponding to estimated maximum compound accelerations from 0.5g to 0.8g.The Con group did not participate in any training,just keeping the normal life as before.
2.3 Efficacy evaluation:Take the bone metabolism active regions as determination of BMD(lumbar,hip).BMD was measured at the lumbar 2～4 spine, femoral neck,trochanter,Wards triangle region of hip using DXA at baseline and after 6-month intervention.
2.4 Safety evaluation:All volunteers were received physical examination,blood routine examination,urine routine examination,stool routine examination,liver and nephric function examination before and after treatment.
Results
1 The re-measurement of BMD in lumbar 2～4 spine(L2-4) after 6-months later showed that the average BMD was decreased by4.7%in Con group,however,it increased by 6.9%in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(＜0.01).
2 The re-measurement of BMD in femur neck after 6-months later showed that the average BMD was decreased by4.8%in Con group,however,it increased by 5.9% in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(P＜0.01).
3 The re-measurement of BMD in trochanter after 6-months later showed that the average BMD was respectively decreased by 4.9%in Con group,however,it increased by 5.9%in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(P＜0.01).
4 The re-measurement of BMD in wards triangle region after 6-months later showed that the average BMD was decreased by 5.1%in Con group,however,it increased by 6.9%in WBCV group.Compared with before the treatment and after the treatment in WBCV group,it displayed significant difference(P＜0.01).The re-measurement of BMD between WBCV group and Con group also has statistical difference(P＜0.01).
Conclusions
1 Compound Vibration Machine can improve the BMD of primary osteoporosis patients.
2 Treatment of Compound Vibration Machine on primary osteoporosis is safe.
3 Long-term outcome therapeutic effect of Compound Vibration Machine on primary osteoporosis,especially the risk of osteoporotic fractures need further study.
引文
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