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骨代谢指标在抗骨质疏松治疗中的变化研究
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摘要
目的:比较骨代谢指标在抗骨质疏松药物治疗前后的变化、初步计算各指标在预测骨质疏松并发骨折时的灵敏性及特异性;并分析药物治疗前骨代谢指标CTX-I、B-ALP、TRACP-5b、PINP之间的相关性;旨在各代谢指标中筛选出能更早期、更灵敏发现骨质疏松及预测骨折的骨代谢指标,为临床应用提供有力依据。
     对象与方法:1、研究对象:选择珠海市人民医院脊柱骨病科住院部患者(2011年1月-2011年9月)100例,纳入86例合格的病例,参照中国老年学会骨质疏松委员会制定的诊断标准(有或有过脆性骨折、有骨痛、身材短缩、驼背等临床表现及符合X片、CT、MRI有阳性指征的检查),以上患者均排除代谢性骨病、甲状旁腺功能亢进、糖尿病、肾功能不全等疾病。2、研究方法:①入院第二天及用药后一周抽取空腹静脉血两管,一管送我院检验科行常规生化检测血清钙(Ca2+)、磷(P5+)、碱性磷酸酶(ALP);另一管将血标本离心后提取血清保存于-70℃的低温冰箱中,后统一采用酶联免疫吸附法(ELISA)检测骨代谢指标:TRACP-5b,B-ALP,CTX-I,PINP;②第一次抽血后开始肌注密钙息50IU/次、天+口服钙尔奇600片,1片/次、天,连续使用一周;③对药物治疗前后骨代谢指标进行比较,对用药前骨代谢指标之间行相关性分析;④记录症状的变化、药物的不良反应、新骨折发生等不良事件,监测血、尿常规、肝肾功能等药物安全性指标。
     结果:1:用药后骨代谢指标数值下降,P<0.01;骨代谢指标改变率在≥50%及≥25%时,CTX-I指标的变化均大于其他指标,P<0.01;
     2:用药前TRACP-5b,B-ALP,CTX-I,PINP代谢指标之间呈明显正相关,P<0.01,通过多元线性回归分析CTX-I与PINP相关性最为显著;
     3:女性患者骨代谢指标明显高于男性,其中在55~65年龄段数值最高;
     4:骨折患者BMI低于非骨折患者,P<0.05,骨折发生后各骨代谢指标值升高;
     5:脆性骨折诊断试验ROC曲线图:CTX-I的曲线下面积为0.77,比其他指标大。结论: CTX-I在监测药物疗效、预测骨质疏松及骨折等方面有较好的灵敏性及特异性;四个代谢指标中CTX-I与PINP相关性最好;骨折后骨量丢失加快,容易加重骨质疏松,BMI为脆性骨折的保护因素之一,即BMI高者发生骨折机率小;发生骨折后积极抗骨质疏松治疗能改善患者症状、促进骨折愈合进而提高生活质量;骨代谢指标检测简单、经济、方便,值得在临床运用推广。
Objective: To compare the changes of bone metabolism index before and after thetreatment by using anti-osteoporosis drugs and initially calculate the sensitivity andcharacteristics of each index for forecasting osteoporosis and fractures; To analyze therelativity of among bone metabolism index CTX-I, B-ALP, TRACP-5b and PINP beforemedication treatment; The purpose is to screen out the bone metabolism index that cansensitively discover osteoporosis at its early stage and forecast fractures, by which, powerfulsupport will be provided in clinical application.
     Objects and Methods:1、The Objects of Study: Patients, of the clinical impatientdepartment of spinal disease department in Zhuhai People’s Hospital (within the period ofJanuary2011-September2011). A total of100patients were selected. According to thediagnostic criteria set down by Osteoporosis Committee of China Gerontological Society(have or used to have clinical manifestations of fragility fracture, ostalgia, body shorteningand kyphosis etc, and in accord with positive test of X ray, CT and MRI),86eligible patientswere taken for study. All the patients mentioned above don’t have metabolic bone diseases,hyperparathyroidism, diabetes or renal insufficiency, etc.2、The Methods of Study:①Register two tubes of fasting venous blood were drawn in the morning the next day and oneweek later after medication. One tube of the blood was sent to the clinical laboratory of ourhospital for a regular biochemical test of blood calcium (Ca2+), phosphorus (P5+) and alkalinephosphatase (ALP); For the other tube, blood serum was extracted and stored in a-70low-temperature refrigerator after the blood sample was centrifuged. Then Enzyme LinkedImmunosorbent Assay (ELISA) was adopted to test bone metabolism index: TRACP-5b,B-ALP, CTX-I and PINP;②After the first blood draw and on that same day, intramuscularinjection of50IU miacalcic each time daily was given, and one tablet of Caltrate600wasorally taken daily. These medication went on consecutively for a week;③Compare bonemetabolism indexes before and after medication treatment, analyze the relativity ofmetabolism indexes before medication;④Record the changes of symptoms, adverse drug reaction, the occurrence of new fractures and adverse events etc, and safety index of drugs fortesting blood, routine urine, and hepatic and renal function.
     Results1: After medication, bone metabolism index fell, P<0.01; When the change rateof bone metabolism index equals to or is bigger than50%and25%, The change of CTX-Iindex are larger than other indexes, P<0.01;
     2:Before medication, metabolism indexes of TRACP-5b, B-ALP, CTX-I and PINP hadevident and positive correlation, P<0.01,through multiple linear regression analysis, thecorrelation between CTX-I and PINP is more evident;
     3:Bone metabolism index of women patients was evidently higher than that of men patients,and highest in the age group of55-65;
     4:BMI of patients with fractures was lower than that of patients without fractures, P<0.05,when fractures happened, each bone metabolism index went up;
     5:ROC graph for diagnosis and experiment of fragility fracture: area under curve of CTX-Iwas0.77, bigger than that of other indexes.
     Conclusion: CTX-I has better sensitivity and characteristics in the aspects of monitoringdrug effect and forecasting osteoporosis and fractures etc. Among the four metabolismindexes, the correlation between CTX-I and PINP was best; After fracture, Loss of bone massaccelerated, and thus increased osteoporosis, BMI is one of the protective factors of fragilityfractures, which means the higher BMI is, the lower the fracture rate will be; After fracture,positive anti-osteoporosis treatment can be effective in treating symptoms of patients andimproving the fracture to heal, by which, the quality of life is also enhanced; The test of bonemetabolism is easy, economic and convenient, it is worthy of promotion in clinical application.
引文
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