补肾活血药对绝经后骨质疏松妇女血清骨代谢因子的调控作用

The effect of kidney-tonifying and activating-blood herb on the serum bone metabolic factors in postmenopausal women with osteoporosis

目的观察补肾活血中药对绝经后骨质疏松妇女血清骨代谢因子的调控作用。方法选择2012年7月~2013年12月到广州市天河社区卫生院和广州中医药大学第一附属医院骨科门诊就诊的绝经后骨质疏松症患者共110例,所有患者均以钙尔奇D（600mg/日）作为基础药,将试验组（补肾活血中药＋钙尔奇D）55例与对照组（钙尔奇D）55例进行比较研究。临床疗效评估指标包括VAS疼痛评分、不良反应、双能X线骨密度仪检测腰椎和股骨颈骨密度（BMD）、酶联免疫吸附法（ELISA）检测服用补肾活血中药治疗前后血清OPN浓度,电化学发光免疫分析法（ECLIA）检测血清25（OH）D、PINP和β-CTX的浓度。结果 （1）VAS疼痛评分：与治疗前相比,试验组VAS评分明显下降（P〈0.01）;对照组有一定程度降低,但无统计学意义（P〉0.05）。（2）腰椎、左侧股骨颈的BMD：与治疗前相比,试验组腰椎、左侧股骨颈的BMD治疗后显著增加（P〈0.05）,对照组治疗前后比较均无显著性差异。（3）血清OPN、25（OH）D、PINP和β-CTX指标：与治疗前相比,试验组OPN、PINP和β-CTX浓度治疗后明显下降（均为P〈0.05）,25（OH）D浓度治疗后明显升高（P〈0.05）,对照组治疗前后各项指标间比较均无显著性差异。试验过程中,两组间均未见严重不良反应发生。结论补肾活血中药可缓解绝经后骨质疏松症患者疼痛症状,安全有效。它提高腰椎和股骨颈BMD的作用可能是通过降低血清OPN、PINP和β-CTX浓度,提高25（OH）D水平实现的。

Objective To evaluate the effect of a kidney-tonifying and activating-blood herb on the serum bone metabolic factors in women postmenopausal with osteoporosis.Methods A total of 110 postmenopausal women with osteoporosis who were in the outpatient of Community Health Center of the Forward Street of Tianhe district of Guangzhou and the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine from July 2012 to December 2013,were evaluated.All the patients received Caltrate D（600mg/day） as a basic medication.Patients in the experimental group（kidney-tonifying and activating-blood herb ＋Caltrate D,n = 55） and in the control group（Caltrate D,n =55） were compared.The methods to evaluate the clinical efficacy included the VAS pain scale,adverse reaction,BMD of the lumbar spine and the femoral neck measured by DXA,the serum level of OPN measured by enzyme-linked immunosorbent assay（ELISA）,and serum levels of 25（OH） D,PINP,and β-CTX measured by electrochemiluminescence immunoassay（ECLIA）.Results（1） VAS scale：The VAS scale decreased significantly in the experiment group after the treatment compared to that before the treatment（P0.01）.It decreased in the control group with no statistical significance.（2） BMD of the lumbar spine and femoral neck increased significantly in the experiment group after the treatment compared to that before the treatment（P0.01）.No significant difference was found in control group between pretreatment and post-treatment.（3） Serum levels of OPN,25（OH） D,PINP,and β-CTX decreased,but serum 25（OH） D level increased significantly,in the experiment group after the treatment compared to those before the treatment（P〈0.01）.No significant difference was found in control group between pre-treatment and post-treatment.In the process of clinic test,there was no serious adverse reaction in both groups.Conclusion Kidney-tonifying and activating-blood herb relieves pain in post menopausal women with osteoporosis.It is safe and effective.The increase of BMD of the lumbar spine and the femoral neck may be through the decrease of the serum levels of OPN,PINP,and β-CTX,and the increase of serum 25（OH） D.