补肾填精方联合施氏十二字养生功治疗骨量减少肝肾不足证的多中心临床研究  

Bushen Tianjing Fang(补肾填精方)combined with Shi’s twelve-character health nourishing exercises for treatment of osteopenia with liver-kidney deficiency syndrome:a multi-center clinical study

作　　者：陈倩 李芳芳 李攀 陈苹华 王诗云 李学飞 李方语 郭苏霞 赵长伟[2] 闵文[3] 路仁杰 刘丹[1] 胡志俊[1] CHEN Qian;LI Fangfang;LI Pan;CHEN Pinghua;WANG Shiyun;LI Xuefei;LI Fangyu;GUO Suxia;ZHAO Changwei;MIN Wen;LU Renjie;LIU Dan;HU Zhijun(Longhua Hospital Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China;The Affiliated Hospital of Changchun University of Chinese Medicine,Changchun 130021,Jilin,China;The First Clinical Medical College of Nanjing University of Chinese Medicine,Nanjing 210023,Jiangsu,China)

机构地区：[1]上海中医药大学附属龙华医院,上海200032 [2]长春中医药大学附属医院,吉林长春130021 [3]南京中医药大学第一临床医学院,江苏南京210023

出　　处：《中医正骨》2025年第3期29-38,共10页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：国家重点研发计划项目(2019YFC1709905);上海市浦东新区卫生系统浦东名中医培养计划项目(PWRzm2020-15);上海中医药大学附属龙华医院课题(医务032)。

摘　　要：目的:观察补肾填精方联合施氏十二字养生功治疗骨量减少肝肾不足证的临床疗效,并初步探讨其作用机制。方法:采用随机、对照、多中心临床试验,纳入600例骨量减少肝肾不足证患者,每组300例。健康宣教组采用健康宣教方式进行干预,联合干预组在健康宣教基础上口服补肾填精方联合施氏十二字养生功锻炼,共干预3个月。评价指标包括腰椎和左髋骨密度T值、血清Ⅰ型前胶原氨基末端肽(typeⅠprocollagen amino-terminal peptide,PⅠNP)含量、血清骨钙素(osteocalcin,OC)含量、血清Ⅰ型胶原交联羧基末端肽β特殊序列(β-isomerized carboxy-terminal telopeptide collagen typeⅠ,β-CTX)含量、血清25-羟维生素D3[25-hydroxyvitamin D3,25(OH)D3]含量、血清甲状旁腺激素(parathyroid hormone,PTH)含量、腰背痛视觉模拟量表(visual analogue scale,VAS)评分、中医证候积分、16条目骨质疏松症患者健康相关生存质量评估(16-item assessment of health-related quality of life in osteoporosis,ECOS-16)问卷评分及综合疗效。结果:①骨密度T值。干预3个月后,联合干预组的腰椎和左髋部骨密度T值均高于健康宣教组(Z=-3.145,P=0.002;Z=-2.048,P=0.041)。联合干预组干预3个月后的腰椎和左髋部骨密度T值均较干预前增高(Z=-10.244,P=0.000;Z=-3.782,P=0.000);健康宣教组干预3个月后的腰椎骨密度T值较干预前降低(Z=-2.451,P=0.014),干预前后左髋部骨密度T值的差异无统计学意义(Z=-0.686,P=0.493)。②骨代谢指标。干预3个月后,2组的血清PⅠNP、25(OH)D3含量比较,组间差异均无统计学意义(Z=-0.494,P=0.622;Z=-0.744,P=0.457);联合干预组的血清OC含量高于健康宣教组(Z=-3.645,P=0.000),血清β-CTX、PTH含量均低于健康宣教组(Z=-6.617,P=0.000;Z=-2.614,P=0.009)。联合干预组干预3个月后的血清PⅠNP、OC、25(OH)D3含量均较干预前增高(Z=-4.800,P=0.000;Z=-10.065,P=0.000;Z=-3.898,P=0.000),血清β-CTX、PTH含量均较干预前�Objective:To observe the clinical outcomes of Bushen Tianjing Fang(补肾填精方,BSTJF)combined with Shi’s twelve-character health nourishing exercises in treatment of osteopenia with liver-kidney deficiency syndrome,and to explore its mechanism of action.Methods:Six hundred osteopenia patients with liver-kidney deficiency syndrome were enrolled in the randomized,controlled,multi-center clinical trial,and were randomized into 2 groups,with 300 ones in each group.All patients in the 2 groups received health education,while the ones in combined intervention group were further treated with oral application of BSTJF and practicing Shi’s twelve-character health nourishing exercises for consecutive 3 months.After that,the bone mineral density(BMD)T-score of lumbar vertebrae and left hip,serum levels of bone metabolism markers including typeⅠprocollagen amino-terminal peptide(PⅠNP),osteocalcin(OC),β-isomerized carboxy-terminal telopeptide collagen typeⅠ(β-CTX),25-hydroxyvitamin D3(25(OH)D3)and parathyroid hormone(PTH),low back pain visual analogue scale(VAS)score,traditional Chinese medicine(TCM)syndrome score,16-item assessment of health-related quality of life in osteoporosis(ECOS-16)questionnaire score and total clinical outcome were measured and evaluated.Results:①The BMD T-score.After 3-month intervention,the BMD T-scores of lumbar vertebrae and left hip were higher in combined intervention group compared to health education group(Z=-3.145,P=0.002;Z=-2.048,P=0.041).The BMD T-scores of lumbar vertebrae and left hip increased after 3-month intervention compared to pre-intervention in combined intervention group(Z=-10.244,P=0.000;Z=-3.782,P=0.000).The BMD T-score of lumbar vertebrae decreased after 3-month intervention compared to pre-intervention in health education group(Z=-2.451,P=0.014),while,that of left hip had no significant difference between pre-intervention and post-intervention(Z=-0.686,P=0.493).②The bone metabolism markers.After 3-month intervention,there was no statistical difference in

关 键 词：骨质疏松 骨量减少 肝肾不足 补肾填精方 施氏十二字养生功 随机对照试验专题 

分 类 号：R259[医药卫生—中西医结合]