中医正骨2025，Vol.37Issue(3)：29-38,10.
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
摘要
Abstract
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 ac-tion.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 type Ⅰ procollagen amino-terminal peptide(P Ⅰ NP),osteocalcin(OC),β-isomerized carboxy-terminal telopeptide collagen type Ⅰ(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 the serum levels of P Ⅰ NP and 25(OH)D3 between the 2 groups(Z=-0.494,P=0.622;Z=-0.744,P=0.457);while,the serum level of OC was higher,that of β-CTX and PTH were lower in combined intervention group compared to health education group(Z=-3.645,P=0.000;Z=-6.617,P=0.000;Z=-2.614,P=0.009).The serum levels of P Ⅰ NP,OC and 25(OH)D3 increased,while that of β-CTX and PTH decreased after 3-month intervention compared to pre-intervention in combined intervention group(Z=-4.800,P=0.000;Z=-10.065,P=0.000;Z=-3.898,P=0.000;Z=-7.167,P=0.000;Z=-3.707,P=0.000).The serum levels of OC,β-CTX and 25(OH)D3 increased after 3-month intervention compared to pre-intervention in health education group(Z=-3.724,P=0.000;Z=-2.716,P=0.007;Z=-2.405,P=0.016),while,that of P Ⅰ NP and PTH had no significant difference between pre-intervention and post-intervention(Z=-1.421,P=0.155;Z=-1.159,P=0.247).③The low back pain VAS score.The low back pain VAS score presented a gradual down-ward trend over time in the 2 groups(F=750.707,P=0.000;F=499.655,P=0.000).The low back pain VAS score was lower in com-bined intervention group compared to health education group after 1-,2-and 3-month intervention,and at 6 months after the end of interven-tion(t=43.508,P=0.000;t=88.074,P=0.000;t=99.590,P=0.000;t=74.462,P=0.000).④The TCM syndrome score.The TCM syndrome score presented a gradual downward trend over time in the 2 groups(F=11 680.902,P=0.000;F=2 279.014,P=0.000).The TCM syndrome score was lower in combined intervention group compared to health education group after 1-,2-and 3-month interven-tion,and at 6 months after the end of intervention(t=133.453,P=0.000;t=661.673,P=0.000;t=1 440.622,P=0.000;t=2 019.873,P=0.000).⑤The ECOS-16 questionnaire score.The ECOS-16 questionnaire score presented a gradual downward trend over time in the 2 groups(F=1 798.683,P=0.000;F=1 900.262,P=0.000).The ECOS-16 questionnaire score was lower in combined in-tervention group compared to health education group after 1-,2-and 3-month intervention,and at 6 months after the end of intervention(t=34.331,P=0.000;t=166.937,P=0.000;t=409.169,P=0.000;t=565.344,P=0.000).⑥The total outcome.The total clinical out-come was better in combined intervention group compared to health education group after 3-month intervention and at 6 months after the end of intervention((R)combinedinterventi ongroup=234.90,(R)health educationgroup=366.10,Z=-10.552,P=0.000;(R)combinedinterventiongroup=231.28,(R)health education group=369.72,Z=-11.192,P=0.000).Conclusion:Combination of health education with oral application of BSTJF and Shi's twelve-character health nourishing exercises can delay the osteopenia,improve the clinical symptoms,and enhance the quality of life in treatment of osteopenia with liver-kidney deficiency syndrome,and its clinical efficacy is better than that of health education alone.It may work by regulating the bone metabolism.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Key words
osteoporosis/osteopenia/deficiency of liver and kidney/Bushen Tianjing Fang/Shi's twelve-character health nourishing exerci-ses/randomized controlled trials as topic引用本文复制引用
陈倩,闵文,路仁杰,刘丹,胡志俊,李芳芳,李攀,陈苹华,王诗云,李学飞,李方语,郭苏霞,赵长伟..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[J].中医正骨,2025,37(3):29-38,10.基金项目
国家重点研发计划项目(2019YFC1709905) （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) （PWRzm2020-15）
上海中医药大学附属龙华医院课题(医务032) （医务032）
