补髓丹治疗老年性骨质疏松症肾阳虚证的临床研究OA

Objective:To investigate the clinical efficacy and safety of Busui Dan(补髓丹,BSD)in the treatment of senile osteoporosis(SOP)with kidney-yang deficiency syndrome.Methods:One hundred and ninety eligible SOP patients with syndrome of kidney-yang defi-ciency were enrolled in the study and were randomized into conventional group and BSD group,with 95 cases in each group.All patients in the 2 groups were treated with oral application of calcium carbonate and Vitamin D3 tablets,as well as alendronate sodium tablets;more-over,the ones in BSD group were further treated with oral application of BSD.All patients were treated for consecutive 24 weeks.The tradi-tional Chinese medicine(TCM)syndrome score,bone mineral density(BMD),comprehensive therapeutic efficacy,knee flexor and extensor muscle strength,gait parameters,falls and fractures,as well as adverse events,were recorded and compared between the two groups.Results:①General conditions.During the trial,9 patients in the conventional group withdrew from the trial,among which 4 cases for failing to complete treatment due to personal reasons,1 case for failing to take medication as prescribed,and 4 cases for losing to follow-up;while 6 patients in the BSD group withdrew from the trial,among which 2 cases for failing to complete treatment due to personal reasons,1 case for failing to take medication as prescribed,and 3 cases for losing to follow-up.②TCM syndrome score.The TCM syndrome scores showed a trend of initial decrease followed by a slight increase over time in the 2 groups(F=2 788.379,P=0.000;F=843.742,P=0.000).Ex-cept for pretreatment,the TCM syndrome scores were significantly lower in the BSD group compared to the conventional group at post-treat-ment and 1 year post-treatment(t=-18.992,P=0.000;t=-16.555,P=0.000).③BMD.No significant differences were observed be-tween the 2 groups in lumbar spine and femoral neck BMD before the treatment.The BMD at both sites increased in the 2 groups at 1 year post-treatment compared to pretreatment(lumbar spine BMD:t=-16.253,P=0.000;t=-181.220,P=0.000;femoral neck BMD:t=-10.060,P=0.000;t=-96.045,P=0.000),with higher values observed at both sites in BSD group compared to the conventional group(t=4.622,P=0.000;t=7.564,P=0.000).④Comprehensive therapeutic efficacy.At 1 year post-treatment,the BSD group demon-strated superior comprehensive efficacy compared to the conventional group(BSD grouP=83.95,conventional grouP=107.05,Z=-3.129,P=0.002).⑤Knee flexor and extensor muscle strength.The peak torques of bilateral knee flexors and extensors showed a trend of initial increase followed by a slight decrease over time in the 2 groups(left knee flexor peak torque:F=2 546.155,P=0.000;F=463.112,P=0.000;right knee flexor peak torque:F=1 745.728,P=0.000;F=401.167,P=0.000;left knee extensor peak torque:F=6 784.344,P=0.000;F=1 127.294,P=0.000;right knee extensor peak torque:F=33 937.260,P=0.000;F=448.546,P=0.000).No signifi-cant differences were observed between the 2 groups in the peak torques of bilateral knee flexors and extensors before the treatment.At post-treatment,the peak torque values were all greater in BSD group compared to the conventional group(left knee flexor peak torque:t=7.004,P=0.000;right knee flexor peak torque:t=7.545,P=0.000;left knee extensor peak torque:t=9.830,P=0.000;right knee extensor peak torque:t=5.525,P=0.000),and these differences persisted at 1 year post-treatment(left knee flexor peak torque:t=6.574,P=0.000;right knee flexor peak torque:t=9.717,P=0.000;left knee extensor peak torque:t=6.978,P=0.000;right knee extensor peak torque:t=7.641,P=0.000).⑥Gait parameters.The step length and stride frequency showed a trend of initial increase followed by a slight decrease over time in the 2 groups(step length:F=22 707.271,P=0.000;F=110.801,P=0.000;stride frequency:F=1 301.949,P=0.000;F=103.065,P=0.000).No significant differences were observed between the 2 groups in the step length and stride frequency before the treatment.At post-treatment,both parameters were significantly greater in BSD group compared to the conven-tional group(step length:t=8.029,P=0.000;stride frequency:t=5.265,P=0.000),and these differences persisted at 1 year post-treat-ment(step length:t=3.651,P=0.000;stride frequency:t=3.813,P=0.000).The support phases decreased over time in the 2 groups(F=8 796.480,P=0.000;F=955.811,P=0.000),with the BSD group showing significantly smaller values at post-treatment and 1 year post-treatment(t=-7.581,P=0.000;t=-5.854,P=0.000).⑦Falls and fractures.The incidence of falls and fractures was sig-nificantly lower in the BSD group compared to the conventional group(x2=6.236,P=0.013;x2=4.336,P=0.037).⑧Safety evaluation.No significant abnormalities in routine blood,urine,stool tests,liver and kidney function,or electrocardiogram were observed before or after the treatment in either group.Seven patients in the BSD group and 5 cases in the conventional group experienced gastrointestinal discomfort or dizziness,all of which were relieved after symptomatic management.There was no significant difference in the incidence of adverse events between the 2 groups(x2=0.356,P=0.551).Conclusion:Combination of oral application of BSD with calcium and alendronate sodium in the treatment of SOP with syndrome of kidney-yang deficiency can not only further alleviate kidney-yang deficiency symptoms and improve BMD but also enhance knee flexor and extensor muscle strength and improve gait,thereby reducing the risk of falls and fractures.Its com-prehensive therapeutic efficacy is superior to that of calcium combined with alendronate sodium alone,with a favorable safety profile.