补肾填精方对绝经后骨质疏松症肾精亏虚证患者的临床疗效及血清能量代谢标志物的影响OA

Objective To evaluate the clinical efficacy of Bushen Tianjing Formula in treating postmenopausal osteoporosis(PMOP)with kidney essence deficiency pattern,and to investigate its effect on serum energy metabolism markers of patients.Methods A randomized,double-blind,placebo-controlled trial was conducted.A total of 130 patients of PMOP with kidney essence deficiency pattern who were admitted to Jiangsu Provincial Hospital of Integrated Traditional and Western Medicine were randomly assigned to an experimental group and a control group using block randomization design,with 65 cases in each group.During the trial,2 participants in the control group withdrew,and 3 in the treatment group discontinued.Consequently,63 and 62 participants in the control and treatment groups,respectively,were included in the final analysis.Both groups received basic Western medicine treatment(alendronate sodium tablets+Caltrate D tablets+calcitriol soft capsules).The experimental group additionally received Bushen Tianjing Formula granule,while the control group received a placebo granules.The treatment lasted for 12 months.Lumbar spine bone mineral density(T-score),visual analogue scale(VAS)score for back pain,36-Item Short Form Health Survey(SF-36)score,bone metabolism markers(PⅠNP and β-CTX),and serum levels of energy metabolism markers(AMPK,PGC-1α,and ATP)were measured at baseline,6 months,and 12 months of treatment.Results Bone mineral density increased in both groups,but the inter-group comparison showed no statistically significant difference(P>0.05).Compared to the control group,the treatment group showed a significantly greater reduction in VAS scores and a greater improvement in SF-36 scores(P<0.01).The experimental group showed significantly higher serum PⅠNP levels than the control group(P<0.01),while no statistically significant difference was found in β-CTX levels between the two groups(P>0.05).Compared to the control group,the experimental group significantly upregulated the serum p-AMPK/AMPK ratio,PGC-1α,and ATP levels(P<0.01).Correlation analysis confirmed that the improvement in these energy metabolism markers was positively correlated with the clinical efficacy indicators.Conclusion Bushen Tianjing Formula can effectively alleviate pain,improve quality of life,and promote bone formation in patients of PMOP with kidney essence deficiency pattern.Its mechanism of action may be related to the activation of the AMPK/PGC-1α signaling pathway and the improvement of the body's energy metabolism status.