Observation of Yiqi Wenyang Huoxue formula combined with denosumab in reducing postoperative re-fracture risk in patients with osteoporotic vertebral compression fracture
YU Jia-sheng,QIN Yong,FENG Dong-qian
Department of Orthopedics and Traumatology Shuyang Traditional Chinese Medicine Hospital, Suqian, Jiangsu223600, China
Abstract:
Objective To investigate the effects of the Yiqi Wenyang Huoxue formula combined with denosumab on the risk of postoperative refracture, bone metabolism, and quality of life in patients with osteoporotic vertebral compression fracture (OVCF). Methods A prospective randomized controlled trial was conducted. Ninety OVCF patients were divided into a western medicine group (denosumab + Chinese medicine placebo), a Chinese medicine group (Yiqi Wenyang Huoxue formula + western medicine placebo), and a combination group (denosumab + Yiqi Wenyang Huoxue formula). All three groups underwent percutaneous vertebroplasty. After one year of treatment, clinical efficacy was assessed. Comparisons were made regarding the Visual Analog Scale (VAS) score, Osteoporosis Quality of Life Scale (OQOLS) score, bone mineral density (BMD), serum levels of osteoprotegerin (OPG), receptor activator for nuclear factor-κB ligand (RANKL), and β-CrossLaps (β-CTX). The incidence of refractures and adverse reactions was recorded. Results At 12 months postoperatively, the clinical efficacy of the combination group was superior to that of the two monotherapy groups (P <0.05). At both 6 and 12 months postoperatively, the combination group showed significantly greater improvement in pain scores, quality of life, BMD, and bone metabolic markers compared to the monotherapy groups (P <0.05). The incidence of refracture within one year after surgery was also lower in the combination group than in the monotherapy groups (P <0.05). Conclusion The Yiqi Wenyang Huoxue formula combined with denosumab can effectively improve bone metabolism, reduce the risk of postoperative refracture, and enhance the quality of life in OVCF patients. The mechanism may be related to the regulation of the OPG/RANKL signaling pathway and the reduction of the bone resorption marker β-CTX.
