地舒单抗与唑来膦酸治疗老年女性骨质疏松症的疗效比较

Comparative observation of the efficacy of denosumab and zoledronic acid in the treatment of osteoporosis in the elderly women

摘要:

目的 比较地舒单抗与唑来膦酸治疗老年骨质疏松症的临床疗效。重点评估两种药物在提高骨密度、调节血清骨代谢标志物水平、降低骨折再发风险及不良反应发生率方面的差异。方法 选取2022年6月—2024年6月于汉中市中心医院骨关节外科诊治的105例老年骨质疏松症女性患者为研究对象，根据治疗方式不同分为地舒单抗组（45例）与唑来膦酸组（60例）。收集两组患者的一般临床资料。地舒单抗组每6个月皮下注射1次，持续1年；唑来膦酸组每年1次静脉滴注。分别于治疗前、治疗后1年采用双能X射线吸收法（DXA）对骨密度变化情况进行检测。采用酶联免疫吸附试验对患者血清骨代谢标志物［25-羟维生素D（25OHD）、β-胶原降解产物（β-crosslaps）、总Ⅰ型胶原氨基端延长肽、N-端骨钙素］进行检测。统计两组患者不良反应发生情况（背痛、四肢疼痛、肌肉骨骼疼痛、高胆固醇血症、膀胱炎）、骨折再发情况，并计算不良反应发生率与脆性骨折发生率。结果 治疗前，两组患者一般临床资料、骨密度及血清骨代谢标志物水平比较，差异均无统计学意义（P >0.05）。治疗1年后，地舒单抗组骨密度和25OHD水平均高于唑来膦酸组（P <0.05），总Ⅰ型胶原氨基端延长肽、β-crosslaps、N-端骨钙素水平均低于唑来膦酸组（P <0.05）。地舒单抗组不良反应发生率、脆性骨折再发率均低于唑来膦酸组（P <0.05）。结论 在治疗老年骨质疏松症中，地舒单抗相较于唑来膦酸在提高骨密度、调节血清骨代谢标志物水平、降低骨折再发率方面展现出更优异的疗效，且药物相关急性期反应更少。

Abstract:

Objective The aim was to compare the efficacy of denosumab and zoledronic acid in the treatment of osteoporosis in the elderly, with a particular focus on the differences between these two medications in improving bone density, affecting serum bone metabolism markers, reducing the recurrence of fractures, and the incidence of adverse reactions.Methods 105 elderly female patients with osteoporosis admitted to the Department of Orthopaedic Surgery, Hanzhong Central Hospital from June 2022 to June 2024 were selected and divided into the denosumab group (45 cases) and the zoledronic acid group (60 cases) according to different treatment methods. General clinical data of patients in both groups were collected. Patients in the denosumab group received subcutaneous injection once every 6 months for 1 year, while those in the zoledronic acid group received intravenous infusion once a year. Before treatment and 1 year after treatment, bone mineral density changes were detected by Dual energy X-ray absorptiometry (DXA), and serum bone metabolic markers [25-hydroxyvitamin D (25OHD), β-crosslaps, total N-terminal propeptide of type I collagen (PINP), N-terminal osteocalcin (N-MID OC) ] were measured by enzyme-linked immunosorbent assay. The incidence of adverse reactions (back pain, limb pain, musculoskeletal pain, hypercholesterolemia, cystitis) and recurrent fractures in both groups were recorded, and the incidence of adverse reactions and fragility fractures was calculated. Data of the two groups were compared and analyzed.Results Before treatment, there were no significant differences in general clinical data, bone mineral density, or serum bone metabolic markers between the two groups (P > 0.05), indicating comparability. After 1 year of treatment, bone mineral density and 25OHD levels were significantly higher in the denosumab group than in the zoledronic acid group (P < 0.05), while levels of total N-terminal propeptide of type I procollagen, β-crosslaps and N-terminal osteocalcin were significantly lower (P < 0.05).The incidence of adverse reactions and the rate of recurrent fragility fractures in the denosumab group were both lower than those in the zoledronic acid group (P < 0.05).Conclusion In the treatment of osteoporosis in the elderly, denosumab demonstrated superior efficacy over zoledronic acid in improving bone density, enhancing serum bone metabolism markers, reducing the recurrence rate of fractures, and decreasing adverse reactions.