阿仑膦酸钠序贯抗骨吸收药物对原发性骨质疏松症患者骨代谢的影响分析

Effect of Sequential Use of Anti-Resorptive Agents Following Initial Alendronate Sodium Therapy on Bone Metabolism in Patients with Primary Osteoporosis

摘要

目的 探讨阿仑膦酸钠基础治疗后序贯不同抗骨吸收药物（地舒单抗/唑来膦酸）对原发性骨质疏松症（primary osteoporosis，POP）患者骨代谢的影响。方法 前瞻性选取 2019 年 6 月至 2023 年 12 月在民航总医院接受诊治并定期随访的 102 例 POP 患者作为研究对象，按照随机数字表法分为地舒单抗组（予以阿仑膦酸钠序贯地舒单抗治疗，n= 57）和唑来膦酸组（予以阿仑膦酸钠序贯唑来膦酸治疗，n= 45），对比 2 组临床疗效。结果 地舒单抗组患者的日均药物成本低于唑来膦酸组。2 组在治疗 3、6、12、18 个月后的血清钙、Ⅰ型原胶原氨基端前肽（procollagen type I N-terminal propeptide，PINP）、Ⅰ型胶原 C 端 β 特殊序列（β isomer of C-terminal telopeptide of type Ⅰ collagen，β-CTX）、骨钙素（osteocalcin，OC）水平及视觉模拟评分法（visual analogue scale，VAS）评分均显著低于治疗前（ P< 0.05），2 组在治疗 12、18 个月后的腰椎和股骨颈骨密度 T 值均显著高于治疗前、治疗 6 个月后（ P< 0.05）；地舒单抗组在治疗 3、6、12、18 个月后的 PINP、β-CTX、OC 水平显著低于唑来膦酸组（ P< 0.05），地舒单抗组在治疗 3、6 个月后的 VAS 评分显著低于唑来膦酸组（ P< 0.05）；2 组在治疗 6、12、18 个月后的腰椎、股骨颈骨密度 T 值比较差异无统计学意义（ P> 0.05）。地舒单抗组的不良反应总发生率显著低于唑来膦酸组（ P< 0.05）。结论 阿仑膦酸钠基础治疗后序贯地舒单抗或唑来膦酸均可有效改善骨代谢；相较而言，地舒单抗成本更低、疗效更优，且安全性较高。

Abstract

Objective To evaluate the effects of sequential administration of different anti-resorptive agents (denosumab/zoledronic acid) following initial alendronate sodium therapy on bone metabolism in patients with primary osteoporosis (POP). Methods A total of 102 patients with POP who were prospectively enrolled and under regular follow-up at Civil Aviation General Hospital from June 2019 to December 2023 were randomized, using a random number table, into the denosumab group (alendronate sodium followed by denosumab, n= 57) and the zoledronic acid group (alendronate sodium followed by zoledronic acid, n= 45). The clinical efficacy was compared between the two groups. Results The average daily drug costs in the denosumab group were lower than those in the zoledronic acid group. At 3, 6, 12, and 18 months post-treatment, serum levels of calcium, procollagen type I N-terminal propeptide (PINP), β isomer of C-terminal telopeptide of type I collagen (β-CTX), and osteocalcin (OC), as well as the visual analogue scale (VAS) scores were significantly lower than those at baseline in both groups (P< 0.05). At 12 and 18 months of treatment, the lumbar spine and femoral neck bone mineral density (BMD) T-scores in both groups were significantly higher than those at baseline and at 6 months ( P< 0.05). The levels of PINP, β-CTX, and OC in the denosumab group were significantly lower than those in the zoledronic acid group at 3, 6, 12, and 18 months post-treatment ( P< 0.05). The VAS scores in the denosumab group were significantly lower than those in the zoledronic acid group at 3 and 6 months post-treatment ( P< 0.05). There was no statistically significant difference in the BMD T-scores at lumbar spine and femoral neck between the two groups at 6, 12, and 18 months post-treatment ( P> 0.05). The overall incidence of adverse reactions in the denosumab group was significantly lower than that in the zoledronic acid group ( P< 0.05). Conclusion Sequential treatment with denosumab or zoledronic acid following initial alendronate sodium therapy can effectively improve bone metabolism. Compared with zoledronic acid, denosumab was associated with lower medication costs, better therapeutic efficacy, and a more favorable safety profile.

关键词

地舒单抗 / 唑来膦酸 / 阿仑膦酸钠 / 序贯治疗 / 原发性骨质疏松症 / 骨代谢

Key words

denosumab / zoledronic acid / alendronate sodium / sequential treatment / primary osteoporosis / bone metabolism

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