地舒单抗在老年骨质疏松性椎体压缩骨折患者中应用的效果观察

Observation on application effect of denosumab in elderly patients with osteoporotic vertebral compression fracture

中文关键词:  骨质疏松性椎体压缩骨折  老年  地舒单抗  骨密度  骨代谢

英文关键词:Osteoporotic vertebral compression fracture  Elderly  Denosumab injection  Bone mineral density  Bone metabolism

中文摘要:

  【摘要】 目的：观察老年骨质疏松性椎体压缩骨折（osteoporotic vertebral compression fracture，OVCF）患者行经皮椎体成形术（percutaneous vertebroplasty，PVP）后应用地舒单抗治疗的效果。方法：选择2022年10月~2024年1月在我院行PVP治疗的217例老年OVCF患者，男性84例，女性133例，年龄60～80岁。按入院顺序编号，并采用随机数字表法按1∶1∶1比例分成对照组（n=73）、唑来膦酸钠组（n=72）和地舒单抗组（n=72）。对照组术后给予碳酸钙D3片和骨化三醇胶囊治疗（口服，1片或粒/d，治疗12个月）；唑来膦酸钠组在对照组基础上加用唑来膦酸钠治疗（5mg静脉输注，12个月1次）；地舒单抗组在对照组基础上加用地舒单抗治疗（60mg皮下注射，每6个月1次）。比较三组患者治疗前、治疗后6个月和12个月时的疼痛视觉模拟量表（visual analog scale，VAS）评分、骨密度、骨代谢指标血清β胶原降解产物（beta collagen degradation products，β-CTX）和Ⅰ型胶原N端前肽（procollagen type Ⅰ N-terminal propeptide，PⅠNP）水平、腰椎Oswestry功能障碍指数（Oswestry disability index，ODI）以及再骨折发生率。结果：对照组脱失3例，唑来膦酸钠组和地舒单抗组各脱失2例，最终每组纳入70例患者，三组患者的性别比、年龄、骨折部位均无统计学差异（P>0.05）。三组患者治疗前的VAS评分、骨密度、血清β-CTX和PⅠNP、ODI均无显著性差异（P>0.05）；治疗后6个月、12个月三组患者的VAS评分、ODI均较术前显著性改善（P<0.05），地舒单抗组改善情况好于唑来膦酸钠组和对照组（P<0.05）；治疗后6个月、12个月地舒单抗组和唑来膦酸钠组的血清β-CTX、PⅠNP水平均显著性降低（P<0.05），骨密度显著性升高（P<0.05），对照组无显著性变化（P>0.05）；地舒单抗组治疗后血清β-CTX、PⅠNP水平低于同时间点唑来膦酸钠组（P<0.05），骨密度显著性高于同时间点唑来膦酸钠组（P<0.05）。地舒单抗组治疗后12个月骨折再发生率（4.29%）显著性低于对照组（17.14%）（P<0.05），与唑来膦酸钠组无显著性差异（P>0.05）。结论：老年OVCF患者PVP术后应用地舒单抗能够更好地缓解患者疼痛，降低骨代谢指标水平，提高骨密度，减轻患者腰椎功能障碍，降低再骨折发生率。

英文摘要:

  【Abstract】 Objectives: To observe the effect of applying denosumab after percutaneous vertebroplasty(PVP) in the treatment of osteoporotic vertebral compression fracture(OVCF) in elderly patients. Methods: 217 elderly patients(male 84, female 133; aged 60-80 years old) with OVCF who received PVP in the hospital from October 2022 to January 2024 were selected and numbered according to the order of admission, and they were divided into control group(n=73), zoledronic acid sodium group(n=72) and denosumab group(n=72) at a ratio of 1:1:1 by random number table method. The control group was treated with calcium carbonate D3 tablets and calcitriol capsules(oral administration, 1 tablet/capsule every day for 12 months) after surgery, and the zoledronic acid sodium group was added with zoledronic acid sodium injection(5mg, intravenous infusion, once every 12 months) on the basis of the control group, and the denosumab group was treated with denosumab(60mg, subcutaneous injection, once every 6 months) based on the control group. The pain visual analog scale(VAS) score, bone mineral density, bone metabolism indicators such as serum beta collagen degradation products(β-CTX) and procollagen type Ⅰ N-terminal propeplide(PⅠNP), Oswestry disability index(ODI) and fracture recurrence rate were compared between the three groups before treatment and at 6 months and 12 months after treatment. Results: 3 cases were lost in the control group, and 2 cases were lost in both zoledronic acid sodium group and denosumab group. Finally, 70 patients were enrolled in each group. There were no statistical differences in gender ratio, age and fracture site between the three groups(P>0.05). No significant differences were found in VAS score, bone mineral density, serum β-CTX, PⅠNP and ODI between the three groups before treatment(P>0.05). At 6 months and 12 months after treatment, the VAS score and ODI score in the three groups of patients were significantly improved compared with those before surgery(P<0.05), and the improvements in denosumab group were better than those in zoledronic acid sodium group and control group(P<0.05). The levels of serum β-CTX and PⅠNP in denosumab group and zoledronic acid sodium group at 6 months and 12 months after treatment were significantly decreased(P<0.05) while the bone mineral density was significantly increased(P<0.05), and there were no significant changes in control group(P>0.05). After treatment, serum β-CTX and PⅠNP in denosumab group were lower than those in zoledronic acid sodium group(P<0.05), while the bone mineral density was significantly higher than that in zoledronic acid sodium group(P<0.05). The incidence rate of fracture recurrence in denosumab group(4.29%) was significantly lower than that in control group(17.14%) at 12 months after treatment(P<0.05), and there was no significant difference compared to zoledronic acid sodium group(P>0.05). Conclusions: Denosumab injection after PVP in elderly patients with OVCF can relieve pain, reduce the levels of bone metabolism indicators, enhance the bone mineral density, relieve the lumbar dysfunction and reduce the fracture recurrence rate.