密固达在老年骨质疏松治疗中的安全观察

The safety observation of zoledronic acid in the treatment of senile osteoporosis

目的本研究通过与口服阿仑膦酸钠(alendronate sodium)的对比,旨在评价老年人使用唑来膦酸注射液(zoledronic acid)的疗效、应用、安全性、依从性。方法回顾性分析2012年8月至2013年9月,重庆医科大学附属第一医院的116例原发性骨质疏松患者的医疗记录。两组药物组各包含58例,选取绝经后妇女、60岁以上原发性骨质疏松患者且首次使用阿仑膦酸钠/唑来膦酸注射液患者入组。通过对比两组用药前后腰椎和(或)髋部骨密度改变、依从性、不良反应和新发骨折率,比较两种药物的疗效。结果两组入组患者性别、年龄、骨密度相似。唑来膦酸注射液组的骨密度增加量比阿仑膦酸钠组有显著差异,其中腰椎骨密度(P=0.007)、髋部骨密度(P=0.006)。唑来膦酸注射液组有更多的不良反应(n=50);新发骨折数较阿仑膦酸钠组少(n=12)。两组患者中,疼痛为主的主观症状以视觉模拟标度尺(visual analogue scale,VAS)表示,唑来膦酸注射液组中疼痛症状明显缓解(P<0.01)。两组中治疗前后血钙(blood calcium,BC)和碱性磷酸酶(alkaline phosphatase,AP)均无明显差异。结论唑来膦酸注射液治疗老年性骨质疏松更优于阿仑膦酸钠。在提高腰椎及髋部骨密度方面疗效相似。虽然在治疗前3天有更多的不良反应,但减少了新发骨折率,缓解症状更显著。两组药物对血生化的影响均无明显差异。

Objective To assess real-life effectiveness, health care resource utilization, safety, and compliance to the treatment with zoledronic acid in comparison with orally administered alendronate sodium in senile patients with osteoporosis. Methods The medical records of 116 patients with primary osteoporosis, who were treated in the First Affiliated Hospital of Chongqing Medical University from August 2012 to September 2013, were retrospectively analyzed. The study cohort consisted of 58 patients treated with each drug. Eligible patients were postmenopausal females and males over 60 years old with osteoporosis, and first time use of alendronate sodium or zoledronic acid. Outcomes were the changes of the bone mineral density （BMD） of the lumbar vertebrae and the hip, the adherence, the adverse effects, and the occurrence of new fractures in patients. Results Patients in both groups were similar with regards to sex, age, and BMD. The increase of BMD in zoledronic acid group was more significant than that in alendronate sodium group, including BMD of the lumbar vertebrae （ P = 0. 007） and the hip （ P = 0. 006）. Zoledronic acid group had more adverse effects （n = 50）. Meanwhile, the number of patients with new fracture （n = 3） was less than that in alendronate sodium group （n = 12）. The subjective symptoms were measured with visual analogue scale （VAS） and the pain scores. In zoledronic acid group, the pain significantly reduced （P 〈 0. 01 ）. Theblood calcium （BC） and alkaline phosphatase （AP） were in the normal ranges before and after the treatment in both groups. Conclusion Zoledronic acid has advantages over alendronate sodium in treating senile osteoporosis. They can increase BMD of the lumbar vertebrae and the hip the same. While patients in zoledroni＇c acid group have more adverse effects in the first 3 days, it can reduce the occurrence of fresh fracture. It also reduces the subjective symptoms markedly. Both drugs appear to be safe in terms of blood calcium and alkaline phosphatase.