评价地诺单抗治疗血液透析患者骨质疏松症的疗效和安全性

B. Al-Helal, E. Abdallah, Reem Asad, M. Kassab, Anas Al Yousef, G. Nessim, A. Radi, M. Mostafa, Y. Elsharkawi, Esam Allam, A. Elmasry, Mohamed Hemida, Mohamed Fathy Mohamed Abdelgelil, Sahar Abdelkareem, M. Kamal, A. Saad, Shaikha Al-Bader, Rania Tharwat, Y. Shaaban, M. Reda, A. Ahmed, Nadeen Abdelhaleem, Zeinab Zeid
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摘要

骨质疏松症在慢性肾脏疾病(CKD)患者中很常见,可导致代谢异常并加速骨质流失。双膦酸盐治疗骨质疏松症是严重肾损害患者的禁忌症。目的:在目前的研究中,我们评估地诺单抗治疗血液透析(HD)患者骨质疏松症的有效性和安全性。患者和方法:回顾性分析74例HD合并骨质疏松患者接受denosumab治疗的情况。所有个体均补充维生素d,每3个月测定一次血清钙、磷酸盐、甲状旁腺激素(PTH)和碱性磷酸酶(ALP)。通过评估骨密度(BMD)和血浆ALP的变化来衡量Denosumab的疗效。结果:denosumab治疗后HD患者脊柱、髋部t评分均值与治疗前比较,差异无统计学意义(P=0.7019, P=0.494)。denosumab治疗后HD患者的平均血清ALP低于治疗前,但差异无统计学意义(P=0.0625)。血浆钙浓度在注射地诺单抗后不久下降,但在14天内恢复。补充维生素D (1.0 - 1.5 μg/天)似乎可以预防低钙血症,并支持denosumab的长期治疗。结论:我们的研究表明,denosumab与慢性肾病合并HD患者脊柱和髋关节骨密度的增加无关,低钙血症是一个值得关注的并发症。
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Assessment the efficacy and safety of denosumab use for treatment of osteoporosis in hemodialysis patients
Introduction: Osteoporosis is common in patients with chronic kidney disease (CKD) that could direct to metabolic abnormalities and accelerate bone loss. The administration of bisphosphonates for the management of osteoporosis is contraindicated in cases with severe kidney impairment. Objectives: In the current investigation, we assess the effectiveness and safety of denosumab administration for the therapy of osteoporosis in hemodialysis (HD) individuals. Patients and Methods: Seventy-four HD cases with osteoporosis who were received denosumab were assessed retrospectively. All individuals received supplemental vitamin D. Serum calcium, phosphate, parathyroid hormone (PTH), and alkaline phosphatase (ALP) had been measured every three months. Denosumab efficacy was measured by assessing the alterations of bone mineral density (BMD) and plasma ALP. Results: The mean values of T-score of the spine and hips in HD patients after treatment with denosumab when compared with before treatment was not statistically significant (P=0.7019 and P=0.494 respectively). There was a low mean serum ALP in the HD patients after treatment with denosumab when compared with before treatment, but not statistically significant (P=0.0625). Plasma calcium concentration decreased shortly after the injection of denosumab however returned within fourteen days. Supplementary vitamin D (1.0 to 1.5 μg/day) looked to prevent hypocalcemia and support long treatment with denosumab. Conclusion: Our study suggests that denosumab is not associated with increases in the BMD of the spine and hip in patients with CKD on HD and hypocalcemia is a concern complication.
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