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比较地舒单抗与双磷酸盐类药物在肾移植患者中的临床疗效和安全性。

Comparison of the clinical effectiveness and safety between the use of denosumab vs bisphosphonates in renal transplant patients.

机构信息

McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.

出版信息

Osteoporos Int. 2020 May;31(5):973-980. doi: 10.1007/s00198-019-05267-1. Epub 2020 Jan 3.

Abstract

UNLABELLED

A retrospective chart review was conducted on 85 renal transplant patients aged 19-88 years, treated with denosumab or bisphosphonate therapy. Bone densitometry measures were compared between treatment groups at baseline; at years 1, 2, and 3; and at final follow-up (average of 3.4 years). Both bisphosphonate and denosumab treatments increased lumbar spine bone density; however, the effect of denosumab was greater compared with that of bisphosphonate treatment. Denosumab treatment increased femoral neck BMD, whereas bisphosphonate treatment had a mean decrease in femoral neck BMD at final follow-up. Thus, our study provides evidence for the efficacy of denosumab treatment in renal transplant patients. Caution around hypocalcemia is warranted. We recommend more prospective studies to analyze the effects of long-term antiresorptive therapy in patients with a renal transplant.

INTRODUCTION

To compare the clinical effectiveness and safety between the use of denosumab and bisphosphonates on bone density and incidence of adverse events in renal transplant patients.

METHODS

A retrospective chart review was conducted on 85 renal transplant patients aged 19-88 years, treated with denosumab or bisphosphonate therapy. Bone densitometry measures were compared between treatment groups at baseline; years 1, 2, and 3; and at final follow-up (average of 3.4 years).

RESULTS

Absolute change in lumbar spine and femoral neck BMD over the treatment period was 0.029 ± 0.075 g/cm and - 0.003 ± 0.064 g/cm, respectively, in the bisphosphonate group. Absolute change in lumbar spine and femoral neck BMD at final follow-up was 0.072 ± 0.094 g/cm and 0.025 ± 0.063 g/cm, respectively, in the denosumab group. Denosumab resulted in significantly greater increases in lumbar spine BMD (0.045 g/cm greater in the denosumab group). Similarly, the absolute change in BMD at the femoral neck was 0.022 g/cm greater in the denosumab group as compared with the bisphosphonate group. The denosumab group had one event of severe hypocalcemia following first injection and one report of hospitalized pneumonia. No serious adverse events were reported in the bisphosphonate group.

CONCLUSIONS

Both treatments increased lumbar spine BMD; however, the effect of denosumab was greater compared with that of bisphosphonate treatment. Our study provides evidence for the efficacy of denosumab treatment in renal transplant patients. Caution around hypocalcemia is warranted. We recommend more prospective studies to analyze the effects of long-term antiresorptive therapy in patients with a renal transplant.

摘要

目的

比较使用地舒单抗和双磷酸盐治疗在肾移植患者中的骨密度和不良事件发生率的临床效果和安全性。

方法

对 85 名年龄在 19-88 岁的接受地舒单抗或双磷酸盐治疗的肾移植患者进行回顾性图表审查。比较治疗组在基线时、第 1 年、第 2 年和第 3 年以及最终随访(平均 3.4 年)时的骨密度测量值。

结果

在双磷酸盐组中,腰椎和股骨颈 BMD 的治疗期间绝对变化分别为 0.029±0.075g/cm 和-0.003±0.064g/cm。在地舒单抗组中,腰椎和股骨颈 BMD 的最终随访时的绝对变化分别为 0.072±0.094g/cm 和 0.025±0.063g/cm。地舒单抗可显著增加腰椎 BMD(地舒单抗组增加 0.045g/cm)。同样,地舒单抗组股骨颈的 BMD 绝对变化比双磷酸盐组增加 0.022g/cm。地舒单抗组在首次注射后发生 1 例严重低钙血症事件和 1 例住院肺炎报告。双磷酸盐组未报告严重不良事件。

结论

两种治疗方法均增加了腰椎 BMD;然而,地舒单抗的效果大于双磷酸盐治疗。我们的研究为地舒单抗治疗肾移植患者的疗效提供了证据。需要警惕低钙血症。我们建议进行更多的前瞻性研究,以分析肾移植患者长期抗吸收治疗的效果。

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