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利塞膦酸钠用于减轻袖状胃切除术后的骨丢失:一项初步随机对照试验的结果。

Risedronate use to attenuate bone loss following sleeve gastrectomy: Results from a pilot randomized controlled trial.

机构信息

Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina, USA.

Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

出版信息

Clin Obes. 2021 Dec;11(6):e12487. doi: 10.1111/cob.12487. Epub 2021 Sep 27.

Abstract

The purpose of this study was to explore the efficacy of 150 mg once monthly oral risedronate use in the prevention of sleeve gastrectomy (SG) associated bone loss. Twenty-four SG patients (56 ± 7 years, 83% female, 21% black) were randomized to risedronate or placebo for 6 months, with an optional 12-month assessment. Outcome measures included 6 (n = 21) and 12 (n = 14) month change in dual energy x-ray absorptiometry-acquired regional areal bone mineral density (aBMD). Six-month treatment effect estimates [mean (95% CI)] revealed significant between group aBMD differences at the femoral neck [risedronate: +0.013 g/cm (-0.021, 0.046) vs. placebo: -0.041 g/cm (-0.067, -0.015)] and lumbar spine [risedronate: +0.028 g/cm (-0.006, 0.063) vs. placebo: -0.029 g/cm (-0.054, -0.004)]; both p ≤ 0.02. When followed postoperatively to 12 months, differential aBMD treatment effects were observed at the total hip [risedronate: -0.035 g/cm (-0.061, -0.009) vs. placebo: -0.072 g/cm (-0.091, -0.052)] and lumbar spine [risedronate: +0.012 g/cm (-0.038, 0.063) vs. placebo: -0.052 g/cm (-0.087, -0.017)]; both p < 0.05. Preliminary treatment effect estimates signal 6 months of risedronate use may be efficacious in reducing aBMD loss at the axial skeleton post-SG, with benefit largely maintained throughout the 1-year postoperative period. Confirmatory data from an adequately powered trial are needed.

摘要

这项研究的目的是探讨每月口服 150 毫克利塞膦酸钠预防袖状胃切除术(SG)相关骨丢失的疗效。24 名 SG 患者(56±7 岁,83%为女性,21%为黑人)随机分为利塞膦酸钠或安慰剂组,治疗 6 个月,可选 12 个月评估。结果测量包括 6(n=21)和 12(n=14)个月时双能 X 线吸收法测量的区域骨矿物质密度(aBMD)的变化。6 个月的治疗效果估计值[平均值(95%CI)]显示,股骨颈[利塞膦酸钠:+0.013 g/cm(-0.021,0.046)比安慰剂:-0.041 g/cm(-0.067,-0.015)]和腰椎[利塞膦酸钠:+0.028 g/cm(-0.006,0.063)比安慰剂:-0.029 g/cm(-0.054,-0.004)]的两组间 aBMD 差异有统计学意义;均为 p≤0.02。术后随访至 12 个月时,全髋关节[利塞膦酸钠:-0.035 g/cm(-0.061,-0.009)比安慰剂:-0.072 g/cm(-0.091,-0.052)]和腰椎[利塞膦酸钠:+0.012 g/cm(-0.038,0.063)比安慰剂:-0.052 g/cm(-0.087,-0.017)]的 aBMD 治疗效果差异有统计学意义;均为 p<0.05。初步的治疗效果估计表明,SG 术后 6 个月使用利塞膦酸钠可能有效减少轴向骨骼的 aBMD 丢失,且在术后 1 年期间获益基本保持。需要来自足够大的试验的确认性数据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f7e1/8563448/2beb62ada5a4/nihms-1745199-f0001.jpg

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