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双膦酸盐对胃癌术后患者预防骨丢失的影响:一项随机对照试验。

Effect of bisphosphonate on the prevention of bone loss in patients with gastric cancer after gastrectomy: A randomized controlled trial.

机构信息

Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.

Division of Endocrinology and Metabolism, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Republic of Korea.

出版信息

Bone. 2020 Jan;130:115138. doi: 10.1016/j.bone.2019.115138. Epub 2019 Nov 6.

Abstract

BACKGROUND

Bone loss is highly prevalent after gastrectomy in gastric cancer patients. Therefore, the efficacy of medical treatment should be evaluated in patients undergoing gastrectomy.

METHODS

We conducted an unblinded, randomized controlled trial of patients who underwent gastrectomy to treat gastric cancer. The intention-to-treat participants (n = 107) were randomly assigned to receive either alendronate at a weekly dose of 70 mg and daily elemental calcium (500 mg) with cholecalciferol (1000 IU) or daily elemental calcium (500 mg) with cholecalciferol (1000 IU) only. The primary endpoint was defined by the changes in bone mineral density of four measurement sites: the lumbar spine, femur neck, total hip, and trochanter. Changes in bone turnover markers, osteocalcin and collagen I carboxyterminal telopeptide were also observed.

RESULTS

At baseline, there were no differences between the two groups in bone mineral density. In the lumbar spine and trochanter, there were no significant percentage changes compared with the baseline in the alendronate group, but a significant decrease was noted in the control group (p < 0.001 for both lumbar spine and trochanter). In the femur neck and total hip, a larger decrease was observed compared with the baseline in the control group (p < 0.001 for both femur neck and total hip). Significant percentage increases in serum osteocalcin compared with baseline were noted in the control group (p for trend <0.001), but there was no change in the alendronate group (p for trend = 0.713). Collagen I carboxyterminal telopeptide significantly declined in the alendronate group over 12 months (p for trend <0.001).

CONCLUSIONS

Prevention and treatment with bisphosphonate effectively reduces bone loss by suppressing bone resorption in gastric cancer patients undergoing gastrectomy.

摘要

背景

胃癌患者行胃切除术后,骨丢失极为常见。因此,应评估胃切除术后患者的药物治疗效果。

方法

我们对行胃切除术治疗胃癌的患者进行了一项非盲、随机对照试验。意向治疗参与者(n=107)被随机分配接受每周 70mg 阿仑膦酸钠和每日元素钙(500mg)加胆钙化醇(1000IU)或仅每日元素钙(500mg)加胆钙化醇(1000IU)治疗。主要终点定义为四个测量部位(腰椎、股骨颈、全髋和转子间)的骨密度变化。还观察了骨转换标志物骨钙素和 I 型胶原羧基端肽的变化。

结果

基线时,两组间骨密度无差异。与基线相比,阿仑膦酸钠组腰椎和转子间的百分比变化无显著差异,但对照组显著下降(腰椎和转子间均 p<0.001)。与基线相比,对照组股骨颈和全髋的下降幅度更大(股骨颈和全髋均 p<0.001)。对照组血清骨钙素较基线显著升高(趋势 p<0.001),但阿仑膦酸钠组无变化(趋势 p=0.713)。阿仑膦酸钠组在 12 个月时 I 型胶原羧基端肽显著下降(趋势 p<0.001)。

结论

双膦酸盐的预防和治疗通过抑制胃切除术后胃癌患者的骨吸收,有效减少骨丢失。

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