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本文引用的文献

1
Efficacy of Switching From Teriparatide to Bisphosphonate or Denosumab: A Prospective, Randomized, Open-Label Trial.从特立帕肽转换为双膦酸盐或地诺单抗的疗效:一项前瞻性、随机、开放标签试验。
JBMR Plus. 2018 Jun 2;2(5):289-294. doi: 10.1002/jbm4.10054. eCollection 2018 Sep.
2
Denosumab compared to bisphosphonates to treat postmenopausal osteoporosis: a meta-analysis.地诺单抗与双膦酸盐类药物治疗绝经后骨质疏松症的比较:一项荟萃分析。
J Orthop Surg Res. 2018 Aug 2;13(1):194. doi: 10.1186/s13018-018-0865-3.
3
THERAPY OF ENDOCRINE DISEASE: Denosumab vs bisphosphonates for the treatment of postmenopausal osteoporosis.内分泌疾病治疗学:地舒单抗与双磷酸盐类药物治疗绝经后骨质疏松症的比较。
Eur J Endocrinol. 2018 Jul;179(1):R31-R45. doi: 10.1530/EJE-18-0056. Epub 2018 Apr 24.
4
Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update From the American College of Physicians.治疗男性和女性的低骨密度或骨质疏松症以预防骨折:美国医师学院临床实践指南更新。
Ann Intern Med. 2017 Jun 6;166(11):818-839. doi: 10.7326/M15-1361. Epub 2017 May 9.
5
Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates.地诺单抗或唑来膦酸用于曾接受口服双膦酸盐治疗的绝经后骨质疏松症女性。
J Clin Endocrinol Metab. 2016 Aug;101(8):3163-70. doi: 10.1210/jc.2016-1801. Epub 2016 Jun 6.
6
Denosumab versus zoledronic acid in patients previously treated with zoledronic acid.在先前接受唑来膦酸治疗的患者中,地诺单抗与唑来膦酸的对比研究
Osteoporos Int. 2015 Oct;26(10):2521-7. doi: 10.1007/s00198-015-3174-2. Epub 2015 May 20.
7
Clinician's Guide to Prevention and Treatment of Osteoporosis.骨质疏松症防治临床指南
Osteoporos Int. 2014 Oct;25(10):2359-81. doi: 10.1007/s00198-014-2794-2. Epub 2014 Aug 15.
8
Time course of bone mineral density changes with denosumab compared with other drugs in postmenopausal osteoporosis: a dose-response-based meta-analysis.唑来膦酸对比其他药物治疗绝经后骨质疏松症时骨密度的时间变化:基于剂量反应的荟萃分析。
J Clin Endocrinol Metab. 2014 Oct;99(10):3746-55. doi: 10.1210/jc.2013-3795. Epub 2014 Jun 10.
9
The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine.基于股骨颈或腰椎骨密度的美国近期骨质疏松症和低骨量患病率
J Bone Miner Res. 2014 Nov;29(11):2520-6. doi: 10.1002/jbmr.2269.
10
Clinical Trials Express: fracture risk reduction with denosumab in Japanese postmenopausal women and men with osteoporosis: denosumab fracture intervention randomized placebo controlled trial (DIRECT).临床试验快讯:地诺单抗降低日本绝经后骨质疏松症女性和男性骨折风险:地诺单抗骨折干预随机安慰剂对照试验(DIRECT)
J Clin Endocrinol Metab. 2014 Jul;99(7):2599-607. doi: 10.1210/jc.2013-4175. Epub 2014 Mar 19.

比较骨质疏松症患者使用地舒单抗和双膦酸盐类药物的疗效:一项随机对照试验的荟萃分析。

Comparison of Denosumab and Bisphosphonates in Patients With Osteoporosis: A Meta-Analysis of Randomized Controlled Trials.

机构信息

Department of Orthopedics, Chinese PLA General Hospital, Beijing, China.

Department of Medicine, Harvard Medical School, Boston, Massachusetts.

出版信息

J Clin Endocrinol Metab. 2019 May 1;104(5):1753-1765. doi: 10.1210/jc.2018-02236.

DOI:10.1210/jc.2018-02236
PMID:30535289
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6447951/
Abstract

CONTEXT

It is uncertain which osteoporosis therapy is more effective: bisphosphonates or denosumab.

OBJECTIVE

To determine whether denosumab therapy increases bone mineral density (BMD) and reduces fracture risk more so than bisphosphonates in patients with low BMD or osteoporosis.

METHODS

The PubMed, Embase, and the Cochrane Library databases were searched through November 2018 for head-to-head, randomized, controlled trials comparing denosumab and bisphosphonates among adult patients with low BMD or osteoporosis. Random-effects models were used.

RESULTS

We identified 10 eligible trials including 5361 participants. Denosumab increased BMD more than bisphosphonate at 12 months (mean difference, 1.42%; 95% CI, 0.95% to 1.89%; P < 0.001) at lumbar spine, 1.11% (95% CI, 0.91% to 1.30%; P < 0.001) at total hip, and 1.00% (95% CI, 0.78% to 1.22%; P < 0.001) at femoral neck. At 24 months, the respective increase differences were 1.74% (95% CI, 1.05% to 2.43%; P < 0.001), 1.22% (95% CI, 0.66% to 1.77%; P < 0.001), and 1.19% (95% CI, 0.65% to 1.72%; P < 0.001). There was no difference in fracture end point at 12 months, but denosumab had a lower osteoporotic fracture incidence than alendronate at 24 months (risk ratio, 0.51; 95% CI, 0.27 to 0.97).

CONCLUSION

Denosumab improved BMD significantly more than bisphosphonate treatment at the lumbar spine, total hip, and femoral neck at 12 and 24 months. Only one study demonstrated greater osteoporotic fracture reduction with denosumab treatment. Longitudinal studies with longer follow-up and large sample size are needed to confirm the efficacy difference.

摘要

背景

目前尚不确定哪种骨质疏松症治疗方法更有效:双磷酸盐类药物还是地舒单抗。

目的

旨在确定地舒单抗治疗是否比双磷酸盐类药物更能增加低骨密度或骨质疏松症患者的骨密度(BMD)并降低骨折风险。

方法

通过检索 PubMed、Embase 和 Cochrane 图书馆数据库,检索截止日期为 2018 年 11 月,查找比较地舒单抗和双磷酸盐类药物治疗低骨密度或骨质疏松症成年患者的头对头、随机对照试验。采用随机效应模型。

结果

我们共确定了 10 项符合条件的试验,共纳入 5361 名参与者。地舒单抗在 12 个月时比双磷酸盐类药物更能增加 BMD,差异具有统计学意义(腰椎骨:平均差值为 1.42%;95%CI:0.95%至 1.89%;P<0.001;全髋关节:1.11%;95%CI:0.91%至 1.30%;P<0.001;股骨颈:1.00%;95%CI:0.78%至 1.22%;P<0.001)。在 24 个月时,相应的增加差值分别为 1.74%(95%CI:1.05%至 2.43%;P<0.001)、1.22%(95%CI:0.66%至 1.77%;P<0.001)和 1.19%(95%CI:0.65%至 1.72%;P<0.001)。12 个月时两组骨折终点事件无差异,但地舒单抗组 24 个月时骨质疏松性骨折发生率低于阿仑膦酸钠组(风险比为 0.51;95%CI:0.27 至 0.97)。

结论

地舒单抗在 12 个月和 24 个月时在腰椎、全髋关节和股骨颈处的 BMD 改善程度显著优于双磷酸盐类药物治疗。仅有一项研究显示地舒单抗治疗可降低更多的骨质疏松性骨折风险。需要进行更长时间随访和大样本量的纵向研究来证实疗效差异。