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[地诺单抗用于治疗绝经后骨质疏松症]

[Denosumab for treatment of postmenopausal osteoporosis].

作者信息

Syversen Unni, Halse Johan I, Geisler Jürgen, Eriksen Erik Fink

机构信息

Avdeling for endokrinologi, St. Olavs hospital og Institutt for kreftforskning og molekylær medisin, Norges teknisk-naturvitenskapelige universitet, Norway.

出版信息

Tidsskr Nor Laegeforen. 2011 Oct 4;131(19):1893-6. doi: 10.4045/tidsskr.10.1116.

Abstract

BACKGROUND

Treatment with bisphosphonates reduces the risk of new fractures and is the treatment of choice for osteoporosis. Denosumab inhibits bone resorption via a different mechanism than bisphosphonates, and is a new option in the treatment of osteoporosis. In this paper we give an overview of the mode of action and clinical effects.

MATERIAL AND METHODS

The paper is based on a non-systematic literature search in Pubmed/Medline.

RESULTS

Denosumab is a human monoclonal antibody to receptor-activated nuclear factor kappa B (RANKL), a member of the TNF family that is formed in the osteoblast. Binding to RANKL results in reduced recruitment and activity of osteoclasts. Denosumab 60 mg given subcutaneously every six months is shown to inhibit bone resorption to a greater degree than bisphosphonates. In a three-year study of 7,868 women with postmenopausal osteoporosis, a reduction in the relative risk of vertebral, non-vertebral and hip fractures compared to placebo was found (68. 20 and 40 %, correspondingly). In the clinical trials with denosumab, the safety profile was similar to placebo, except for a slightly higher incidence of cellulitis and exanthema. Denosumab has also shown promising skeletal effects in the treatment of cancer and rheumatoid arthritis.

INTERPRETATION

Treatment with denosumab has an effect on postmenopausal osteoporosis and may be an alternative to treatment with bisphosphonates. There are few adverse effects and it is simple to administer.

摘要

背景

双膦酸盐治疗可降低新发骨折风险,是骨质疏松症的首选治疗方法。地诺单抗通过与双膦酸盐不同的机制抑制骨吸收,是骨质疏松症治疗的新选择。本文概述了其作用方式和临床效果。

材料与方法

本文基于在Pubmed/Medline上进行的非系统性文献检索。

结果

地诺单抗是一种针对受体激活核因子κB(RANKL)的人单克隆抗体,RANKL是成骨细胞中形成的TNF家族成员。与RANKL结合可减少破骨细胞的募集和活性。每六个月皮下注射60mg地诺单抗显示出比双膦酸盐更大程度地抑制骨吸收。在一项对7868名绝经后骨质疏松症女性进行的为期三年的研究中,与安慰剂相比,椎体、非椎体和髋部骨折的相对风险降低(分别为68%、20%和40%)。在地诺单抗的临床试验中,除蜂窝织炎和皮疹的发生率略高外,安全性与安慰剂相似。地诺单抗在癌症和类风湿关节炎的治疗中也显示出有前景的骨骼效应。

解读

地诺单抗治疗对绝经后骨质疏松症有效,可能是双膦酸盐治疗的替代方法。不良反应少,给药简便。

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