地诺单抗
Denosumab.
作者信息
Pageau Steven C
机构信息
Department of Anatomy and Cellular Biology, Tufts University School of Medicine, Boston, MA 02111, USA.
出版信息
MAbs. 2009 May-Jun;1(3):210-5. doi: 10.4161/mabs.1.3.8592. Epub 2009 May 29.
Abstract
Denosumab is an anti-receptor activator of nuclear factor (NF)-kappaB (RANK) ligand human monoclonal antibody studied as a treatment for postmenopausal osteoporosis (PMO) and bone destruction due to rheumatoid arthritis (RA) or metastatic cancers. As of February 2009, the candidate was undergoing US Food and Drug Administration review, and might be approved by October 2009. Late phase clinical trials demonstrated that denosumab possesses a similar safety profile to bisphosphonates and that it can be either equally or more effective than bisphosphonates at preventing bone loss due to PMO, RA or cancer treatment and metastases.
摘要
地诺单抗是一种抗核因子（NF）-κB受体激活剂（RANK）配体人单克隆抗体，正在作为绝经后骨质疏松症（PMO）以及类风湿性关节炎（RA）或转移性癌症所致骨破坏的治疗药物进行研究。截至2009年2月，该候选药物正在接受美国食品药品监督管理局的审评，可能于2009年10月获批。晚期临床试验表明，地诺单抗具有与双膦酸盐相似的安全性，并且在预防PMO、RA或癌症治疗及转移所致骨质流失方面，其疗效可能与双膦酸盐相当或更优。
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本文引用的文献
1
Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates.地诺单抗用于接受静脉双膦酸盐治疗后的前列腺癌、乳腺癌或其他肿瘤骨转移患者的随机II期试验。
J Clin Oncol. 2009 Apr 1;27(10):1564-71. doi: 10.1200/JCO.2008.19.2146. Epub 2009 Feb 23.
2
Comparison of effects of the bisphosphonate alendronate versus the RANKL inhibitor denosumab on murine fracture healing.双膦酸盐阿仑膦酸钠与RANKL抑制剂地诺单抗对小鼠骨折愈合影响的比较。
J Bone Miner Res. 2009 Feb;24(2):196-208. doi: 10.1359/jbmr.081113.
3
Denosumab, a fully human monoclonal antibody to RANKL, inhibits bone resorption and increases BMD in knock-in mice that express chimeric (murine/human) RANKL.地诺单抗是一种针对核因子κB受体活化因子配体（RANKL）的全人单克隆抗体，在表达嵌合型（鼠/人）RANKL的基因敲入小鼠中，它可抑制骨吸收并增加骨密度。
J Bone Miner Res. 2009 Feb;24(2):182-95. doi: 10.1359/jbmr.081112.
4
Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial.地诺单抗与阿仑膦酸钠对低骨量绝经后妇女骨密度及骨转换生化标志物影响的比较：一项随机、双盲、3期试验
J Bone Miner Res. 2009 Jan;24(1):153-61. doi: 10.1359/jbmr.0809010.
5
Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial.地诺单抗对长期持续、中断及重新开始治疗的低骨量绝经后女性骨密度和骨转换的影响：一项随机双盲2期临床试验
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Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases.地诺单抗治疗乳腺癌相关骨转移患者疗效与安全性的随机活性对照II期研究
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8
Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD.在一项针对低骨密度绝经后女性的随机2期研究中，使用地诺单抗（AMG 162）进行为期两年的治疗。
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9
A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. 2004.一项针对绝经后女性的单剂量安慰剂对照研究，研究对象为抗核因子κB受体活化因子配体（RANKL）的全人源单克隆抗体AMG 162。2004年。
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10
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