特立帕肽与骨肉瘤风险的研究进展  

Research Progress of Teriparatide and Osteosarcoma Risk

作　　者：史明敏 严世贵[1] 霍丽 邢伯威 胡雪倩 SHI Mingmin;YAN Shigui;HUO Li;XING Bowei;HU Xueqian(The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 330109,China;Lilly Suzhou Pharmaceutical Co.Ltd.,Shanghai 200041,China)

机构地区：[1]浙江大学医学院附属第二医院,杭州330109 [2]礼来苏州制药有限公司,上海200041

出　　处：《药品评价》2020年第14期1-4,共4页Drug Evaluation

摘　　要：特立帕肽作为促骨形成药物,被批准用于治疗骨质疏松症,2011年在中国上市。因大鼠毒理学研究发现特立帕肽增加骨肉瘤风险,美国食品药品监督管理局(U.S. Food and Drug Administration, FDA)和国家药品监督管理局药品审评中心(Center for Drug Evaluation, CDE)在批准的说明书给予黑框警示。本文将从分子机制、动物研究、临床研究及上市后安全性研究等多维度论证特立帕肽治疗与骨肉瘤风险间的相关性,以期为骨质疏松患者临床用药提供参考,使黑框警告不再成为其治疗的阻碍。Teriparatide,a bone-forming agent,was approved for the treatment of osteoporosis.It was marketed in China in 2011.Given the increased risk to develop osteosarcoma in rat toxicology studies,the black-box warning regarding osteosarcoma was added by U.S.Food and Drug Administration and Center for Drug Evaluation(FDA/CDE)to teriparatide labeling.This article conducts a multi-dimensional analysis of the relevance of teriparatide therapy and osteosarcoma risk from molecular mechanisms,animal studies,clinical trials,and post-marketing safety studies in an attempt to provide a reference for the clinical application for osteoporosis patients,and the black-box warning would be no longer an obstacle to their treatment.

关 键 词：特立帕肽 重组人甲状旁腺激素1-34 骨质疏松症 骨肉瘤 黑框警示 

分 类 号：R917[医药卫生—药物分析学]