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立场声明:韩国双膦酸盐治疗骨质疏松症中的药物假期

Position Statement: Drug Holiday in Osteoporosis Treatment with Bisphosphonates in South Korea.

作者信息

Lee Seung Hun, Gong Hyun Sik, Kim Tae-Hee, Park Si Young, Shin Jung-Ho, Cho Sun Wook, Byun Dong-Won

机构信息

Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.

出版信息

J Bone Metab. 2015 Nov;22(4):167-74. doi: 10.11005/jbm.2015.22.4.167. Epub 2015 Nov 30.

Abstract

Bisphosphonates have been widely used in the treatment of osteoporosis with robust data from many placebo-controlled trials demonstrating its efficacy in fracture risk reduction over 3 to 5 years of treatment. Although bisphosphonates are generally safe and well tolerated, concerns have emerged about the adverse effects related to its long-term use, including osteonecrosis of the jaw and atypical femur fractures. Because bisphosphonates are incorporated into the skeleton and continue to exert an anti-resorptive effect for a period of time after the discontinuation of drugs, the concept of a "drug holiday" has emerged, whereby the risk of adverse effects might be decreased while the patient still benefits from anti-fracture efficacy. As randomized clinical trial evidence is not yet available on who may qualify for a drug holiday, there is considerable controversy regarding the selection of candidates for the drug holiday and monitoring during a drug holiday, both of which should be based on individual assessments of risk and benefit. This statement will provide suggestions for clinicians in South Korea on the identification of possible candidates and monitoring during a bisphosphonate drug holiday.

摘要

双膦酸盐已广泛用于治疗骨质疏松症,许多安慰剂对照试验的有力数据表明,在3至5年的治疗中,其在降低骨折风险方面具有疗效。尽管双膦酸盐总体上安全且耐受性良好,但人们对其长期使用相关的不良反应产生了担忧,包括颌骨坏死和非典型股骨骨折。由于双膦酸盐会融入骨骼,并在停药后一段时间内继续发挥抗吸收作用,因此出现了“药物假期”的概念,即在此期间,不良反应的风险可能会降低,而患者仍能从抗骨折疗效中获益。由于尚无关于谁有资格享受药物假期的随机临床试验证据,因此在药物假期候选人的选择和药物假期期间的监测方面存在相当大的争议,这两者都应基于对风险和益处的个体评估。本声明将为韩国的临床医生提供关于识别双膦酸盐药物假期可能候选人及监测的建议。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5eea/4691590/15d773d7274a/jbm-22-167-g001.jpg

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