双膦酸盐与狄诺塞麦治疗PMOP的“药物假期”EMAS立场声明要点解读  

Bisphosphonates and denosumab treatment of PMOP the key points of the EMAS position statement on“drug holiday”

作　　者：孔西建 KONG Xijan(Diagnosis and Treatment Center of Osteoporosis,Luoyang Orthopedic Hospital of Henan Province（Orthopedic Hospital of Henan Province）,Luoyang 471002,China)

机构地区：[1]河南省洛阳正骨医院(河南省骨科医院)骨质疏松诊疗中心,河南洛阳471002

出　　处：《中国骨质疏松杂志》2018年第8期1000-1007,共8页Chinese Journal of Osteoporosis

基　　金：国家中医药管理局国家中医临床研究基地业务建设科研专项(JDZX2015037)

摘　　要：目的为了使骨质疏松领域相关医生能够进一步了解和掌握双膦酸盐与狄诺塞麦的药物假期规律,提高临床治疗水平,本文就欧洲女性与男性更年期协会(EMAS)对双膦酸盐与狄诺塞麦治疗绝经后骨质疏松症(postmenopausal osteoporosis,PMOP)"药物假期"的立场声明进行要点解读,供同仁参考。方法 EMAS系统性回顾分析了双膦酸盐和狄诺塞麦中止使用后在骨折风险方面的影响,同时,评估降低不良事件风险的可能性,形成立场声明。结果 (1)考虑双膦酸盐的长期疗效、安全性及骨折风险,建议采取个性化的药物假期方案;(2)药物假期时机:阿仑膦酸钠治疗超过5年,利塞膦酸钠、唑来膦酸治疗超过3年的患者,应该考虑药物假期;(3)鉴于伊班膦酸钠证据有限,狄诺塞麦停药后可能引起骨折的"反弹效应",所以,不强烈推荐伊班膦酸钠和狄诺塞麦进行药物假期;(4)药物假期时长:一般情况下,双膦酸盐药物假期为1~3年;(5)重启治疗评估内容:双膦酸盐药物假期中,每年应评估病人的特征,包括患者的年龄、跌倒史、是否有新的骨折、可能危险因素、骨密度和骨代谢生化标志物;(6)重启治疗药物:双膦酸盐、狄诺塞麦,特立帕肽,雌激素受体调节剂(selective estrogen receptor modulators,SERMs),性激素补充(menopausal hormone replacement therapy,MHT)和雷奈酸锶等,是药物假期后重启治疗的选择药物。结论双磷酸盐药物假期遵循个体化原则,不推荐狄诺塞麦药物假期。Objective Through summarizing the key points of the EMAS position statement on ＂drug holiday＂,providing reference to clinicians for the understanding of bisphosphonate or denosumab＂drug holiday＂,in order to enhance the treatment standard of osteoporosis. Methods EMAS performed systematic review on the effect of bisphosphonate and denosumab discontinuation on fracture risk,as well as its possible benefits in reducing the risk of adverse effects,and published the position statement. Results（1）Considering the long-term efficacy and safety of bisphosphonates and fracture risk,individual treatment plan should be applied.（2） Timing for drug holiday： discontinuation of bisphosphonates should be considered in all patients who have been treated for more than five years with alendronate,and more than three years with risedronate or zoledronic acid.（3） In view of the limited evidence for ibandronate,and the possibility of rebound fractures after denosumab discontinuation,drug holiday for ibandronate and denosumab is not recommended.（4） Length of drug holiday,in general 1-3 years for bisphosphonates is suggested. After this time,the patient should be reassessed.（5） Evaluation for treatment re-initiation： during bisphosphonates drug holiday,patients＇ characteristics including age,history of falls,presence of new fracture,possible risk factors,bone mineral density and bio-markers of bone turnover should be considered.（6） Drugs for treatment re-initiation： bisphosphonates,denosumab,teriparatide,SERMs,MHT and strontium ranelate could be considered after a＂drug holiday＂. Conclusions The bisphosphonate drug holidays follow the principle of individuation and do not recommend the denosumab medicine holiday.

关 键 词：双膦酸盐 阿仑膦酸钠 伊班膦酸钠 利塞膦酸钠 唑来膦酸 狄诺塞麦 药物假期 

分 类 号：R452[医药卫生—治疗学]