双膦酸药物的选择-张晓莉.pptVIP

Version 11-Sep-07 MA-* HORIZON-PFT Study 2301 Slide Library V4 3-May-07 CONFIDENTIAL HORIZON-PFT Slide Library - * 唑来膦酸治疗绝经后骨质疏松患者具有广泛疗效 在绝经后骨质疏松妇女中，每年一次输注ZOL 5mg治疗3年可显著减少1: 椎体骨折(形态学 70%, 临床 77%)1 髋部骨折(41%)1 非椎体骨折(25%)1 因骨折或背痛导致的活动受限或卧床时间2 身高的降低1 36个月期间，ZOL 5 mg在增加或维持全髋、股骨颈和腰椎骨密度方面的疗效优于安慰剂。1 骨形成和吸收标记在接受ZOL 5 mg 治疗后降低并在每个为期12个月的治疗阶段结束时维持于绝经前水平，对骨标记物降低的效应维持了整个研究的36个月。1 ZOL 5 mg 每年注射一次耐受性良好。1 对骨折的疗效以及可保证一年的依从性提示ZOL 5 mg 可能将在骨质疏松治疗中占据重要地位。1 参考文献 1. Black DM, Delmas PD, Eastell R, et al, for the HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007;356:1809-1822. 2. Black DM, Boonen S, Cauley J, et al. Effect of once-yearly infusion of zoledronic acid 5 mg on spine and hip fracture reduction in postmenopausal women with osteoporosis: the HORIZON Pivotal Fracture Trial. Presented at: The American College of Rheumatology Annual Scientific Meeting 2006; November 10-15, 2006; Washington DC. Abstract 665. Version 11-Sep-07 MA-* * Version 11-Sep-07 MA-* Zoledronic Acid 5 mg Reduced Cumulative 3-Year Risk of Clinical Fractures by 35% Over Time As illustrated in this Kaplan-Meier curve, zoledronic acid reduced the cumulative 3-year risk of clinical fractures by 35%. It should be noted that after Month 36 (Day 1080), the changes in the Kaplan-Meier curves become oversensitive to the occurrence of clinical fractures due to the small number of patients who are at risk of clinical fracture after this time point (119 on placebo and 129 on zoledronic acid). As such, every clinical fracture event that occurs has considerable influence on the cumulative incidence of clinical fractures as well as the shape of the Kaplan-Meier curves. Data reliability issues were identified for one center representing a total of 95 patients (48 patients in the zoledronic acid group and 47 in the placebo group). An analysis excluding data from this center was repeated for the ITT population, and the results were similar: hazard ratio