福美加：治疗骨质疏松防骨折新里程.ppt

抗骨质疏松治疗越来越被各科医生所重视，鉴于阿仑膦酸钠已经有用于骨质疏松治疗超过十年的确切疗效，以及维生素D对骨健康的重要作用，美国2005年上市了阿仑膦酸钠+维生素D3复方制剂（福美加?）。该药也于2011年在中国上市。它是全球首个抗骨质疏松药物与维生素D3的复合制剂，是治疗骨质疏松的新里程。 * 我们将分两个部分介绍，首先阐明为什么说“抗骨质疏松药物和维生素D都是治疗骨质疏松所必需的” * 2011年《原发性骨质疏松症诊疗指南》指出：抗骨质疏松药物和维生素D都是骨质疏松症治疗所必需的。抗骨质疏松药物可以通过提高骨量和骨质量来降低骨折风险；维生素D可以促进骨吸收，保持骨骼健康。抗骨质疏松药物和维生素D联合使用可以有效降低骨折风险。 * Slide * The findings of an international epidemiologic study indicate that vitamin D inadequacy is highly prevalent among postmenopausal women with osteoporosis throughout the world, even in regions with ample sunlight. This cross-sectional, observational, single-visit study enrolled 2589 postmenopausal women with osteoporosis between May 2004 through March 2005 who were living independently within the community in 18 countries in Europe, Latin America, the Middle East, Asia, and Australia.7 Vitamin D inadequacy was defined by serum 25(OH)D level 30 ng/ml.6 The mean 25(OH)D concentration among the study population as a whole was 26.8 ng/ml. Nearly 64% of the study population demonstrated a serum 25(OH)D concentration 30 ng/ml and approximately 31% had a concentration 20 ng/ml. (See previous slide.) The prevalence of vitamin D inadequacy (30 ng/ml) was at least 53% in all five regions involved in the study and was highest in the Middle East (81.8%) and Asia (71.4%).6-8 Nearly 58.4% of the study participants used a medication approved for the treatment of osteoporosis, such as bisphosphonates, selective estrogen receptor modulator, calcitonin, or parathyroid hormone, and approximately 54.2% used vitamin D supplements.8 指南指出：维生素D作为骨健康的补充剂，可以促进钙吸收，维持正常的骨形成和正常的甲状旁腺激素（PHT）水平，并能改善身体稳定性，降低跌到风险。 指南指出：维生素D作为骨健康的补充剂，可以促进钙吸收，维持正常的骨形成和正常的甲状旁腺激素（PHT）水平，并能改善身体稳定性，降低跌到风险。 一项口服维生素D及其剂量依赖性与预防非椎体骨折疗效的荟萃分析显示：补充400IU/日以上维生素D可以使非椎体骨折的相对风险降低20%，使髋部骨折的相对风险降低18%. 《中国骨质疏松症诊疗指南》指出：双膦酸盐类：有效抑制破骨细胞活性，降低骨转换。大样本随机双盲对照研究证据表明，阿仑膦酸钠可明显提高腰椎和髋部的骨密度，显著降低椎体及髋部等部位发生骨折的危险。 大型临床研究——FIT研究，即骨干预试验，包括两项（3年期研究和4年期研究）在绝经后女性中进行的随机、双盲、多中心研究，目的是评价阿仑膦酸钠对低骨量或有椎体骨折的绝经后妇女降低骨折发生的疗效。总共6459例妇女随机分组