鲑鱼降钙素对骨质疏松性骨折患者疼痛及生活质量的影响:12周多中心开放标记性观察研究  

Efficacy and safety of Miacalcic ( salmon calcitonin ) in osteoporotic fracture patients: A 12 weeks,open-label,multicenter,observational study

作　　者：薛庆云[1] 纪泉[1] 张良[1] 文良元[1] 盛正妍[2] 李毅中[3] 郑明[4] 林玉芬 姜文学[6] 贾世孔[7] 白雪松[8] 王炳强[9] 肖克明[10] 路青林[11] 芮钢 潘伟明 杨连梓[14] 马雄君[15] 何荣新[16] 马楚平 欧阳跃平[18] 徐福祥[19] 张建中[20] 张春[21] 

机构地区：[1]北京医院骨科,北京100730 [2]上海交通大学附属第一人民医院内分泌科,上海200080 [3]福建医科大学附属第二医院骨科,泉州362000 [4]福州市第二医院骨科,福州350301 [5]福建泉州正骨医院康复科,泉州362000 [6]天津第一中心医院骨科,天津300192 [7]天津市人民医院创伤骨科,天津300121 [8]天津大港油田医院骨科,天津300280 [9]北京友谊医院骨科,北京100050 [10]北京煤炭总医院骨科,北京100028 [11]山东省千佛山医院骨科,济南250014 [12]厦门第一医院骨科,厦门361011 [13]佛山市第五人民医院外科,佛山528211 [14]福建省第二人民医院骨伤科,福州350003 [15]北京安贞医院骨科,北京100029 [16]浙江大学医学院附属第二医院骨科,杭州310052 [17]深圳市南山人民医院骨科,深圳518052 [18]第二军医大学附属长征医院骨科,上海200003 [19]江苏省级机关医院普外科,南京210024 [20]北京同仁医院骨科,北京100005 [21]浙江省立同德医院骨科,杭州310012

出　　处：《中华骨质疏松和骨矿盐疾病杂志》2013年第2期137-142,共6页Chinese Journal Of Osteoporosis And Bone Mineral Research

基　　金：诺华制药有限公司对本研究的支持

摘　　要：目的了解鲑鱼降钙素对骨质疏松性骨折患者疼痛及生活质量、骨折愈合的影响,评价治疗的安全性与依从性。方法采用多中心、非干预、上市后观察性研究。研究对象为骨质疏松性股骨粗隆间骨折手术内固定患者,均接受鲑鱼降钙素注射或鼻喷剂治疗并且观察随访12周。分别以视觉模拟评分量表(VAS)和SF-36量表评价患者治疗后急性疼痛缓解的效果和生活质量改善情况。统计分析手术后12周患者骨折愈合情况以及各种不良事件的发生率。结果全国21个研究中心、共计327例患者入选本研究,完成试验患者317例,占总人数的96.9%,其中男性92例,女性235例,年龄53～96岁。给药前基线VAS均值为(83.6±17.3)分,给药后第1周VAS均值下降至(55.6±23.1)分,第4周下降至(19.1±19.9)分。生活质量评分:基线总分均值为(79.3±29.0)分,给药后第2周为(92.0±16.6)分,给药后第4周为(106.9±17.0)分,与基线相比升高27.7分(P<0.001);给药后第12周为(126.8±16.7)分,与基线相比升高47.8分(P<0.001)。手术后12周患者骨折愈合率为89.9%。2例患者(0.6%)发生与鲑鱼降钙素有关的轻度不良事件。结论鲑鱼降钙素可有效控制骨折部位疼痛,提高患者生活质量,未见对骨折愈合明显的不利影响。Objective To assess the efficacy,safety and compliance of Miacalcic in osteoporotic fracture patients. Methods An open-label,multicenter,non-interventional,post marketing surveillance. Patients with osteoporotic intertrochanteric fracture were treated with internal fixation. All the patients were treated with Miacalcic injection or nasal spray and were followed up for 12 weeks. The extent of pain relief,fracture healing rate and the safety data were recorded in the observational period. Results Three hundred and twenty seven cases （ 92 males,235 females） from 22 centers were enrolled in the study and 317 cases were followed up for 12 weeks. The age ranged between 53 and 89 years old. The average VAS score at the baseline,1st week,and 4th week were 83. 6,55. 6,and 19. 1. The SF-36 score at the baseline,2nd week,4th week,and 12th week were 79. 3,92. 0,106. 9,and 126. 8,respectively. At the end of 12th week the fracture healing rate is 89. 9% . Conclusion Miacalcic could effectively relieve the pain after acute fracture and improve the life quality without negative effect to the fracture healing.

关 键 词：骨质疏松症 降钙素 骨折愈合 安全性 内固定 

分 类 号：R681[医药卫生—骨科学]