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.
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
关键词
骨质疏松症
降钙素
骨折愈合
安全性
内固定
osteoporosis
calcitonin
fracture healing
safety
internal fixation
