依降钙素治疗绝经后骨质疏松性髋部骨折:前瞻性随机对照试验  

Calcitonin for postmenopausal osteoporotic hip fractures:a prospective randomized controlled trial

作　　者：刘志 朱勇[1,2] 林涨源 赵瑞波[1,2] 龙海涛 卢邦宝[1,2] 孙步华 成亮[1,2] 赵树山 Liu Zhi;Zhu Yong;Lin Zhangyuan;Zhao Ruibo;Long Haitao;Lu Bangbao;Sun Buhua;Cheng Liang;Zhao Shushan(Department of Orthopedics,Xiangya Hospital,Central South University,Changsha,Hunan Province,China;National Clinical Research Center of Geriatrics,Xiangya Hospital,Central South University,Changsha 410008,Hunan Province,China)

机构地区：[1]中南大学湘雅医院骨科,湖南省长沙市410008 [2]国家老年疾病临床医学研究中心(湘雅医院),湖南省长沙市410008

出　　处：《中国组织工程研究》2023年第11期1739-1743,共5页Chinese Journal of Tissue Engineering Research

基　　金：国家自然科学基金(81902222),项目负责人:赵树山;湖南省自然科学基金(2020JJ4928),项目负责人:赵树山。

摘　　要：背景:依降钙素作为抗骨质疏松的经典药物,已经广泛应用于临床抗骨质疏松治疗中,越来越多的研究发现其在骨质疏松性骨折的治疗中也有着显著的疗效。目的:评估依降钙素治疗绝经后骨质疏松性髋部骨折的临床疗效和安全性。方法:采用前瞻性随机对照方法,纳入60例绝经后骨质疏松性髋部骨折老年患者,采用随机信封法按1∶1比例随机分配至试验组和对照组,试验组给予国产依降钙素(每周1次)联合碳酸钙+维生素D(1次/d)治疗,对照组给予碳酸钙+维生素D(1次/d)治疗,疗程6个月。通过对比骨代谢指标、骨折愈合率、骨密度、血钙、血磷及不良反应来系统评估依降钙素的临床疗效及安全性。结果与结论:①试验组有26例患者,对照组有28例患者完成试验,两组患者基线数据基本一致;②依降钙素组在8,12,24周能明显抑制骨吸收指标β-Ⅰ型胶原交联C末端肽质量浓度(P<0.01),以及改善4,8周患者的疼痛目测类比评分(P<0.01),并对骨折愈合、血钙及血磷无影响;③两组的骨密度及不良反应发生率相比差异无显著性意义;④提示依降钙素能够降低绝经后骨质疏松性骨折患者术后的高转化状态,减少急性骨丢失,缓解术后患者疼痛,安全性好。BACKGROUND:Calcitonin acts as a classic anti-osteoporosis drug and has been widely used in clinical anti-osteoporosis treatment.Increasing studies have found that it also has a marked effect in the treatment of osteoporotic fractures.OBJECTIVE:To evaluate the clinical efficacy and safety of calcitonin in the treatment of postmenopausal osteoporotic hip fractures.METHODS:A prospective randomized control trial was conducted.Sixty elderly patients with osteoporotic hip fractures were enrolled and randomly assigned to an experimental group or a control group in a 1:1 ratio.The experimental group was given domestic calcitonin(once a week)combined with calcium carbonate+vitamin D(once a day)for 6 months;and the control group was given calcium carbonate+vitamin D(once a day)for 6 months.Clinical efficacy and safety of calcitonin were then evaluated by comparing bone turnover marker,fracture healing rate,bone mineral density,serum calcium,serum phosphorus and adverse effects between two groups.RESULTS AND CONCLUSION:Both experimental group(n=26)and control group(n=28)completed the experiment and their baseline data were basically the same.Calcitonin could significantly inhibit the mass concentration of C-terminal crosslinked telopeptides of type 1 collagen at 8,12,and 24 weeks(P<0.01)and improve visual analogue scale score at 4 and 8 weeks(P<0.01)but have no effect on fracture healing,serum calcium and serum phosphorus levels.(3)There were no significant differences in bone mineral density and adverse effects between the two groups.To conclude,calcitonin can reduce postoperative high conversion state,reduce acute bone loss,relieve postoperative pain,and have good safety in postmenopausal osteoporotic fracture patients.

关 键 词：依降钙素 绝经后骨质疏松 骨质疏松性骨折 急性骨丢失 骨代谢指标 

分 类 号：R459.9[医药卫生—治疗学] R318[医药卫生—临床医学] R683