鲑鱼降钙素在预防人工股骨头置换术后假体无菌性松动的临床应用研究

Study of the clinical application of salmon calcitonin in the prevention of aseptic loosening of the prosthesis after artificial femoral head replacement

目的探讨鲑鱼降钙素在预防人工股骨头置换术后假体无菌性松动的临床应用效果。方法通过随访江门市五邑中医院骨伤科二区2010年1月至2011年1月146例人工股骨头置换术后患者,按照随机数字表法分为对照组和治疗组,各73例,对照组每天口服钙剂片(钙尔奇D,每片含元素钙600 mg,含维生素D 125u);治疗组在对照组的基础上应用鲑鱼降钙素(密盖息50 u),每日皮下注射一次,连续治疗6个月。两组均分别于术前、术后4、8、12和24周检测假体周围感应区(ROI)骨密度(BMD);于术前及术后4、12、24周行血清骨代谢指标检测:骨钙素(BGP)、I型胶原C端异构肽(β-CTX),通过测量术后随访过程中假体周围骨密度、骨代谢和生化指标与术前上述指标对比,进行临床分析。结果术后24周,实验组假体周围局部感应区BMD增加近5%,而对照组假体周围局部感应区BMD下降了6%,两组比较有显著性差异(P<0.01);骨代谢指标中,术后24周实验组的BGP、β-CTX稍有下降,但组内无显著性差异(P>0 05),这些指标与对照组比较差异显著(P<0.05或P<0.01)。结论鲑鱼降钙素(密盖息)联合基础治疗,能显著提高人工股骨头假体周围的骨量,是预防无菌性松动的有效方法之一,值得推广。

Objective To investigate the clinical efficacy of salmon calcitonin in the prevention of aseptic loosening of the prosthesis after artificial femoral head replacement.Methods One hundred and forty-six patients who received artificial femoral head replacement from January 2010 to January 2011 in the Department of Orthopedics and Traumatology of Wuyi Hospital of Traditional Chinese Medicine were followed up.They were randomly divided into treatment group and control group, with 73 cases in each group.Patients in control group received oral calcium tablets daily （Caltrate D, containing 600mg calcium and 125u vitamin D）.Patients in the treatment group received subcutaneous injection of calcitonin salmon （Miacalcic 50U） daily besides calcium tablets.The treatment lasted for 6 months.Bone mineral density （ BMD ） around the prosthesis （ ROI ） in both groups were examined before and 4-, 8-, 12-, and 24-week after the operation.Serum bone metabolic markers osteocalcin （ BGP） and type I collagen peptide （ C end of heterogeneous beta,β-CTX） were deterimined in patients of both groups before and 4-, 12-, and 24-week after the operation.BMD and bone metabolic markers before and after the operation were comparied and analyzed. Results After 24-week of operation, BMD of ROI in the treatment group increased nearly 5%, while BMD of ROI in the control group decreased 6%.The difference between the two groups was significant （ P〈0.01 ） .Bone metabolic index BGP and β-CTX decreased slightly after 24-week of the operation in the treatment group, but no significant difference was within the group （ P＆gt;005）.However, these indexes were significantly different comparing to those in the control group （P 〈0.05 or P 〈0.01）. Conclusion The treatment of salmon calcitonin （ Miacalcic） combined with basic therapy can significantly improve bone mass around the prosthesis, which is one of the effective methods for prevention of aseptic loosening.