地舒单抗对比阿仑膦酸钠对全髋关节置换术后假体周围骨密度的影响  

Effect of denosumab versus alendronate on periprosthetic bone mineral density after total hip arthroplasty

作　　者：傅蔚聪 王天宝 李晓飞 FU Weicong;WANG Tianbao;LI Xiaofei(Department of Orthopedics,Affiliated Jinhua Hospital,Zhejiang University School of Medicine,Jinhua 321000,Zhejiang Province,China)

机构地区：[1]浙江大学医学院附属金华医院骨科,浙江金华321000

出　　处：《药学前沿》2024年第9期34-40,共7页China Pharmacist

基　　金：浙江省基础公益研究计划项目(LQ20H060011)。

摘　　要：目的探究地舒单抗(DEN)和阿仑膦酸钠(AL)对全髋关节置换术(THA)后假体周度骨密度的影响。方法回顾性分析2022年3月至2023年3月浙江大学医学院附属金华医院初次行THA的原发性骨质疏松(POP)患者的临床资料,根据术后方案不同分为DEN组和AL组。本研究主要观察指标为假体周围骨密度[Gruen分区:1区和7区;时间点:术后第5天(T_(1))、术后6个月(T_(2))及12个月(T_(3));检测方法:双能X线骨密度检测仪]。次要观察指标为骨转化指标[骨钙素(OC)、β-胶原特殊序列(β-Crosslaps)和1型前胶原蛋白N端前肽(P1NP);时间点:术前(T_(4))、术后6个月(T_(2))及12个月(T_(3));检测方法:酶联免疫吸附法]。结果研究共纳入患者120例,DEN组59例,AL组61例。基线时,两组患者血清OC、β-Crosslaps和P1NP含量差异无统计学意义(P>0.05)。两组患者假体周围骨密度均呈现下降趋势,且在T_(2)和T_(3)时间点上,DEN组Gruen 1区和Gruen 7区的假体周围骨密度均高于AL组(P<0.05)。在骨转化标志物方面,随着治疗时间延长,两组患者血清OC、β-Crosslaps和P1NP含量均呈现下降趋势(P<0.05)。此外,在T2和T3时间点上,DEN组血清OC、β-Crosslaps和P1NP含量显著低于AL组(均P<0.05)。结论与AL相比,DEN在预防股骨近端假体周围骨丢失更有效,且安全性较好。Objective To investigate the effects of denosumab(DEN)and alendronate(AL)on bone mineral density(BMD)around the prosthesis after total hip arthroplasty(THA).Methods A retrospective analysis was conducted on the clinical data of primary osteoporosis(POP)patients who underwent THA at the Affiliated Jinhua Hospital of Zhejiang University School of Medicine from March 2022 to March 2023,the patients were divided into the DEN group and the AL group according to the postoperative protocols.The main observation index was the bone density around the implant(Gruen zone:1st and 7th zones;time points:postoperative day 5(T_(1)),6 months(T_(2)),and 12 months(T_(3));detection method:dual-energy X-ray absorptiometry).The secondary observation index was the bone metabolism index(bone calcitonin(OC),β-collagen special sequence(β-Crosslaps),and type 1 procollagen N-terminal peptide(P1NP);time points:preoperative(T_(4)),6 months(T_(2)),and 12 months(T_(3));detection method:enzyme-linked immunosorbent assay).Results A total of 120 patients were included in the study,with 59 in the DEN group and 61 in the AL group.At baseline,there was no statistically significant difference in serum OC,β-Crosslaps and P1NP levels between the two groups(P>0.05).Periprosthetic BMD showed a decreasing trend in both groups,and periprosthetic BMD was higher in the DEN group than in the AL group in both Gruen zone 1 and Gruen zone 7 at the T_(2)and T_(3)time points(P<0.05).In terms of bone transformation markers,serum OC,β-Crosslaps and P1NP levels showed decreasing trends with prolonged treatment time in both groups(P<0.05).In addition,serum OC,β-Crosslaps and P1NP levels were significantly lower in the DEN group than in the AL group at T_(2)and T_(3)time points(P<0.05).Conclusion Compared with AL,DEN is more effective in preventing periprosthetic bone loss of the proximal femur and has a better safety profile.

关 键 词：地舒单抗 骨密度 假体周围骨丢失 全髋关节置换术 双膦酸盐 

分 类 号：R969.4[医药卫生—药理学]