国产抗生素骨水泥应用于全膝关节置换术的有效性和安全性  

The effectiveness and safety of domestic antibiotic bone cement in total knee arthroplasty

作　　者：杨闯[1] 王俏杰[1] 尹宗生[2] 周建生[3] 沈灏[1] 张先龙[1] YANG Chuang;WANG Qiaojie;YIN Zongsheng;ZHOU Jiansheng;SHEN Hao;ZHANG Xianlong(Department of Orthopaedics,Shanghai Sixth People's Hospital,Shanghai 200233,China;Department of Orthopaedics,the First Affiliated Hospital of Anhui Medical University,Hefei 230022,China;Department of Orthopaedics,the First Affiliated Hospital of Bengbu Medical College,Bengbu 233004,Anhui,China)

机构地区：[1]上海市第六人民医院骨科,上海200233 [2]安徽医科大学第一附属医院骨科,合肥230022 [3]蚌埠医学院第一附属医院骨科,安徽蚌埠233004

出　　处：《中华骨与关节外科杂志》2024年第11期968-974,共7页Chinese Journal of Bone and Joint Surgery

基　　金：国家自然科学基金面上项目(82272513);国家自然科学基金青年科学基金(82302717)。

摘　　要：目的:评价国产抗生素骨水泥应用于初次全膝关节置换术(TKA)中固定假体的有效性和安全性。方法:采用多中心、随机、单盲、平行对照研究,2018年6月22日至2019年2月27日在上海市第六人民医院、安徽医科大学第一附属医院和蚌埠医学院第一附属医院招募拟行初次单侧TKA的患者84例,其中82例患者完成手术。随机使用国产抗生素骨水泥(国产组,46例)或进口抗生素骨水泥(进口组,36例)对假体进行固定。出院前、术后3周、术后12周和术后24周对患者进行随访。分别以假体固定的稳定性和是否发生感染作为抗生素骨水泥有效性评估的主要和次要指标。通过患者生命体征、不良反应和并发症发生情况及血液学检查评估抗生素骨水泥的安全性。结果:两组患者年龄、身高、体重、基础疾病等差异均无统计学意义(P均>0.05)。两组患者术前血液学检查指标差异均无统计学意义(P均>0.05)。两组患者术中骨水泥使用量、术中出血量及手术时间差异均无统计学意义(P均>0.05)。出院前、术后3周、术后12周和术后24周随访X线检查提示两组患者假体稳定性均良好,切口愈合均良好,均无切口愈合不良、关节积液或皮肤坏死等表现。术后24周,进口组2例(5.9%)患者出现疼痛,国产组1例(2.2%)患者出现疼痛,两组患者疼痛发生率差异无统计学意义(P>0.05)。随访期间,进口组6例(18.2%)患者发生不良事件,国产组3例(6.7%)患者发生不良事件,两组患者不良事件发生率差异无统计学意义(P>0.05)。两组患者均未发生关节不稳定、假体松动、关节强直、神经损伤等严重并发症。出院前、术后24周两组患者血常规、肝肾功能、凝血功能、心肌酶谱和抗体水平等血液学检查指标差异均无统计学意义(P均>0.05)。结论:国产抗生素骨水泥应用于TKA术中固定假体的疗效与进口抗生素骨水泥相当,可以实现假体的稳定固Objective:To evaluate the efficacy and safety of domestic gentamicin bone cement for prosthesis fixation in primary total knee arthroplasty(TKA).Methods:This multicenter,randomized,single-blind,parallel-group controlled study included 84 patients who were scheduled for primary unilateral TKA at the Shanghai Sixth People's Hospital,the First Affiliated Hospital of Anhui Medical University,and the First Affiliated Hospital of Bengbu Medical College from June 22,2018 to February 27,2019.A total of 82 patients completed the surgery.The patients were randomly assigned to receive prosthesis fixation with Harmony BioTech gentamicin bone cement(domestic group,46 cases) or Johnson CMW gentamicin bone cement(import group,36 cases).Patients were followed up before discharge and at 3,12,and 24 weeks postoperatively.The primary and secondary outcomes for the efficacy of antibiotic bone cement were prosthesis stability and infection rate,respectively.Safety was assessed by patient vital signs,adverse events,complications,and hematological examinations.Results:There were no statistically significant differences in age,height,weight,or underlying diseases between the two groups(all P>0.05),and preoperative hematological parameters are comparable(all P>0.05).The amount of bone cement used,intraoperative blood loss,and operative time were not significantly different between the two groups(all P>0.05).Follow-up X-rays at discharge and at 3,12 and 24 weeks postoperatively showed stable prosthesis fixation and satisfactory wound healing in both groups,with no signs of poor wound healing,joint effusion or skin necrosis.At 24 weeks postoperatively,two patients(5.9%) in the import group and one patient(2.2%) in the domestic group reported pain,with no statistically significant difference(P>0.05).During the follow-up period,adverse events occurred in six patients(18.2%) in the import group and three patients(6.7%) in the domestic group,with no significant difference in rates(P>0.05).No severe complications,such as joint instability,prost

关 键 词：抗生素骨水泥 庆大霉素 全膝关节置换术 

分 类 号：R684[医药卫生—骨科学]