[1]孟利斌,张立康,王魁向,等.不同浓度抗生素骨水泥静态间隔器在膝关节感染二期翻修中的药物释放动力学及对再感染率的影响[J].陕西医学杂志,2026,(7):919-924,951.[doi:DOI:10.3969/j.issn.1000-7377.2026.07.008]
　MENG Libin,ZHANG Likang,WANG Kuixiang,et al.Drug release kinetics and impact on reinfection rate of antibiotic-loaded bonecement spacers at different concentrations in the two-stage revision of knee joint infections[J].,2026,(7):919-924,951.[doi:DOI:10.3969/j.issn.1000-7377.2026.07.008]
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不同浓度抗生素骨水泥静态间隔器在膝关节感染二期翻修中的药物释放动力学及对再感染率的影响

《陕西医学杂志》[ISSN:1000-7377/CN:61-1281/TN]

卷:
期数:
2026年7期
页码:
919-924,951
栏目:
临床研究
出版日期:
2026-07-05

文章信息/Info

Title:
Drug release kinetics and impact on reinfection rate of antibiotic-loaded bonecement spacers at different concentrations in the two-stage revision of knee joint infections
作者:
孟利斌1; 张立康1; 王魁向1; 梁芳2
（1.河北医科大学附属邢台市人民医院骨外科，河北 邢台 054000；2.河北医科大学附属邢台市人民医院内分泌科，河北 邢台 054000）
Author(s):
MENG Libin1; ZHANG Likang1; WANG Kuixiang1; LIANG Fang2
(1.Department of Orthopaedic Surgery,Xingtai People’s Hospital Affiliated to Hebei Medical University,Xingtai 054000,China;2.Department of Endocrinology,Xingtai People’s Hospital Affiliated to Hebei Medical University,Xingtai 054000,China)
关键词:
抗生素骨水泥; 膝关节感染; 二期翻修; 药物释放动力学; 再感染率; 静态间隔器
Keywords:
Antibiotic cement; Knee joint infection; Two-stage revision; Drug release kinetics; Reinfection rate; Static spacer
分类号:
R 684
DOI:
DOI:10.3969/j.issn.1000-7377.2026.07.008
文献标志码:
A
摘要:
目的：探讨不同浓度抗生素骨水泥静态间隔器在膝关节感染二期翻修中的药物释放动力学特征，分析其对术后再感染率的影响，为临床优化间隔器抗生素配比提供依据。方法：选取收治的84例膝关节置换术后感染需行二期翻修患者，根据抗生素骨水泥中万古霉素浓度分为低浓度组（2 g/40 g骨水泥，n=28）、中浓度组（4 g/40 g骨水泥，n=28）和高浓度组（6 g/40 g骨水泥，n=28）。一期手术清除感染组织后植入对应浓度抗生素骨水泥静态间隔器，同步进行体外释放实验，二期手术时收集体内间隔器样本及术后不同时间点血清、关节液样本，采用高效液相色谱法（HPLC）检测药物浓度，拟合药物释放动力学方程；随访12个月，记录再感染率，结合致病菌谱等潜在混杂因素分析药物释放特征与再感染率的相关性。结果：体外释放实验显示，三组间隔器药物释放均符合一级动力学方程（R2>0.95），高浓度组和中浓度组累计药物释放量、平均释放速率显著高于低浓度组（均P<0.05）；体内检测显示，高浓度组与中浓度组术后7 d内关节液药物浓度比较无统计学差异（均P>0.05），但高浓度组术后14~28 d关节液药物浓度仍维持在有效抑菌浓度以上，显著高于中浓度组（P<0.05）。三组患者致病菌谱、窦道存在情况等基线指标比较无统计学差异（P>0.05）；随访12个月，低浓度组再感染率为21.43%（6/28），中浓度组为7.14%（2/28），高浓度组为3.57%（1/28），三组再感染率比较差异有统计学意义（均P<0.05）；药物累计释放量与再感染率呈负相关（r=-0.628，P<0.001），多因素Logistic回归验证抗生素浓度是再感染率的独立影响因素（OR=0.312，95%CI：0.157~0.620，P=0.001）。结论：抗生素骨水泥静态间隔器药物释放符合一级动力学特征，提高抗生素浓度可增加累计释放量、延长有效药物浓度维持时间，降低膝关节感染二期翻修术后再感染率；4~6 g/40 g万古霉素浓度骨水泥间隔器临床疗效更优，高浓度组在长期药物维持及低再感染率方面略具优势，但需警惕药物毒性风险。
Abstract:
Objective:To investigate the drug release kinetic characteristics of static spacers with different concentrations of antibiotic cement in the two-stage revision of knee joint infection,and to analyze their impact on the postoperative reinfection rate,so as to provide a basis for optimizing the antibiotic ratio in spacers clinically.Methods：Eighty-four patients with knee joint infection after knee arthroplasty who underwent two-stage revision from January 2020 to January 2023 were selected.They were divided into a low-concentration group (2 g of vancomycin per 40 g of cement,n=28),a medium-concentration group (4 g/40 g,n=28),and a high-concentration group (6 g/40 g,n=28) according to the vancomycin concentration in the antibiotic cement.After the first-stage surgery to remove infected tissue,static spacers with the corresponding concentration of antibiotic cement were implanted.In vitro release experiments were performed simultaneously.During the second-stage surgery,in vivo spacer samples,serum and joint fluid samples at different time points after surgery were collected.High-performance liquid chromatography (HPLC) was used to detect drug concentrations,and drug release kinetic equations were fitted.A 12-month follow-up was conducted to record the reinfection rate.The correlation between drug release characteristics and reinfection rate was analyzed,combined with potential confounding factors such as pathogenic bacteria spectrum.Results:In vitro release experiments showed that the drug release of spacers in all three groups fitted the first-order kinetic equation (R2>0.95).The cumulative drug release amount and average release rate in the high-concentration group and medium-concentration group were significantly higher than those in the low-concentration group (all P<0.05).In vivo detection showed that there was no significant difference in joint fluid drug concentration between the high-concentration group and the medium-concentration group within 7 days after surgery (P>0.05),but the joint fluid drug concentration in the high-concentration group remained above the effective bacteriostatic concentration from 14 to 28 days after surgery,which was significantly higher than that in the medium-concentration group (P<0.05).There were no significant differences in baseline indicators such as pathogenic bacteria spectrum and presence of sinus tract among the three groups (P>0.05).After a 12-month follow-up,the reinfection rate was 21.43% (6/28) in the low-concentration group,7.14% (2/28) in the medium-concentration group,and 3.57% (1/28) in the high-concentration group.There was a statistically significant difference in reinfection rate among the three groups (P<0.05).The cumulative drug release amount was negatively correlated with the reinfection rate (r=-0.628,P<0.001).Multivariate logistic regression confirmed that antibiotic concentration was an independent influencing factor for reinfection rate (OR=0.312,95%CI：0.157~0.620,P=0.001).Conclusion:The drug release of antibiotic cement static spacers conforms to the first-order kinetic characteristics.Increasing the antibiotic concentration can increase the cumulative drug release amount,prolong the maintenance time of effective drug concentration,and reduce the reinfection rate after two-stage revision of knee joint infection.The clinical efficacy of cement spacers with 4~6 g/40 g vancomycin concentration is better.The high-concentration group has a slight advantage in long-term drug maintenance and low reinfection rate,but the risk of drug toxicity needs to be alerted.

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备注/Memo

备注/Memo:
国家自然科学基金资助项目（91949203）
更新日期/Last Update: 2026-07-10