概述COPAL® G+C是一种负载抗生素的高粘度聚甲基丙烯酸甲酯(PMMA)骨水泥,配方中结合了庆大霉素和克林霉素,用于关节置换术中的局部感染预防与处理。该配方可在局部提供初始高浓度抗生素释放,并对常见的假体关节感染(PJI)相关病原体具有广谱覆盖能力。
主要特性- 高粘度PMMA骨水泥,双重抗生素配方
- 每单位含庆大霉素1 g和克林霉素1 g
- 造影性(X线可见)
- 着色为绿色(着色剂 E141)
适应证- 用于髋、膝、踝、肩、肘的初次及翻修关节置换中内假体的固定
临床依据与疗效COPAL® G+C提供初始的高局部抗生素释放,有助于防止植入物及其邻近组织的细菌定植,尤其对对庆大霉素和/或克林霉素敏感的病原体有效。两种抗生素的联合可扩展抗菌谱,可能覆盖约90%与PJI相关的常见病原体。临床应用包括高风险初次置换患者的预防、股骨颈骨折后相关的创伤置换以及无菌翻修手术。
可用附加文件- 电子使用说明书(eIFU)
- Summary of Safety and Clinical Performance (SSCP)
参考文献- Berberich CE, Josse J, Laurent F, Ferry T. Dual antibiotic loaded bone cement in patients at high infection risks in arthroplasty: Rationale of use for prophylaxis and scientific evidence. World J Orthop 2021; 12(3):119–28.
- Gehrke T., von Förster G., Frommelt L. Pharmacokinetic Study of a Gentamicin/Clindamicin Bone Cement Used in One-stage Revision Arthroplasty. In: Walenkamp GHIM et al., Bone Cements and Cementing Technique. Springer, 2001.
- Sanz-Ruiz P., Berberich C. Infection Risk-Adjusted Antibiotic Prophylaxis Strategies in Arthroplasty. OrthopRes Rev. 2020;12:89-96.
- Abdelaziz H. et al. Minimum 5 years' follow-up after gentamicin- and clindamycin-loaded PMMA cement in total joint arthroplasty. J Med Microbiol. 2019 Mar;68(3):475-479.
- Sprowson AP et al. The Fractured Hip Infection trial. Bone Joint J. 2016 Nov;98-B(11):1534-41.
- Savage P. et al. Arthroplasty infection rates in fractured neck of femur: single vs dual antibiotic cement. Ann R Coll Surg Engl. 2019 Sep;101(7):514-518.
- Tyas B. et al. Antibiotic resistance profiles of deep surgical site infections in hip hemiarthroplasty. J Bone Jt Infect. 2018;3(3):123-9.
- Sanz-Ruiz P. et al. Is Dual Antibiotic-Loaded Bone Cement More Effective and Cost-Efficient Than a Single Antibiotic-Loaded Bone Cement to Reduce the Risk of PJI in Aseptic Revision Knee Arthroplasty? J Arthroplasty. 2020 Dec;35(12):3724-3729.
技术规格- 产品名称:COPAL® G+C
- 类型:高粘度PMMA骨水泥,双抗生素配方
- 抗生素含量:庆大霉素1 g + 克林霉素1 g(每单位)
- 造影性:是(radiopaque)
- 着色剂:绿色(E141)
- 临床应用:髋、膝、踝、肩、肘的内假体固定(初次与翻修关节置换)
- 治疗目的:在关节置换中实现局部感染预防/管理,对常见PJI病原体提供广谱覆盖
- 显著性能:初始高局部抗生素释放;组合配方可覆盖约90%的典型PJI病原体