载万古霉素骨水泥的人体局部释放及全身药物浓度监测

目的：通过测定载万古霉素骨水泥链珠植入骨感染患者体内后全身及局部的药物浓度，了解万古霉素骨水泥链珠的释放规律，为临床使用万古霉素骨水泥治疗骨感染提供依据。方法：2017年1月-2018年3月收治的骨感染患者20例，手术感染灶局部植入万古霉素和骨水泥混合制成的链珠，局部埋置引流管，分别于术后2 h及此后每日清晨留取患者静脉血及伤口引流液标本，直至术后引流管拔除。使用酶放大免疫法进行静脉血及引流液万古霉素浓度测定。结果：20例患者平均年龄48.35±19.37岁，男16例，女4例，引流管留置时间中位数为5 d，血药峰浓度为0.99 mg·L^-1，达峰时间为33.33 h，局部释放率最高峰值出现在10.5 h，最大释放速率为6.107 mg·h^-1。累计局部释放率为5.68%，溶出模型拟合符合Weibull方程，r=0.984 5。结论：局部植入万古霉素骨水泥可以至少在术后一周内伤口局部达到很高的药物治疗浓度，而全身药物浓度很低，可以避免全身使用万古霉素带来的不良反应，具有很高的安全性。

The release and the drug concentration of vancomycin mixed in bone cement in human

OBJECTIVE To evaluate the release of vancomycin bone cement by measuring the systemic and local drug concentrations in patients implanted vancomycin mixed in bone cement, provide a reference for vancomycin bone cement for bone infection patients. METHODS Twenty patients with bone infections from January to July in 2017 were treated with vancomycin and PMMA bone cement for their bone local infection. The localized drainage tube was implanted. Respectively at the postoperative 2h and thereafter every morning, the patient venous blood and wound drainage fluid specimens were collected until the drainage tubes were removed. Enzyme amplification immunoassay was used to determine vancomycin concentrations in the venous blood and drainage fluid. RESULTS The mean age of the patients was 48.35±19.37 for 16 males and 4 females. The median time of drainage was 5 days, the C_max was 0.99 mg·L^-1, the T_max was 33.33h and the highest peak rate appeared at 10.5 h and the maximum release rate was 6.107 mg·h^-1. The cumulative local release rate was 5.68%, and the dissolution model was fitted to the Weibull equation, r=0.984 5. CONCLUSION The local implantation of vancomycin PMMA bone cement chain beads can achieve a high concentration of drug in the wound at least one week after operation, and the drug blood concentration is very low, which can avoid the adverse effects of vancomycin, so it is a safe method.