Pruss A, Baumann B, Seibold M, Kao M, Tintelnot K, von Versen R, Radtke H, Dörner T, Pauli G, Göbel U B
Institute for Transfusion Medicine, Tissue Bank, University Hospital Charité, Medical Faculty of Humboldt-University, Berlin, Germany.
Biologicals. 2001 Jun;29(2):59-66. doi: 10.1006/biol.2001.0286.
Different procedures are available to inactivate bacteria and fungi, including their spores, as well as viruses in human bone transplants. The most efficient methods are considered to be gamma irradiation and thermal inactivation as well as chemical sterilization methods like the peracetic acid-ethanol treatment (PES). Following national and international standards or draft standards, the antimicrobial effectiveness of this procedure was evaluated. Due to the standardizable size as well as the clinical relevance, defatted human spongiosa cuboids (15x15x15 mm) served as model system. After treatment with PES for 2 and 4 hours, respectively, the titre of living micro-organisms was determined in the supernatant and the cuboid. A reduction in the titre of viable micro-organisms below the detection level (reduction factor >5 log10) was already achieved after an incubation time of 2 hours (Staphylococcus aureus, Enterococcus faecium, Pseudomonas aeruginosa, Bacillus subtilis, Clostridium sporogenes, Mycobacterium terrae, Candida albicans as well as spores of Bacillus subtilis). No viable micro-organisms could be detected in any of the PES-treated test cuboids. Spores of Aspergillus niger were also completely inactivated. The PES procedure proved to be a reliable method for the sterilization of human bone transplants derived from spongiosa.
有多种方法可用于灭活人类骨移植中的细菌、真菌（包括其孢子）以及病毒。最有效的方法被认为是伽马射线辐照、热灭活以及化学灭菌方法，如过氧乙酸 - 乙醇处理（PES）。按照国家和国际标准或标准草案，对该程序的抗菌效果进行了评估。由于脱脂人松质骨长方体（15×15×15毫米）尺寸可标准化且具有临床相关性，因此用作模型系统。分别用PES处理2小时和4小时后，测定上清液和长方体中活微生物的滴度。孵育2小时后（金黄色葡萄球菌、粪肠球菌、铜绿假单胞菌、枯草芽孢杆菌、产芽孢梭菌、土地分枝杆菌、白色念珠菌以及枯草芽孢杆菌的孢子），活微生物滴度已降至检测水平以下（降低因子>5 log10）。在任何经PES处理的测试长方体中均未检测到活微生物。黑曲霉的孢子也被完全灭活。PES程序被证明是一种可靠的方法，可用于对源自松质骨的人类骨移植进行灭菌。
