Bucher P, Mathe Z, Bosco D, Oberholzer J, Toso C, Andres A, Buhler L, Morel P, Berney T
Cell Isolation and Transplantation Center, Geneva University Hospitals, Geneva, Switzerland.
Transplant Proc. 2004 May;36(4):1147-8. doi: 10.1016/j.transproceed.2004.04.025.
The study aim was to investigate the microbiological safety of islet isolation and transplantation.
Between 1996 and 2002, prospective microbiological screening was performed on all pancreata procured for islet transplantation. Pancreas transport media and postpurification preparations were screened for microbiological contamination. Prior to isolation, pancreata were washed with either Hanks solution (group I, n = 170) or decontaminated with antiseptic and antimicrobial drugs (group II, n = 45).
Microbiological contamination of the pancreas preservation media was shown in 62%. Analysis of the contaminants showed 74% gram-positive, 21% gram-negative organisms, and 5% fungi. The donor condition or procurement center did not influence the contamination rate. Longer pancreas transport duration was significantly associated with bacterial contamination (P <.05). In group I, 16 (9.4%) of 170 islet preparations presented microbial contamination at the end of the isolation procedures. Gram-positive organisms were present in 10 (6%), gram-negative organisms in 4 (2.4%), and fungi in 2 (1.2%) preparations. Four islet preparations (2.4%) from pancreata with noninfected transport medium were positive on postpurification cultures, all with gram-positive organisms. In group II, only 2 of 45 islet preparations (4.4%) presented microbial contamination at the end of the isolation process.
The rate of microbial contamination during pancreas procurement and transport is high. Significant contaminants present when beginning islet isolation become undetectable by the conclusion of isolation. Diminishing the bio-burden by pancreas decontamination reduces the risk of contamination of the final islet preparation.
本研究旨在调查胰岛分离和移植的微生物安全性。
1996年至2002年期间,对所有用于胰岛移植的胰腺进行前瞻性微生物筛查。对胰腺运输培养基和纯化后制剂进行微生物污染筛查。在分离前,胰腺用汉克斯溶液冲洗(I组,n = 170)或用防腐剂和抗菌药物进行去污处理(II组,n = 45)。
62%的胰腺保存培养基显示有微生物污染。对污染物的分析显示,74%为革兰氏阳性菌,21%为革兰氏阴性菌,5%为真菌。供体状况或获取中心并未影响污染率。胰腺运输时间延长与细菌污染显著相关(P <.05)。在I组中,170份胰岛制剂中有16份(9.4%)在分离程序结束时出现微生物污染。10份制剂(6%)中存在革兰氏阳性菌,4份制剂(2.4%)中存在革兰氏阴性菌,2份制剂(1.2%)中存在真菌。4份来自运输培养基未感染的胰腺的胰岛制剂在纯化后培养中呈阳性,均为革兰氏阳性菌。在II组中,45份胰岛制剂中只有2份(4.4%)在分离过程结束时出现微生物污染。
胰腺获取和运输过程中的微生物污染率很高。开始胰岛分离时存在的重要污染物在分离结束时变得无法检测到。通过胰腺去污减少生物负荷可降低最终胰岛制剂污染的风险。