门静脉高压症标本库的初步建立、质控及管理

目的 探索建立门静脉高压症（portal hypertension，PH）生物标本库及数据信息化管理方法和标准化操作流程，为PH基础与临床研究提供高质量的临床标本资源。方法 收集PH患者的血液、尿液、唾液、组织标本，将处理好的标本于-80 ℃冰箱保存，新鲜组织标本置于液氮保存，定期随机抽取标本进行质量控制。结果 现收集并保存有完整临床信息及随访资料的PH患者血液标本434份、组织标本13份、尿液标本337份、唾液标本337份。随机抽取38份慢性乙型病毒性肝炎患者血液标本进行乙肝病毒DNA鉴定，结果证实标本冻存前后DNA扩增无统计学差异（P＞0.05），符合生物标本质量控制标准。结论 初步建立了标准化、规范化的PH标本库，制定了标准化的标本库维护和管理规程，为PH的基础和临床研究提供宝贵的实验材料。

Preliminary establishment,quality control and management of the biological specimen bank of portal hypertension

Objective To explore the establishment of portal hypertension (PH) biological specimen database and data information management methods and standardized operation process, and to provide high-quality clinical specimen resources for PH basic and clinical research. Methods Blood samples, urine samples, saliva samples and tissue samples of PH patients were collected. The processed samples were stored in refrigerator at -80 ℃, and fresh tissue samples were stored in liquid nitrogen. Samples were randomly selected for quality control regularly. Results Samples including 434 blood samples, 13 tissue samples, 337 urine samples and 337 saliva samples with complete clinical information and follow-up data were collected and preserved. Blood samples of 38 patients with chronic hepatitis B (HBV) were randomly selected for HBV DNA identification. The results showed that there was no significant difference in DNA amplification between before and after cryopreservation (P>0.05), which met the quality control standard of biological samples. Conclusion A standardized PH specimen bank is preliminarily established, and standardized maintenance and management procedures have been formulated, which provides valuable experimental materials for basic and clinical research of PH.