子宫内膜异位症中医证候样本库的构建

Construction of the biobank for TCM syndrome of endometriosis

目的探讨子宫内膜异位症中医证候样本库样本采集与保存,生物样本库的建立及信息化管理方法。方法以中国中医科学院广安门医院为依托,依照子宫内膜异位症中医慢病管理课题设计方案,标准化采集妇科赵瑞华主任医师门诊与子宫内膜异位症专题门诊就诊的符合子宫内膜异位症临床或病理诊断的患者的外周血样本,分离血清、血浆、外周血单核细胞等成分,以朗珈同创BioBank样本库管理系统软件为平台,完成样本入库、临床信息与随访信息录入、样本质控、出库等管理。结果自2018年7月起,截止2019年12月已经实现对465人次,包括1016管血清、426管外周血单核细胞、308管血浆的收集与信息化管理,在生物样本库建立与维护的过程中,从样本入库、保存、临床信息录入、出库等多个环节实现对样本的标准化技术质量控制。结论初步建设完成拥有中医"证候"特色标识、西医诊断、检验指标相结合的标准化收集、处理、储存和管理临床生物样本以及生物样本捐赠者的临床诊治、随访等信息的院级子宫内膜异位症临床生物样本库。

Objective To explore the way to collect and preserve samples for endometriosis TCM syndrome, and the method for establishment of biobank and accomplishment of its information management. Methods The project was based on Guang’anmen Hospital, China Academy of Chinese Medical Sciences, following the design of chronic disease management of traditional Chinese medicine for endometriosis. Samples were collected from patients with clinical or pathological diagnosis of endometriosis in the outpatient department of Zhao Rui-hua, and special outpatient department of endometriosis. The components such as serum, plasma and peripheral blood monocyte were separated. Sample storage, clinical and follow-up information input, sample quality control and delivery management were completed on the platform of LOGENE Biobank management system software. Results The samples from 465 person-times were collected and finished their information management, including 1016 tubes of serum, 426 tubes of peripheral blood mononuclear cells, 308 tubes of plasma from July 2018 to December 2019. In the process of building and maintaining the biobank, standardized technical quality control of samples was completed from inbound, storage, clinical information input and delivery. Conclusion The hospital level clinical biobank of endometriosis with traditional Chinese medicine characteristics has been preliminarily constructed including the characteristic logo of "syndrome" of traditional Chinese medicine, diagnosis of western medicine, standardized collection, processing, storage and management of clinical biological samples combined with laboratory indicators, clinical diagnosis and treatment, follow-up of biological sample donors.