基于多囊卵巢综合征多中心大样本临床试验血样本的管理策略

Management strategy of blood specimen of a large sample size multicenter clinical trial of polycystic ovary syndrome

多囊卵巢综合征(PCOS)是引起女性不孕的最常见的内分泌紊乱疾病。因其病因复杂、发病率高,已得到国内外研究者的广泛关注。多囊卵巢综合征多中心临床试验项目(PCOSAct)所获取的大量血样本是临床研究的宝贵资源,其不仅包含了疾病相关的临床信息,也能够为疾病的诊断和治疗提供重要的指导意义。本文介绍了PCOS血样本的收集、处理、储存和检测等各个环节,强调样本质量对高质量研究的重要性,以期为今后样本库的标准化建设及完善临床试验血样本管理过程提供经验和依据。

Polycystic ovary syndrome （PCOS） is the most common endocrine disorder in women of reproductive age, which may result in infertility. Because of the complicated etiology and high morbidity, it has attracted wild attention of researchers around the world. The large quantity of blood specimens that have been obtained from multicenter clinical trials （PCOSAct） are precious resources for clinical research. It could not only contain clinical data of the related diseases but also provide vital guidance for the diagnosis and treatment of the disease. This paper discusses the collection, processing, storage, and testing of blood specimens as well as the potential problems, and emphasizes the importance of specimen quality for high quality clinical research. The purpose of this paper is to provide experience and reference for the standardized construction of biobank in future and improve the management of blood specimen in clinical trials.