Study the pathological features of diseases using induced pluriPOtent stem cells derived form patient's somatic cells
The limited experimental access to disease-affected human tissues has severely impeded the elucidating of molecular mechanisms underlying disease development. Generation of induced pluriPOtent stem cells (iPSCs) by over-expression of defined transcription factors in somatic cells, in particular in those from patient somatic cells, presents an attractive and promising approach to model the early stages of diseases in vitro and to screen novel biomarkers as well as therapeutic medicines. Recently, many research groups have independently rePOrted that patient-specific iPSC-derived cells recapitulated multiple features of pathological events of a particular disease, offering experimental evidence of utilizing patient-specific iPSCs to model diseases and reevaluate the current therapies. We have derived iPSC lines using somatic cells of patients suffering from Klinefelter's Syndrome (KS) and Alzheimer's Disease (AD) and explored the POssibility to use these iPSC lines to recapitulate the pathological features of the diseases. Our results show that patient's specific iPSC lines provide good opPOrtunity to study the development and treatment of diseases.
杨瑞馥：POCT：个体化医疗时代和公共安全的需求与挑战
随着生物安全、食品安全、突发和新发疫情和自然灾害等问题日益突出，POCT在现场快速检测、确定病原等危害因子和制定有效预防措施中将发挥不可替代的作用。但是，POCT技术与中心实验室的检测手段不同，还存着管理、质量控制、培训、认证认可等问题。我们还需从POCT文化建设、管理机构确定和管理标准化以及质控、认证等的规范化等角度逐步解决。
sRNA Induces the Large-scale Transdetermination of Mesenchymal Stem Cells into HematoPOietic Stem Cells in Human.
Mesenchymal stem cells (MSCs) can differentiate into cells of bone, endothelium, adiPOse tissue, cartilage, muscle, and brain. However, whether they can transdeterminate into hematoPOietic stem cells (HSCs) remains unsolved. We rePOrt here that a subPOpulation of human MSCs that are CD44+,CD29+, CD105+, CD166+,CD133-,CD34- could differentiate into hematoPOietic stem cells (CD150+/CD133+/CD34+) and their descending blood cells in vitro, when transfected with new endogenous shRNAs The sRNA was high-effectively delivered into MSCs by a novel peptide means. These induced MSC-HSCs could form different types of hematoPOietic colonies as nature-occurring HSCs did. UPOn transplantation into sublethally irradiated NOD/SCID mice, these MSC-HSCs engrafted and differentiated into all hematoPOietic lineages such as erythrocytes, lymphocytes, myelocytes and thrombocyte. More imPOrtantly, these induced HSCs could successfully engraft and effectively function in patients with severe aplastic anemia. Furthermore, we demonstrated the first evidence that the transdetermination of MSCs was induced by acetylation of histone proteins and activation of many transcriptional factors. Together, our findings identify the sRNAs that dictates a directed differentiation of MSCs toward HSCs and open up a new source for HSCs used for the treatment of blood diseases and artificial stem cell-made blood.
immunotherapy against cancers(POsition of sellular therapy)
Study the pathological features of diseases using induced pluriPOtent stem cells derived form patient's somatic cells
The limited experimental access to disease-affected human tissues has severely impeded the elucidating of molecular mechanisms underlying disease development. Generation of induced pluriPOtent stem cells (iPSCs) by over-expression of defined transcription factors in somatic cells, in particular in those from patient somatic cells, presents an attractive and promising approach to model the early stages of diseases in vitro and to screen novel biomarkers as well as therapeutic medicines. Recently, many research groups have independently rePOrted that patient-specific iPSC-derived cells recapitulated multiple features of pathological events of a particular disease, offering experimental evidence of utilizing patient-specific iPSCs to model diseases and reevaluate the current therapies. We have derived iPSC lines using somatic cells of patients suffering from Klinefelter's Syndrome (KS) and Alzheimer's Disease (AD) and explored the POssibility to use these iPSC lines to recapitulate the pathological features of the diseases. Our results show that patient's specific iPSC lines provide good opPOrtunity to study the development and treatment of diseases.
POCT类体外诊断试剂技术审评基本要求
POCT类体外诊断试剂涉及产品的类别主要包括注册申报的二、三类，在技术审评过程中根据不同产品的特性有针对性地进行，例如常规的生化免疫属于二类，传染病、毒品属于三类。二类三类产品的审评要求差别很大。进口的所有POCT产品都会在医疗器械技术审评中心进行技术审评，国产的POCT二类产品在省食药监做技术审评，三类产品的技术审评在国家食品药品监督管理局医疗器械技术审评中心。安娟娟同时提到，国家食品药品监督管理局医疗器械技术审评中心将根据产品的风险程度以及在注册过程中问题比较集中的产品编写指南，已完成自测血糖监测系统，即将完成HIV临床POCT产品指南。
新医改大背景下，中国POCT发展路径的探讨
徐建新认为：大力推广POCT产品国产化，应进一步整合成本、质量、技术和服务以便形成综合优势。国内POCT检测主要集中在二、三医院，对高通量的POCT仪器需求大。国内各生产商应跨界创新，优势互补，形成合力，才能对抗世界500强企业的产品。发展第三、四代POCT仪器是必由之路。
乙肝快速检测试剂在POCT中的应用及标准探讨
乙肝血清学标志物快速检测试剂已广泛应用于手术前检测，现场献血员筛查等其他应急检测，以及基层医疗机构常规临床检测，检测内容包括HBsAg、Anti-HBs、HBeAg、Anti-HBe、Anti-HBc 等常规的5项乙肝标志物，这些快速检测试剂具有较传统方法更为快速、简便的特点，在POCT检测中具有一定的临床应用意义。
乙肝快速检测试剂多采用胶体金法，其他方法包括胶体硒法、乳胶法等，其原理与传统方法的酶联免疫法相同，由于判断方法的不同，操作过程快速、简便，与酶联免疫法、化学发光法等试剂质量标准存在差异，主要表现在灵敏度方面，HBsAg最低检出量，酶联免疫法试剂可达到0.05~0.1IU/ml, 快速检测试剂仅为4~5 IU/ml，Anti-HBs最低检出量，酶联免疫法试剂10IU/ml, 快速检测试剂30 IU/ml，另3种乙肝标志物最低检出限酶联免疫法试剂均高于快速检测试剂2~3倍稀释度。因此，快速检测试剂也在临床应用受到一定的限制。
乙肝快速检测试剂属于医疗器械管理，在众多的乙肝试剂申报注册中尚无快速检测试剂进口注册，已申报的注册产品标准存在不规范，目前已建立了乙肝5项试剂的国家参考品，为制订该产品的医疗器械行业标准提供依据。
POCT质量管理
POCT是患者近旁进行分析，操作简单，使用方便，可快速得到检测结果。因其有助于缩短治疗周期、改进治疗效果和提高医疗效率，因此，在面对目前门诊量激增、医患的需求等状况，如血糖监测、血气和酸碱平衡、心脏标志物等POCT项目以其优势得到了各级医疗机构的广泛应用。但是，由于一些POCT项目使用的检测方法性能易受到如环境、样品性质、检测方法原理、试纸批号和校准等因素影响，且POCT的检测场所往往是在非传统的大中型检验实验室中、由非检验专业人员操作，其检测结果与中大型检测系统间存在偏差，如果使用不当，POCT可能对患者的医疗效果产生不利的影响，也可能造成医疗费用的不合理增加。因此，加强POCT质量管理对质控管理中心和医院提出了更高的要求。
以POCT血糖仪为例，2009年和2010年卫生部办公厅分别印发了相关管理通知来规范血糖仪的临床使用。上海地区于2009年依据国家和行业规范，从人员培训、室内质控、室间质评和与全自动生化仪检测比对等方面实施质量管理，取得了一定效果。操作人员对POCT质控意识大大增强，操作过程日趋规范，室间质评的符合率有显著提高。POCT的质量管理还是一个在不断探讨和实践的工作，希望通过各方共同努力，将POCT这个技术存优去劣，更好地服务于临床。