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1.
监管科学是被世界卫生组织和美欧日等制药强国高度重视和发展的一门前沿交叉学科,有力提升了药品创新能力和监管效能,已被美国教育部门明确认定为大门类一级学科,初步形成本科、硕士和博士层面完备的教育培养体系。为提高我国药品监管的科技化、法治化、现代化和国际化水平,2019年国家药监局启动"中国药品监管科学行动计划"。明确监管科学学科定位和培养高层次专业人才是促进监管科学可持续发展的基础和根本保障。本文梳理了监管科学在美欧日高校的学科设置、学术研究、人才培养和转化应用情况,对比分析了我国监管科学发展的特点和优势,提出在我国高校设置专业学位、培养监管人才的重要意义和发展路径。 相似文献
2.
《Research in social & administrative pharmacy》2022,18(9):3694-3698
In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area. 相似文献
3.
神经纤毛蛋白-1(Neuropilin-1,NRP-1)是一种非酪氨酸激酶跨膜蛋白,可表达于多种肿瘤细胞及免疫细胞,与不同配体结合后参与轴突形成、血管发育、免疫调节和肿瘤发生等过程。最近,NRP-1在肿瘤免疫学领域引起广泛关注,其在肿瘤免疫微环境中发挥着强大的双重作用,不仅可协调免疫细胞介导的免疫抑制作用,同时可限制抗肿瘤免疫反应,与肿瘤的发生发展密切相关。越来越多的研究表明,NRP-1是肿瘤免疫治疗中独特的免疫调节分子,是最有前景的免疫检查点分子,深入探讨NRP-1在肿瘤免疫调节中的作用机制,有望为以NRP-1为靶点的免疫治疗提供新策略。本文就国内外关于NRP-1在肿瘤免疫调节作用中的最新研究进展作一综述。 相似文献
4.
急性髓系白血病(acute myeloid leukemia,AML)是常见的髓系原始细胞单克隆性恶性增殖的造血系统疾病,但是其免疫学机制目前尚不清楚。一般认为参与恶性肿瘤免疫反应的细胞包括调节性T细胞(regulatory T cells,Treg)、效应性T细胞(effective T cells,Teff)和B细胞等。B细胞具有活化T细胞、产生抗体等功能,近年发现一群具有免疫调节功能的B细胞(调节性B细胞,regulatory B cells,Breg),能够对Treg、Teff等细胞起调节作用。深入研究Breg细胞在AML的免疫学发病机制有重要意义。因此,本文就Breg细胞在AML中的研究进展进行综述。 相似文献
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6.
目的:通过检测幼年特发性关节炎(JIA)相关性葡萄膜炎(JIA-U)患儿外周血中CDld(hi)CD5+CD19+调节性B细胞(Breg)水平,探究其在JIA-U中的变化及意义。方法:选取2018-04/2020-05本院确诊收治的JIA-U患儿95例作为JIA-U组;70例JIA患儿作为JIA组;另选同时期正常健康体检儿童75例作为对照组。流式细胞仪检测外周血中CDld(hi)CD5+CD19+Breg比例;ELISA法检测外周血中IL-10水平;采用Pearson相关系数法分析CD1d(hi)CD5+CD19+Breg比例与IL-10表达及JIA-U患者病情严重程度的相关性;Logistic回归分析影响JIA-U发生的因素。结果:与对照组相比,JIA组、JIA-U组患儿外周血中CD1d(hi)CD5+CD19+Breg比例显著降低(均P<0.01),而IL-10水平显著增加(均P<0.01);与JIA组相比,JIA-U组CD1d(hi)CD5+CD19+Breg比例显著降低(P<0.01),而IL-10水平显著增加(P<0.01);与静止期相比,活动期JIA及JIA-U患者CD1d(hi)CD5+CD19+Breg比例显著降低(均P<0.01),IL-10水平显著增加(均P<0.01)。CD1d(hi)CD5+CD19+Breg比例与IL-10表达及JIA-U患者病情严重程度呈显著负相关。多因素分析发现,CD1d(hi)CD5+CD19+Breg低比例、JIA亚型为少关节型、关节炎病程<4a、IL-10高水平均是影响JIA-U发生的危险因素。结论:CDld(hi)CD5+CD19+Breg在JIA-U患儿外周血中比例显著降低,其可能参与JIA-U的发生发展,有作为JIA-U疾病严重程度判断指标的潜能。 相似文献
7.
Ralf Wagner Juliane Meißner Elena Grabski Yuansheng Sun Stefan Vieths Eberhard Hildt 《Allergy》2022,77(1):72-82
The ongoing COVID-19 pandemic caused by the SARS-CoV-2 coronavirus has affected the health of tens of millions of people worldwide. In particular, in elderly and frail individuals the infection can lead to severe disease and even fatal outcomes. Although the pandemic is primarily a human health crisis its consequences are much broader with a tremendous impact on global economics and social systems. Vaccines are considered the most powerful measure to fight the pandemic and protect people from COVID-19. Based on the concerted activities of scientists, manufacturers and regulators, the urgent need for effective countermeasures has provoked the development and licensure of novel COVID-19 vaccines in an unprecedentedly fast and flexible manner within <1 year. To ensure the safety and efficacy of these novel vaccines during the clinical development and the routine use in post-licensure vaccination campaigns existing regulatory requirements and procedures had to be wisely and carefully adapted to allow for an expedited evaluation without compromising the thoroughness of the regulatory and scientific assessment. In this review, we describe the regulatory procedures, concepts and requirements applied to guide and promote the highly accelerated development and licensure of safe and efficacious COVID-19 vaccines in Europe. 相似文献
8.
Background:This meta-analysis aimed to systematically review current available literature to assess the impact of regulatory T cells (Tregs) on the prognosis of hepatocellular carcinoma (HCC).Methods:We will browse the online databases of PubMed and Cochrane Library. The summary hazard ratio (HR) and their 95% confidence intervals (CIs) will be combined to present the value reported in the study.Conclusion:Our meta-analysis will provide useful guidance in treatment of HCC based on the reported evidences regarding the impact of Tregs on the prognosis of HCC.OSF registration number:10.17605/OSF.IO/3Q8PW 相似文献
9.
Kangni Wu Li-mengmeng Wang Meng Liu Yanghui Xiu Yongxian Hu Shan Fu He Huang Bing Xu Haowen Xiao 《Cancer science》2021,112(8):3233-3242
Vγ9Vδ2 T cells are attractive effector cells for immunotherapy with potent cytotoxic activity against a variety of malignant cells. However, the effect of Vγ9Vδ2 T cells on chemotherapy-resistant acute myeloid leukemia (AML) blasts, especially highly refractory leukemia stem cells (LSCs) is still unknown. In this study, we investigated the effect of cytotoxicity of allogeneic Vγ9Vδ2 T cells on chemotherapy-resistant AML cell lines, as well as on primary AML blasts and LSCs obtained from refractory AML patients. The results indicated that Vγ9Vδ2 T cells can efficiently kill drug-resistant AML cell lines in vitro and in vivo, and the sensitivity of AML cells to Vγ9Vδ2 T cell–mediated cytotoxicity is not influenced by the sensitivity of AML cells to chemotherapy. We further found that Vγ9Vδ2 T cells exhibited a comparable effect of cytotoxicity against LSCs to primary AML blasts. More importantly, we revealed that the CD226–extracellular signal–regulatory kinase1/2 (ERK1/2)–lysosome-associated membrane protein 1 (LAMP1) pathway is an important mechanism for Vγ9Vδ2 T cell–induced cytotoxicity against AML cells. First, Vγ9Vδ2 T cells recognized AML cells by receptor-ligand interaction of CD226–Nectin-2, which then induced ERK1/2 phosphorylation in Vγ9Vδ2 T cells. Finally, triggering the movement of lytic granules toward AML cells induced cytolysis of AML cells. The expression level of Nectin-2 may be used as a novel marker to predict the susceptibility/resistance of AML cells to Vγ9Vδ2 T cell treatment. 相似文献
10.