目的:通过对美国FDA的紧急使用授权(Emergency Use Authorization,EUA)制度进行研究,结合我国国情,探讨在我国建立医疗产品紧急使用授权机制。方法:文献研究、专题访谈。结果与结论:紧急使用授权制度有别于我国现有的特别审评程序,对于...目的:通过对美国FDA的紧急使用授权(Emergency Use Authorization,EUA)制度进行研究,结合我国国情,探讨在我国建立医疗产品紧急使用授权机制。方法:文献研究、专题访谈。结果与结论:紧急使用授权制度有别于我国现有的特别审评程序,对于应对突发事件应急状态下所需药物的评估和使用授权,提高药物使用的安全性、时效性、可及性及合规性具有重要意义。本研究初步提出了在我国建立医疗产品紧急使用授权机制的考虑要点,包括建立紧急使用授权制度的必要性、制度的基本定位、上位法的支持、制度构建的关键要素、配套的技术指南及其他需要关注的问题。展开更多
AIM： To study the morphology and ontogeny of dendritic cells of Peyer＇s patches in rats at different development periods. METHODS： The morphometric and flow cytometric analyses were performed to detect all the para...AIM： To study the morphology and ontogeny of dendritic cells of Peyer＇s patches in rats at different development periods. METHODS： The morphometric and flow cytometric analyses were performed to detect all the parameters of villous-crypts axis and the number of OX62＋DC, OX62＋CD4＋SIRP＋DC, and OX62＋CD4-SIRP-DC in the small intestine in different groups of rats. The relationship between the parameters of villous-axis and the number of DC and DC subtype were analyzed. RESULTS： All morphometric parameters changed significantly with the development of pups in the different age groups （F = 10.751, 12.374, 16.527, 5.291, 3.486; P = 0.000, 0.000, 0.000, 0.001, 0.015）. Villous height levels were unstable and increased from 115.24μm to 140.43 μm as early as 3 wk postpartum. Villous area increased significantly between 5 and 7 wk postpartum, peeked up to 13817.60 tam2 at 7 wk postpartum. Villous height and crypt depth ratios were relatively stable and increased significantly from 2.80 ＋ 1.01 to 4.54 =1= 1.56, 9-11 wk postpartum. The expression of OX62＋DC increased from 33.30%±5.80% to 80%± 17.30%, 3-11 wk postpartum （F =5.536, P = 0.0013）. OX62＋CD4＋SIRP＋DC subset levels detected in single-cell suspensions of rat total Peyer＇s patch dendritic cells （PP-DCs） increased significantly from 30.73% ± 5.16% to 35.50% ± 4.08%, 5-7 wk postpartum and from 34.20% ±1.35% to 43.60% ± 2.07% 9-11 wk postpartum （F = 7.216, P = 0.005）. CONCLUSION： This study confirms the agerelated changes in villous-crypt axis differentiation in the small intestine. Simultaneously, there are also development and maturation in rat PP-DCs phenotypic expression. Furthermore, the morphological changes of intestinal mucosa and the development of immune cells （especially DC） peaked at 9-11 wk postpartum, indicating that the intestinal mucosae reached a relatively mature state at 11 wk postpartum.展开更多
A number of contingencies simulated during dynamic security assessment do not generate unacceptable values of power system state variables, due to their small influence on system operation. Their exclusion from the se...A number of contingencies simulated during dynamic security assessment do not generate unacceptable values of power system state variables, due to their small influence on system operation. Their exclusion from the set of contingencies to be simulated in the security assessment would achieve a significant reduction in computation time. This paper defines a critical contingencies selection method for on-line dynamic security assessment. The selection method results from an off-line dynamical analysis, which covers typical scenarios and also covers various related aspects like frequency, voltage, and angle analyses among others. Indexes measured over these typical scenarios are used to train neural networks, capable of performing on-line estimation of a critical contingencies list according to the system state.展开更多
文摘目的:通过对美国FDA的紧急使用授权(Emergency Use Authorization,EUA)制度进行研究,结合我国国情,探讨在我国建立医疗产品紧急使用授权机制。方法:文献研究、专题访谈。结果与结论:紧急使用授权制度有别于我国现有的特别审评程序,对于应对突发事件应急状态下所需药物的评估和使用授权,提高药物使用的安全性、时效性、可及性及合规性具有重要意义。本研究初步提出了在我国建立医疗产品紧急使用授权机制的考虑要点,包括建立紧急使用授权制度的必要性、制度的基本定位、上位法的支持、制度构建的关键要素、配套的技术指南及其他需要关注的问题。
基金Supported by Grants from the National Natural Science Foundation of China,No.30571979
文摘AIM： To study the morphology and ontogeny of dendritic cells of Peyer＇s patches in rats at different development periods. METHODS： The morphometric and flow cytometric analyses were performed to detect all the parameters of villous-crypts axis and the number of OX62＋DC, OX62＋CD4＋SIRP＋DC, and OX62＋CD4-SIRP-DC in the small intestine in different groups of rats. The relationship between the parameters of villous-axis and the number of DC and DC subtype were analyzed. RESULTS： All morphometric parameters changed significantly with the development of pups in the different age groups （F = 10.751, 12.374, 16.527, 5.291, 3.486; P = 0.000, 0.000, 0.000, 0.001, 0.015）. Villous height levels were unstable and increased from 115.24μm to 140.43 μm as early as 3 wk postpartum. Villous area increased significantly between 5 and 7 wk postpartum, peeked up to 13817.60 tam2 at 7 wk postpartum. Villous height and crypt depth ratios were relatively stable and increased significantly from 2.80 ＋ 1.01 to 4.54 =1= 1.56, 9-11 wk postpartum. The expression of OX62＋DC increased from 33.30%±5.80% to 80%± 17.30%, 3-11 wk postpartum （F =5.536, P = 0.0013）. OX62＋CD4＋SIRP＋DC subset levels detected in single-cell suspensions of rat total Peyer＇s patch dendritic cells （PP-DCs） increased significantly from 30.73% ± 5.16% to 35.50% ± 4.08%, 5-7 wk postpartum and from 34.20% ±1.35% to 43.60% ± 2.07% 9-11 wk postpartum （F = 7.216, P = 0.005）. CONCLUSION： This study confirms the agerelated changes in villous-crypt axis differentiation in the small intestine. Simultaneously, there are also development and maturation in rat PP-DCs phenotypic expression. Furthermore, the morphological changes of intestinal mucosa and the development of immune cells （especially DC） peaked at 9-11 wk postpartum, indicating that the intestinal mucosae reached a relatively mature state at 11 wk postpartum.
文摘A number of contingencies simulated during dynamic security assessment do not generate unacceptable values of power system state variables, due to their small influence on system operation. Their exclusion from the set of contingencies to be simulated in the security assessment would achieve a significant reduction in computation time. This paper defines a critical contingencies selection method for on-line dynamic security assessment. The selection method results from an off-line dynamical analysis, which covers typical scenarios and also covers various related aspects like frequency, voltage, and angle analyses among others. Indexes measured over these typical scenarios are used to train neural networks, capable of performing on-line estimation of a critical contingencies list according to the system state.
