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Incidence of luminal gastrointestinal cancers in patients with cirrhosis:A systematic review and meta-analysis
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作者 Manisha Jogendran Kai Zhu +4 位作者 Rohit Jogendran Nasruddin Sabrie Trana Hussaini Eric M Yoshida Daljeet Chahal 《World Journal of Meta-Analysis》 2025年第1期38-45,共8页
BACKGROUND The global incidence of cirrhosis and luminal gastrointestinal cancers are increasing.It is unknown if cirrhosis itself is a predisposing factor for luminal gastrointestinal cancer.Such an association would... BACKGROUND The global incidence of cirrhosis and luminal gastrointestinal cancers are increasing.It is unknown if cirrhosis itself is a predisposing factor for luminal gastrointestinal cancer.Such an association would have significant clinical implications,particularly for cancer screening prior to liver transplantation.AIM To investigate the incidence of luminal gastrointestinal cancers in patients with underlying cirrhosis.METHODS An electronic search was conducted to study the incidence of luminal gastrointestinal cancers in patients with cirrhosis.Study-specific standardized incidence ratios(SIR)along with corresponding 95%CI for both overall cancer incidence and luminal cancer incidence were analyzed using a random-effects model.Subgroup analysis was performed based on cirrhosis etiology and location of luminal malignancy.RESULTS We identified 5054 articles;4 studies were selected for data extraction.The overall incidence of all cancers was significantly higher in patients with cirrhosis,with an SIR of 2.79(95%CI:2.18–3.57).When stratified by cirrhosis etiology,the incidence of luminal cancers remained significantly elevated for alcohol(SIR=3.13,95%CI:2.24–4.39),Primary Biliary Cholangitis(SIR=1.40,95%CI:1.10–1.79),and unspecified cirrhosis(SIR=3.52,95%CI:1.87–6.65).CONCLUSION The incidence of luminal gastrointestinal cancer is increased amongst patients with cirrhosis.Oral cavity,pharyngeal and esophageal cancer had increased incidence across all cirrhosis etiologies compared to gastric and colorectal cancer.Therefore,increased screening of luminal cancers,and in particular these upper luminal tract subtypes,should be considered in this population. 展开更多
关键词 Liver disease Cancer epidemiology CIRRHOSIS
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New low noise interface circuit for detecting weak current of micro-sensors
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作者 谭晓昀 孙明 +2 位作者 王佳琪 尹亮 刘晓为 《Journal of Harbin Institute of Technology(New Series)》 EI CAS 2011年第4期9-12,共4页
A new low noise interface circuit for detecting weak current of micro-sensors is designed.By using the transimpedance amplifier to substitute the charge amplifier,the closed-loop circuit can avoid the phase error of t... A new low noise interface circuit for detecting weak current of micro-sensors is designed.By using the transimpedance amplifier to substitute the charge amplifier,the closed-loop circuit can avoid the phase error of the charge amplifier.Therefore,the phase compensation devices will be cancelled,because there is no phase transformation through the transimpedance amplifier.As well as,by using CCCII devices to implement the high value feedback resistor of the impedance amplifier,the noise of the I-V transformation devices is reduced,comparing with the passive resistor.The floating resistor is easy to be integrated into chips,making the integration of the interface circuit of the intelligent sensors increase.Through the simulation,the phase error of the charge amplifier is almost 9°at 2 kHz and it changes with the working frequency of the micro-sensors making the phase compensation not easy.The value of the floating resistor is 250 kΩ where the bias current is 50 μA.The noise of the active resistor is 0.037 fV2/Hz,comparing with the noise of the passive resistor,which is 4.14 fV2/Hz. 展开更多
关键词 micro-sensor weak signal detection phase error low noise
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Relationship between adipose tissue dysfunction,vitamin D deficiency and the pathogenesis of non-alcoholic fatty liver disease 被引量:13
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作者 Flavia A Cimini Ilaria Barchetta +5 位作者 Simone Carotti Laura Bertoccini Marco G Baroni Umberto Vespasiani-Gentilucci Maria-Gisella Cavallo Sergio Morini 《World Journal of Gastroenterology》 SCIE CAS 2017年第19期3407-3417,共11页
Non-alcoholic fatty liver disease(NAFLD)is the most common chronic liver disease worldwide.Its pathogenesis is complex and not yet fully understood.Over the years many studies have proposed various pathophysiological ... Non-alcoholic fatty liver disease(NAFLD)is the most common chronic liver disease worldwide.Its pathogenesis is complex and not yet fully understood.Over the years many studies have proposed various pathophysiological hypotheses,among which the currently most widely accepted is the"multiple parallel hits"theory.According to this model,lipid accumulation in the hepatocytes and insulin resistance increase the vulnerability of the liver to many factors that act in a coordinated and cooperative manner to promote hepatic injury,inflammation and fibrosis.Among these factors,adipose tissue dysfunction and subsequent chronic low grade inflammation play a crucial role.Recent studies have shown that vitamin D exerts an immune-regulating action on adipose tissue,and the growing wealth of epidemiological data is demonstrating that hypovitaminosis D is associated with both obesity and NAFLD.Furthermore,given the strong association between these conditions,current findings suggest that vitamin D may be involved in the relationship between adipose tissue dysfunction and NAFLD.The purpose of this review is to provide an overview of recent advances in the pathogenesis of NAFLD in relation to adipose tissue dysfunction,and in the pathophysiology linking vitamin D deficiency with NAFLD and adiposity,together with an overview of the evidence available on the clinical utility of vitamin D supplementation in cases of NAFLD. 展开更多
关键词 Adipose tissue dysfunction Vitamin D Non-alcoholic fatty liver disease STEATOSIS Non-alcoholic steatohepatitis OBESITY ADIPOKINES
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数字时代中国话语国际传播的问题与应对策略 被引量:6
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作者 王晨佳 陆航 《陕西师范大学学报(哲学社会科学版)》 CSSCI 北大核心 2022年第5期167-176,共10页
数字技术进步和广泛应用推动了数字经济的蓬勃发展,对国际传播的格局、场景、内容和途径都产生了深远的影响。数字时代中国国际话语传播的问题包括:文化传播失衡、大众话语匮乏、话语误读误传、学术话语说服力不足,以及学术话语逆差等... 数字技术进步和广泛应用推动了数字经济的蓬勃发展,对国际传播的格局、场景、内容和途径都产生了深远的影响。数字时代中国国际话语传播的问题包括:文化传播失衡、大众话语匮乏、话语误读误传、学术话语说服力不足,以及学术话语逆差等。针对数字时代话语传播的底层基础和深层次内容问题,其应对的策略有:突破“自我塑造”“他者塑造”的单向路径,转向大众话语和学术话语一体两翼,内容构建和国际传播融合共生,构建“人类命运共同体”,提高传播影响力、中国话语说服力、国际舆论引导力。 展开更多
关键词 中国话语 国际传播 大众话语 学术话语 人类命运共同体
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Revascularization for Iliac-femoral Artery Pseudoaneurysm with Greater Saphenous Vein 被引量:4
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作者 Ji-dong Wu Yue-hong Zheng +1 位作者 Nim Choi Furtado Rui 《Chinese Medical Sciences Journal》 CAS CSCD 2010年第1期57-60,共4页
Objective To investigate the role of revascularization procedures with autologous greater saphenous vein in surgical management of iliac-femoral artery pseudoaneurysm in parenteral drug abusers. Methods Twenty-one pat... Objective To investigate the role of revascularization procedures with autologous greater saphenous vein in surgical management of iliac-femoral artery pseudoaneurysm in parenteral drug abusers. Methods Twenty-one patients with iliac-femoral artery pseudoaneurysm caused by parenteral drug abuse from 2004 to 2007 were enrolled. Among them,15 patients were male and 6 were female; their average age was 31.3 years. The size of pseudoaneurysms ranged from 3.0 cm to 7.5 cm. Common femoral artery and distal external iliac artery were often involved. We performed arterial reconstruction on these patients with autologous greater saphenous vein as a graft after excising iliac-femoral artery pseudoaneurysm through a single curved inguinal incision. All patients were followed up,and the complications were recorded. Results The surgical procedures were finished without intraoperative mortality or perioperative complications. All patients were free of claudication symptoms after the surgery except one case with preoperative popliteal artery stenosis. One case of infection and wound tissue fistula was found later. One case had inguinal incisional hematoma and another complained of numbness in thigh skin. Conclusions The use of autologous greater saphenous venous grafts for arterial reconstruction after pseudoaneurysm excision in drug abusers is safe and effective. This technique offers more advantages than arterial ligation alone without revascularization. An optimal greater saphenous venous graft is a prerequisite for revascularization. 展开更多
关键词 PSEUDOANEURYSM drug abuser BYPASS greater saphenous vein
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Discharge-Stage Relationship on Urban Streams Evaluated at USGS Gauging Stations,St.Louis,Missouri 被引量:1
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作者 Robert E.Criss David L.Nelson 《Journal of Earth Science》 SCIE CAS CSCD 2020年第6期1133-1141,共9页
Extensive USGS data tables and detailed,1 m2 Li DAR surveys are used to determine the optimal power n that relates discharge(Q)to stage(h*)above channel bottom(ho)at 39 gauging stations on small streams in the St.Loui... Extensive USGS data tables and detailed,1 m2 Li DAR surveys are used to determine the optimal power n that relates discharge(Q)to stage(h*)above channel bottom(ho)at 39 gauging stations on small streams in the St.Louis,Missouri area,all of which have catchments of 0.6 to 220 km2.Four different methodologies are employed to determine both n and ho:(1)optimizing linearity in a plot of Q1/n vs.local stage(hL)using USGS field measurements at each site;(2)optimizing linearity in a plot of Q1/n vs.hL using USGS rating tables at each site;(3)a mathematical inverse method applied to the same USGS rating tables;(4)use of Li DAR data on channel geometry to determine the power dependences of channel area A and hydraulic radius H on h*,combined with the Manning and rational equations to predict n.Of these methods,only methods 2 and 3 compare favorably,and these values compare poorly with Method 1 based on field data,and with method 4 based on theoretical and empirical relationships.Because Method 4 is predictive,it provides a useful alternative to methods 1–3 that are based on USGS field measurements,which are heavily weighted toward low discharges.We conclude that the apparent values of n in the USGS rating tables are systematically too low for small streams. 展开更多
关键词 stream gauging Li DAR topography urban flooding DISCHARGE HYDROLOGY
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The Application of BP Neural Networks to Analysis the National Vulnerability 被引量:1
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作者 Guodong Zhao Yuewei Zhang +2 位作者 Yiqi Shi Haiyan Lan Qing Yang 《Computers, Materials & Continua》 SCIE EI 2019年第2期421-436,共16页
Climate change is the main factor affecting the country’s vulnerability,meanwhile,it is also a complicated and nonlinear dynamic system.In order to solve this complex problem,this paper first uses the analytic hierar... Climate change is the main factor affecting the country’s vulnerability,meanwhile,it is also a complicated and nonlinear dynamic system.In order to solve this complex problem,this paper first uses the analytic hierarchy process(AHP)and natural breakpoint method(NBM)to implement an AHP-NBM comprehensive evaluation model to assess the national vulnerability.By using ArcGIS,national vulnerability scores are classified and the country’s vulnerability is divided into three levels:fragile,vulnerable,and stable.Then,a BP neural network prediction model which is based on multivariate linear regression is used to predict the critical point of vulnerability.The function of the critical point of vulnerability and time is established through multiple linear regression analysis to obtain the regression equation.And the proportion of each factor in the equation is established by using the partial least-squares regression to select the main factors affecting the country’s vulnerability,and using the neural network algorithm to perform the fitting.Lastly,the BP neural network prediction model is optimized by genetic algorithm to get the chaotic time series BP neural network prediction model.In order to verify the practicability of the model,Cambodia is selected to be an example to analyze the critical point of the national vulnerability index. 展开更多
关键词 Climate change BP neural networks national vulnerability GA-BP
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Case study scenarios in site selection of hazardous material facilities based on transportation preferences 被引量:1
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作者 Babak Mehran Musharraf Ahmad Khan +2 位作者 Mina Mehran Hyukjae Roh Satish Sharma 《Journal of Modern Transportation》 2019年第4期317-333,共17页
A methodology is proposed to evaluate and rank potential sites for facilities dealing with hazardous materials(HAZMAT).The proposed methodology incorporates HAZMAT route planning into facility siting while considering... A methodology is proposed to evaluate and rank potential sites for facilities dealing with hazardous materials(HAZMAT).The proposed methodology incorporates HAZMAT route planning into facility siting while considering transportation preferences and challenges.The area of interest is divided into smaller zones representing potential sites for a HAZMAT facility.A multimodal transportation network including railways and roads is considered for transportation of HAZMAT.Each zone is evaluated based on its accessibility from a set of selected points of interests(POIs),which are defined as potential origin/destination points for transportation of HAZMAT.The shortest routes between each POI and potential zones are evaluated based on a cost function which can accommodate multiple criteria to determine the associated disutility for each potential zone.Finally,zones are ranked based on their cumulative disutility scores.The proposed analysis method is quantitative,and at the same time it is adequately flexible to allow inclusion of subjective criteria.Application of the proposed methodology is demonstrated for identifying optimal locations for a HAZMAT facility(e.g.,a nuclear facility)using the Canadian province of Saskatchewan as an example.Three scenarios were evaluated including(1)all network segments and POIs were treated equally,(2)network segments were rank ordered based on their functional classification while POIs were treated equally and(3)network segments were rank ordered based on their functional classification with preferences given to specific POI(s). 展开更多
关键词 HAZMAT TRANSPORTATION SITE selection ROUTE PLANNING Shortest PATH analysis
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一种miRNA标记在胶质瘤侵袭性表型的确定与预后评估中的价值(英文) 被引量:6
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作者 Barbano R Palumbo O +13 位作者 Pasculli B Galasso M Volinia S D'Angelo V Icolaro N Coco M Dimitri L Graziano P Copetti M Valori VM Maiello E Carella M Fazio VM Parrella P 《中华神经外科疾病研究杂志》 CAS 2014年第5期433-433,共1页
Gliomas represent a disparate group of tumours for which there are to date no cure. Thus,there is a recognized need for new diagnostic and therapeutic approaches based on increased understanding of their molecular nat... Gliomas represent a disparate group of tumours for which there are to date no cure. Thus,there is a recognized need for new diagnostic and therapeutic approaches based on increased understanding of their molecular nature. We performed the comparison of the microRNA( miRNA) profile of 8 WHO grade II gliomas and 24 higher grade tumours( 2 WHO grade III and 22 glioblastomas) by using the Affymetrix Gene Chip miRNA Array v. 1. 0. A relative quantification method( RT-q PCR) with standard curve was used to confirm the 22 miRNA signature resulted by array analysis. The prognostic performances of the confirmed miRNAs were estimated on the Tumor Cancer Genome Atlas( TCGA) datasets. We identified 22 miRNAs distinguishing grade II gliomas from higher grade tumours.RT-q PCR confirmed the differential expression in the two patients' groups for 13 out of the 22 miRNAs. The analysis of the Glioblastoma Multiforme( GBM) and Lower Grade Glioma( LGG) datasets from TCGA demonstrated the association with prognosis for 6 of those miRNAs. Moreover,in the GBM dataset miR-21 and miR-210 were predictors of worse prognosis in both univariable and multivariable Cox regression analyses( HR 1. 19,P = 0. 04,and HR 1. 18,P = 0. 029 respectively). Our results support a direct contribution of miRNAs to glioma cancerogenesis and suggest that miR-21 and miR-210 may play a role in the aggressive clinical behaviour of glioblastomas. 展开更多
关键词 神经外科学 疾病 临床研究 医学
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监测国际人用药品注册技术协调会(ICH)指南的执行和落实情况——2021年项目报告 被引量:2
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作者 Juan Lara Magda Bujar 曾亚莉 《中国食品药品监管》 2022年第6期92-107,共16页
本研究通过国际监管科学创新中心(CIRS)与国际人用药品注册技术协调会(ICH)合作开发并定义的在线调研问卷,监测并评估ICH非常任、非创始的监管机构成员对ICH二、三级指南,以及ICH观察员对ICH一级指南的执行和落实情况,重点介绍ICH指南... 本研究通过国际监管科学创新中心(CIRS)与国际人用药品注册技术协调会(ICH)合作开发并定义的在线调研问卷,监测并评估ICH非常任、非创始的监管机构成员对ICH二、三级指南,以及ICH观察员对ICH一级指南的执行和落实情况,重点介绍ICH指南执行和落实情况评估结果、主要监管机构成员和ICH观察员的自我评估,以及跨国制药公司对各监管机构执行情况的反馈。研究结果表明,各参与研究的监管机构对ICH指南的执行和落实程度非常高,制药企业看法与监管机构自我评估结果一致。 展开更多
关键词 ICH 监管 指南 执行
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监管科学发展下药品审批提效的实践探讨 被引量:3
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作者 王刚 曾亚莉 +3 位作者 雷灿 黄庭颖 Magda Bujar Ting Wang 《中国食品药品监管》 2021年第7期34-41,共8页
药品监管科学研究在最近10年取得了长足的发展。不管是从研究论文的产出,还是监管机构的法规以及指南文件的及时发布,均体现了顺应当前科技发展的需求。面对持续增长的审评压力,监管机构在资源有限的情况下,通过设置监管促进路径、开启... 药品监管科学研究在最近10年取得了长足的发展。不管是从研究论文的产出,还是监管机构的法规以及指南文件的及时发布,均体现了顺应当前科技发展的需求。面对持续增长的审评压力,监管机构在资源有限的情况下,通过设置监管促进路径、开启共享审评模式等方式,提高审评效率,加速新药上市。展望未来的药品审评审批发展,将始终坚持以患者为中心的宗旨,全面考虑和平衡多个利益相关方的诉求,从而真正加速并优化创新产品从法规审评到患者可及的全流程。 展开更多
关键词 监管审评 监管科学 共享审评模式 监管促进路径 卫生技术评估
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Thoraco-abdominal Aorta Revascularization through a Retroperitoneal Approach 被引量:1
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作者 Yue-hong Zheng Kun Yu +3 位作者 Jie-feng Zhang Nim Choi Hong-ru Deng Furtado Rui 《Chinese Medical Sciences Journal》 CAS CSCD 2010年第4期233-236,共4页
Objective To investigate the application of the retroperitoneal approach in aortic surgery. Methods We collected and analyzed data of 7 patients in Macao who presented with aortic diseases from 2007 to 2008 and were t... Objective To investigate the application of the retroperitoneal approach in aortic surgery. Methods We collected and analyzed data of 7 patients in Macao who presented with aortic diseases from 2007 to 2008 and were treated with aorta repair through retroperitoneal approach. Demographic features as well as intraoperative and postoperative data were analyzed. One case of thoracoabdominal aneurysm and 4 cases of abdominal aneurysm received artificial graft, among which hybrid iliac artery reconstruction with Zenith stent covering the ostium of the left subclavian artery was performed in 2 cases of infrarenal abdominal aneurysm. Aortic-iliac artery bypass was performed in 2 cases of aortoiliac occlusion. Results No operative or early postoperative death was observed. No perioperative intestinal adhesion or ureteral obstruction was found. One case reported delayed paraplegia and graft infection as postoperative complications. The complications were partially removed 3 months later after rehabilitation. Conclusion Retroperitoneal approach is a safe and feasible technique, which associated with a low incidence of postoperative pulmonary complications. 展开更多
关键词 AORTA retroperitoneal approach REVASCULARIZATION
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2012~2021年国外六大监管机构新药审评情况分析:聚焦监管促进路径和国际化 被引量:1
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作者 Juan Lara Magda Bujar +1 位作者 Neil McAuslane 张颖(编译) 《中国食品药品监管》 2023年第6期12-29,共18页
本文介绍了国际监管科学创新中心(CIRS)对六大监管机构批准的新活性物质(NAS)的年度分析结果,重点分析了2021年NAS批准情况,并回顾了2012~2021年的情况。通过分析可以看出,尽管中位批准时间可以作为考量监管机构工作效率和药物获批上市... 本文介绍了国际监管科学创新中心(CIRS)对六大监管机构批准的新活性物质(NAS)的年度分析结果,重点分析了2021年NAS批准情况,并回顾了2012~2021年的情况。通过分析可以看出,尽管中位批准时间可以作为考量监管机构工作效率和药物获批上市所需时间的重要指标,但同时也需要考虑其他因素,包括监管促进路径(FRP)、NAS的国际化以及新数据来源[包括真实世界数据(RWD)]的使用等。 展开更多
关键词 监管机构 批准时间 监管促进路径
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聚焦加速审评通道和国际化——2010~2019年国外六大监管机构新药审批情况分析 被引量:1
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作者 Celine Rodier Magda Bujar 曾亚莉(编译) 《中国食品药品监管》 2020年第9期54-71,共18页
本文介绍了国际监管科学创新研究中心(CIRS)对六大监管机构批准的新活性物质(NAS)的年度分析结果,对2010~2019年情况进行回顾,重点介绍了2019年六大监管机构NAS批准情况和关注的2个因素,即加速审评通道(FRP)和基于企业为确保能够在全球... 本文介绍了国际监管科学创新研究中心(CIRS)对六大监管机构批准的新活性物质(NAS)的年度分析结果,对2010~2019年情况进行回顾,重点介绍了2019年六大监管机构NAS批准情况和关注的2个因素,即加速审评通道(FRP)和基于企业为确保能够在全球范围内及时供应药品制定的申报策略而实施的药物国际化进程,以期为新药审评审批提供参考。 展开更多
关键词 新活性物质 监管 加速审评 EMA FDA
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U-Pb SHRIMP-II Baddeleyite and Zircon Dating of the Early Proterozoic Monchegorsk Layered Mafite-Ultramafite Complex(Kola Peninsula): Evidence of Synchronous Magmatism
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作者 Nickolay V.Rodionov Anton A.Antonov +1 位作者 Boris V.Belyatsky Sergey A.Sergeev 《Acta Geologica Sinica(English Edition)》 SCIE CAS CSCD 2016年第S1期79-80,共2页
The Early Paleoproterozoic Monchegorsk Complex is exposed over an area of 550 km;and comprises two layered mafite–ultramafite intrusions:the Monchepluton of ultramafic and mafic rocks and the predominantly gabbroid
关键词 SHRIMP U-Pb SHRIMP-II Baddeleyite and Zircon Dating of the Early Proterozoic Monchegorsk Layered Mafite-Ultramafite Complex Pb Kola Peninsula Evidence of Synchronous Magmatism II
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Intra-Domiciliary Transmission of Chagas’ Disease in Rural Areas of Yucatan Mexico
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作者 Eugenia Guzman-Marin Karla Y. Acosta-Viana +2 位作者 Marylin Puerto-Solís Antonio Ortega-Pacheco Matilde Jimenez-Coello 《Open Journal of Epidemiology》 2016年第4期244-255,共12页
With the objective to describe the relationship between T. cruzi infection in humans and sinantropic reservoir and vectors in the rural conditions a study was performed in municipalities of the Yucatan state in Mexico... With the objective to describe the relationship between T. cruzi infection in humans and sinantropic reservoir and vectors in the rural conditions a study was performed in municipalities of the Yucatan state in Mexico. Blood samples from humans, dogs and opossum were taken from the households. Vectors were also collected and the infection and infestation indexes were calculated. Serum samples were evaluated by indirect hemagglutination (IH) and indirect immunofluorescence (IFI) to determine IgG antibodies against Trypanosoma cruzi. The polymerase chain reaction (PCR) was also performed in the samples taken from humans and reservoirs. Blood smears were performed in reservoirs. Sampled humans underwent to an electrocardiographic study to identify functional and conduction alterations of the heart. Household building characteristics were noted. A total of 367 blood samples were collected from people. The presence of IgG antibodies was 16.6% and 71.0% at PCR. Electrocardiographic studies revealed that 31% of patients seropositive to T. cruzi have a medical condition. 20.0% of dogs were seropositive and 68.5 positive to PCR. At the direct detection 13.6% resulted positive. In opossum 29.1% were seropositive and 72.9% positive to PCR. A total of 269 triatomineos were captured and 52.7% were infected with T. cruzi. The infection and infestation index were 52.4% and 60.8% respectively. The presence of adult vectors and their nymph’s were more frequently found in households made with wattle roofs (45.2 and 73.9 % respectively) than other kind of building materials. Electrocardiographic abnormalities found in positive persons were: Incomplete right bundle branch block (55%), tachycardia (35%), old myocardial infarction (5%) and incomplete block of the left bundle (5%). This work highlights the importance of comprehensive studies on the transmission of T. cruzi in the Yucatan where the link between human infection in synanthropic reservoirs and vectors is established. This information is important to design programs for the epidemiological surveillance and control to break the chain of transmission of the disease. 展开更多
关键词 Trypanosoma cruzi VECTORS SEROLOGY PCR Zoonosis.
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韩国K-REACH监管扩容
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《中国洗涤用品工业》 2017年第3期96-96,98,100,共3页
2016年11月29号,为了全面审查和升级家用化学产品的安全性,韩国国家内阁委员会确定并且宣布K-REACH法规中正式加入"家用化学产品安全管理办法"。该办法主要针对公众健康有影响的家用化学产品并以此来预防类似加湿器杀菌剂等重大事故... 2016年11月29号,为了全面审查和升级家用化学产品的安全性,韩国国家内阁委员会确定并且宣布K-REACH法规中正式加入"家用化学产品安全管理办法"。该办法主要针对公众健康有影响的家用化学产品并以此来预防类似加湿器杀菌剂等重大事故发生。 展开更多
关键词 韩国 扩容 监管 化学产品 安全管理办法 事故发生 公众健康 安全性
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2014~2023年六大监管机构新药审评情况分析:不断演变的监管环境与监管促进路径
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作者 Juan Lara Magda Bujar +4 位作者 Adem Kermad Neil McAuslane Anna Somuyiwa 曾亚莉(编译) 李丹(整理) 《中国食品药品监管》 2024年第11期60-73,共14页
本文介绍了国际监管科学创新研究中心(CIRS)对六大监管机构批准的新活性物质(NAS)的年度审评情况,重点分析了2023年NAS批准情况,回顾了2014~2023年的审评情况。通过分析可以看出,虽然各监管机构的中位批准时间仍存在显著差异,但从递交... 本文介绍了国际监管科学创新研究中心(CIRS)对六大监管机构批准的新活性物质(NAS)的年度审评情况,重点分析了2023年NAS批准情况,回顾了2014~2023年的审评情况。通过分析可以看出,虽然各监管机构的中位批准时间仍存在显著差异,但从递交到科学审评时间的差异在逐渐缩小。美国食品药品监督管理局依然是批准NAS最多的机构,欧洲药品管理局批准数量显著增加,罕见病药占比整体呈上升趋势,这主要与各企业申报策略和规模、未满足的医疗需求、监管审评速度,基于风险的审评路径以及采用合作或共享审评机制等有关。 展开更多
关键词 新活性物质 监管 批准时间 监管促进路径 罕见病药
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Analysis of Regulatory Policies and Registration/Record Keeping Status of Domestic Cosmetics in China
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作者 CIRS 《China Detergent & Cosmetics》 2018年第2期54-56,共3页
On December 5,2017,CFDA issued a notice on regulating cosmetics registration and filing application(Decree No.195,2017),in order to ensure that the company information on the new version of Cosmetics Production Licens... On December 5,2017,CFDA issued a notice on regulating cosmetics registration and filing application(Decree No.195,2017),in order to ensure that the company information on the new version of Cosmetics Production License and recorded products is consistent.For approved domestic special use cosmetics,the application for the change of company info is not required when the actual production place has no change,but should apply for the change when applying for 展开更多
关键词 化妆品行业 行业管理 发展现状 中国
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Latest Update of Cosmetic Regulations in China Since 2017
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作者 CIRS 《China Detergent & Cosmetics》 2018年第2期66-69,共4页
Great changes happened to Chinese cosmetics regulations in 2017. This article focuses on the latest update of cosmetics regulations in China since 2017 and assesses how those changes will impact the import of cosmetic... Great changes happened to Chinese cosmetics regulations in 2017. This article focuses on the latest update of cosmetics regulations in China since 2017 and assesses how those changes will impact the import of cosmetics to China.Data of registered or recorded cosmetics with CFDA or local FDAs Import cosmetics by 展开更多
关键词 化妆品行业 法律法规 发展现状 行业管理
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