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某机构临床试验用药品管理的现存问题及改进措施

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中国处方药 2024年第5期22卷 53-56页

作者：黎静波彭评志玉林市第一人民医院药物临床试验机构办公室广西玉林537000

目的提升临床试验用药品管理水平,保证临床试验的质量。方法调取2021年3月~2023年7月某机构承接的32个在研项目的试验用药品管理的质控结果,对发现的问题进行归纳分析,并提出改进措施和建议。结果汇总不合格项25项,共计57个问题。通过... 详细信息

目的提升临床试验用药品管理水平,保证临床试验的质量。方法调取2021年3月~2023年7月某机构承接的32个在研项目的试验用药品管理的质控结果,对发现的问题进行归纳分析,并提出改进措施和建议。结果汇总不合格项25项,共计57个问题。通过总结分析各环节出现的问题,从人员、管理、软硬件等方面找出试验用药品管理不规范的原因。提出了完善试验用药品的管理流程,增强试验用药品标准操作规程(SOP)和管理制度的可操作性,加强研究人员的培训,加强受试者的用药教育,建立试验用药品的信息化管理系统,对试验用药品进行定期质量管理的改进措施。结论药物临床试验机构应加强试验用药品的管理和培训,通过建立《药物临床试验质量管理规范》(GCP)中心药房,配备专职药师,提高试验用药品管理水平,保证药物临床试验过程真实规范、结果科学可靠。

关键词：试验用药品药物临床试验管理问题措施

西蒙得木HSP20基因家族的进化、表达和功能分析

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生物技术通报 2024年第6期40卷 190-202页

作者：李博静郑腊梅吴乌云高飞周宜君中央民族大学生命与环境科学学院北京100081

【目的】研究西蒙得木HSP20家族成员的结构和功能,为后续研究提供支撑。【方法】从结构分析、系统发育、表达模式等方面对西蒙得木HSP20家族成员(ScHSP20s)进行系统分析,并对ScHSP20-17进行功能分析。【结果】西蒙得木基因组中包含35个H... 详细信息

【目的】研究西蒙得木HSP20家族成员的结构和功能,为后续研究提供支撑。【方法】从结构分析、系统发育、表达模式等方面对西蒙得木HSP20家族成员(ScHSP20s)进行系统分析,并对ScHSP20-17进行功能分析。【结果】西蒙得木基因组中包含35个HSP20基因座位,其中8个基因涉及串联重复,5个涉及片段重复。系统发育分析表明,35个ScHSP20聚为12个亚家族,其中核质亚家族数量最多。启动子分析表明,多数ScHSP20家族成员启动子区域含有激素响应和非生物胁迫等相关顺式作用元件。转录组分析表明,ScHSP20-35和ScHSP20-17等部分热激蛋白基因在花和种子发育过程中表达量发生显著性改变,而ScHSP20-17和ScHSP20-28等基因受高温诱导。亚细胞定位分析表明,ScHSP20-17编码的蛋白定位于细胞核中,并且在大肠杆菌、酵母和烟草中过表达ScHSP20-17能显著提高它们对高温胁迫的耐受性。【结论】部分ScHSP20家族成员参与了西蒙得木生殖发育和非生物胁迫应答。

关键词：西蒙得木 HSP20 亚细胞定位表达分析高温胁迫

Animal models of eosinophilic esophagitis,review and perspectives

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Animal Models and Experimental Medicine 2024年第2期7卷 127-135页

作者： Dong li Yujia Wei jing Wang bo Wang Department of Dermatology Huazhong University of Science and Technology Tongji Medical College Tongji HospitalWuhanChina Health Management Center Huazhong University of Science and Technology Tongji Medical College Tongji HospitalWuhanChina Department of Gastroenterology Huazhong University of Science and Technology Tongji Medical College Tongji HospitalWuhanChina

Eosinophilic oesophagitis(EoE)is an allergen/immune-mediated chronic esophageal disease characterized by esophageal mucosal eosinophilic infiltration and esophageal dysfunction.Although the disease was originally attributed to a delayed allergic reaction to allergens and a Th2-type immune response,the exact pathogenesis is complex,and the efficacy of existing treatments is unsatisfactory.Therefore,the study of the pathophysiological process of EOE has received increasing attention.Animal models have been used extensively to study the molecular mechanism of EOE pathogenesis and also provide a preclinical platform for human clinical intervention studies of novel therapeutic agents.To maximize the use of existing animal models of EOE,it is important to understand the advantages or limitations of each modeling approach.This paper systematically describes the selection of experimental animals,types of allergens,and methods of sensitization and excitation during the preparation of animal models of EoE.It also discusses the utility and shortcomings of each model with the aim of providing the latest perspectives on EoE models and leading to better choices of animal models.

关键词： anaphylaxis disease models animal eosinophilic esophagitis methods

Single-cell RNA sequencing to understand host-virus interactions

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Virologica Sinica 2024年第1期39卷 1-8页

作者： Jia-Tong Chang li-bo liu Pei-Gang Wang jing An Department of Microbiology School of Basic Medical SciencesCapital Medical UniversityBeijing 100069China

Single-cell RNA sequencing(scRNA-seq)has allowed for the profiling of host and virus transcripts and host-virus interactions at single-cell resolution.This review summarizes the existing scRNA-seq technologies together with their strengths and weaknesses.The applications of scRNA-seq in various virological studies are discussed in depth,which broaden the understanding of the immune atlas,host-virus interactions,and immune repertoire.scRNA-seq can be widely used for virology in the near future to better understand the pathogenic mechanisms and discover more effective therapeutic strategies.

关键词： Single-cell RNA sequencing(scRNA-seq) Host-virus interaction COVID-19 Flavivirus

Flexible tuning of multifocal holographic imaging based on electronically controlled metasurfaces

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Photonics Research 2024年第1期12卷 61-69页

作者： OWEN ZENG CHENXIA li bo FANG ZHI HONG XUFENG jing Institute of Optoelectronic Technology China Jiliang UniversityHangzhou 310018China Centre for THz Research China Jiliang UniversityHangzhou 310018China College of Metrology&Measurement Engineering China Jiliang UniversityHangzhou 310018China

Programmable hyper-coded holography has the advantage of being programmable as well as being flexibly modifiable.Digitally coded metamaterials with excellent electromagnetic modulation capability and the ability to control the phase to modulate the spatial radiation field through external excitation in the form of switching can be used to realize low-cost digital arrays.We design a 1-bit encoded programmable metasurface,which is electrically connected to control the PIN diode in the switching state and to switch the condition of each metasurface cell between“0”and“1.”Using the designed programmable metasurface,we can randomly encode the cell structure to realize single-focus focusing,multi-focusing,and simple holographic letter imaging.Based on the nonlinear holographic model,we employ the Gerchberg-Saxton improvement algorithm to modulate the energy distribution at the focus by adjusting the phase distribution.Importantly,we introduce the Fourier convolution principle to regulate the holographic imaging focus flexibly.

关键词： holographic letter excitation

犀角地黄汤联合常规治疗对瘀热证急性脑梗死患者临床疗效及对血脂水平的影响

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现代生物医学进展 2024年第8期24卷 1495-1499页

作者：姜婧李静波房铭铭江淑婷刘红权南京中医药大学附属中西医结合医院(江苏省中医药研究院)神经内科江苏南京210028

目的:观察犀角地黄汤联合常规疗法治疗瘀热证急性脑梗死(acute cerebral infarction,ACI)的临床效果及对患者血脂水平的影响。方法:前瞻性纳入本院神经内科在2021年1月至2022年12月收治的100例瘀热证型ACI患者,分为对照组和观察组,各50... 详细信息

目的:观察犀角地黄汤联合常规疗法治疗瘀热证急性脑梗死(acute cerebral infarction,ACI)的临床效果及对患者血脂水平的影响。方法:前瞻性纳入本院神经内科在2021年1月至2022年12月收治的100例瘀热证型ACI患者,分为对照组和观察组,各50例。给予对照组患者常规内科治疗,在此基础上给予观察组患者加用犀角地黄汤,两组均连续治疗14 d。比较两组患者临床疗效、治疗后改良Rankin量表(m RS)评分以及治疗前后美国国立卫生研究院卒中量表(NIHSS)评分、瘀热证候积分、血清脂蛋白相关磷脂酶A2(Lp-PLA2)、同型半胱氨酸(Hcy)、D-二聚体(DD)、纤维蛋白原(FIB)和血脂[总胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)]水平。结果:(1)两组患者治疗结束时的NIHSS评分、瘀热证候评分和m RS评分均显著降低,观察组患者下降幅度更显著(P0.05)。观察组患者治疗结束时的血清Lp-PLA2、Hcy、DD和FIB水平均显著低于对照组(P0.05)。观察组患者治疗结束时的血清TC、TG、LDL-C水平均显著低于对照组(P0.05)。结论:犀角地黄汤能够显著提高瘀热证ACI患者临床疗效,减轻神经功能缺损和瘀热征象,提高生活能力,这可能与犀角地黄汤进一步改善患者脂代谢和异常血凝,减轻血管内皮损伤等有关。

关键词：犀角地黄汤急性脑梗死瘀热证疗效血脂

Effect of aflibercept combined with triamcinolone acetonide on aqueous humor growth factor and inflammatory mediators in diabetic macular edema

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International Journal of Ophthalmology(English edition) 2024年第2期17卷 297-303页

作者： De-Shuang li Hong-Xia liao jing-lin Zhang bo Qin Shenzhen Aier Eye Hospital Aier Eye HospitalJinan UniversityShenzhen 518031Guangdong ProvinceChina Guangzhou Aier Eye Hospital Jinan UniversityGuangzhou 510040Guangdong ProvinceChina

AIM:To investigate the efficacy of aflibercept combined with sub-tenon injection of triamcinolone acetonide(TA)in treating diabetic macular edema(DME)and to examine changes in growth factors and inflammatory mediator levels in aqueous humor after injection.METHODS:Totally 67 DME patients(67 eyes)and 30 cataract patients(32 eyes)were enrolled as the DME group and the control group,respectively.The DME group was divided into the aflibercept group(34 cases)and the aflibercept combined with TA group(combined group,33 cases).The aqueous humor of both groups was collected during the study period.The aqueous levels of vascular endothelial growth factor(VEGF),monocyte chemoattractant protein-1(MCP-1),interleukin-6(IL-6),interleukin-8(IL-8),and interleukin-1β(IL-1β)were detected using a microsphere suspension array technology(Luminex 200TM).Aqueous cytokines,best-corrected visual acuity(BCVA),central macular thickness(CMT),and complications before and after treatment were compared between the aflibercept group and combined group.RESULTS:The concentrations of VEGF,MCP-1,IL-6,and IL-8 in the aqueous humor were significantly higher in the DME group than those of the control group(all Plibercept group(all P0.05).CONCLUSION:The cytokines VEGF,MCP-1,IL-6,and IL-8 in the aqueous humor of DME patients are significantly increased.Aflibercept and aflibercept combined with TA have good efficacy in DME patients,can effectively reduce CMT,improve the patient’s vision,and have high safety.Aflibercept combined with TA can quickly downregulate the aqueous humor cytokines and help to relieve macular edema rapidly.However,the long-term efficacy is comparable to that of aflibercept alone

关键词： diabetic macular edema aqueous humor cytokines aflibercept triamcinolone acetonide

A data-driven model of drop size prediction based on artificial neural networks using small-scale data sets

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Chinese Journal of Chemical Engineering 2024年第2期66卷 71-83页

作者： bo Wang Han Zhou Shan jing Qiang Zheng Wenjie Lan Shaowei li Institute of Nuclear and New Energy Technology Tsinghua UniversityBeijing 100084China State Key Laboratory of Heavy Oil Processing China University of Petroleum(Beijing)Beijing 102249China State Key Laboratory of Chemical Engineering Tsinghua UniversityBeijing 100084China

An artificial neural network(ANN)method is introduced to predict drop size in two kinds of pulsed columns with small-scale data sets.After training,the deviation between calculate and experimental results are 3.8%and 9.3%,respectively.Through ANN model,the influence of interfacial tension and pulsation intensity on the droplet diameter has been developed.Droplet size gradually increases with the increase of interfacial tension,and decreases with the increase of pulse intensity.It can be seen that the accuracy of ANN model in predicting droplet size outside the training set range is reach the same level as the accuracy of correlation obtained based on experiments within this range.For two kinds of columns,the drop size prediction deviations of ANN model are 9.6%and 18.5%and the deviations in correlations are 11%and 15%.

关键词： Artificial neural network Drop size Solvent extraction Pulsed column Two-phase flow Hydrodynamics

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A Dietary Supplement jinghuosu Ameliorates Reproductive Damage Induced by Tripterygium Glycosides

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Chinese Journal of Integrative Medicine 2024年第4期30卷 330-338页

作者： MA jing SUN bo TE li-ger HUANG Xin ZUO Xin HAN Xiao-ke WANG Shu-song Hebei Key Laboratory of Reproductive Medicine Hebei Institute of Reproductive HealthHebei Reproductive Health HospitalShijiazhuang(050071)China Graduate School of Hebei Medical University Shijiazhuang(050017)China School of Chemistry and Materials Science Hebei Normal UniversityShijiazhuang(050024)China Xingtai Infertility Specialist Hospital XingtaiHebei Province(054000)China

Objective To determine the possible protective effects of jinghuosu,a dietary supplement(DS),on tripterygium glycosides(TG)-induced reproductive system injury in rats and its underlying mechanisms.Methods A reproductive damage model was established in rats by feeding of TGs.Twenty-eight male Sprague Dawley rats were randomly divided into 4 groups using a random number table(n=7 in each):control(C)group,model(M)group,DS group and L-carnitine(LC)group.Rats in M,DS and LC groups received 40 mg/kg TGs orally.Starting from the 5th week,after administration of TGs for 4 h every day,rats in DS and LC groups were administered with 2.7 g/kg DS and 0.21 g/kg LC,respectively,for protective treatment over the next 4 weeks.Rats in Group C continued to receive the control treatment.Hematoxylin-eosin staining was used for histopathological analysis of rat testicular tissues.Enzyme-linked immunosorbent assay was performed to measure alkaline phosphatase(ALP),lactate dehydrogenase,alcohol dehydrogenase,total antioxidant capacity(T-AOC),superoxide dismutase,glutathione peroxidase(GSH-Px),and malondialdehyde(MDA)concentrations.Chemiluminescence assay was used to determine the serum testosterone content.Quantitative real-time PCR and Western blotting were conducted to analyze the expression of genes and proteins related to the testosterone synthesis pathway and the nuclear factor erythroid 2-related factor 2/heme oxygenase 1 antioxidant pathway.Results Oral administration of TGs induced significant increases in the testicular levels of zinc transporter 1 and MDA(Plity,and serum testosterone,serum zinc,testicular zinc,Zrt-,Irt-like protein 1,ALP,luteinizing hormone(LH)receptor,steroidogenic acute regulatory protein,Cytochrome P450 family 11 subfamily A member 1,3β-hydroxysteroid dehydrogenase 1 T-AOC,GSH-Px,nuclear factor erythroid 2-related factor 2,heme oxygenase-1 and NAD(P)H:quinone oxidoreductase 1 levels decreased following TGs exposure(P<0.05).All of these phenotypes were

关键词： dietary supplement jinghuosu tripterygium glycosides reproductive damage infertility