1.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
2.Expression efficiency of three DNA plamids and their mRNAs expressing foot-and-mouth disease virus (FMDV) antigenic proteins.
Lixin JIANG ; Haiyun LIU ; Yifan LIU ; Yuqing MA ; Shiqi SUN ; Zezhong ZHENG ; Huichen GUO
Chinese Journal of Biotechnology 2025;41(7):2623-2633
Foot-and-mouth disease (FMD) is one of the major animal infectious diseases in the world. All cloven-hoofed animals are susceptible to FMD. Vaccination is still the first choice for the prevention and control of FMD. mRNA vaccines can be rapidly designed, synthesized, and produced on a large scale in vitro, and they can induce effective protective immune responses, demonstrating the advantages of rapid development, easy preparation, and low biosafety risks. The design of untranslated regions is a key to enhancing the expression and efficacy of mRNA vaccines. In order to generate an efficient FMD mRNA vaccine, we designed three FMD P12A3C expression vectors with different untranslated regions and synthesized corresponding mRNAs. By comparing expression efficiency of these vectors and their mRNAs at different time points and in different cell lines, we found that the mRNA P12A3C-UTR3 had the best expression and universality. This study laid a foundation for the development of mRNA vaccines against FMD and provided a theoretical basis for the optimal sequence design of efficient mRNA.
Foot-and-Mouth Disease Virus/genetics*
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Animals
;
RNA, Messenger/biosynthesis*
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Foot-and-Mouth Disease/immunology*
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Antigens, Viral/biosynthesis*
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Viral Vaccines/biosynthesis*
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Genetic Vectors/genetics*
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Cell Line
;
Vaccines, DNA/immunology*
3.Establishment of internal quality control methodology for blood transfusion compatibility testing
Lu LI ; Xiaolin SUN ; Junjie WEI ; Ruiqi LIU ; Weixin WU ; Haiyun LIU ; Yinze ZHANG
Chinese Journal of Blood Transfusion 2024;37(4):399-404
【Objective】 To monitor the effectiveness and accuracy of the blood transfusion compatibility test system by self-made weakly positive internal quality control products. 【Methods】 Red blood cells from DAT(-) healthy subjects were selected, and B/RhD(-)E(-) red blood cells were selected as tube 1. A/RhD(+ )E(+ ) was selected as tube 2 to prepare blood group quality control products according to the principle of blood group antigen compatibility, and red blood cell preservation solution and corresponding ABO blood group reagent antibody were added to make the agglutination intensity of microcolumn gel method in reverse blood typing reach a low positive value (1+ ). Tube 3 and tube 4 were prepared with five different preservation media: plasma, serum, antibody diluent, mixture of equal plasma and antibody diluent, and mixture of equal serum and antibody diluent, respectively. IgM anti-E antibody was added to tube 3, and IgG anti-D antibody was added to tube 4, so that the agglutination intensity of microcolumn gel method reached a low positive value (1+ ). 【Results】 Comparison between the 5 different preservation media showed that the preservation medium of antibody diluent was the most stable for weakly positive antibody (F=11.35, P<0.05), Agglutination intensity 1+ is assigned 5 points by AABB Technical Manual, and its score was 5.25±1.75 points. 【Conclusion】 The use of self-made weakly positive quality control products can improve the effectiveness, accuracy and sensitivity of the monitoring system, thus achieving internal quality control and ensuring the safety of clinical blood use.
4.Effect and Mechanism of Cyclocarya paliurus(Batal.)lljinskaja Polysaccharides on Type 2 Diabetic Rats by Regulating GLUT4 Translocation in Islet and Liver
Haiyun LIU ; Miaoting SHI ; Xinyi LUO ; Minyan SUN ; Chenxi XU ; Kunhan CHEN ; Xiaomin WANG ; Rengeng SHU
Herald of Medicine 2024;43(1):13-19
Objective To investigate the effect of Cyclocarya paliurus(Batal.)lljinskaja polysaccharides on insulin resistance in type 2 diabetic rats by regulating glucose transporter 4(GLUT4)translocation in islet and liver.Methods High-fat diet combined with low-dose streptozotocin(35 mg·kg-1)to induce type 2 diabetes model,all the rats were randomly divided into model control group,Cyclocarya paliurus polysaccharides groups(5,10 g·kg-1)and metformin group(0.25 g·kg-1),and treated for eight weeks(n=9 in each group).Fasting glucose and lipid were determined.Histopathology of rat islet and liver were observed by hematoxylin and eosin staining.Protein expressions of phosphorylated phosphoinositide-3-kinase(p-PI3K),phosphorylated serine-threonine kinase 1(p-Akt1),and GLUT4 in islet were measured by immunohistochemistry staining.GLUT4 translocation in the islet and liver was detected by immunofluorescence.Results Compared with the model control group,the Cyclocarya paliurus polysaccharides group and metformin group had declined fasting glucose levels and increased high-density lipoprotein(P<0.05).The structure of the islets and liver was relatively complete.The content of p-PI3K,p-Akt1 and GLUT4 in the islet increased(P<0.05).GLUT4 translocation in the liver and islet enhanced(P<0.05).Conclusions Cyclocarya paliurus polysaccharides alleviate glucose and lipid metabolism disorders.The mechanism may lay in it activating protein expressions of p-PI3K,p-Akt1,and GLUT4 in islet cells.GLUT4 translocation to the islet and liver cell membrane are increased to regulate peripheral islet resistance.
5.Effect of RhD antigen expression intensity on preparation of low positive quality control products for transfusion compatibility test
Lu LI ; Junjie WEI ; Xiaolin SUN ; Weixin WU ; Ruiqi LIU ; Haiyun LIU ; Yinze ZHANG
Chinese Journal of Blood Transfusion 2024;37(6):690-693
Objective To determine the reference red blood cells with weak agglutination intensity of low positive quali-ty control products by comparing RhD antigen expression intensity difference according to the serological results.Methods The RhD(+)red blood cells were detected by microcolumn gel method with 1 500 times diluted anti-D typing reagent.The samples with weak and strong RhD antigen expression intensity were selected as the reference red blood cells for weak agglu-tination intensity of low positive quality control products,and verification was performed.Results Ten RhD(+)red blood cells were detected with diluted anti-D typing reagent,of which 8 were 1+and 2 were±.Red blood cells with agglutination intensity of 1+were used as the benchmark to determine the maximum dilution ratio of anti-D typing reagent when their ag-glutination intensity was 1+.As the preparation standard of low positive quality control products,the agglutination intensity of red blood cells with low RhD antigen expression intensity was extremely weak±,which was difficult to ensure the stability of its control limit properties.Based on red blood cells with agglutination intensity of±,the maximum dilution ratio of anti-D typing reagent with agglutination intensity of 1+was re-determined as the preparation standard of low positive quality con-trol products,and the results met the requirements of quality control product setting.Conclusion Using red blood cells with low RhD antigen expression intensity as the benchmark to set the weak agglutination intensity of the low positive quality control products can avoid the loss of control due to the low target value.
6.Relationship between BCRP-BBB and dexmedetomidine-induced improvement in postoperative cognitive function in patients with mild hyperbilirubinemia
Yi SUN ; Haiyun WANG ; Mingshu ZHAO ; Qing LI ; Yizhen WANG
Chinese Journal of Anesthesiology 2024;44(8):927-931
Objective:To evaluate the relationship between breast cancer resistance protein (BCRP)-blood brain barrier (BBB) and dexmedetomidine-induced improvement in postoperative cognitive function in patients with mild hyperbilirubinemia.Methods:This was a prospective study. Ninety patients of both sexes with mild hyperbilirubinemia caused by choledocholithiasis, aged 55-69 yr, with body mass index of 22-28 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅱ or Ⅲ, with preoperative Mini-Mental State Examination (MMSE) scores≥20, scheduled for elective cholecystectomy, exploratory choledocholithotomy and T-tube drainage from December 2022 to August 2023 in the Third Central Hospital of Tianjin, were divided into 2 groups( n=45 each) using a random number table method: control group (C group) and dexmedetomindine group (D group). After induction of anesthesia, dexmedetomidine was intravenously infused at a loading dose of 0.5 μg/kg over 10 min, followed by an infusion of 0.6 μg·kg -1·h -1 until the end of operation in group D, and the equal volume of normal saline was given instead in group C. At 2 days before operation and 1, 3, 5, 7 and 14 days after operation, the cognitive function was assessed using MMSE and Montreal Cognitive Assessment, and the serum BCRP concentration, concentrations of cognitive function serological indicators (serum S100β, β amyloid 42, malondialdehyde), and concentrations of BBB serological indicators (serum glial fibrillary acidic protein, thrombospondin 1, claudin 5) were determined using enzyme-linked immunosorbent assay. Results:Compared with group C, MMSE and Montreal Cognitive Assessment scores were significantly increased, the incidence of cognitive impairment was decreased, the serum concentrations of S100β, β amyloid 42 and malondialdehyde were decreased, the serum concentrations of BCRP were increased, and the serum concentrations of glial fibrillary acidic protein, claudin-5 and thrombospondin 1 were decreased in group D ( P<0.05). Conclusions:The mechanism by which dexmedetomidine improves postoperative cognitive function may be related to up-regulating BCRP levels and improving BBB function in patients with mild hyperbilirubinemia.
7.Optimization of determination method for residual solvents of esmolol hydrochloride
Siming CHEN ; Xiankun WENG ; Haiyun SUN ; Zongyu LUO
Drug Standards of China 2024;25(2):154-158
Objective:To optimize the detection method for residual solvents of esmolol hydrochloride for control of internal quality.Methods:Gas chromatography headspace injection method was adopted by selecting appropriate headspace equilibrium temperature and time in order to reduce sample contamination of the instrument,optimizing solvent ratio for reducing matrix effect and adjusting carrier gas flow rate and split ratio.Polar capillary column pro-grammed temperature rise method was used with high temperature holding time,etc.,and methodological validation was conducted.Results:Ether,ethyl acetate,methanol,and toluene could all be effectively separated with good precision,and there were good linear relationships between peak areas and mass concentrations.The accuracy of sample spiking at 50%,100%,and 150%concentrations was investigated,and the average recovery rates could all reach ranges of 94.8%-105.6%.Conclusion:This method is accurate,highly sensitive,and overcomes the shortcomings of the Chinese Pharmacopoeia methods.It can be used for the detection of residual solvents in esmolol hydrochloride.
8.Construction of a competency evaluation indicator system for infection prevention and control nurses in Operating Rooms
Liqun SUN ; Zengmei ZHANG ; Haiyun ZHAO ; Ying ZHANG ; Zi JIN ; Yunfei NIE ; Wei WEI ; Yu WANG ; Shengyun LI ; Ruifang HUA
Chinese Journal of Modern Nursing 2024;30(13):1698-1705
Objective:To construct a competency evaluation indicator system for infection prevention and control nurses in Operating Rooms (hereinafter referred to as "IPC") and provide an objective basis for the management of IPC nurses.Methods:From June to November 2022, an initial competency evaluation indicator system for IPC nurses was developed through literature review and semi-structured interviews. The Delphi method was employed to consult 20 experts from 11 provinces and municipalities across the country. Analytical Hierarchy Process (AHP) and mean distribution method were applied to quantify and determine the weight of each level of indicators within the system.Results:Nineteen experts were finally included, with two rounds of questionnaire recovery rates of 95.00% (19/20) and 100.00% (19/19), respectively. The authority coefficients of the experts were 0.858 and 0.861, familiarity coefficients were 0.850 and 0.853, and coefficients of judgment basis were 0.865 and 0.868, respectively. The Kendall's W coefficient of concordance for the two rounds of inquiries were 0.139 and 0.202 ( P<0.05), respectively. The final IPC nurse competency evaluation indicator system included six primary indicators, 22 secondary indicators, and 66 tertiary indicators. Conclusions:The constructed IPC nurse competency evaluation indicator system is scientific, reasonable, objective, and comprehensive, providing a valuable reference for the capability training, assessment, entry standards, and qualification certification of IPC nurses.
9.Research progress in polysaccharide-modified lipid nanoparticles for drug delivery.
Yuqing MA ; Haiyun LIU ; Xiaoqiang WANG ; Shiqi SUN ; Huichen GUO
Chinese Journal of Biotechnology 2024;40(12):4339-4350
Lipid nanoparticles serve as a promising drug delivery system due to the good biocompatibility, non-immunogenicity, and high drug loading efficiency. However, unmodified lipid nanoparticles have limitations such as poor stability, easy hydrolysis, and rapid removal. To overcome these shortcomings, researchers have developed peptide modification, antibody modification, ligand modification, nucleic acid aptamer modification, and polysaccharide modification for lipid nanoparticles. Polysaccharides are a class of natural polymers, and the polysaccharide-modified lipid nanoparticles exhibit good biocompatibility, precise targeting, and low toxicity. Therefore, polysaccharide-modified lipid nanoparticles demonstrate great potential in clinical treatment. This review summarizes the preparation and application of polysaccharide-modified lipid nanoparticles, aiming to provide a reference for further research and development of new lipid nanoparticles.
Polysaccharides/chemistry*
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Nanoparticles/chemistry*
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Lipids/chemistry*
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Drug Delivery Systems
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Humans
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Drug Carriers/chemistry*
10.Changes of thickness and area of ligamenta flavum after lateral lumbar interbody fusion
Hanming BIAN ; Wentao WAN ; Chao CHEN ; Xun SUN ; Dong ZHAO ; Haiyun YANG ; Binggang GUAN ; Qiang YANG
Chinese Journal of Orthopaedics 2023;43(8):500-507
Objective:To investigate the changes of thickness and area of the ligamentum flavum after lateral lumbar interbody fusion (LLIF) for lumbar degenerative diseases.Methods:From 2019 to 2021, a total of 54 patients with lumbar degenerative diseases who underwent LLIF combined with percutaneous pedicle screw internal fixation were retrospectively analyzed. There were 9 males and 45 females, aged 59.46±6.91 years (range, 45-76 years), followed up for 14.69±6.87 months (range, 12-33 months). The disc height (DH), midsagittal canal diameter (CD), dural sac axial cross-sectional area (DCSA), ligamentum flavum area (LFA) and ligamentum flavum thickness (LFT) before and after surgery and at the last follow-up were evaluated and compared. Pearson correlation analysis was used to assess the relationship between the amount of change in the DCSA and LFA in the immediate postoperative period and at the last follow-up, as well as the correlation between the two and the amount of change in the DH. The data of patients at the last follow-up of 12 months after operation were extracted. Pearson correlation was used to evaluate the changes in DCSA and LFA at the last follow-up and the visual analogue scale (VAS) of low back pain and leg pain and Oswestry disability index (ODI) at 1 year after surgery.Results:All patients were followed up for 14.69±6.87 months (range, 12-33 months). The differences in DH ( F=354.93, P<0.001), sagittal CD ( F=44.78, P<0.001) and DCSA ( F=130.97, P<0.001) before, immediately after surgery and at the last follow-up were statistically significant. The DH, sagittal CD, and DCSA immediate after surgery and last follow-up were higher than those before surgery ( P<0.05). The differences in LFA ( F=51.59, P<0.001) and bilateral LFT ( F=53.49, P<0.001; F=50.53, P<0.001) before and after surgery and at the last follow-up were statistically significant, and both LFA and bilateral LFT at immediate after surgery and last follow-up were smaller than those before surgery ( P<0.05). Pearson correlation analysis showed that the change of DH immediately after surgery was moderately correlated with the change of DCSA ( r=0.57, P<0.001), and was strongly correlated with the change of LFA ( r=0.65, P<0.001). The change of DH at the last follow-up was moderately correlated with the change of DCSA ( r=0.43, P<0.001), and was weakly correlated with the change of LFA ( r=0.25, P=0.042). The differences in VAS-leg ( F=199.51, P<0.001), VAS-low back ( F=233.90, P<0.001), and ODI ( F=199.17, P<0.001) were statistically significant in patients before operation, 3 months after operation and 12 months after operation. There was no correlation between the changes of DCSA and LFA at the last follow-up and the changes of VAS and ODI at 1 year after operation ( P>0.05). Conclusion:LFA and LFT decrease and DCSA increase in patients with lumbar degenerative diseases after LLIF. LFA and LFT gradually decrease with time, and VAS and ODI are significantly improved compared with those before surgery. The DH loss caused by a certain degree of cage subsidence after surgery does not affect the clinical efficacy. There is no correlation between the improvement of DCSA and LFA and the improvement of clinical symptoms.

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