1.A reporter gene assays for bioactivity determination of human chorinonic gonadotropin
Ying HUANG ; Xiao-ming ZHANG ; He-yang LI ; Lü-yin WANG ; Hui ZHANG ; Ping LÜ ; Jing LI ; Xiang-dong GAO ; Cheng-gang LIANG
Acta Pharmaceutica Sinica 2024;59(2):432-438
This study constructed a LHCGR-CRE-luc-HEK293 transgenic cell line according to the activation of the cAMP signaling pathway after recombinant human chorionic gonadotropin binding to the receptor. The biological activity of recombinant human chorionic gonadotropin was assayed using a luciferase assay system. The relative potency of the samples was calculated using four-parameter model. And the method conditions were optimized to validate the specificity, relative accuracy, precision and linearity of the method. The results showed that there was a quantitative potency relationship of human chorinonic gonadotropin (hCG) in the method and it was in accordance with the four-parameter curve. After optimization, the conditions were determined as hCG dilution concentration of 2.5 μg·mL-1, dilution ratio of 1∶4, cell number of 10 000-15 000 cells/well, and induction time of 6 h. The method had good specificity, relative accuracy with relative bias ranging from -8.9% to 3.4%, linear regression equation correlation coefficient of 0.996, intermediate precision geometric coefficient of variation ranging from 3.3% to 15.0%, and linearity range of 50% to 200%. This study successfully established and validated a reporter gene method to detect hCG biological activity, which can be used for hCG biological activity assay and quality control.
2.Bioequivalence study of tenofovir alafenamide fumarate tablets in Chinese healthy subjects
Xiao-Bin LI ; Nan WANG ; Ni-Na HU ; Ning WANG ; Chen-Dong DONG ; Xiao-Tong CUI ; He XIE ; Yan TIAN ; Wen-Ping WANG
The Chinese Journal of Clinical Pharmacology 2024;40(14):2113-2117
Objective To evaluate the pharmacokinetics(PK)of tenofovir alafenamide Fumarate tablets(25 mg)in healthy Chinese subjects after single oral administration to provide a basis for bioequivalence evaluation.Methods Using a single-dose,randomized,open-lable,two-period,two-way crossover design under fasting condition,while three-way crossover design under fed condition,42 healthy subjects respectively for fasting and fed study were enrolled,and randomized into two groups to receive a single dose of test product(T)or reference product(R)25 mg.Plasma concentration of tenofovir alafenamide and tenofovir were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS)method.The pharmacokinetic parameters were calculated by WinNonlin software(8.1 version)using non-compartmental model,and bioequivalence evaluation was performed for the two preparations.Relevant safety evaluations were performed during the trial.Results The test product and the reference product under fasting study,the main PK parameters of tenofovir alafenamide were as follows:Cmax were(215.17±94.24)and(199.30±71.11)ng·mL-1;AUC0-t were(135.44±71.60)and(123.91±53.82)h·ng·mL-1;the main PK parameters of tenofovir were as follows:Cmax were(7.30±2.27)and(7.12±1.74)ng·mL-1,AUC0-t of tenofovir were(237.16±47.09)and(230.06±43.41)h·ng·mL-1,respectively.The test product and the reference product under fed study,the main PK parameters of tenofovir were as follows:Cmax were(197.69±82.19)and(197.10±110.54)ng·mL-1;AUC0-t were(197.69±82.19)and(197.10±110.54)h·ng·mL-1;the main PK parameters of tenofovir were as follows:CMax were(2.57±1.37)and(2.58±1.31)ng·mL-1;AUC0-t were(227.08±74.33)and(238.51±128.30)h·ng·mL-1,respectively.The 90%confidence interval for geometric mean ratio of Cmax,AUC0-tof T and R under fed condition were between 80.00%-125.00%,respectively.The incidence of adverse events in fasting and fed tests was 21.43%and 30.95%,respectively,and no serious adverse event was reported.Conclusion The test formulation and reference formulation of tenofovir alafenamide fumarate tablets were equivalent and was safe.
3.Growth and development status and related factors of children in drinking-water-borne endemic fluorosis area after water improvement in Xi'an
Xuehua SHI ; Ping LI ; Yong WANG ; Shanshan HE ; Lu DONG ; Wei CHEN
Chinese Journal of Endemiology 2024;43(3):212-218
Objective:To investigate the current situation and related factors of children's growth and development in drinking-water-borne endemic fluorosis areas after water improvement, and provide a basis for improving the control strategies.Methods:The stratified random sampling method was used to select children aged 7 to 13 in villages with different years of water improvement in Xi'an from November 2019 to June 2020. The height and weight of children were measured, and body mass index (BMI) was calculated. The height development level of children was graded according to the "Standard for Height Level Classification among Children and Adolescents Aged 7 - 18 Years" (WS/T 612-2018), and the physical development (BMI) level of children was determined according to the "Comprehensive Evaluation of Development Level for Children and Adolescents" (GB/T 31178-2014). At the same time, according to the standard of "Diagnosis of Dental Fluorosis" (WS/T 208-2011), the diagnosis of dental fluorosis in children was performed. The serum fluoride level was determined by ion selective electrode method, and the levels of other chemical elements (calcium, iron, magnesium, copper, zinc, iodine, selenium, lead, arsenic, cadmium, chromium, mercury, nickel) in blood were determined by inductively coupled plasma mass spectrometry.Results:A total of 469 children were included in the investigation. After water improvement, 67.38% (316/469) of the children in the disease area were at the moderate level of height development, 7.89% (37/469) were at the medium to upper and upper levels, and 24.73% (116/469) were at the medium to lower and lower levels. The BMI of the children in the emaciation group was 8.53% (40/469), while it was 10.87% (51/469) in the overweight group and 8.74% (41/469) in the obesity group. There was statistically significant difference in the distribution of height development level of children in areas with different water improvement years ( P = 0.005), but no statistically significant difference in BMI distribution ( P = 0.154). There was no significant difference in height development level and BMI distribution of children with or without dental fluorosis ( P > 0.05). There were significant differences in serum levels of iron and zinc among children with different height development levels ( P < 0.05). There were significant differences in serum levels of magnesium, copper, iodine and chromium among children with different BMI ( P < 0.05). Conclusion:The growth and development of children in drinking-water-borne endemic fluorosis area after water improvement are not correlated with the prevalence of dental fluorosis, but may be related to the levels of chemical elements such as iron, magnesium, copper, and iodine in the body.
4.Inhibitory effect of miR-133a on liver cancer through tar-geted regulation of G6PD expression
Ya-Dong WANG ; Xue-Jun SUN ; Chun-Yu YANG ; Gui-Ping WANG ; Ming JIN ; He LI ; Jia-Jun YIN
Chinese Journal of Current Advances in General Surgery 2024;27(1):25-29
Objective:To explore if miR-133a is involved in the occurrence and development of hepatocellular carcinoma(HCC)via regulating G6PD.Methods:Bioinformatics analysis predicted the binding sites of miR-133a and G6PD;RT-PCR or western blot was used to assess the expres-sion of miR-133a and G6PD in HCC tissues and the adjacent normal tissues;CCK-8 and flow cy-tometry assays were performed to evaluate the effects of miR-133a/G6PD on cell proliferation,apop-tosis;Fluorescent reporter gene and western blot assays were used to assess the effect of miR-133a on G6PD expression.Results:miR-133a expression was decreased in HCC tissues while G6PD was increased(P0.01);Up-regulation of miR-133a significantly reduced G6PD expression(P<0.01);up-reg-ulation of miR-133a inhibited cell growth and promoted cell apoptosis(P<0.05),whereas these effects induced by miR-133a over-expression were all abolished when G6PD was up-regulated(P<0.01).Conclusion:miR-133a represses the occurrence and development of HCC via targeting G6PD.
5.Exploration and Practice of Constructing a Structured Specialized Disease Database Based on NLP for Medical Records
Yanan ZHANG ; Liang DONG ; Ping HE
Journal of Medical Informatics 2024;45(9):82-86
Purpose/Significance To construct a specialized disease database based on structured electronic medical records(EMR),and to improve the standardization and usability of the specialized disease database and improve the efficiency of clinical scien-tific research.Method/Process By using templated input,natural language processing(NLP)and other technologies,unstructured EMR are converted into structured EMR,and a specialized disease database is constructed based on structured EMR.Result/Conclu-sion The psoriasis specialized disease database sub center built by Longhua Hospital based on structured EMR provides clinical research-ers with a structured scientific research data source,assists researchers in improving analysis efficiency,and effectively supports the con-struction of Shanghai Shenkang's"multi center psoriasis specialized disease big data clinical research follow-up integrated platform",which is conducive to the high-quality and large-scale development of specialized disease databases.
6.Research progress on sarcopenia in patients with lung cancer
Dan-Ni DONG ; Qiao CHU ; Mi XIANG ; Ya-Ping HE
Parenteral & Enteral Nutrition 2024;31(3):184-188,192
Sarcopenia is a syndrome associated with decreased muscle mass,decreased muscle strength,and reduced physical performance. Due to multiple factors such as tumor metabolism,systemic inflammatory response,disease progression,and reduced physical activity associated with treatment itself,the risk of sarcopenia in patients with lung cancer is higher than that of the general population. Sarcopenia is closely related to the clinical outcomes,including increased risk for mortality,and significantly impacts patients' long-term quality of life and mental health. This study systematic reviewed the risk factors for sarcopenia in patients with lung cancer,its negative effects on clinical outcomes,long-term quality of life and mental health,and the interventions for sarcopenia. Given the significant impact of sarcopenia on patients with lung cancer,it is urgent to explore a multidisciplinary intervention model to improve their survival and quality of life.
7.Clinical characterization and prediction modeling of lung cancer patients with high energy metabolism
Jiang-Shan REN ; Jun-Mei JIA ; Ping SUN ; Mei PING ; Qiong-Qiong ZHANG ; Yan-Yan LIU ; He-Ping ZHAO ; Yan CHEN ; Dong-Wen RONG ; Kang WANG ; Hai-Le QIU ; Chen-An LIU ; Yu-Yu FAN ; De-Gang YU
Medical Journal of Chinese People's Liberation Army 2024;49(9):1004-1010
Objective To analyze the clinical characteristics of high energy metabolism in lung cancer patients and its correlation with body composition,nutritional status,and quality of life,and to develop a corresponding risk prediction model.Methods Retrospectively analyzed 132 primary lung cancer patients admitted to the First Hospital of Shanxi Medical University from January 2022 to May 2023,and categorized into high(n=94)and low energy metabolism group(n=38)based on their metabolic status.Differences in clinical data,body composition,Patient Generated Subjective Global Assessment(PG-SGA)scores,and European Organization for Research and treatment of Cancer(EORTC)Quality of Life Questionnaire-Core 30(QLQ-C30)scores were compared between the two groups.Logistic regression was used to identify the risk factors for high energy metabolism in lung cancer patients,and a risk prediction model was established accordingly;the Hosmer-Lemeshow test was used to assess the model fit,and the ROC curve was used to test the predictive efficacy of the model.Results Of the 132 patients with primary lung cancer,94(71.2%)exhibited high energy metabolism.Compared with low energy metabolism group,patients in high-energy metabolism group had a smoking index of 400 or higher,advanced disease staging of stage Ⅲ or Ⅳ,and higher levels of IL-6 level,low adiposity index,low skeletal muscle index,and malnutrition(P<0.05),and lower levels of total protein,albumin,hemoglobin level,and prognostic nutritional index(PNI)(P<0.05).There was no significant difference in age,gender,height,weight,BMI and disease type between the two groups(P>0.05).Logistic regression analysis showed that smoking index≥400,advanced disease stage,IL-6≥3.775 ng/L,and PNI<46.43 were independent risk factors for high energy metabolism in lung cancer patients.The AUC of the ROC curve for the established prediction model of high energy metabolism in lung cancer patients was 0.834(95%CI 0.763-0.904).Conclusion The high energy metabolic risk prediction model of lung cancer patients established in this study has good fit and prediction efficiency.
8.A multicenter study of neonatal stroke in Shenzhen,China
Li-Xiu SHI ; Jin-Xing FENG ; Yan-Fang WEI ; Xin-Ru LU ; Yu-Xi ZHANG ; Lin-Ying YANG ; Sheng-Nan HE ; Pei-Juan CHEN ; Jing HAN ; Cheng CHEN ; Hui-Ying TU ; Zhang-Bin YU ; Jin-Jie HUANG ; Shu-Juan ZENG ; Wan-Ling CHEN ; Ying LIU ; Yan-Ping GUO ; Jiao-Yu MAO ; Xiao-Dong LI ; Qian-Shen ZHANG ; Zhi-Li XIE ; Mei-Ying HUANG ; Kun-Shan YAN ; Er-Ya YING ; Jun CHEN ; Yan-Rong WANG ; Ya-Ping LIU ; Bo SONG ; Hua-Yan LIU ; Xiao-Dong XIAO ; Hong TANG ; Yu-Na WANG ; Yin-Sha CAI ; Qi LONG ; Han-Qiang XU ; Hui-Zhan WANG ; Qian SUN ; Fang HAN ; Rui-Biao ZHANG ; Chuan-Zhong YANG ; Lei DOU ; Hui-Ju SHI ; Rui WANG ; Ping JIANG ; Shenzhen Neonatal Data Network
Chinese Journal of Contemporary Pediatrics 2024;26(5):450-455
Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75%(27/36);boys accounted for 64%(23/36).Among the 36 neonates,31(86%)had disease onset within 3 days after birth,and 19(53%)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61%)had left cerebral infarction and 13(36%)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75%)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72%)and seizures in 10 neonates(34%).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33%,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44%(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.
9.Changing distribution and resistance profiles of common pathogens isolated from urine in the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Yanming LI ; Mingxiang ZOU ; Wen'en LIU ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Fengbo ZHANG ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2024;24(3):287-299
Objective To investigate the distribution and antimicrobial resistance profiles of the common pathogens isolated from urine from 2015 to 2021 in the CHINET Antimicrobial Resistance Surveillance Program.Methods The bacterial strains were isolated from urine and identified routinely in 51 hospitals across China in the CHINET Antimicrobial Resistance Surveillance Program from 2015 to 2021.Antimicrobial susceptibility was determined by Kirby-Bauer method,automatic microbiological analysis system and E-test according to the unified protocol.Results A total of 261 893 nonduplicate strains were isolated from urine specimen from 2015 to 2021,of which gram-positive bacteria accounted for 23.8%(62 219/261 893),and gram-negative bacteria 76.2%(199 674/261 893).The most common species were E.coli(46.7%),E.faecium(10.4%),K.pneumoniae(9.8%),E.faecalis(8.7%),P.mirabilis(3.5%),P.aeruginosa(3.4%),SS.agalactiae(2.6%),and E.cloacae(2.1%).The strains were more frequently isolated from inpatients versus outpatients and emergency patients,from females versus males,and from adults versus children.The prevalence of ESBLs-producing strains in E.coli,K.pneumoniae and P.mirabilis was 53.2%,52.8%and 37.0%,respectively.The prevalence of carbapenem-resistant strains in E.coli,K.pneumoniae,P.aeruginosa and A.baumannii was 1.7%,18.5%,16.4%,and 40.3%,respectively.Lower than 10%of the E.faecalis isolates were resistant to ampicillin,nitrofurantoin,linezolid,vancomycin,teicoplanin and fosfomycin.More than 90%of the E.faecium isolates were ressitant to ampicillin,levofloxacin and erythromycin.The percentage of strains resistant to vancomycin,linezolid or teicoplanin was<2%.The E.coli,K.pneumoniae,P.aeruginosa and A.baumannii strains isolated from ICU inpatients showed significantly higher resistance rates than the corresponding strains isolated from outpatients and non-ICU inpatients.Conclusions E.coli,Enterococcus and K.pneumoniae are the most common pathogens in urinary tract infection.The bacterial species and antimicrobial resistance of urinary isolates vary with different populations.More attention should be paid to antimicrobial resistance surveillance and reduce the irrational use of antimicrobial agents.
10.Changing resistance profiles of Enterococcus in hospitals across China:results from the CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Na CHEN ; Ping JI ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Yunjian HU ; Xiaoman AI ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WEN ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2024;24(3):300-308
Objective To understand the distribution and changing resistance profiles of clinical isolates of Enterococcus in hospitals across China from 2015 to 2021.Methods Antimicrobial susceptibility testing was conducted for the clinical isolates of Enterococcus according to the unified protocol of CHINET program by automated systems,Kirby-Bauer method,or E-test strip.The results were interpreted according to the Clinical & Laboratory Standards Institute(CLSI)breakpoints in 2021.WHONET 5.6 software was used for statistical analysis.Results A total of 124 565 strains of Enterococcus were isolated during the 7-year period,mainly including Enterococcus faecalis(50.7%)and Enterococcus faecalis(41.5%).The strains were mainly isolated from urinary tract specimens(46.9%±2.6%),and primarily from the patients in the department of internal medicine,surgery and ICU.E.faecium and E.faecalis strains showed low level resistance rate to vancomycin,teicoplanin and linezolid(≤3.6%).The prevalence of vancomycin-resistant E.faecalis and E.faecium was 0.1%and 1.3%,respectively.The prevalence of linezolid-resistant E.faecalis increased from 0.7%in 2015 to 3.4%in 2021,while the prevalence of linezolid-resistant E.faecium was 0.3%.Conclusions The clinical isolates of Enterococcus were still highly susceptible to vancomycin,teicoplanin,and linezolid,evidenced by a low resistance rate.However,the prevalence of linezolid-resistant E.faecalis was increasing during the 7-year period.It is necessary to strengthen antimicrobial resistance surveillance to effectively identify the emergence of antibiotic-resistant bacteria and curb the spread of resistant pathogens.

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