1.Prediction of lymph node metastasis in invasive lung adenocarcinoma based on radiomics of the primary lesion, peritumoral region, and tumor habitat: A single-center retrospective study
Hongchang WANG ; Yan GU ; Wenhao ZHANG ; Guang MU ; Wentao XUE ; Mengen WANG ; Chenghao FU ; Liang CHEN ; Mei YUAN ; Jun WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(08):1079-1085
Objective To predict the lymph node metastasis status of patients with invasive pulmonary adenocarcinoma by constructing machine learning models based on primary tumor radiomics, peritumoral radiomics, and habitat radiomics, and to evaluate the predictive performance and generalization ability of different imaging features. Methods A retrospective analysis was performed on the clinical data of 1 263 patients with invasive pulmonary adenocarcinoma who underwent surgery at the Department of Thoracic Surgery, Jiangsu Province Hospital, from 2016 to 2019. Habitat regions were delineated by applying K-means clustering (average cluster number of 2) to the grayscale values of CT images. The peritumoral region was defined as a uniformly expanded area of 3 mm around the primary tumor. The primary tumor region was automatically segmented using V-net combined with manual correction and annotation. Subsequently, radiomics features were extracted based on these regions, and stacked machine learning models were constructed. Model performance was evaluated on the training, testing, and internal validation sets using the area under the receiver operating characteristic curve (AUC), F1 score, recall, and precision. Results After excluding patients who did not meet the screening criteria, a total of 651 patients were included. The training set consisted of 468 patients (181 males, 287 females) with an average age of (58.39±11.23) years, ranging from 29 to 78 years, the testing set included 140 patients (56 males, 84 females) with an average age of (58.81±10.70) years, ranging from 34 to 82 years, and the internal validation set comprised 43 patients (14 males, 29 females) with an average age of (60.16±10.68) years, ranging from 29 to 78 years. Although the habitat radiomics model did not show the optimal performance in the training set, it exhibited superior performance in the internal validation set, with an AUC of 0.952 [95%CI (0.87, 1.00)], an F1 score of 84.62%, and a precision-recall AUC of 0.892, outperforming the models based on the primary tumor and peritumoral regions. Conclusion The model constructed based on habitat radiomics demonstrated superior performance in the internal validation set, suggesting its potential for better generalization ability and clinical application in predicting lymph node metastasis status in pulmonary adenocarcinoma.
2.Long non-coding RNA LINC00261 promotes progression of gastric cancer by regulating miR-324-3p/EST1
Rui XIE ; Yuan YIN ; Jun TENG ; Hongliang LIANG
Chinese Journal of Immunology 2024;40(10):2101-2107
Objective:To investigate the role of long non-coding RNA LINC00261 in regulating E26 transcription factor 1(EST1)by interfering with the expression of miR-324-3p in promoting the development of gastric cancer(GC).Methods:Cancer tis-sues and corresponding adjacent normal tissues of GC patients(n=80)who underwent surgical treatment in 363 Hospital from June 2018 to October 2020 were collected as research samples,and the expression levels of LINC00261 and miR-324-3p were detected by qRT-PCR.The correlation between LINC00261 and clinicopathological parameters were analyzed.siRNA(si-LINC00261),miRNA mimic(miR-324-3p),miRNA inhibitor(miR-324-3p in)and their corresponding controls were transfected into MGC-803 and SGC-7901 cells.Clonogenesis assay was used to evaluate cell proliferation.The Transwell assay assessed cell migration and invasion.The protein expression levels of E-cadherin,N-cadherin and ETS1 were detected by Western blot.Tumor xenotransplantation assay was used to detect the tumorigenesis of LINC00261 in vivo.Luciferase report and RNA precipitation were used to analyze the interaction between LINC00261,miR-324-3p and EST1.Results:Compared with adjacent tissues,the expression of LINC00261 in GC tissues was significantly up-regulated with statistical significance(P<0.05).The expression of LINC00261 was correlated with TNM stage,tissue differentiation degree,lymph node metastasis and microvascular invasion(P<0.05).The database prediction,firefly luciferase assay and RNA immunoprecipitation results showed that LINC00261 had a targeted relationship with miR-324-3p.The level of miR-324-3p in GC tissues was significantly lower than that in paracellular normal tissues(P<0.05).There was a negative correlation between miR-324-3p level and LINC00261 expression(P<0.05).Compared with in NC+si-NC group,the cell proliferation,migration and invasion ability and the expression of N-cadherin in in NC+si-LINC00261 group were significantly inhibited(P<0.05),while the expression of E-cadherin was significantly increased(P<0.05).Compared with in NC+si-LINC00261 group,cell proliferation,migra-tion and invasion ability and expression of N-cadherin in si-LINC00261+miR-324-3p in group were significantly increased(P<0.05),while the expression of E-cadherin was significantly decreased(P<0.05).Targetscan prediction and firefly luciferase assay showed that ETS1 was the downstream binding site of miR-324-3p.After transfection with miR-324-3p,ETS1 protein level was significantly down-regulated(P<0.05),but after transfection with miR-324-3p in,ETS1 protein level was significantly up-regulated(P<0.05).The expression of ETS1 in GC tissue was significantly higher than that in adjacent normal tissue(P<0.05).The miR-324-3p level was negatively correlated with ETS1(P<0.05).The tumor weight of MGC-803 cells transfected with si-LINC00261 was lower than that of MGC-803 cells transfected with si-NC(P<0.05),and the protein level of ETS1 in si-LINC00261-derived tumors was lower than that of si-NC tumors(P<0.05).Conclusion:LINC00261 is highly expressed in GC tissue,which may affect EST1 expression and promote GC progress by regulating miR-324-3p.
3.Epidemiological and pathogenic analyses of three cases of imported Corynebacterium diphtheriae infection in Fujian Province
Qu-Wen LI ; Xue-Chen LIANG ; Ya-Dong GAO ; Shun-Tai WENG ; Yuan GAO ; Zhu-Jun SHAO
Chinese Journal of Zoonoses 2024;40(6):590-594,598
The epidemiology and etiology of three suspected cases of imported skin diphtheria infection in Fujian Province were investigated.Secretion samples of patients with skin damage were collected for isolation and culture of Corynebacterium diphtheriae.Biochemical identification and mass spectrum analysis of pure cultures of suspected C.diphtheriae were conduc-ted,the virulence-related genes,including diphtheria toxin reporter(dtxR),toxin A(toxA),and toxin B(toxB)were detec-ted,and multilocus sequence typing(MLST)was performed.All three cases had typical clinical manifestations of cutaneous diphtheria,and C.diphtheriae was isolated from the damaged skin.The virulence genes of two C.diphtheriae strains isolated from two cases were identified as dtxR(+),toxA(-),and toxB(-),and the MLST type was ST-703.The virulence genes of C.diphtheriae isolated from one case were identified as dtxR(+),toxA(+),toxB(+),and the MLST type was ST-248.There is an increased risk of diphtheria in Fujian Province.C.diphtheriae without diphtheria toxin genes can also cause skin diphtheria.
4.Rigid-body inverse dynamics modelling and analysis of 6RSS parallel bio-inspired masticatory robot
Chen CHENG ; Xiao-Jing YUAN ; Neng-Jun YANG ; Gen-Liang HOU ; Fan-Qi ZENG ; You-Cai WANG ; Wei-Peng LUO ; Guan ZHAO
Chinese Medical Equipment Journal 2024;45(3):16-22
Objective To carry out rigid-body inverse dynamics modelling and analysis of a self-designed 6RSS parallel bio-inspired masticatory robot.Methods Firstly,the functions of kinematic variables including translational/rotational velocities and accelerations were derived for rigid-body inverse dynamics modelling.Secondly,the rigid-body inverse dynamics model was established with the Newton-Euler's law.Finally,the chewing motion trajectories of the oral health volunteers were tracked and numerical calculations were carried out in the case where the robot was subjected to a chewing reaction force.Results Numerical calculations showed that the driving torque and the constraint force of the robot peaked when the chewing reaction force was at its maximum.Conclusion The external force has a large impact on the inverse dynamics of the robot,and theoretical references are provided for the motion control and optimal design of the robot.[Chinese Medical Equipment Journal,2024,45(3):16-22]
5.Homology analysis of Acinetobacter baumannii in intensive care unit be-fore and after COVID-19 pandemic
Xiao WANG ; Yan-Ru LIANG ; Yue ZHANG ; Xiang-Hua LU ; Jun FENG ; Yuan-Ping WANG ; Bing ZHAO
Chinese Journal of Infection Control 2024;23(10):1213-1219
Objective To investigate the distribution of pathogens and change of homology of Acinetobacter bau-mannii(AB)in intensive care units(ICUs)of partial medical institutions in Shanghai before and after the pandemic of coronavirus disease 2019(COVID-19).Methods Pathogens were isolated and identified by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry(MALDI-TOF MS),the whole genome of AB was sequenced using Illumina Miseq sequencing platform,and its genetic relationship was explored based on multilocus sequence typing(MLST)and core genome multilocus sequence typing(cgMLST).Results The total detection rate of patho-gens in ICU environment after the pandemic was lower than before the pandemic([6.10%,101/1 656]vs[10.77%,181/1 680];P<0.05).Before and after the pandemic,the proportion of AB detected on the surface of bedding in the ICU environment remained at the highest level.After the pandemic,the ST types showed a diverse distribution.MLST_Pasteur results showed that 162 strains of AB were divided into 20 ST types,with ST2(80.25%,n=130)being the main type.MLST_Oxford results showed that there were 19 ST types among 162 strains,with ST208(37.04%,n=60)being the main type.The clustering analysis based on cgMLST showed that ST208_Oxford had closer genetic relationship with ST540_Oxford and ST369_Oxford after the pandemic.ST164_Pasteur clone changed from ST234_Oxford before the pandemic to ST1418_Oxford after the pandemic,and 2 new types of ST_Pasteurr and 11 new types of ST_Oxford were discovered.Conclusion The detection rate of pathogens from ICU environment after the pandemic is lower than before the pandemic,and the distribution of ST types is slightly different at the same detection sites before and after the pandemic.ST2_Pasteur/ST208_Oxford is still the dominant epidemic clone before and after the pandemic,but some alleles have changed.cgMLST is more accurate than MLST_Oxford and MLST_Pasteur in homology analysis,evolution,spread,and outbreak analysis.
6.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
7.Impact of radiation dose to the immune system on prognosis for peripheral early-stage NSCLC treated with stereotactic body radiation therapy
Meigui LI ; Jiacheng LI ; Xiaofeng WANG ; Hui BAI ; Zhiyong YUAN ; Jun LIANG
Chinese Journal of Radiation Oncology 2024;33(5):405-412
Objective:To investigate the effects of radiation dose to the host immune system during radiotherapy on disease progression and survival in patients with peripheral early-stage non-small cell lung cancer (ES-NSCLC) receiving stereotactic body radiation therapy (SBRT).Methods:Clinical data of pathologically confirmed ES-NSCLC patients who were treated with SBRT at Tianjin Medical University Cancer Institute and Hospital between January 2007 and December 2020 were retrospectively analyzed. The prognostic significance of the estimated dose of radiation to immune cells (EDRIC) in ES-NSCLC patients undergoing SBRT was cited and validated. EDRIC was calculated using the model developed by Kong et al. and improved by Ladbury et al. Kaplan-Meier method and Cox proportional hazards regression were adopted to estimate cancer-specific survival (CSS), progression-free survival (PFS), local progression-free survival (LPFS), and distant metastasis-free survival (DMFS). Pearson's correlation was used to assess the correlation between variables. Results:The median prescription dose/fraction was 60 Gy/5 fractions (range: 48-60 Gy in 3-10 fractions). The median follow-up time was 52.17 (1.17-154.77) months. The median gross tumor volume (GTV) and EDRIC were 10.98 (0.91-120.34) cm 3 and 2.064 (0.426-6.015) Gy, respectively. Person's correlation analysis showed that GTV was positively correlated with EDRIC ( r=0.712, P<0.001). In multivariate analysis, EDRIC was an important prognostic variable of CSS and DMFS. Higher EDRIC was significantly associated with worse CSS ( HR=1.763, P=0.004) and DMFS ( HR=1.902, P=0.004). Compared to patients with EDRIC ≤ 1.56 Gy, those with EDRIC > 2.64 Gy and EDRIC between <2.06-2.64 Gy exhibited significantly lower CSS ( P<0.001, P=0.049). There were significant differences in DMFS among the groups divided by quartiles of EDRIC (compared to EDRIC ≤1.56 Gy, the P values were <0.001, 0.004, and 0.022 respectively). Conclusions:EDRIC is an important predictor of CSS and DMFS in ES-NSCLC patients treated with SBRT, suggesting that radiation dose to the immune system is a critical determinant of treatment outcomes. EDRIC can be used to quantify the effects of radiation therapy on the host immune system.
8.Changes in PLC and survival analysis of early NSCLC patients treated with SBRT
Rui LI ; Xiaofeng WANG ; Hui BAI ; Jun LIANG ; Zhiyong YUAN
Chinese Journal of Radiation Oncology 2024;33(10):909-914
Objective:To investigate the variations in peripheral lymphocyte count (PLC) and evaluate the impact of PLC on clinical prognosis of patients with early-stage non-small cell lung cancer (NSCLC) during stereotactic body radiation therapy (SBRT).Methods:Clinical data of early-stage NSCLC patients who received SBRT at Tianjin Medical University Cancer Institute and Hospital from January 2007 to January 2021 were retrospectively analyzed. The PLC of early-stage NSCLC patients was recorded at four different time points: 1 week before SBRT, 1 week after SBRT, 1 month after SBRT, and 3 months after SBRT. Kaplan-Meier method and Cox proportional hazards regression analysis were used to estimate cancer-specific survival (CSS), progression-free survival (PFS), local progression-free survival (LPFS), and distant metastasis-free survival (DMFS) and their influencing factors. Pearson correlation analysis was used to evaluate the correlation among different variables. The optimal cut-off value of nadir-PLC is determined using the 'maxstat package' in R language.Results:Throughout the treatment process, the nadir-PLC generally occurred approximately at 1 week after SBRT, and was gradually increased thereafter, and almost restored to the level before SBRT at approximately 3 months after SBRT. The median nadir-PLC was 1.03×10 9/L, significantly lower than the baseline value of 1.90×10 9/L before treatment ( P<0.001). The nadir-PLC in patients with central NSCLC was lower compared with that of patients with peripheral NSCLC ( P=0.030). The median survival for the entire group was 91.5 months, and 89.8%, 78.6%, 93.2%, and 82.5% for the 2-year CSS, PFS, LPFS, and DMFS rates, respectively. In multivariate analysis, nadir-PLC ≥1.01×10 9/L was an important favorable prognostic factor for CSS, PFS and DMFS. Pearson correlation analysis showed that gross tumor volume (GTV) was negatively correlated with nadir-PLC ( r=-0.55, P<0.001). Conclusions:In early-stage NSCLC patients treated with SBRT, PLC will decline after treatment. The nadir-PLC is an important favorable prognostic factor for CSS, PFS and DMFS.
9.Stability study of umbilical cord mesenchymal stem cells formulation in large-scale production
Wang-long CHU ; Tong-jing LI ; Yan SHANGGUAN ; Fang-tao HE ; Jian-fu WU ; Xiu-ping ZENG ; Tao GUO ; Qing-fang WANG ; Fen ZHANG ; Zhen-zhong ZHONG ; Xiao LIANG ; Jun-yuan HU ; Mu-yun LIU
Acta Pharmaceutica Sinica 2024;59(3):743-750
Umbilical cord mesenchymal stem cells (UC-MSCs) have been widely used in regenerative medicine, but there is limited research on the stability of UC-MSCs formulation during production. This study aims to assess the stability of the cell stock solution and intermediate product throughout the production process, as well as the final product following reconstitution, in order to offer guidance for the manufacturing process and serve as a reference for formulation reconstitution methods. Three batches of cell formulation were produced and stored under low temperature (2-8 ℃) and room temperature (20-26 ℃) during cell stock solution and intermediate product stages. The storage time intervals for cell stock solution were 0, 2, 4, and 6 h, while for intermediate products, the intervals were 0, 1, 2, and 3 h. The evaluation items included visual inspection, viable cell concentration, cell viability, cell surface markers, lymphocyte proliferation inhibition rate, and sterility. Additionally, dilution and culture stability studies were performed after reconstitution of the cell product. The reconstitution diluents included 0.9% sodium chloride injection, 0.9% sodium chloride injection + 1% human serum albumin, and 0.9% sodium chloride injection + 2% human serum albumin, with dilution ratios of 10-fold and 40-fold. The storage time intervals after dilution were 0, 1, 2, 3, and 4 h. The reconstitution culture media included DMEM medium, DMEM + 2% platelet lysate, 0.9% sodium chloride injection, and 0.9% sodium chloride injection + 1% human serum albumin, and the culture duration was 24 h. The evaluation items were viable cell concentration and cell viability. The results showed that the cell stock solution remained stable for up to 6 h under both low temperature (2-8 ℃) and room temperature (20-26 ℃) conditions, while the intermediate product remained stable for up to 3 h under the same conditions. After formulation reconstitution, using sodium chloride injection diluted with 1% or 2% human serum albumin maintained a viability of over 80% within 4 h. It was observed that different dilution factors had an impact on cell viability. After formulation reconstitution, cultivation in medium with 2% platelet lysate resulted in a cell viability of over 80% after 24 h. In conclusion, the stability of cell stock solution within 6 h and intermediate product within 3 h meets the requirements. The addition of 1% or 2% human serum albumin in the reconstitution diluent can better protect the post-reconstitution cell viability.
10.Study on the effect of different administration regimens of iprrazole enteric-coated tablets on inhibiting gastric acid secretion
Ting-Yuan PANG ; Zhi WANG ; Zi-Shu HU ; Zi-Han SHEN ; Yue-Qi WANG ; Ya-Qian CHEN ; Xue-Bing QIAN ; Jin-Ying LIANG ; Liang-Ying YI ; Jun-Long LI ; Zhi-Hui HAN ; Guo-Ping ZHONG ; Guo-Hua CHENG ; Hai-Tang HU
The Chinese Journal of Clinical Pharmacology 2024;40(1):92-96
Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH>3 after 20 mg qd and 10 mg bid were 82.64%and 61.92%,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.

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