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Safety and effectiveness of lurasidone in the treatment of Chinese schizophrenia patients:An interim analysis of post-marketing surveillance

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World Journal of Psychiatry 2023年第11期13卷 937-948页

作者： Yu-Mei Wei xi-Jin Wang xiao-Dong Yang Chuan-Sheng Wang Li-Li Wang xiao-Ying Xu Gui-Jun Zhao Bin Li Dao-Min Zhu Qi Wu Yi-Feng Shen Shanghai Clinical Research Center for Mental Health School of MedicineShanghai Jiao Tong UniversityShanghai 200030China Department of Psychiatry The First Psychiatric Hospital of HarbinHarbin 150056Heilongjiang ProvinceChina Department of Psychiatry Shandong Provincial Mental Health CenterJinan 250014Shandong ProvinceChina Department of Psychiatry The Second Affiliated Hospital of Xinxiang Medical UniversityXinxiang 453002Henan ProvinceChina Department of Psychiatry Tianjin Mental Health CenterTianjin Anding HospitalTianjin 300222China Department of Psychiatry The Fifth People’s Hospital of ZigongZigong 643020Sichuan ProvinceChina Department of Psychiatry Guangyuan Mental Health CenterGuangyuan 628001Guizhou ProvinceChina Department of Psychology Fujian Energy General HospitalFuzhou 350001Fujian ProvinceChina Department of Sleep Disorders Affiliated Psychological Hospital of Anhui Medical UniversityHefei Fourth People’s HospitalAnhui Mental Health CenterHefei 230022Anhui ProvinceChina Sumitomo Pharma(China) Co.Ltd.Shanghai 200025China Shanghai Key Laboratory of Psychotic Disorders Shanghai Clinical Research Center for Mental HealthShanghai Jiao Tong UniversityShanghai 200030China

BACKGROUND Schizophrenia is a psychiatric disorder characterized by chronic or recurrent *** was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 mg/***,post-market surveillance(PMS)with an adequate sample size is required for further validation of the drug’s safety profile and *** To conduct PMS in real-world clinical settings and evaluate the safety and effectiveness of lurasidone in the Chinese *** A prospective,multicenter,open-label,12-wk surveillance was conducted in China's *** patients with schizophrenia from 10 sites who had begun medication with lurasidone between September 2019 and August 2022 were eligible for *** assessments included adverse events(AEs),adverse drug reactions(ADRs),extrapyramidal symptoms(EPS),akathisia,use of EPS drugs,weight gain,and laboratory values as metabolic parameters and the QTc *** effectiveness was assessed using the brief psychiatric rating scale(BPRS)from baseline to the end of *** A total of 965 patients were enrolled in the full analysis set and 894 in the safety set in this interim *** average daily dose was 61.7±19.08 mg(mean±SD)during the *** and ADRs were experienced by 101 patients(11.3%)and 78 patients(8.7%),respectively,which were mostly *** occurred in 25 individuals with a 2.8%incidence,including akathisia in 20 individuals(2.2%).Moreover,59 patients received drugs for treating EPS during the treatment,with an incidence of 6.6%which dropped to 5.4%at the end of the *** average weight change was 0.20±2.36 kg(P=0.01687)with 0.8%of patients showing a weight gain of≥7%at week 12 compared with that at the *** mean values of metabolic parameters and the QTc interval at baseline and week 12 were within normal *** mean changes in total BPRS scores were-8.9±9.76(n=959),-13.5±12.29(n=959),and-16.8±13.97(n=959)after 2/4,6/8,a

关键词： Lurasidone Safety Effectiveness Surveillance Schizophrenia Chinese

Psychiatric Epidemiology and Mental Health Service in the Tibet Autonomous Region of the People＇s Republic of China

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上海精神医学 2018年第2期30卷 127-130页

作者：谢靓魏赓徐艳黄悦勤刘协和李涛郭万军 Mental health Center West China Hospital Sichuan University Mental Health Center Xi Hua University Biorepository State Key Laboratory of Biotherapy West China Hospital Sichuan University Peking University Sixth hospital Peking University Institute of Mental Health Key Laboratory of Mental Health Ministry of Health (Peking University) National Clinical Research Cnter for Mental Disorders (Peking University Sixth Hospital)

概述:西藏自治区的精神疾病流行病学和精神卫生服务情况在国际上鲜有提及。本文综述了中国西藏自治区的精神疾病流行病学和精神卫生服务以及相关研究。目前在西藏,有很多人存在精神障碍和心理问题,但由于缺乏现代精神治疗机构和专家,仍... 详细信息

概述:西藏自治区的精神疾病流行病学和精神卫生服务情况在国际上鲜有提及。本文综述了中国西藏自治区的精神疾病流行病学和精神卫生服务以及相关研究。目前在西藏,有很多人存在精神障碍和心理问题,但由于缺乏现代精神治疗机构和专家,仍有很多的治疗需求没有被满足。

关键词：西藏自治区心理健康传染病学中华人民共和国精神病服务心理问题国际性

CYTOTOxiCITY OF INDIRECT IMMUNOTOxiN MEDIATED BY ANTI-GASTRIC CANCER MONOCLONAL ANTIBODIES ON TUMOR CELLS

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Chinese Journal of Cancer Research 1990年第2期2卷 34-37页

作者：黎松张学庸陈希陶樊代明 Laboratory of Gastroenterology Xijing Hospital The Fourth Military Medical Vniversity Xi'an Laboratory of Gastroenterology Xijing Hospital The Fourth Military Medical Vniversity Xi'ann the present study an indirect assay was employed to investigate 5 anti-gastric cancer monoclonal antibodies for their cytotoxic potential as ricin A chain-containing immunotoxins. The tumor cell were treated with dilutions of tested antibody followed by ricin A chain coupled to goat anti-mouse immunoglobulin. The cytotoxic effect was determined with tetrazolium colorimetric assay. The results showed that among the 5 antibodies chosen MGb2 and MG7 could be well used for preparation of effective A chain immunotoxins.

In the present study, an indirect assay was employed to investigate 5 anti-gastric cancer monoclonal antibodies for their cytotoxic potential as ricin A chain-containing immunotoxins. The tumor cell, were treated with dilutions of tested antibody followed by ricin A chain coupled to goat anti-mouse immunoglobulin. The cytotoxic effect was determined with tetrazolium colorimetric assay. The results showed that among the 5 antibodies chosen, MGb2 and MG7 could be well used for preparation of effective A chain immunotoxins.

关键词： CYTOTOxiCITY OF INDIRECT IMMUNOTOxiN MEDIATED BY ANTI-GASTRIC CANCER MONOCLONAL ANTIBODIES ON TUMOR CELLS line IT link DEAE

Donor MHC gene to mitigate rejection of transplantation in recipient mice

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Chinese Medical Journal 2011年第24期124卷 4279-4285页

作者： LI Tong YAN Jun TAN Jia-li LU Yue-ping HOU Sheng-cai LI Shen-tao XU Qing TONG Xue-hong DING Jie ZHANG Zhi-tai LI Hui Department of Thoracic Surgery Beijing Chao-Yang hospital Capital Medical University Beijing 100020 China Department of Cardiae Surgery Beijing Chao-Yang hospital Capital Medical University Beijing 100020 China Experimental Centre Beijing Chao-Yang hospital Capital Medical University Beijing 100020 China Department of Orthodontics School of Stomatology FourthMilitary Medical University Xi＇an Shaanxi 710032 China Department of Molecular Biology Capital Medical University Beijing 100069 China Department of Thoracic Surgery Beijing Anzhen Hospital Capital Medical University Beijing 100029 China

Background Donor organ rejection continues to be a significant problem for patients receiving transplants. We therefore tested whether transferring a donor＇s major histocompatibility complex （MHC） gene to the recipient would mitigate the rejection of transplanted hearts in mice. Methods H-2K^kgene from donor mice was amplified using nested polymerase chain reaction （PCR） and ligated into a mammalian expression vector, which was then transfected into thymus ground mass cells collected from the recipients. Clones stably expressing the transgene were then injected into the recipients＇ thymus visualized using ultrasound. Control mice were administered cells previously transfected with empty vector. Following heart transplantation, cardiac activity was monitored electrocardiographically. Recipient thymus cells were tested for MHC antigenicity using flow cytometry and spleen cells were subjected to mixed lymphocyte culture tests. Finally, the transplanted hearts were sectioned, stained and examined under light microscopy. Results Southern analysis following nested PCR revealed clear expression of H-2K^ gene. Following transplantation, electrocardiosignals were detectable highly significantly longer in recipients administered thymal cells expressing donor H-2K^ than in those receiving control cells. Flow cytometric analysis using an anti-H-2K^ antibody confirmed its expression in H-2K^ treated recipients but not in control mice. Mixed lymphocyte cultures containing H-2K^ treated cells showed significantly less proliferation than those containing control cells. Hearts from control mice showed substantially greater lymphocyte infiltration than those from H-2K^ treated mice and large areas of necrosis. Conclusion Rejection of transplanted hearts can be mitigated substantially by introducing the donor＇s MHC into the recipient.

关键词： major histocompatibility complex transplantation gene transference tolerance

Application of metabolomics in urolithiasis:the discovery and usage of succinate

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Signal Transduction and Targeted Therapy 2023年第2期8卷 771-783页

作者： xiu-zhen Zhang xiong-xin Lei Yan-lin Jiang Long-mei Zhao Chen-yu Zou Yun-jin Bai Ya-xing Li Rui Wang Qian-jin Li Qiu-zhu Chen Ming-hui Fan Yu-ting Song Wen-qian Zhang Yi Zhang Jesse Li-Ling Hui-qi xie Laboratory of Stem Cell and Tissue Engineering Orthopedic Research InstituteDepartment of OrthopedicsState Key Laboratory of BiotherapyWest China HospitalSichuan UniversityChengduSichuan 610041China Department of Urology Institute of UrologyWest China HospitalSichuan UniversityChengduSichuan 610041China Research Core Facility of West China hospital Sichuan UniversityChengduSichuan 610041China Department of Medical Genetics West China Second University HospitalChengduSichuan 610041China

Urinary stone is conceptualized as a chronic metabolic disorder punctuated by symptomatic stone *** has been shown that the occurrence of calcium oxalate monohydrate(COM)during stone formation is regulated by crystal growth *** crystallization inhibitors have been recognized as a therapeutic modality for decades,limited progress has been made in the discovery of effective modifiers to intervene with stone *** this study,we have used metabolomics technologies,a powerful approach to identify biomarkers by screening the urine components of the dynamic progression in a bladder stone *** in-depth mining and analysis of metabolomics data,we have screened five differential *** density functional theory studies and bulk crystallization,we found that three of them(salicyluric,gentisic acid and succinate)could effectively inhibit nucleation in *** thereby assessed the impact of the inhibitors with an EG-induced rat model for kidney ***,succinate,a key player in the tricarboxylic acid cycle,could decrease kidney calcium deposition and injury in the *** analysis further showed that the protective effect of succinate was mainly through anti-inflammation,inhibition of cell adhesion and osteogenic *** findings indicated that succinate may provide a new therapeutic option for urinary stones.

关键词： crystallization thereby protective

Evaluation of the New Automatic Mycob.T Stainer andScanner for Detecting Acid-fast Bacilli in China

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Biomedical and Environmental Sciences 2018年第8期31卷 572-578页

作者： LI Qiang ZHAO Yan Lin WANG Qing DENG Yun Feng BAO Xun Di YANG Hong Guo OU xi Chao ZHAO Bing ZHANG Jing Bo Beijing Physical Examination Center Beijing 100077China National Center for Tuberculosis Control and Prevention Chinese Center for Disease Control and PreventionBeijing 102206China Anhui Provincial Chest hospital Hefei 230022AnhuiChina Shandong Provincial Chest hospital Jinan 250013ShandongChina Linyi People's hospital Linyi 276003ShandongChina

Objective To validate the performance of Mycob. T Stainer and Scanner(MTSS) for detecting acid-fast bacilli(AFB). Methods A total of 3,816 sputum samples from 1,515 tuberculosis(TB) suspects were tested at the Anhui Provincial Chest hospital and the Linyi People’s hospital from April-August, 2016. Each specimen was placed on two smear slides. One slide was stained by the ziehl-neelsen(ZN) method to be read by conventional microscopy(CM). The other slide was stained and scanned by MTSS. All specimens were decontaminated with 4% NaO H, and then inoculated into solid culture. The performance of MTSS was assessed. Results MTSS produced higher average positivity rate(27.96%) as compared with the CM(26.83%). The overall sensitivity and specificity of MTSS were 78.9% and 93.9%, respectively. The sensitivity and specificity of CM was 77.4% and 95.0%, respectively. Conclusion MTSS exhibited a favorable performance in the detection of AFB. It may be an alternative to CM for screening TB.

关键词： Tuberculosis Automatic Stainer Scanner

A survey on the epidemiology of trauma and China trauma care training in subtropical regions of Hainan Province

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Journal of Acute Disease 2018年第3期7卷 108-114页

作者： Jiang-Ling Yao Chang-xi Zhou Ji-Min Fu Jian Fu Yun-Tao Gu Zhu-Long Meng Lei Peng Zhong-Lin Zhou Trauma Center The First Affiliated Hospital of Hainan Medical CollegeHainan Province 570102China Nanlou Respiratory Diseases Department PLA General Hospital28 Fuxing RoadBeijing 100853China Hainan Medical College No.3 Xueyuan RoadHaikouHainan Province 570102China

Objective: To investigate the epidemiology of trauma patients in subtropical areas of Hainan Province and the improvement of the level of trauma treatment in China trauma care training (CTCT). Methods: From 01-01-2015 to 01-01-2016, the epidemiological data of 2476 patients with trauma were collected. From 01-01-2016 to 01-01-2017, 105 professional doctors and nurses in emergency surgery took part in CTCT, and their knowledge were compared before and after training. Results: There were 1656 male and 820 female trauma patients with 1614 cases in the middle and young age and 478 cases were the elderly. In terms of occupational distribution, 736 peasants, 574 workers and 458 retirees were involved. In May, the number of patients was the highest 332. October to January was the high-incidence season of trauma. In 24 hours a day: 11:00-13:00, 18:00-19:00, 23:00-03:00 were the high incidence periods. Referred to trauma sites, 904 cases of trauma happened on roads, 540 cases in family and 370 cases in restaurants or entertainment facilities. Through CTCT, the scores of the theoretical examination, the assessment of the trauma treatment skills and the field test scores of the emergency surgery practitioners were better than before (Pfirst aid skills of medical personnel involved in trauma treatment. Health departments and medical education departments may consider extending CTCT training and continuing educati

关键词： Epidemiology CTCT Training Trauma Subtropical

The Ap-2α/Elk-1 axis regulates Sirpα-dependent tumor phagocytosis by tumor-associated macrophages in colorectal cancer

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Signal Transduction and Targeted Therapy 2020年第1期5卷 2065-2076页

作者： xiaojiao Wang xi Luo Chuan Chen Ye Tang Lian Li Banghui Mo Houjie Liang Songtao Yu Department of Oncology Southwest HospitalArmy Medical University30 Gaotanyan StreetChongqing 400038People’s Republic of China Cancer Center Daping Hospital and Research Institute of SurgeryArmy Medical UniversityChongqing 402560People’s Republic of China Department of Oncology Tong Liang District HospitalChongqing 402560People’s Republic of China

The inhibitory receptor signal regulatory protein-α(Sirpα)is a myeloid-specific immune checkpoint that engages the“don’t eat me”signal CD47,which is expressed on tumor and normal tissue ***,the profile and regulatory mechanism of Sirpαexpression in tumor-associated macrophages(TAMs)are still not ***,we found that the expression of Sirpαin TAMs increased dynamically with colorectal cancer(CRC)***,CRC cell-derived lactate induced the nuclear translocation of the transcription factor Ap-2αfrom the cytoplasm in ***-2αfunctioned as a transcription factor for Elk-1 by binding to the conserved element GCCTGC located at−1396/−1391 in the mouse Elk-1 ***,the Elk-1 protein bound to two conserved sites,CTTCCTACA(located at−229/−221)and CTTCCTCTC(located at−190/−182),in the mouse Sirpαpromoter and promoted Sirpαexpression in ***,the macrophage-specific knockout of Ap-2αnotably promoted the phagocytic activity of TAMs and suppressed CRC progression,whereas these effects were prevented by the transgenic macrophage-specific expression of Elk-1,which regulated TAM phagocytosis and CRC development in a Sirpα-dependent ***,we showed that Elk-1 expression was positively correlated with Sirpαexpression in TAMs and was associated with poor survival in CRC *** together,our findings revealed a novel mechanism through which CRC evades innate immune surveillance and provided potential targets for macrophage-based immunotherapy for CRC patients.

关键词： colorectal cancer promoted

Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1:interim analysis of the randomized,controlled,phase 3,non-inferiority TALENT study

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Chinese Medical Journal 2020年第24期133卷 2919-2927页

作者： Bin Su Cheng Yao Qing-xia Zhao Wei-Ping Cai Min Wang Hong-Zhou Lu Yuan-Yuan Chen Li Liu Hui Wang Yun He Yu-Huang Zheng Ling-Hua Li Jin-Feng Chen Jian-Hua Yu Biao Zhu Min Zhao Yong-Tao Sun Wen-Hui Lun Wei xia Li-Jun Sun Li-Li Dai Tai-Yi Jiang Mei-xia Wang Qing-Shan Zheng Hai-Yan Peng Yao Wang Rong-Jian Lu Jian-Hua Hu Hui xing Yi-Ming Shao Dong xie Tong Zhang Fu-Jie Zhang Hao Wu TALENT Study Team Center for Infectious Diseases Beijing Youan HospitalCapital Medical UniversityBeijing 100069China Frontier Biotechnologies Inc. NanjingJiangsu 211122China Department of Infectious Diseases Infectious Disease Hospital of Henan ProvinceZhengzhouHenan 450061China Infectious Disease Center Guangzhou Eighth People’s HospitalGuangzhou Medical UniversityGuangzhouGuangdong 510060China Institute of HIV/AIDS The First Hospital of ChangshaChangshaHunan 410005China Department of Infectious Diseases Shanghai Public Health Clinical CenterFudan UniversityShanghai 201508China Department of Infectious Diseases National Clinical Center for Infectious DiseasesShenzhen Third People’s HospitalShenzhenGuangdong 518112China Department of Infectious Diseases The Second Xiangya HospitalCentral South UniversityChangshaHunan 410011China Department of Infectious Diseases Xixi Hospital of HangzhouHangzhouZhejiang 310023China State Key Laboratory for Diagnosis and Treatment of Infectious Diseases National Clinical Research Center for Infectious DiseasesThe First Affiliated HospitalZhejiang UniversityHangzhouZhejiang 310003China National Clinical Research Center for Infectious Diseases the Fifth Medical Center of PLA General HospitalBeijing 100039China Department of Infectious Diseases Tangdu HospitalThe Fourth Military Medical UniversityXi’anShaanxi 710038China Clinical and Research Center of Infectious Diseases Beijing Ditan HospitalCapital Medical UniversityBeijing 100015China Center for Drug Clinical Research Shanghai University of Traditional Chinese MedicineShanghai 201203China Beijing Co-CRO Medical Development Co. Ltd.Beijing 100711China State Key Laboratory for Infectious Disease Prevention and Control National Center for AIDS/STD Control and PreventionChinese Center for Disease Control and PreventionBeijing 102206China 不详

Background:Albuvirtide is a once-weekly injectable human immunodeficiency virus(HIV)-1 fusion *** present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral ***:We carried out a 48-week,randomized,controlled,open-label non-inferiority trial at 12 sites in *** on the World Health Organization(WHO)-recommended first-line treatment for>6 months with a plasma viral load>1000 copies/mL were enrolled and randomly assigned(1:1)to receive albuvirtide(once weekly)plus ritonavir-boosted lopinavir(ABT group)or the WHO-recommended second-line treatment(NRTI group).The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 ***-inferiority was prespecified with a margin of 12%.Results:At the time of analysis,week 24 data were available for 83 and 92 patients,and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups,*** 48 weeks,80.4%of patients in the ABT group and 66.0%of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL,meeting the criteria for *** the per-protocol population,the superiority of albuvirtide over NRTI was *** frequency of grade 3 to 4 adverse events was similar in the two groups;the most common adverse events were diarrhea,upper respiratory tract infections,and grade 3 to 4 increases in triglyceride *** function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT ***:The TALENT study is the first phase 3 trial of an injectable long-acting HIV *** interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatme

关键词： HIV Fusion inhibitor Albuvirtide LPV/r Phase 3 clinical trial