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Decreased incidence of febrile neutropenia in Michigan following masking and social distancing orders for the COVID-19 pandemic: A population based cohort study

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World Journal of Clinical Oncology 2022年第7期13卷 609-615页

作者： Michael Gerard Baracy Jr Karen Hagglund Sanjana Kulkarni Fareeza Afzal Katherine Arends Robert T.Morris Leigh Ann Solomon Muhammad Faisal Aslam Logan Corey Department of Obstetrics and Gynecology Ascension St.John HospitalDetroitMI 48236United States Medical research Ascension St John Hospital and Medical CenterDetroitMI 48236United States Surveillance and Infectious Disease Epidemiology Section Michigan Department of Health and Human ServicesLansingMI 48933United States Department of Obstetrics and Gynecology Wayne State University School of MedicineKarmanos Cancer InstituteDetroitMI 48201United States Female Pelvic Medicine and Reconstructive Surgery Ascension St.John HospitalDetroitMI 48236United States Department of Gynecologic Oncology Wayne State UniversityDetroitMI 48202United States

BACKGROUND It has been theorized that 75%-80%of febrile neutropenia(FN)is caused by endogenous pathogens,while up to 20%of cases are thought to be caused by a viral *** is unknown if precautions such as masking and social distancing reduce the risk of FN in susceptible *** To determine whether coronavirus disease 2019(COVID-19)infection mitigation efforts,namely masking and social distancing,were associated with a reduction in the incidence of *** This was a retrospective population based cohort study comparing the incidence of FN in the 13 mo prior to(Year 0)and 13 mo following(Year 1)the public health executive orders(PHEO)in *** was queried for all emergency department(ED)visits from April 1,2019 to March 31,2021 from the National Syndromic Surveillance Program,a program which collects data that is voluntarily submitted by approximately 89%of Michigan *** primary study outcome was the incidence of FN as a proportion of ED visits in the 13-mo before and 13-mo after COVID-19 mitigations efforts,namely masking and social *** hypothesized that there would be a significant decrease in the incidence of FN in the period following the PHEO aimed at reducing the spread of the severe acute respiratory syndrome coronavirus 2 *** There was a total of 8979221 total ED visits captured during the study *** Year 0 there were 5073081 recorded ED visits and 3906140 in Year *** was a significant reduction in the proportion of total ED visits with a diagnosis of FN,decreasing 13.3%across periods(0.15%vs 0.13%,P=0.036).In patients with a hematologic malignancy a more impressive reduction in the incidence of FN was evident following PHEO(22%vs 17%,P=0.02).CONCLUSION We found a significant association between social distancing and mask guidelines implemented on a large public scale with decreased rates of FN,particularly in those with a hematologic *** findings may be useful in the design of future res

关键词： Febrile neutropenia COVID-19 SARS-CoV-2 Malignancy hematology Public health

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Journey of Immunohistochemistry in General and Oral Pathology:A Review on its Applications and Updates

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Journal of Clinical and Nursing research 2022年第6期6卷 62-68页

作者： Kanu Jain Rajnish Gakhar Sehrish Deepti Garg Jindal Department of Oral Pathology Maharaja Ganga Singh Dental College and Research CentreSri Ganganagar 335002RajasthanIndia Department of Oral Pathology Bhojia Dental College and HospitalBaddiDistt.Solan 173205Himachal PradeshIndia

Immunohistochemistry is a technique with an interesting *** is one of the well-established and reliable technique in modern pathology and it is extremely useful in diagnosis of sinister pathologies with perplexing *** only does it enhance the diagnostic abilities of a pathologist,but it also has a huge prognostic potential,a great aid in establishing stage of malignancies,determines phenotypic expressions of lymphoid neoplasms and monitors treatment progress and response to *** employing and integrating the basics of varied branches like immunology,histology,microscopy and hematology,it has emerged as a magnificent tool over last few decades,saving pathologists and patients from the impact of serious diseases inflicting the human ***,it has contributed immensely to all aspects of diseases related to oral cavity as *** review has been thus taken to highlight the wide applications of this technique in General and Oral Pathology with an update.

关键词： Applications Immunohistochemistry Oral Pathology Update

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Medium-term surgical outcomes and health-related quality of life after laparoscopic vs open colorectal cancer resection: SF-36 health survey questionnaire

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World Journal of Gastrointestinal Endoscopy 2023年第3期15卷 163-176页

作者： Chao-Ming Hung Kuo-Chuan Hung Hon-Yi Shi Shih-Bin Su Hui-Ming Lee Meng-Che Hsieh Cheng-Hao Tseng Shung-Eing Lin Chih-Cheng Chen Chao-Ming Tseng Ying-Nan Tsai Chi-Zen Chen Jung-Fa Tsai Chong-Chi Chiu Department of General Surgery E-Da Cancer HospitalI-Shou UniversityKaohsiung 82445TaiwanChina School of Medicine College of MedicineI-Shou UniversityKaohsiung 82445TaiwanChina Department of Anesthesiology Chi Mei Medical CenterTainan 71004TaiwanChina Department of Hospital and Health Care Administration College of Recreation and Health ManagementChia Nan University of Pharmacy and ScienceTainan 71710TaiwanChina Department of Healthcare Administration and Medical Informatics Kaohsiung Medical UniversityKaohsiung 80708TaiwanChina Department of Business Management National Sun Yat-Sen UniversityKaohsiung 80424TaiwanChina Department of Medical research Kaohsiung Medical University HospitalKaohsiung 80756TaiwanChina Department of Medical research China Medical University HospitalChina Medical UniversityTaichung 40402TaiwanChina Department of Occupational Medicine Chi Mei Medical CenterLiouying 73657TaiwanChina Department of Occupational Medicine Chi Mei Medical CenterTainan 71004TaiwanChina Department of Leisure Recreation and Tourism ManagementSouthern Taiwan University of Science and TechnologyTainan 71005TaiwanChina College of Medicine I-Shou UniversityKaohsiung 82445TaiwanChina Department of hematology-Oncology E-Da Cancer HospitalI-Shou UniversityKaohsiung 82445TaiwanChina Department of Gastroenterology and Hepatology E-Da Cancer HospitalI-Shou UniversityKaohsiung 82445TaiwanChina Department of Gastroenterology and Hepatology E-Da HospitalI-Shou UniversityKaohsiung 82445TaiwanChina Department of Colon and Rectal Surgery E-Da Cancer HospitalI-Shou UniversityKaohsiung 82445TaiwanChina Department of Gastroenterology and Hepatology E-Da Dachang HospitalI-Shou UniversityKaohsiung 80794TaiwanChina Department of Medical Education and research E-Da Cancer HospitalI-Shou UniversityKaohsiung 82445TaiwanChina Department of General Surgery Chi Mei Medical CenterLiouying 73657TaiwanChina

BACKGROUND Previous studies that compared the postoperative health-related quality of life(HRQoL)outcomes after receiving laparoscopic resection(LR)or open resection(OR)in patients with colorectal cancer(CRC)have different *** To explore the medium-term effect of postoperative HRQoL in such *** This study randomized 567 patients undergoing non-metastatic CRC surgery managed by one surgeon to the LR or OR *** was assessed during the preoperative period and 3,6,and 12 mo postoperative using a modified version of the 36-Item Short Form(SF-36)Health Survey questionnaire,emphasizing eight specific *** This cohort randomly assigned 541 patients to receive LR(n=296)or OR(n=245)surgical *** episodes of postoperative urinary tract infection(P<0.001),wound infection(P<0.001),and pneumonia(P=0.048)were encountered in the OR *** results demonstrated that the LR group subjectively gained mildly better general health(P=0.045),moderately better physical activity(P=0.006),and significantly better social function recovery(P=0.0001)3 mo *** the aspect of social function recovery was claimed at 6 mo,with a significant advantage in the LR group(P=0.001).No clinical difference was found in HRQoL during the 12 *** Our results demonstrated that LR resulted in better outcomes,including intra-operative blood loss,surgery-related complications,course of recovery,and especially some health domains of HRQoL at least within 6 mo *** should undergo LR if there is no contraindication.

关键词： Health-related quality of life Medium-term result Laparoscopic Open surgery Non-metastatic colorectal cancer

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Laboratory Safety of Dupilumab,and Its Effect on Inflammatory Biomarkers,in Chinese Adults With Moderate-to-Severe Atopic Dermatitis:An Analysis of a Randomized,Double-Blind Phase III Study

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International Journal of Dermatology and Venereology 2022年第4期5卷 218-225页

作者： Yan Zhao Li-Ming Wu Qian-Jin Lu Xing-Hua Gao Xiao-Hong Zhu Xu Yao Lin-Feng Li Wei Li Yang-Feng Ding Zhi-Qiang Song Ling-Ling Liu Ning-Ning Dang Chun-Lei Zhang Xiao-Ming Liu Jun Gu Jin-Yan Wang Song-Mei Geng Quan-Zhong Liu Yi-Feng Guo Li Dong Shelley Li Christine Xu John T.O’Malley Elizabeth Laws Nikhil Amin Ashish Bansal Min Wang Jian-Zhong Zhang Department of Dermatology Peking University People’s HospitalBeijing 100044China Hangzhou First People’s Hospital HangzhouZhejiang 310006China The Second Xiangya Hospital of Central South University ChangshaHunan 410011China The First Hospital of China Medical University ShenyangLiaoning 110001China Wuxi Second People’s Hospital WuxiJiangsu 214002China Hospital for Skin Diseases Institute of DermatologyChinese Academy of Medical SciencesNanjingJiangsu 210042China Beijing Friendship Hospital Capital Medical UniversityBeijing 100050China Huashan Hospital Fudan UniversityShanghai 200040China Shanghai Skin Disease Hospital Shanghai 200040China The Southwest Hospital of AMU Chongqing 400038China Peking University First Hospital Beijing 100034China Jinan Central Hospital JinanShandong 250013China Peking University Third Hospital Beijing 100191China University of Hong Kong-Shenzhen Hospital ShenzhenGuangdong 518040China Changhai Hospital of Shanghai Shanghai 200433China Ningbo No.2 Hospital NingboZhejiang 315099China The Second Affiliated Hospital of Xi’an Jiaotong University Xi’anShaanxi 710004China Tianjin Medical University General Hospital Tianjin 300052China Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai 200092China research&Development SanofiBridgewaterNJ 08807USA research&Development RegeneronTarrytownNY 10591USA Medical Sanofi ChinaShanghai 200040China.

Objective:Limited information is available on the use of dupilumab for the treatment of atopic dermatitis(AD)in the Chinese ***:We analyzed laboratory data from a previously published randomized,double-blind phase III trial(NCT03912259)to provide further insight into the safety of dupilumab in Chinese adults with moderate to severe *** trial participants received either 300 mg of dupilumab or placebo every 2 weeks for 16 ***,blood chemistry,serum thymus and activation-regulated chemokine(TARC),and total immunoglobulin E(IgE)were ***:In total,82 participants received dupilumab and 83 received *** the exception of eosinophil counts of>0.8×109/L,which were found less frequently with dupilumab(9.8%)than with placebo(18.7%),the hematology and blood chemistry values were generally stable in both treatment *** were no clinically significant differences between the dupilumab and placebo groups,and no participants developed treatment-emergent abnormalities of potential clinical ***,compared with placebo,greater decreases in serum lactate dehydrogenase(mean change,−97.4 vs.−33.5 IU/L),TARC(median percent change,−78.6%vs.−30.8%),and total IgE(median percent change,−53.4%vs.−0.2%)were observed with dupilumab than placebo at week ***:Dupilumab demonstrated a favorable laboratory safety profile in Chinese adults with moderate to severe AD.

关键词： atopic dermatitis dupilumab laboratory safety Chinese

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Anti-CD 20 monoclonal antibodies and associated viral hepatitis in hematological diseases

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World Journal of hematology 2014年第2期3卷 29-43页

作者： Shih-Hung Yang Chiun Hsu Ann-Lii Cheng Sung-Hsin Kuo Graduate Institute of Clinical Medicine National Taiwan University College of Medicine Department of Oncology National Taiwan University Hospital Cancer research Center National Taiwan University College of Medicine Graduate Institute of Oncology National Taiwan University College of Medicine Department of Internal Medicine National Taiwan University Hospital

Over the past decade, the administration of anti-CD20 monoclonal antibodies such as rituximab has demonstrated various degrees of effectiveness and has improved patients' outcomes during the treatment of autoimmune hematological disorders and hematological malignancies. However, the depletion of B-cells, the distribution of T-cell populations, and the reconstruction of host immunity resulting from the use of anti-CD20 monoclonal antibodies potentially lead to severe viral infections, such as hepatitis B virus(HBV), hepatitis C virus(HCV), parvovirus B19, and herpes viruses, in patients who are undergoing immune therapy or immunochemotherapy. Of these infections, HBV- and HCV-related hepatitis are a great concern in endemic areas because of the high morbidity and mortality rates in untreated patients. As a result, prophylaxis against HBV infection is becoming a standard of care in these areas. Parvovirus B19, a widespread pathogen that causes red blood cell aplasia in immunocompromised hosts, also causes hepatitis in healthy individuals. Recently, its association with hepatitis was recognized in a patient treated with rituximab. In addition, adenovirus, varicella-zoster virus hepatitis E virus, and rituximab itself have been linked to the occurrence of hepatitis during or after rituximab treatments. The epidemiologies and pathogeneses of these etiologies remain unknown. Because of the increasing use of anti-CD20 monoclonal antibodies for the treatment of hematological malignancies or autoimmune hematological disorders, it is imperative that physicians understand and balance the risks of hepatotropic virusassociated hepatitis against the benefits of using antiCD20 monoclonal antibodies.

关键词： CD20 Monoclonal antibody Hepatitis Hepatitis B virus Hepatitis C virus

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Nat Cell Biol:研究发现乳腺癌的新型细胞起源

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现代生物医学进展 2017年第8期17卷 I0002-I0002页

作者： Leander Blaas, Agneta B. Andersson, Marco Gerling, Alexandra Musch, Dorothee Bornhorst Rune Toftg #x000E5 rd Fabio Pucci, Hendrik A. Messal, E. Josue Ruiz Axel Behrens Iyadh Douagi Bradley Spencer-Dene, Richard Stone Gordon Stamp Richard Mitter Leena Bhaw Abdul K. Sesay Jos Jonkers Ilaria Malanchi Axel Behrens Center for Innovative Medicine (CIMED) Department of Biosciences and Nutrition Karolinska Institutet Novum 141 83 Huddinge Sweden Adult Stem Cell Laboratory The Francis Crick Institute 1 Midland Road London NW1 1AT UK Department of Medicine Center for Hematology and Regenerative Medicine Karolinska Institutet Novum 141 83 Huddinge Sweden Experimental Histopathology The Francis Crick Institute 1 Midland Road London NW1 1AT UK Bioinformatics and Biostatistics The Francis Crick Institute 1 Midland Road London NW1 1AT UK Advanced Sequencing Facility The Francis Crick Institute Mill Hill Laboratory The Ridgeway London NW7 1AA UK Division of Molecular Pathology and Cancer The Netherlands Cancer Institute 1066 CX Amsterdam The Netherlands Tumour-Stroma Interactions in Cancer Laboratory The Francis Crick Institute 1 Midland Road London NW1 1AT UK Faculty of Life Sciences & Medicine King&#x02019 s College London Guy&#x02019 s Campus London SE1 1UL UK

乳腺癌是女性常见的癌症类型之一，长期以来科学家们知道并不是所有的乳腺癌都是相似的，腔体肿瘤主要包含一些和乳腺管内层细胞非常相似的细胞类型，而其它肿瘤所包含的细胞则同乳腺上皮组织外层的细胞相似，研究者认为，这种多样性起... 详细信息

乳腺癌是女性常见的癌症类型之一，长期以来科学家们知道并不是所有的乳腺癌都是相似的，腔体肿瘤主要包含一些和乳腺管内层细胞非常相似的细胞类型，而其它肿瘤所包含的细胞则同乳腺上皮组织外层的细胞相似，研究者认为，这种多样性起源于不同干细胞或祖细胞的突变，

关键词：细胞起源乳腺癌 Cell Nat 细胞类型上皮组织种多样性相似

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血管周细胞在表达PDGF-B的实体瘤中诱发造血

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癌症 2023年第8期42卷 385-408页

作者： Kayoko Hosaka 王晨晨张诗悦吕雪 Takahiro Seki Yin Zhang Xu Jing Jieyu Wu Qiqiao Du Xingkang He 范玉龙李轩 Makoto Kondo Masahito Yoshihara Hong Qian 石莉红朱平许元富杨云龙程涛 Yihai Cao Department of Microbiology Tumor and Cell BiologyKarolinska InstituteStockholmSweden 中国医学科学院血液病医院(中国医学科学院血液学研究所) 实验血液学国家重点实验室国家血液系统疾病临床医学研究中心细胞生态海河实验室天津天津医学健康研究院天津 School of Pharmacology Binzhou Medical UniversityYantaiShandongP.R.China Department of Clinical Laboratory the Second Hospital of Shandong UniversityJinanShandongP.R.China Department of Gastroenterology Sir Run Run Shaw HospitalZhejiang University Medical SchoolHangzhouZhejiangP.R.China Center for hematology and Regenerative Medicine Department of MedicineKarolinska InstituteKarolinska University HospitalStockholmSweden Department of Biosciences and Nutrition Karolinska InstituteHuddingeSweden 复旦大学细胞与遗传医学系上海

背景与目的肿瘤组织持续生长需要红细胞充分供氧。在各类病理生理情况下,成年哺乳动物可在主要造血器官骨髓之外发生髓外造血。然而,肿瘤组织能否造血是完全未知的。大量证据表明,在肿瘤微环境中,血管周细胞保留了祖细胞特性,可分化成... 详细信息

背景与目的肿瘤组织持续生长需要红细胞充分供氧。在各类病理生理情况下,成年哺乳动物可在主要造血器官骨髓之外发生髓外造血。然而,肿瘤组织能否造血是完全未知的。大量证据表明,在肿瘤微环境中,血管周细胞保留了祖细胞特性,可分化成其他细胞类型。在此,我们探究了肿瘤组织内周细胞是否能调节造血及其作用机制。方法使用鼠源周细胞进行全基因组表达谱分析以测试周细胞是否可向红细胞分化。使用NG2-CreERT2:R26R-tdTomato小鼠对血管周细胞进行在体遗传示踪。使用流式细胞术、单细胞测序和集落形成实验对分选细胞进行鉴定。使用定量聚合酶链反应(quantitative polymerase chain reactionq,PCR)、酶联免疫吸附实验(enzyme-linked immunosorbent assay,ELISA)、细胞磁珠分选和免疫染色检查红细胞生成素(erythropoietin,EPO)的表达。构建骨髓移植小鼠模型以研究骨髓对肿瘤红细胞生成的影响。结果表达谱显示,在PDGF-B处理后,NG2+周细胞表现出造血干祖样特征,并向红系谱系分化。同时,PDGF-B可靶向癌症相关成纤维细胞以产生促红细胞生成的关键激素EPO。通过遗传示踪及流式分析,我们定义了NG2+细胞衍生的造血亚群。进一步的单细胞测序和集落形成实验结果显示,在PDGF-B刺激下,肿瘤中的NG2+细胞形成了与典型的骨髓造血干细胞不同的红系祖细胞。结论本研究提出了肿瘤组织内造血的新概念,并阐明肿瘤周细胞分化为红细胞的分子机制。靶向肿瘤造血作为一种新的治疗理念,可能对肿瘤治疗产生深远影响。

关键词：癌症造血 PDGF-B 血管周围细胞干细胞肿瘤血管

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Apixaban, an orally available anticoagulant, inhibits SARS-CoV-2 replication and its major protease in a non-competitive way

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Journal of Molecular Cell Biology 2022年第6期14卷 68-71页

作者： Otávio Augusto Chaves Carolina Q.Sacramento Natalia Fintelman-Rodrigues Jairo Ramos Temerozo Filipe Pereira-Dutra Daniella M.Mizurini Robson Q.Monteiro Leonardo Vazquez Patricia T.Bozza Hugo Caire Castro-Faria-Neto Thiago Moreno L.Souza Laboratory of Immunopharmacology Oswaldo Cruz Institute(IOC)Oswaldo Cruz Foundation(Fiocruz)Rio de JaneiroRJ21040-900Brazil National Institute for Science and Technology on Innovation on Neglected Diseases(INCT/IDN) Center for Technological Development in Health(CDTS)Oswaldo Cruz Foundation(Fiocruz)Rio de JaneiroRJ21040-900Brazil National Institute for Science and Technology on Neuroimmunomodulation(INCT/NIM) Oswaldo Cruz Institute(IOC)Oswaldo Cruz Foundation(Fiocruz)Rio de JaneiroRJ21040-900Brazil Laboratory on Thymus research Oswaldo Cruz Institute(IOC)Oswaldo Cruz Foundation(Fiocruz)Rio de JaneiroRJ21040-900Brazil Institute of Medical Biochemistry Leopoldo de Meis Federal University of Rio de Janeiro(UFRJ)Rio de JaneiroRJ21941-590Brazil

Dear Editor,The severe coronavirus disease 2019(COVID-19)is associated with ***,such as low-molecular-weight heparin,warfarin,thrombin inhibitors,and factor Xa(FXa)inhibitors,are thus recommended by the American Society of hematology and National Institutes of Health for COVID-19 patients(Wenzler et al.,2020;Adam et al.,2021).Clinical trials with anticoagulants have shown the increased survival of critically ill COVID-19 patients under non-invasive and invasive ventilatory assistance(Wenzler et al.,2020;Adam et al.,2021),along with decreased consumption of platelets and clotting factors and a reduced risk of hemorrhage(Adam et al.,2021).Among the anti-clotting agents,early use of orally available FXa and thrombin inhibitors(Chowdhury et al.,2020;Rentsch et al.,2021)prevented high levels of D-dimer,which is the final product from the clotting/fibrinolysis cascade and is directly implicated with severe COVID-19(Rentsch et al.,2021).

关键词： al. Clinical heparin

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Epidemiological and Clinical Characteristics of COVID-19 in Adolescents and Young Adults

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The Innovation 2020年第1期1卷 2-14,1页

作者： Jiaqiang Liao Shibing Fan Jing Chen Jianglin Wu Shunqing Xu Yuming Guo Chunhui Li Xianxiang Zhang Chuansha Wu Huaming Mou Chenxi Song Feng Li Guicheng Wu Jingjing Zhang Lian Guo Huawen Liu Jinglong Lv Lixin Xu Chunhui Lang Key Laboratory of Environment and Health Ministry of Education&Ministry of Environmental Protectionand State Key Laboratory of Environmental HealthSchool of Public HealthTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430030People’s Republic of China Department of Neurosurgery Chongqing University Three Gorges Hospital&Chongqing Three Gorges Central HospitalNO.165 Xincheng RoadWanzhouChongqing 404000People’s Republic of China Department of Rheumatology Chongqing University Three Gorges Hospital&Chongqing Three Gorges Central HospitalNO.165 Xincheng RoadWanzhouChongqing404000People’s Republic of China Chongqing University Three Gorges Hospital&Chongqing Three Gorges Central Hospital NO.165 Xincheng RoadWanzhouChongqing 404000People’s Republic of China School of Public Health and Management Binzhou Medical UniversityYantaiShandongChina Department of Epidemiology and Biostatistics School of Public HealthZhengzhou UniversityZhengzhouChina Department of Epidemiology and Preventive Medicine School of Public Health and Preventive MedicineMonash UniversityMelbourneAustralia Fuwai Hospital National Center for Cardiovascular DiseasesChinese Academyof Medical Sciences and Peking Union Medical CollegeA167Beilishi RoadXicheng DistrictBeijing 100037China Department of Endocrinology Chongqing University Three Gorges Hospital&Chongqing Three Gorges Central HospitalNO.165 Xincheng RoadWanzhouChongqing 404000People’s Republic of China Department of Oncology Chongqing University Three Gorges Hospital&Chongqing Three Gorges Central HospitalNO.165 Xincheng RoadWanzhouChongqing 404000People’s Republic of China Department of hematology Chongqing University Three Gorges Hospital&Chongqing Three Gorges Central HospitalNO.165 Xincheng RoadWanzhouChongqing404000People’s Republic of China Department of Clinical Nutrition Chongqing University Three Gorges Hospital&Chongqing Three Gorges Central HospitalNO.165 Xincheng RoadWanzhouChongqing 404000People’s Republic

BACKGROUND Adolescents and young adults might play a key role in the worldwide spread of Coronavirus Disease 2019(COVID-19)because they are more likely to be involved in overseas study,business,work,and ***,the epidem... 详细信息

关键词： Clinical clinical likely

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Bevacizumab biosimilar LY01008 compared with bevacizumab(Avastin)as first-line treatment for Chinese patients with unresectable,metastatic,or recurrent non-squamous non-small-cell lung cancer:A multicenter,randomized,double-blinded,phase Ⅲ trial

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Cancer Communications 2021年第9期41卷 889-903页

作者： Yuankai Shi Kaijian Lei Yuming Jia Bingqiang Ni Zhiyong He Minghong Bi Xicheng Wang Jianhua Shi Ming Zhou Qian Sun Guolei Wang Dongji Chen Yongqian Shu Lianke Liu Zhongliang Guo Yong Liu Junquan Yang Ke Wang Ke Xiao LinWu Tienan Yi Debin Sun Mafei Kang Tianjiang Ma Yimin Mao Jinsheng Shi Tiegang Tang Yan Wang Puyuan Xing Dongqing Lv Wangjun Liao Zhiguo Luo Bin Wang Xiaohong Wu Xiaoli Zhu Shuhua Han Qisen Guo Rongyu Liu Zhiwei Lu Jianyong Zhang Jian Fang Changlu Hu Yinghua Ji Guolong Liu Hong Lu Dedong Wu Junhong Zhang Shuyang Zhu Zheng Liu Wensheng Qiu Feng Ye Yan Yu Yanqiu Zhao Qinhong Zheng Jun Chen Zhanyu Pan Yiping Zhang Wenjuan Lian Bo Jiang Bo Qiu Guojun Zhang Hua Zhang Yanju Chen Yuan Chen Hongbing Duan Manxiang Li Shengming Liu Lijun Ma Hongming Pan Xia Yuan Xueli Yuan Yulong Zheng Emei Gao Li Zhao Shumin Wang Can Wu Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021P.R.China Department of Oncology Yibin Second People’s HospitalYibinSichuan 644000P.R.China Department of Oncology Liuzhou People’s HospitalLiuzhouGuangxi 545006P.R.China Department of Thoracic Oncology Fujian Provincial Cancer HospitalFuzhouFujian 350014P.R.China Oncology Department the First Affiliated Hospital of Bengbu Medical CollegeBengbuAnhui 233030P.R.China Department of Oncology the First Affiliated Hospital of Guangdong Pharmaceutical UniversityGuangzhouGuangdong 510030P.R.China Department of Internal medicine Linyi Cancer HospitalLinyiShandong 276002P.R.China Department of Thoracic Surgery the Affiliated Cancer Hospital of Guangzhou Medical UniversityGuangzhouGuangdong 510095P.R.China Department of Internal Medicine-Oncology/Department of thoracic oncology Henan Chest HospitalZhengzhouHenan 450003P.R.China The Second Department of Radiotherapy Wuwei Cancer Hospital of Gansu ProvinceWuweiGansu 730000P.R.China Department of Oncology the People’s Hospital of Jiangsu ProvinceNanjingJiangsu 210000P.R.China Respiratory Medicine Department Shanghai East HospitalShanghai 200120P.R.China The Second Department of Internal Medicine-Oncology Xuzhou Central HospitalXuzhouJiangsu 221009P.R.China Oncology Department Tangshan People’s HospitalTangshanHebei 063001P.R.China Respiratory Medicine Department West China Hospital of Sichuan UniversityChengduSichuan 610041P.R.China Thoracic Surgery the Second Affiliated Hospital of Shantou University Medical CollegeShantouGuangdong 515051P.R.China Internal Medicine-Oncology Hunan Cancer HospitalChangshaHunan 410013P.R.China Department of Oncology Xiangyang Central HospitalXiangyangHubei 441021P.R.China Respiratory Department Lishui Central HospitalLishuiZ

Background:Previous studies have demonstrated the preclinical pharmacological and toxicological consistency,and clinical pharmacokinetic equivalence of bevacizumab biosimilar LY01008 with reference bevacizumab(Avastin).This randomized controlled trial aimed to compare the efficacy and safety of LY01008 with Avastin in first-line treatment of Chinese patients with advanced or recurrent non-squamous non-small cell lung cancer(NSCLC).Methods:StageⅢB-ⅣNSCLC patients with evaluable lesions,good physical status,and adequate organ functions from 67 centers across China were randomized in a ratio of 1:1 to receive LY01008 or Avastin 15 mg/kg intravenously in combination with paclitaxel/carboplatin(combined treatment)for 4-6 cycles,followed by maintenance monotherapy with LY01008 until disease progression,intolerable toxicity,or *** primary endpoint was objective response rate(ORR)in accordance with Response Evaluation Criteria in Solid Tumors(RECIST)version 1.1 confirmed by independent radiological review committees(IRRC).Secondary endpoints included disease control rate(DCR),duration of response(DoR),progression-free survival(PFS),overall survival(OS),and *** study was registered in Clinical ***(NCT03533127).Results:Between December 15^(th),2017,and May 15^(th),2019,a total of 649 patients were randomized to the LY01008(n=324)or Avastin(n=325)*** of September 25th,2019 for primary endpoint analysis,589 patients received ORR evaluation,with a median number of combined treatment cycles of 5(range 1-6)andmedian duration of treatment of 3.0(range 0.0-5.1)*** responseevaluable patients in the LY01008 and Avastin groups were 48.5% and 53.0%,*** stratified ORR ratio was 0.91(90%CI 0.80-1.04,within the prespecified equivalence margin of 0.75-1.33).Up to May 15^(th),2020,with a median follow-up of 13.6(range 0.8-28.4)months,no notable differences in DCR,median DoR,median PFS,median OS,and 1-year OS rate were observed between the LY010

关键词： anti-angiogenesis anti-VEGF monoclonal antibody avastin bevacizumab biosimilar nonsmall cell lung cancer LY01008 vascular endothelial growth factor

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