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Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma:a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study

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Chinese Medical Journal 2022年第4期135卷 433-440页

作者： Xiaonan Hong Yuqin Song Yuankai Shi Qingyuan Zhang Wei Guo Gang Wu Junmin Li Jifeng Feng Anastasiia Kinkolykh Andrea Knapp Tongyu Lin Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200032China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education) Peking University Cancer Hospital and InstituteBeijing 100142China National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin Medical UniversityHarbinHeilongjiang 150081China Department of Hematology The First Hospital of Jilin UniversityChangchunJilin 130015China Department of Medical Oncology Cancer CenterUnion HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430023China Shanghai Institute of Hematology State Key Laboratory of Medical GenomicsNational Research Center for Translational Medicine at ShanghaiRuijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200025China Department of Medical Oncology Jiangsu Cancer HospitalNanjing Medical University Affiliated Cancer HospitalNanjingJiangsu 210009China Consultant to F.Hoffmann-La roche Ltd BaselSwitzerlandvia GCE Solutions-an IQVIA businessSwitzerland Product Development Oncology F.Hoffmann-La Roche LtdBaselSwitzerland Department of Medical Oncology Sun Yat-Sen University Cancer CenterState Key Laboratory of Oncology in South Chinaand Collaborative Innovation Center for Cancer MedicineGuangzhouGuangdong 510075China

Backgrounds:GALLIUM is a global phase Ⅲ study that demonstrated significant improvements in progression-free survival(PFS)for obinutuzumab plus chemotherapy(G-chemo)*** plus chemotherapy(R-chemo)in previously untreated patients with follicular lymphoma(FL).This study aimed to report the results of a subgroup of patients in ***:Patients were randomized to G-chemo or *** received maintenance therapy for 2 years or until disease *** primary endpoint was investigator(INV)-assessed *** endpoints included the overall response rate(ORR)and complete response rate(CRR)at the end of induction chemotherapy,overall survival(OS),and ***:Overall,58 patients with FL were randomized to the G-chemo(n=25)and R-chemo arms(n=33).The INV-assessed PFS rate at 3 years was 81.8%in the G-chemo arm,vs.70.2%in the R-chemo arm(hazard ratio 0.35;95%confidence interval:0.09-1.34;P=0.1120).The INV-assessed CRRs(without positron emission tomography[PET])in these arms were 24.0%and 21.2%,respectively,whereas the ORRs were 80.0%and 90.9%,***-assessed CRR-PET was 52.6%in the G-chemo,vs.60.9%in the *** OS was not reached in either *** 3 to 5 adverse events were more frequent in the R-chemo arm(97.0%vs.88.0%).Conclusions:The results of this subgroup analysis were consistent with those of the global population,and they suggest that G-chemo has a positive benefit-risk profile in patients from China with *** registration:***,***01332968.

关键词： Chinese Follicular lymphoma GALLIUM Obinutuzumab Rituximab

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口服神经氨酸酶抑制剂奥司他韦治疗急性流行性感冒的效果及安全性研究

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美国医学会杂志（中文版） 2002年第2期21卷 86-93页

作者： JohnJ.Treanor 王震宇等 University of rochester Rochester NY Gilead Sciences Foster City Calif University of Virginia Charlottesville PW Clinical Research WinstonSalem NC Hill Top Research St LouisMo Edmonds Family Medicine Clinic Edmonds Wash Advanced Clinical Research Institute Anaheim Calif SARC Research Center Fresno Calif roche Global Development Welwyn England

据估计,在美国20岁以下的年轻人每年约有1380万～16000万人患流感导致的呼吸系统疾病.

关键词：口服神经氨酸酶抑制剂奥司他韦治疗急性流行性感冒安全性疗效

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甲氟喹1克单剂治疗恶性疟疾的临床研究

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华南预防医学 1983年第2期 51-54页

作者：江静波李国桥郭兴伯江润祥 Keih Arnnold 中山大学生物系广州中医学院疟疾研究小组广州中医学院疟疾研究小组香港中文大学香港roche远东研究基金会

前言甲氟喹(Mefloquine),代号WR142490,是奎宁和合成药WR30090的类似药,化学名d—(2哌啶)-2·8-双三氟甲基-4-喹啉甲醇。是1970年以来由美国陆军研究院研制出来的治疗抗氯喹疟疾的重要抗疟药。

关键词：恶性疟疾间日疟治疗后二盐酸奎宁青篙素环状体期疟疾体内寄生虫原虫无性体单剂

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Mechanics of serotonin-producing human entero-endocrine cells

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Mechanobiology in Medicine 2024年第2期2卷 55-58页

作者： Tom M.J.Evers Joep Beumer Hans Clevers Alireza Mashaghi Medical Systems Biophysics and Bioengineering Leiden Academic Centre for Drug ResearchFaculty of ScienceLeiden Universitythe Netherlands Laboratory for Interdisciplinary Medical Innovations Centre for Interdisciplinary Genome ResearchFaculty of ScienceLeiden Universitythe Netherlands Hubrecht Institute Royal Netherlands Academy of Arts and Sciences(KNAW)and UMC UtrechtUtrechtthe Netherlands Oncode Institute Hubrecht InstituteUtrechtthe Netherlands The Princess Maxima Center for Pediatric Oncology Utrechtthe Netherlands roche Pharmaceutical Research and Early Development BaselSwitzerland

The gastrointestinal(GI)tract's primary role is food digestion,relying on coordinated fluid secretion and bowel movements triggered by *** cells(EECs)are specialized mechanosensitive cells that convert mechanical forces into electrochemical signals,culminating in serotonin release to regulate GI *** their pivotal role,knowledge of EEC mechanical properties has been lacking due to their rarity and limited *** this brief report,we present the first single-cell mechanical characterization of human ECCs isolated from healthy intestinal *** single-cell optical tweezers,we measured EEC stiffness profiles at the physiological temperature and investigated changes following tryptophan metabolism *** findings not only shed light on EEC mechanics but also highlight the potential of adult stem cell-derived organoids for studying these elusive cells.

关键词： Cell mechanics Gut Organoid Serotonin Optical tweezers

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Recent advances in the translation of drug metabolism and pharmacokinetics science for drug discovery and development

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Acta Pharmaceutica Sinica B 2022年第6期12卷 2751-2777页

作者： Yurong Lai Xiaoyan Chu Li Di Wei Gao Yingying Guo Xingrong Liu Chuang Lu Jialin Mao Hong Shen Huaping Tang Cindy Q.Xia Lei Zhang Xinxin Ding Drug Metabolism Gilead Sciences Inc.Foster CityCA 94404USA Department of Pharmacokinetics Pharmacodynamics and Drug MetabolismMerck&Co.Inc.KenilworthNJ 07033USA Pharmacokinetics Dynamics and MetabolismPﬁzer Worldwide Research and DevelopmentGrotonCT 06340USA Eli Lilly and Company IndianapolisIN 46221USA Drug Metabolism and Pharmacokinetics BiogenCambridgeMA 02142USA Drug Metabolism and Pharmacokinetics Accent TherapeuticsInc.LexingtonMA 02421USA Department of Drug Metabolism and Pharmacokinetics GenentechA Member of the Roche GroupSouth San FranciscoCA 94080USA Drug Metabolism and Pharmacokinetics Department Bristol-Myers Squibb CompanyPrincetonNJ 08540USA Bioanalysis and Biomarkers Glaxo Smith KlineKing of the PrussiaPA 19406USA Department of Drug Metabolism and Pharmacokinetics Takeda Pharmaceuticals International Co.CambridgeMA 02139USA Ofﬁce of Research and Standards Ofﬁce of Generic DrugsCDERFDASilver SpringMD 20993USA Department of Pharmacology and Toxicology College of PharmacyUniversity of ArizonaTucsonAZ 85721USA Current afﬁliation:Translational Medicine EMD Serono Research&Development InstituteInc.BillericaMA 01821USA Current afﬁliation:Drug Metabolism Gilead Sciences Inc.Foster CityCA 94404USA

Drug metabolism and pharmacokinetics(DMPK) is an important branch of pharmaceutical *** nature of ADME(absorption,distribution,metabolism,excretion) and PK(pharmacokinetics) inquiries during drug discovery and development has evolved in recent years from being largely descriptive to seeking a more quantitative and mechanistic understanding of the fate of drug candidates in biological *** progress has been made in the past decade,not only in the characterization of physiochemical properties of drugs that influence their ADME,target organ exposure,and toxicity,but also in the identification of design principles that can minimize drug-drug interaction(DDI) potentials and reduce the *** importance of membrane transporters in drug disposition,efficacy,and safety,as well as the interplay with metabolic processes,has been increasingly *** increases in investments on new modalities beyond traditional small and large molecule drugs,such as peptides,oligonucleotides,and antibody-drug conjugates,necessitated further innovations in bioanalytical and experimental tools for the characterization of their ADME *** this review,we highlight some of the most notable advances in the last decade,and provide future perspectives on potential major breakthroughs and innovations in the translation of DMPK science in various stages of drug discovery and development.

关键词： Drug discovery and development New drug application Biologics license application Pharmacokinetics ADME New modalities Model-informed drug development Micro-physiological systems

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IMpower210:A phase Ⅲ study of second-line atezolizumab vs. docetaxel in East Asian patients with non-small cell lung cancer

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Chinese Journal of Cancer Research 2024年第2期36卷 103-113页

作者： Yi-Long Wu Shun Lu Gongyan Chen Jianxing He Jifeng Feng Yiping Zhang Liyan Jiang Hongming Pan Jianhua Chang Jian Fang Amy Cai Lilian Bu Jane Shi Jinjing Xia Guangdong Lung Cancer Institute Guangdong Provincial Key Laboratory of Translational Medicine in Lung CancerGuangdong Provincial People's Hospital&Guangdong Academy of Medical SciencesSouthern Medical UniversityGuangzhou 510080China Shanghai Lung Cancer Center Shanghai Chest HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghai 200025China Department of Respiration Harbin Cancer HospitalHarbin Medical UniversityHarbin 150081China Department of Thoracic Oncology and Surgery the First Affliated Hospital of Guangzhou Medical UniversityGuangzhou 510120China Department of Medical Oncology Jiangsu Cancer HospitalNanjing 210009China Department of Medical Oncology Zhejiang Cancer HospitalHangzhou 330022China Department of Pulmonary Medicine Shanghai Chest HospitalShanghai Jiao Tong UniversityShanghai 200030China Department of Medical Oncology Sir Run Run Shaw HospitalZhejiang University School of MedicineHangzhou 310016China Department of Medical Oncology Shenzhen HospitalCancer Hospital of Chinese Academy of Medical SciencesShenzhen 518116China Department of Thoracic Oncology Beijing Cancer HospitalBeijing 100142China Product Development Shanghai Roche Pharmaceutical LtdShanghai 201203China

Objective: IMpower210(NCT02813785) explored the efficacy and safety of single-agent atezolizumab *** as second-line treatment for advanced non-small cell lung cancer(NSCLC) in East Asian ***: Key eligibility criteria for this phase Ⅲ, open-label, randomized study included age ≥18 years;histologically documented advanced NSCLC per the Union for International Cancer Control/American Joint Committee on Cancer staging system(7th edition);Eastern Cooperative Oncology Group performance status of 0 or 1;and disease progression following platinum-based chemotherapy for advanced or metastatic NSCLC. Patients were randomized 2:1 to receive either atezolizumab(1,200 mg) or docetaxel(75 mg/m^(2)). The primary study endpoint was overall survival(OS) in the intention-to-treat(ITT) population with wild-type epidermal growth factor receptor expression(ITT EGFR-WT) and in the overall ITT ***: Median OS in the ITT EGFR-WT population(n=467) was 12.3 [95% confidence interval(95% CI),10.3-13.8] months in the atezolizumab arm(n=312) and 9.9(95% CI, 7.8-13.9) months in the docetaxel arm[n=155;stratified hazard ratio(HR), 0.82;95% CI, 0.66-1.03]. Median OS in the overall ITT population was 12.5(95% CI, 10.8-13.8) months with atezolizumab treatment and 11.1(95% CI, 8.4-14.2) months(n=377) with docetaxel treatment(n=188;stratified HR, 0.87;95% CI, 0.71-1.08). Grade 3/4 treatment-related adverse events(TRAEs) occurred in 18.4% of patients in the atezolizumab arm and 50.0% of patients in the docetaxel ***: IMpower210 did not meet its primary efficacy endpoint of OS in the ITT EGFR-WT or overall ITT populations. Atezolizumab was comparatively more tolerable than docetaxel, with a lower incidence of grade3/4 TRAEs.

关键词： Atezolizumab East Asia non-small cell lung cancer programmed death-ligand 1 inhibitors monoclonal antibody

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Individual and Environmental Risk Factors for COVID-19 Mortality in Elderly in 7 European University Hospitals

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Journal of Environmental Protection 2022年第7期13卷 508-526页

作者： Thomas Bourdrel Leo Zabrocki Nathalie Compte Bert Bravenboer Romain Decours Hélène Pelerin Laure De Decker Laurence Le Jumeau de Kergaradec Matthieu Lilamand Claire Roubaud Baudron Bertrand Fougère Rachid Mahmoudi Benoit Schorr Georges Kaltenbach Thomas Vogel Vincent-Henri Puech Fréderic Blanc Marie-Abèle Bind ICube Laboratory UMR 7357 and CNRS University of Strasbourg Strasbourg France Paris School of Economics EHESS Paris France Geriatric Department Universitair Ziekenhuis Brussel Bruxelles Belgium Service de Gé riatrie Centre hospitalier d&eacute partemental de Vendé e La Roche Sur Yon France Unité de recherche clinique Centre hospitalier d&eacute partemental de Vendé e La Roche Sur Yon France Service de Mé decine aigü e gé riatrique Centre hospitalier universitaires de Nantes Nantes France Service de Gé rontologie Centre hospitalier universitaires de Nantes Nantes France Service de Gé riatrie Assistance publique Hô pitaux de Paris (APHP) Nord Paris France Unité Post Urgences Gé riatriques Centre hospitalier universitaire de Bordeaux H&ocirc pital Pellegrin Bordeaux France Department of Geriatric Medicine Centre hospitalier universitaire de Tours Tours France Mé decine Interne Gé riatrie et Biologie du Vieillissement Centre hopitalier universitaire de Reims Reims France Pô le de Gé riatrie La Robertsau Geriatric Hospital University Hospital of Strasbourg Strasbourg France European Centre for Medium-Range Weather Forecasts Copernicus Atmosphere Monitoring Service London UK Biostatistics Center Massachusetts General Hospital Boston MA USA

Because the elderly account for 80% of deaths from COVID-19 and they may be more vulnerable to air pollution, in this retrospective study we aimed to explore individual and environmental risk factors for COVID-19 mortality in the geriatric departments of seven European University hospitals, between February and May 2020. Long-term exposure to air pollution was estimated through annual pollutant concentrations at the residential address over the last two years. Short-term variations in air pollutants and weather parameters were also examined through a 20-day period before the confirmed PCR diagnostic of COVID-19. We found positive associations for diabetes and COVID-19 mortality (OR 2.2 CI 95%: 1.1, 4.4). Regarding environmental factors, we found no association between COVID-19 mortality and air pollutants and weather parameters;however, our study suffers from strong disparities—such as patient characteristics—between fairly polluted and less polluted cities. In order to overcome those disparities between cities, we aimed to explore the relationship between air pollution and COVID-19 mortality within each city, but even with the high-efficiency modelisation systems, differences in air pollutants were too small to estimate the effect of air pollution at the city level. Thus, this study highlights the need to improve the estimation of individual exposure to air pollution. To address this issue, solutions exist such as the increase of the number of fixed air monitors, or even better, through the use of individual markers of air pollution exposure such as urinary black carbon or passive individual samplers. Furthermore, we underline that outdoor air pollutant concentrations may not be representative of individual exposure, especially in the elderly, thus, we suggest that further studies focus on indoor air pollution. Regarding meteorological conditions, we found no association between UV, temperature, wind speed and COVID-19 mortality. We found a positive association bet

关键词： COVID-19 Mortality Air Pollution Particulate Matter Ultraviolet Radiation Temperature

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非洲大陆的综合物候模型

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人类环境杂志 1995年第5期24卷 296-302页

作者： JacquesFontés Jean Philippe Gastellu-Etchegorry Olivier Amram Guy Flouzat 齐文虎 L.E.T.T.-I.C.I.V. U.M.R.9964 13 avenue du Colonel RocheBP 440331405 Toulouse cedexFrance。 CESBIO C.N.E.S.-C.N.R.S.-U.P.S. 13 avenue E.Belin31400 ToulouseFrance。

借助适于综合研究的生态模型,用叶绿素活度解译了气象卫星每日提供的各大陆区图像。利用这个模型模拟了非洲大陆广大而又复杂植被系统的物候节律,其结果用数字化地图表示出。本文的目的是提供一种对卫星观测值的更好的理解和解译。通过... 详细信息

借助适于综合研究的生态模型,用叶绿素活度解译了气象卫星每日提供的各大陆区图像。利用这个模型模拟了非洲大陆广大而又复杂植被系统的物候节律,其结果用数字化地图表示出。本文的目的是提供一种对卫星观测值的更好的理解和解译。通过对模拟图像与卫星图像的相关分析,部分证实了这种方法可减轻热带监测任务,并可对由于不断加剧的人类活动所导致的全球生态变化有更深刻的了解。

关键词：非洲综合物候模型生态模型

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光伏系统应用的自适应多相变换器

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电力电子 2012年第2期10卷 45-47,61页

作者： A.Berasategi C.Cabal Y.El Basri B.Estibal M.Vermeersch C.Alonso CNRS LAAS 7 avenue du colonel roche F-31077 Toulouse Cedex 4FRANCE Universite de Toulouse UPS INSAINPISAE UT1 UTMLAAS F-21077 Toulouse CEdex 4FRANCE Dept.Solar&New Energies TOTAL S.ATour Coupole-2place Jean Miler-La Defense 6

本文阐述将一种自适应多相变换器(AMPC)用作适配级来提高光伏系统的功率转换链的效率和可靠性。为了说明AMPC的优点,文中首先介绍了单相和多相变换器效率的概念。针对光伏系统连续变化工作点的主要特性,提出了控制法则也要保证高的转换... 详细信息

本文阐述将一种自适应多相变换器(AMPC)用作适配级来提高光伏系统的功率转换链的效率和可靠性。为了说明AMPC的优点,文中首先介绍了单相和多相变换器效率的概念。针对光伏系统连续变化工作点的主要特性,提出了控制法则也要保证高的转换效率,而且设计了实验性样机来评估该适配级的性能。

关键词：光伏系统多相变换器光伏系统连续变化

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Estimation of Time to Maximum Rate Under Adiabatic Conditions(TMR_(ad)) Using Kinetic Parameters Derived From DSC-Investigation of Thermal Behavior of 3-Methyl-4-Nitrophenol

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化学推进剂与高分子材料 2011年第1期9卷 84-96页

作者： Bertrand Roduit Patrick Folly Alexandre Sarbach Beat Berger Franz Brogli Francesco Mascarello Mischa Schwaninger Thomas Glarner Eberhard Irle Fritz Tobler Jacques Wiss Markus Luginbühl Craig Williams Pierre Reuse Francis Stoessel AKTS AG TechnoArk 13960 SidersSwitzerland Armasuisse Science and Technology Centre3602 ThunSwitzerland Ciba Schweizerhalle AG P.O.Box4002 BaselSwitzerland DSM Nutritional Products Ltd. Safety laboratory4334 SisselnSwitzerland F.Hoffmann-La roche Ltd Safety laboratories4070 BaselSwitzerland Lonza AG Safety Laboratory VispRottenstr.63930 Visp Switzerland Novartis Pharma AG Novartis CampusWSJ-145.8.544002 BaselSwitzerland Syngenta Crop Protection Münchwilen AG WMU 3120.1.544333 MünchwilenSwitzerland Swiss Safety Institute Schwarzwaldallee 215WRO-1055.5.024002 BaselSwitzerland

Kinetic parameters of the decomposition of hazardous chemicals can be applied for the estimation of their thermal behavior under any temperature *** paper describes the application of the advanced kinetic approach for the determination of the thermal behavior also under adiabatic conditions occurring *** batch reactors in case of cooling *** kinetics of the decomposition of different samples(different manufacturers and batches) of 3-methyl-4-nitrophenol were investigated by conventional DSC in non-isothermal(few heating rates varying from 0.25 to 8.0K/min) and isothermal(range of 200~260℃) *** kinetic parameters obtained with AKTS-Thermokinetics Software were applied for calculating reaction rate and progress under different heating rates and temperatures and verified by comparing simulated and experimental *** application of the heat balance to compare the amount of heat generated during reaction and its removal from the system,the knowledge of reaction rate at any temperature profiles allowed the determination of the temperature increase due to the self-heating in adiabatic and pseudo-adiabatic *** advanced kinetic approach allowed simulation the course of the Heat-Wait-Search(HWS) mode of operation of adiabatic *** thermal safety diagram depicting dependence of Time to Maximum Rate(TMR) on the initial temperature was calculated and compared with the results of HWS experiments carried out in the system with Ф-factor amounting to *** influence of the Ф-factor and reaction progress reached at the end of the HWS monitoring on the TMR is *** calculations clearly indicate that even very minor reaction progress reduces the TMRad of 24h characteristic for a sample with initial reaction progress amounting to *** estimation method can be verified by just one HWS-ARC,or by one correctly chosen ISO-ARC run of reasonable duration by knowing in advance the dependence of the TMR

关键词： adiabatic condition methyl nitrophenol DSC Ф-factor kinetics thermal runaway,TMR

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