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| 1 | The Reference Genome of Tea Plant and Resequencing of 81 Diverse Accessions Provide Insights into Its Genome Evolution and Adaptation显示文摘Tea plant is an important economic crop,which is used to produce the world's oldest and most widely consumed tea beverages.Here,we present a high-quality reference genome assembly of the tea plant(Camellia sinensis var.sinensis)consisting of 15 pseudo-chromosomes.LTR retrotransposons(LTR-RTs)account for 70.38%of the genome,and we present evidence that LTR-RTS play critical roles in genome size expansion and the transcriptional diversification of tea plant genes through preferential insertion in promoter regions and introns.Genes,particularly those coding for terpene biosynthesis pro-teins,associated with tea aroma and stress resistance were significantly amplified through recent tandem duplications and exist as gene clusters in tea plant genome.Phylogenetic analysis of the sequences of 81 tea plant accessions with diverse origins revealed three well-differentiated tea plant populations,support-ing the proposition for the southwest origin of the Chinese cultivated tea plant and its later spread to western Asia through introduction.Domestication and modern breeding left significant signatures on hundreds of genes in the tea plant genome,particularly those associated with tea quality and stress resis-tance.The genomic sequences of the reported reference and resequenced tea plant accessions provide valuable resources for future functional genomics study and molecular breeding of improved cul-tivars of tea plants. | Enhua Xia Wei Tong Yan Hou Yanlin An Linbo Chen Qiong Wu Yunlong Liu Jie Yu Fangdong Li Ruopei Li Penghui Li Huijuan Zhao Ruoheng Ge Jin Huang Ali Inayat Mallano Yanrui Zhang Shengrui Liu Weiwei Deng Chuankui Song Zhaoliang Zhang Jian Zhao Shu Wei Zhengzhu Zhang Tao Xia Chaoling Wei Xiaochun Wan | 2020 | Molecular Plant2020，13，7： | 51 |
| 2 | Neuroprotective effects of rutaecarpine on cerebral ischemia reperfusion injury显示文摘Rutaecarpine,an active component of the traditional Chinese medicine Tetradium ruticarpum,has been shown to improve myocardial ischemia reperfusion injury.Because both cardiovascular and cerebrovascular diseases are forms of ischemic vascular disease,they are closely related.We hypothesized that rutaecarpine also has neuroprotective effects on cerebral ischemia reperfusion injury.A cerebral ischemia reperfusion model was established after 84,252 and 504 μg/kg rutaecarpine were given to mice via intraperitoneal injection,daily for 7 days.Results of the step through test,2,3,5-triphenyl tetrazolium chloride dyeing and oxidative stress indicators showed that rutaecarpine could improve learning and memory ability,neurological symptoms and reduce infarction volume and cerebral water content in mice with cerebral ischemia reperfusion injury.Rutaecarpine could significantly decrease the malondialdehyde content and increase the activities of superoxide dismutase and glutathione peroxidase in mouse brain.Therefore,rutaecarpine could improve neurological function following injury induced by cerebral ischemia reperfusion,and the mechanism of this improvement may be associated with oxidative stress.These results verify that rutaecarpine has neuroprotective effects on cerebral ischemia reperfusion in mice. | Chunlin Yan Ji Zhang Shu Wang Guiping Xue Yong Hou | 2013 | Neural Regeneration Research2013，8，22： | 20 |
| 3 | Adenovirus-mediated gene delivery:Potential applications for gene and cell-based therapies in the new era of personalized medicine显示文摘With rapid advances in understanding molecular pathogenesis of human diseases in the era of genome sciences and systems biology,it is anticipated that increasing numbers of therapeutic genes or targets will become available for targeted therapies.Despite numerous setbacks,efficacious gene and/or cell-based therapies still hold the great promise to revolutionize the clinical management of human diseases.It is wildly recognized that poor gene delivery is the limiting factor for most in vivo gene therapies.There has been a long-lasting interest in using viral vectors,especially adenoviral vectors,to deliver therapeutic genes for the past two decades.Among all currently available viral vectors,adenovirus is the most efficient gene delivery system in a broad range of cell and tissue types.The applications of adenoviral vectors in gene delivery have greatly increased in number and efficiency since their initial development.In fact,among over 2000 gene therapy clinical trials approved worldwide since 1989,a significant portion of the trials have utilized adenoviral vectors.This review aims to provide a comprehensive overview on the characteristics of adenoviral vectors,including adenoviral biology,approaches to engineering adenoviral vectors,and their applications in clinical and preclinical studies with an emphasis in the areas of cancer treatment,vaccination and regenerative medicine.Current challenges and future directions regarding the use of adenoviral vectors are also discussed.It is expected that the continued improvements in adenoviral vectors should provide great opportunities for cell and gene therapies to live up to its enormous potential in personalized medicine. | Cody S.Lee Elliot S.Bishop Ruyi Zhang Xinyi Yu Evan M.Farina Shujuan Yan Chen Zhao Zongyue Zeng Yi Shu Xingye Wu Jiayan Lei Yasha Li Wenwen Zhang Chao Yang Ke Wu Ying Wu Sherwin Ho Aravind Athiviraham Michael J.Lee Jennifer Moriatis Wolf Russell R.Reid Tong-Chuan He | 2017 | Genes & Diseases2017，4，2： | 19 |
| 4 | An Integrated Analysis of Risk Factors of Cognitive Impairment in Patients with Severe Carotid Artery Stenosis显示文摘Objective To investigate cognitive dysfunction in patients with carotid artery stenosis(CAS) and potential risk factors related to cognitive-especially memory-dysfunction. Methods Forty-seven patients with carotid artery stenosis were recruited into our study cohort. The Mini-Mental State Examination(MMSE) and the Montreal Cognitive Assessment(MoCA) were adopted to assess cognitive function, the Wechsler Memory Scale(WMS) to assess memory function, high-resolution MRI and enhanced ultrasound to evaluate carotid plaques, and computed tomography perfusion(CTP) imaging to evaluate intracranial blood perfusion. Single-factor analysis and multiple-factor regression analysis were used to analyze potential risk factors of cognitive impairment. Results Mini-Mental State Examination test results showed that 22 patients had cognitive impairment, and MoCA test results showed that 10 patients had cognitive impairment. Analysis of various risk factors indicated that the average memory quotient of female patients was higher than that of males(P = 0.024). The cognitive and memory performance of those with an educational background above high school were significantly better than those of participants with high school or lower(P = 0.045). Patients with abnormal intracranial perfusion performed worse on the MMSE test(P = 0.024), and their WMS scores were significantly lower(P = 0.007). The MMSE scores and the memory quotients were significantly lower in patients with a history of cerebral infarction(MMSE, P = 0.047, memory quotient score, P = 0.018). Conclusion A history of cerebral infarction and abnormal cerebral perfusion are associated with decline in overall cognitive function and memory in patients with carotid stenosis. Being female and having an educational background above high school may be protective factors in the development of cognitive dysfunction. | LUO Ru Tao WANG Pei Jiong DENG Xiao Feng ZHOU Shu Jie ZHAO Meng QIAN Jing ZHANG Dong WANG Rong ZHANG Yan | 2018 | Biomedical and Environmental Sciences2018，31，11： | 17 |
| 5 | "Fast-track" and "Minimally Invasive" Surgery for Gastric Cancer显示文摘 | Xin-Xin Liu Hua-Feng Pan Zhi-Wei Jiang Shu Zhang Zhi-Ming Wang Ping Chen Yan Zhao Gang Wang Kun Zhao Jie-Shou Li | 2016 | Chinese Medical Journal2016，，19： | 15 |
| 6 | Synthesis and characterization of lower generation broom molecules显示文摘与亢奋的分支被迈克尔增加与 dodecylamine 和甲基压克力在甲醇综合的十二烷基组一起的树枝状的分子作为原料吃了。这新型的树枝状的分子生动地被叫“在这的扫帚分子”报导。扫帚分子的水溶液的表面张力解雇了氨基的组被使用落下卷方法测量。为油 / 水(O/W ) 的扫帚分子的反乳化表演模仿了原油乳状液被检验。试验性的结果揭示了那,作为一表面活化剂新型,扫帚分子解雇了为 O/W 给反乳化看的氨基的组模仿的原油乳状液。 | Jun Wang Cui Qin Li Shu Yan Zhang Fang Sun Teng Jie Ge | 2008 | Chinese Chemical Letters2008，19，1： | 13 |
| 7 | A comparative study of natural and experimental nano-sized grinding grain textures in rocks显示文摘In three shallow-level fault systems in eastern China, nano-sized (30―100 nm) grinding grain textures are found in the thin-shelled rheological layer representing frictional-viscous high strain field. The surface layer near slipping plane is composed of stacks of grinding grains with high sphericity and uniform nano-sized diameter, while the underlying layer appears as a mixture of irregular ones with diverse diameters. Rock deformation experiments indicate that the grinding grain texture is a common phenomenon in shearing fractures, suggesting a potential transition from sliding friction to rolling one during the rock deformation process. This transition is crucial for many tribological processes in geo- logical fields. | SUN Yan SHU LiangShu LU XianCai LIU Hao ZHANG XiHui K. KOSAKA LIN AiMing | 2008 | Chinese Science Bulletin2008，53，8： | 13 |
| 8 | Associations of big endothelin-1 and C-reactive protein in atrial fibrillation显示文摘 | Li-Hui ZHENG Wei SUN Yan YAO Bing-Bo HOU Yu QIAO Shu ZHANG | 2016 | Journal of Geriatric Cardiology2016，13，5： | 13 |
| 9 | Negative feedback regulation of cellular antiviral signaling by RBCKl-mediated degradation of IRF3显示文摘 | Min Zhang Yang Tian Rui-Peng Wang Dong Gao Yan Zhang Fei-Ci Diao Dan-Ying Chen Zhong-HeZhai Hong-Bing Shu | 2008 | Cell Research2008，18，11： | 12 |
| 10 | Insight-HXMT observations of the first binary neutron star merger GW170817显示文摘Finding the electromagnetic(EM) counterpart of binary compact star merger, especially the binary neutron star(BNS) merger,is critically important for gravitational wave(GW) astronomy, cosmology and fundamental physics. On Aug. 17, 2017,Advanced LIGO and Fermi/GBM independently triggered the first BNS merger, GW170817, and its high energy EM counterpart,GRB 170817 A, respectively, resulting in a global observation campaign covering gamma-ray, X-ray, UV, optical, IR, radio as well as neutrinos. The High Energy X-ray telescope(HE) onboard Insight-HXMT(Hard X-ray Modulation Telescope) is the unique high-energy gamma-ray telescope that monitored the entire GW localization area and especially the optical counterpart(SSS17 a/AT2017 gfo) with very large collection area(~1000 cm^2) and microsecond time resolution in 0.2-5 MeV. In addition,Insight-HXMT quickly implemented a Target of Opportunity(ToO) observation to scan the GW localization area for potential X-ray emission from the GW source. Although Insight-HXMT did not detect any significant high energy(0.2-5 MeV) radiation from GW170817, its observation helped to confirm the unexpected weak and soft nature of GRB 170817 A. Meanwhile,Insight-HXMT/HE provides one of the most stringent constraints(~10^(-7) to 10^(-6) erg/cm^2/s) for both GRB170817 A and any other possible precursor or extended emissions in 0.2-5 MeV, which help us to better understand the properties of EM radiation from this BNS merger. Therefore the observation of Insight-HXMT constitutes an important chapter in the full context of multi-wavelength and multi-messenger observation of this historical GW event. | TiPei Li ShaoLin Xiong ShuangNan Zhang FangJun Lu LiMing Song XueLei Cao Zhi Chang Gang Chen Li Chen TianXiang Chen Yong Chen YiBao Chen YuPeng Chen Wei Cui WeiWei Cui JingKang Deng YongWei Dong YuanYuan Du MinXue Fu GuanHua Gao He Gao Min Gao MingYu Ge YuDong Gu Ju Guan ChengCheng Guo DaWei Han Wei Hu Yue Huang Jia Huo ShuMei Jia LuHua Jiang WeiChun Jiang Jing Jin YongJie Jin Bing Li ChengKui Li Gang Li MaoShun Li Wei Li Xian Li XiaoBo Li XuFang Li YanGuo Li ZiJian Li ZhengWei Li XiaoHua Liang JinYuan Liao CongZhan Liu GuoQing Liu HongWei Liu ShaoZhen Liu XiaoJing Liu Yuan Liu YiNong Liu Bo Lu XueFeng Lu Tao Luo Xiang Ma Bin Meng Yi Nang JianYin Nie Ge OU JinLu Qu Na Sai Liang Sun Yin Tan Lian Tao WenHui Tao YouLi Tuo GuoFeng Wang HuanYu Wang Juan Wang WenShuai Wang YuSa Wang XiangYang Wen BoBing WU Mei Wu GuangCheng Xiao He Xu YuPeng Xu LinLi Yan JiaWei Yang Sheng Yang YanJi Yang AiMei Zhang ChunLei Zhang ChengMo Zhang Fan Zhang HongMei Zhang Juan Zhang Qiang Zhang Shu Zhang Tong Zhang Wei Zhang WanChang Zhang WenZhao Zhang Yi Zhang Yue Zhang YiFei Zhang YongJie Zhang Zhao Zhang ZiLiang Zhang HaiSheng Zhao JianLing Zhao XiaoFan Zhao ShiJie Zheng Yue Zhu YuXuan Zhu ChangLin Zou | 2018 | Science China(Physics,Mechanics & Astronomy)2018，61，3： | 12 |
| 11 | Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China:focus on the safety显示文摘Background:World Health Organization recommends countries introducing new drug and short treatment regimen for drug resistant tuberculosis(DR-TB)should develop and implement a system for active pharmacovigilance that allows for detection,reporting and management of adverse events.The aim of the study is to evaluate the frequency and severity of adverse events(AEs)of bedaquiline-containing regimen in a cohort of Chinese patients with multidrug-resistant(MDR)/extensively drug-resistant(XDR)-TB based on active drug safety monitoring(aDSM)system of New Drug Introduction and Protection Program(NDIP). | Jing-Tao Gao Juan Du Gui-Hui Wu Yi Pei Meng-Qiu Gao Leonardo Martinez Lin Fan Wei Chen Li Xie Yu Chen Hua Wang Long Jin Guo-Bao Li Pei-Lan Zong Yu Xiong Qian-Hong Wu Ming-Wu Li Xiao-Feng Yan Yan-Fang Miao Qing-Shan Cai Xin-Jie Li Da-Peng Bai Shu-Jun Geng Guo-Li Yang Pei-JunTang Yi Zeng Xiao-Hong Chen Tong-Xia Li Cui Cai Yun Zhou Ma Zhuo Jian-Yun Wang Wen-Long Guan Lin Xu Ji-Chan Shi Wei Shu Li-Li Cheng FeiTeng Yu-Jia Ning Shi-Heng Xie Yu-Xian Sun Li-Jie Zhang Yu-Hong Liu | 2021 | Infectious Diseases of Poverty2021，10，2： | 11 |
| 12 | An Optimization Algorithm for Service Composition Based on an Improved FOA显示文摘Large-scale service composition has become an important research topic in Service-Oriented Computing(SOC). Quality of Service(Qo S) has been mostly applied to represent nonfunctional properties of web services and to differentiate those with the same functionality. Many studies for measuring service composition in terms of Qo S have been completed. Among current popular optimization methods for service composition, the exhaustion method has some disadvantages such as requiring a large number of calculations and poor scalability. Similarly,the traditional evolutionary computation method has defects such as exhibiting slow convergence speed and falling easily into the local optimum. In order to solve these problems, an improved optimization algorithm, WS FOA(Web Service composition based on Fruit Fly Optimization Algorithm) for service composition, was proposed, on the basis of the modeling of service composition and the FOA. Simulated experiments demonstrated that the algorithm is effective, feasible, stable, and possesses good global searching ability. | Yiwen Zhang Guangming Cui Yan Wang Xing Guo Shu Zhao | 2015 | Tsinghua Science and Technology2015，20，1： | 11 |
| 13 | Transcriptomic landscape regulated by the 14 types of bone morphogenetic proteins(BMPs)in lineage commitment and differentiation of mesenchymal stem cells(MSCs)显示文摘Mesenchymal stem cells(MSCs)are ubiquitously-existing multipotent progenitors that can self-renew and differentiate into multiple lineages including osteocytes,chondrocytes,adipocytes,tenocytes and myocytes.MSCs represent one of the most commonly-used adult progenitors and serve as excellent progenitor cell models for investigating lineagespecific differentiation regulated by various cellular signaling pathways,such as bone morphogenetic proteins(BMPs).As members of TGFb superfamily,BMPs play diverse and important roles in development and adult tissues.At least 14 BMPs have been identified in mammals.Different BMPs exert distinct but overlapping biological functions.Through a comprehensive analysis of 14 BMPs in MSCs,we demonstrated that BMP9 is one of the most potent BMPs in inducing osteogenic differentiation of MSCs.Nonetheless,a global mechanistic view of BMP signaling in regulating the proliferation and differentiation of MSCs remains to be fully elucidated.Here,we conducted a comprehensive transcriptomic profiling in the MSCs stimulated by 14 types of BMPs.Hierarchical clustering analysis classifies 14 BMPs into three subclusters:an osteo/chondrogenic/adipogenic cluster,a tenogenic cluster,and BMP3 cluster.We also demonstrate that six BMPs(e.g.,BMP2,BMP3,BMP4,BMP7,BMP8,and BMP9)can induce ISmads effectively,while BMP2,BMP3,BMP4,BMP7,and BMP11 up-regulate Smad-independent MAP kinase pathway.Furthermore,we show that many BMPs can upregulate the expression of the signal mediators of Wnt,Notch and PI3K/AKT/mTOR pathways.While the reported transcriptomic changes need to be further validated,our expression profiling represents the first-of-its-kind to interrogate a comprehensive transcriptomic landscape regulated by the 14 types of BMPs in MSCs. | Linghuan Zhang Qing Luo Yi Shu Zongyue Zeng Bo Huang Yixiao Feng Bo Zhang Xi Wang Yan Lei Zhenyu Ye Ling Zhao Daigui Cao Lijuan Yang Xian Chen Bin Liu William Wagstaff Russell R*Reid Hue H*Luu Rex C*Haydon Michael J*Lee Jennifer Moriatis Wolf Zhou Fu Tong-Chuan He Quan Kang | 2019 | Genes & Diseases2019，6，3： | 11 |
| 14 | 穴位贴敷治疗慢性功能性便秘临床效果的Meta分析显示文摘目的:系统评价穴位贴敷疗法对慢性功能性便秘患者的临床疗效。方法:计算机检索中国知网(CNKI)、万方数据库(WANFANG)、维普全文期刊数据库(VIP)、中国生物医学数据库(CBM)、PubMed、The Cochrane Library、EMBASE、Web of Science核心合集、CINAHL、Medline,全面收集中药穴位贴敷疗法治疗慢性功能性便秘的文献资料。检索时限为建库至2020年9月。由两名研究者按照纳入、排除标准独立进行文献的筛选和资料的提取。运用Revman5.3软件对相关的结局指标进行Meta分析。结果:最终纳入12个RCT,共1114例患者。Meta分析结果显示,中药穴位贴敷疗法与部分常规西药相比,有效率方面优于对照组[RR=1.18,95%CI(1.12,1.25),P<0.00001];在改善排便费力度、排便频率、排便时间、Bristol粪便性状评分方面效果均较好,其疗效均优于部分常规西药([排便困难度:MD=-0.55,95%CI(-0.65~-0.44),P<0.00001]、[排便时间:MD=-0.28,95%CI(-0.34~-0.21),P<0.00001]、[排便频率:MD=-0.32,95%CI(-0.42~-0.21),P<0.00001]、[Bristol粪便性状评分:MD=-0.59,95%CI(-0.66~-0.51),P<0.00001])。结论:基于目前的临床证据表明,中药穴位贴敷疗法与部分常规西药相比,有一定的疗效优势,但受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。 | 章玲 汪莉 范德兰 ZHANG Yan SHU Yao | 2021 | 按摩与康复医学2021，12，21： | 10 |
| 15 | Relationships of High-sensitive C-reactive Protein ant P-wave Dispersion in Lone Atrial Fibrillation显示文摘 | Li-Hui Zheng Yan Yao Ling-Min Wu Kui-Jun Zhang Shu Zhang | 2015 | Chinese Medical Journal2015，，11： | 10 |
| 16 | Redox-sensitive prodrug nanoassemblies based on linoleic acid-modified docetaxel to resist breast cancers显示文摘Prodrug nanoassemblies, which can refrain from large excipients, achieve higher drug loading and control drug release, have been placed as the priority in drug delivery system. Reasoning that glutathione(GSH) and reactive oxygen species(ROS) are highly upgraded in tumor tissues which makes them attractive targets for drug delivery system, we designed and synthetized a novel prodrug which utilized mono thioether bond as a linker to bridge linoleic acid(LA) and docetaxel(DTX). This mono thioether-linked conjugates(DTX-S-LA) could self-assemble into nanoparticles without the aid of much excipients. The mono thioether endowed the nanoparticles redox sensitivity resulting in specific release at the tumor tissue. Our studies demonstrated that the nanoassemblies had uniform particle size, high stability and fast release behavior. DTX-S-LA nanoassemblies outperformed DTX solution in pharmacokinetic profiles for it had longer circulation time and higher area under curve(AUC). Compared with DTX solution, the redox dual-responsive nanoassemblies had comparable cytotoxic activity. Besides, the antitumor efficacy was evaluated in mice bearing 4 T1 xenograft. It turned out this nanoassemblies couldenhance anticancer efficacy by increasing the dose because of higher tolerance. Overall, these results indicated that the redox sensitivity nanoassemblies may have a great potential to cancer therapy. | Meng Li Liwen Zhao Tao Zhang Yue Shu Zhonggui He Yan Ma Dan Liu Yongjun Wang | 2019 | Acta Pharmaceutica Sinica B2019，9，2： | 10 |
| 17 | Long-term eficacy of plasma-derived hepatitis B vaccine among Chinese children:a 12-year folow-up study显示文摘INTRODUCTIONToevaluatelongtermeficacyofaplasmaderivedhepatitisBvaccineandprovideevidencefordecisionmakingonthevaccineboost... | LIAO Su Su 1, LI Rong Cheng 2, LI Hui 1, YANG Jin Ye 2, ZENG Xian Jia 1, GONG Jian 2, WANG Shu Sheng 2, LI Yan Ping 2 and ZHANG Kong Lai 1 | 1999 | World Journal of Gastroenterology1999，5，2： | 9 |
| 18 | On the Kinematic Characteristics and Dynamic Process of Boundary faults of the Nansha Ultra-crust Layer-Block显示文摘The Nansha ultra-crust layer-block is confined by ultra-crustal boundary faults of distinctive features, bordering the Kangtai-Shuangzi-Xiongnan extensional faulted zone on the north, the Baxian-Baram-Yoca-Cuyo nappe faulted zone on the south, the Wan’an-Natuna strike-slip tensional faulted zone on the west and the Mondoro-Panay strike-slip compressive faulted zone on the east. These faults take the top of the Nansha asthenosphere as their common detachmental surface. The Cenozoic dynamic process of the ultra-crust layer-block can be divided into four stages: K2-E21, during which the northern boundary faults extended, this ultra-crust layer-block was separated from the South China-Indosinian continental margin, the Palaeo-South China Sea subducted southwards and the Sibu accretion wedge was formed; E22-E31, during which the Southwest sub-sea basin extended and orogeny was active due to the collision of the Sibu accretion wedge; E32-N11, during which the central sub-sea basin extended, the Miri | LIU Hailing SUN Yan GUO Lingzhi SHU Liangshu YANG Shukang ZHOU Di ZHANG Yixiang | 1999 | Acta Geologica Sinica(English Edition)1999，73，4： | 9 |
| 19 | Improved approach to atrial septum puncture: experience in 539 cases显示文摘 | YAO Yan GUO Jun DING Li-gang BAO Jing-ru HUANG Wen SHI Rui WU Ling-min ZHANG Shu | 2012 | Chinese Medical Journal2012，，6： | 9 |
| 20 | Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer:an open-label,randomized controlled phase 3 trial(ORIENT-3)显示文摘Background:Treatment options for Chinese patients with locally advanced or metastatic squamous-cell non-small-cell lung cancer(sqNSCLC)after failure of first-line chemotherapy are limited.This study(ORIENT-3)aimed to evaluate the efficacy and safety of sintilimab versus docetaxel as second-line treatment in patients with locally advanced or metastatic sqNSCLC.Methods:ORIENT-3 was an open-label,multicenter,randomized controlled phase 3 trial that recruited patients with stage IIIB/IIIC/IV sqNSCLC after failure with first-line platinum-based chemotherapy.Patients were randomized in a 1:1 ratio to receive either 200 mg of sintilimab or 75 mg/m^(2) of docetaxel intravenously every 3 weeks,stratified by the Eastern Cooperative Oncology Group performance status.The primary endpoint was overall survival(OS)in the full analysis set(FAS).Secondary endpoints included progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),duration of response(DoR)and safety.Results:Between August 25,2017,and November 7,2018,290 patients were randomized.For FAS,10 patients fromthe docetaxel armwere excluded.Themedian OS was 11.79(n=145;95%confidence interval[CI],10.28-15.57)months with sintilimab versus 8.25(n=135;95%CI,6.47-9.82)months with docetaxel(hazard ratio[HR]:0.74;95%CI,0.56-0.96;P=0.025).Sintilimab treatment significantly prolonged PFS(median 4.30 vs.2.79 months;HR:0.52;95%CI,0.39-0.68;P<0.001)and showed higher ORR(25.50%vs.2.20%,P<0.001)and DCR(65.50%vs.37.80%,P<0.001)than the docetaxel arm.The median DoRwas 12.45(95%CI,4.86-25.33)months in the sintilimab arm and 4.14(95%CI,1.41-7.23)months in the docetaxel arm(P=0.045).Treatment-related adverse events of grade≥3were reported in 26(18.1%)patients in the sintilimab arm and 47(36.2%)patients in the docetaxel arm.Exploratory biomarker analysis showed potential predictive values of expression levels of two transcription factors,including OVOL2(HR:0.35;P<0.001)and CTCF(HR:3.50;P<0.001),for sintilimab treatment.Conclusions:Compared with docetaxel,sintilimab significantly improved the OS,PFS,and ORR of Chinese patients with previously treated locally advanced or metastatic sqNSCLC. | Yuankai Shi Lin Wu Xinmin Yu Puyuan Xing Yan Wang Jianying Zhou Airong Wang Jianhua Shi Yi Hu Ziping Wang Guangyu An Yong Fang Sanyuan Sun Caicun Zhou Changli Wang Feng Ye Xingya Li Junye Wang Mengzhao Wang Yunpeng Liu Yanqiu Zhao Ying Yuan Jifeng Feng Zhendong Chen Jindong Shi Tao Sun Gang Wu Yongqian Shu Qisen Guo Yi Zhang Yong Song Shucai Zhang Yuan Chen Wei Li Hongrui Niu Wenwei Hu Lijun Wang Jianan Huang Yang Zhang Ying Cheng Zhengdong Wu Bo Peng Jiya Sun Christoph Mancao Yanqi Wang Luyao Sun | 2022 | Cancer Communications2022，42，12： | 8 |
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