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Tildrakizumab for moderate-to-severe plaque psoriasis in Chinese patients:A 12-week randomized placebo-controlled phase III trial with long-term extension

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Chinese Medical Journal 2024年第10期137卷 1190-1198页

作者： Chen Yu songmei Geng Bin Yang Yunhua Deng Fuqiu Li Xiaojing Kang Mingye Bi Furen Zhang Yi Zhao Weili Pan Zhongwei Tian Jinhua Xu Zhenghua Zhang Nan Yu Xinsuo Duan Shuping Guo Qing sun Weiquan Li Juan Tao Zhijun Liu Yuanyuan Yin Gang Wang Department of Dermatology Xijing HospitalThe Fourth Military Medical UniversityXi’anShaanxi 710032China Department of Dermatology The Second Affiliated Hospital of Xi’an Jiaotong UniversityXi’anShaanxi 710004China Department of Dermatology Dermatology Hospital of Southern Medical UniversityGuangzhouGuangdong 510091China Department of Dermatology Tongji HospitalHuazhong University of Science and TechnologyWuhanHubei 430030China Department of Dermatology The Second Hospital of Jilin UniversityChangchunJilin 130041China Department of Dermatology People’s Hospital of Xinjiang Uygur Autonomous RegionUrumqiXinjiang 830001China Department of Dermatology Wuxi People’s Hospital of Wuxi CityWuxiJiangsu 214023China Department of Dermatology Shandong Provincial Hospital for Skin Diseases&Shandong Provincial Institute of Dermatology and VenereologyShandong First Medical University&Shandong Academy of Medical SciencesJinanShandong 250022China Department of Dermatology Beijing Tsinghua Changgung HospitalBeijing 102218China Department of Dermatology Zhejiang Provincial People’s HospitalHangzhouZhejiang 310014China Department of Dermatology The First Affiliated Hospital of Xinxiang Medical CollegeXinxiangHenan 453100China Department of Dermatology Huashan Hospital Affiliated to Fudan UniversityShanghai 200040China Department of Dermatology General Hospital of Ningxia Medical UniversityYinchuanNingxia 750000China Department of Dermatology Affiliated Hospital of Chengde Medical UniversityChengdeHebei 067000China Department of Dermatology The First Hospital of Shanxi Medical UniversityTaiyuanShanxi 030001China Department of Dermatology Qilu Hospital of Shandong UniversityJinanShandong 250012China Department of Dermatology Yuebei People’s HospitalShaoguanGuangdong 512026China Department of Dermatology Union Hospital Tongji Medical Collage Huazhong University of Science and TechnologyWuhanHubei 430022China Department of Dermatology and Venereal Diseases The First Affiliated Hospit

Background:There is a need for effective and safe therapies for psoriasis that provide sustained *** aim of this study was to assess the efficacy and safety of tildrakizumab,an anti-interleukin-23p19 monoclonal antibody,for treating moderate-to-severe plaque psoriasis in Chinese ***:In this multi-center,double-blind,phase III trial,patients with moderate-to-severe plaque psoriasis were enrolled and randomly assigned(1:1)to receive subcutaneous tildrakizumab 100 mg or placebo at weeks 0 and *** initially assigned to placebo were switched to receive tildrakizumab at weeks 12,16,and every 12 weeks *** in the tildrakizumab group continued with tildrakizumab at week 16,and every 12 weeks until week *** primary endpoint was the Psoriasis Area and Severity Index(PASI 75)response rate at week ***:At week 12,tildrakizumab demonstrated significantly higher PASI 75 response rates(66.4%[73/110]vs.12.7%[14/110];difference,51.4%[95%confidence interval(CI),40.72,62.13];P<0.001)and Physician’s Global Assessment(60.9%[67/110]vs.10.0%[11/110];difference,49.1%[95%CI,38.64,59.62];P<0.001)compared to *** 75 response continued to improve over time in both tildrakizumab and placebo-switching to tildrakizumab groups,reaching maximal efficacy after 28 weeks(86.8%[92/106]vs.82.4%[89/108])and maintained up to 52 weeks(91.3%[95/104]vs.87.4%[90/103]).Most treatment-emergent adverse events were mild and not related to ***:Tildrakizumab demonstrated durable efficacy through week 52 and was well tolerated in Chinese patients with moderate-to-severe plaque *** registration:***,NCT05108766.

关键词： Tildrakizumab Interleukin 23 Plaque psoriasis Chinese Randomized controlled trial

Efficacy and safety of bilastine *** for the treatment of chronic idiopathic urticaria:A multicenter,double-blind,double-dummy,phase III,non-inferiority,randomized clinical trial

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Chinese Medical Journal 2024年第12期137卷 1480-1482页

作者： Xue Chen Xiuping Han Bo Cheng Hui Li Lingling Liu songmei Geng Linfeng Li Jie Li Qing Guo Guoyi Zhang Hong Fang Jianzhong Zhang Department of Dermatology Peking University People’s HospitalBeijing 100044China Department of Dermatology Shengjing Hospital of China Medical UniversityShenyangLiaoning 110055China Department of Dermatology The First Affiliated Hospital of Fujian Medical UniversityFuzhouFujian 350004China Department of Dermatology The First Affiliated Hospital of Chongqing Medical UniversityChongqing 400016China Department of Dermatology Peking University First HospitalBeijing 100034China Department of Dermatology The Second Affiliated Hospital of Xi’an Jiaotong University(Xibei Hospital)Xi’anShaanxi 710006China Department of Dermatology Beijing Friendship HospitalCapital Medical UniversityBeijing 100050China Department of Dermatology Xiangya HospitalCentral South UniversityChangshaHunan 410008China Department of Dermatology Sun Yat-sen Memorial HospitalSun Yat-sen UniversityGuangzhouGuangdong 510120China Department of Dermatology Hospital for Skin DiseasesChinese Academy of Medical SciencesNanjingJiangsu 210042China Department of Dermatology The First Affiliated HospitalCollege of MedicineZhejiang UniversityHangzhouZhejiang 310003China

To the Editor:Chronic urticaria,prevalent globally and increasing in China,predominantly affects young and middle-aged women,impacting their quality of life(QoL).[1]Standard treatment involves second-generation H1 antihistamines,with bilastine showing promise due to its selective action and minimal side ***,direct comparative studies are scarce,particularly in the Chinese *** aimed to evaluate the efcacy and safety of bilastine compared to levocetirizine in Chinese patients.

关键词： treatment double globally

基于MRI的肾囊性病变2005版BosniakⅡ-Ⅲ类阅片者间一致性分析

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解放军医学院学报 2021年第5期42卷 513-519页

作者：孙松梅白旭李林张晶张晓晶许伟于梅艳王美凤叶慧义王海屹解放军医学院北京100853 解放军总医院第二医学中心放射诊断科北京100853 解放军总医院第五医学中心放射诊断科北京100039 解放军总医院医学创新研究部医院管理研究所北京100853 解放军总医院第一医学中心放射诊断科北京100853 首都医科大学附属北京中医医院北京100010

背景肾囊性病变的Bosniak分类影响临床决策,现有阅片者间一致性研究多采用计算机体层成像(computed tomography,CT)图像,而磁共振成像(magnetic resonance imaging,MRI)正凭借其优越的图像分辨率和软组织对比度、提供更详细的影像学信息... 详细信息

背景肾囊性病变的Bosniak分类影响临床决策,现有阅片者间一致性研究多采用计算机体层成像(computed tomography,CT)图像,而磁共振成像(magnetic resonance imaging,MRI)正凭借其优越的图像分辨率和软组织对比度、提供更详细的影像学信息,临床应用日益广泛。目的本研究通过评估不同阅片者基于MRI、依据现行的2005版Bosniak分类系统判读Ⅱ-Ⅲ类肾囊性病变(cystic renal mass,CRM)的一致性,为临床决策提供影像学依据。方法收集解放军总医院第一医学中心2009年1月-2018年12月完成常规MRI平扫及增强检查并符合2005版BosniakⅡ-Ⅲ分类标准的CRM病例,由3名影像医师依据2005版Bosniak分类系统对MRI图像进行独立判读并记录分类结果,通过计算全部病例、不同分类和不同病理类型病例的阅片者间一致性加权Kappa系数(Cohen/Conger’s Kappa,k_(w)),衡量全部病例、不同分类和不同病理类型病例的阅片者间一致性。结果共有123例患者的123个CRM纳入本研究,其中男84例,女39例,平均年龄(49.1±11.1)岁,单纯囊肿、良性肿瘤和恶性肿瘤分别有61例(49.6%)、15例(12.2%)、47例(38.2%),Ⅱ、ⅡF、Ⅲ类病例分别有24例(19.5%)、49例(39.8%)、50例(40.7%)。全部病例阅片者间一致性k_(w)系数为0.43。Ⅱ、ⅡF、Ⅲ类病例的k_(w)系数分别为0.05、0.34、0.29;单纯囊肿、良性肿瘤、恶性肿瘤的k_(w)系数分别为0.33、0.16、0.31。结论基于2005版Bosniak分类系统,对于全部病例阅片者间一致性程度中等;BosniakⅡ类病例的一致性较低;BosniakⅡF和Ⅲ类病例的一致性一般;单纯囊肿和恶性肿瘤的一致性均一般;良性肿瘤的一致性较低;单纯囊肿的一致性高于良性肿瘤和恶性肿瘤。

关键词： 2005版Bosniak分类肾囊性病变肾肿瘤磁共振成像阅片者间一致性

Adsorption performance and mechanism of Schiff base functionalized polyamidoamine dendrimer/silica for aqueous Mn(Ⅱ) and Co(Ⅱ)

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Chinese Chemical Letters 2020年第10期31卷 2742-2746页

作者： Wenzhu Qiao Peixu Zhang Lixiang sun songmei Ma Wenlong Xu Shengguang Xu Yuzhong Niu School of Chemistry and Materials Science Ludong UniversityYantai 264025China

Schiff base functionalized polyamidoamine(PAMAM) dendrimer/silica were prepared for the adsorption of aqueous Mn(Ⅱ) and Co(Ⅱ).The effects that influence the adsorption were investigated systematically and the adsorption mechanism was illustrated by theoretical *** optimum adsorption pH are 4 and 6 for Mn(II) and Co(Ⅱ).Adsorption kinetics follow pseudo-second-order model and the ratecontrolling step is film diffusion *** isotherm shows that high initial metal ion concentration facilitates the uptake of metal *** adsorption capacity increases first and then decreases in the temperature range of 15-35℃.Density functional theory(DFT) calculation demonstrates that Schiff base functionalized PAMAM dendrimer tends to coordinate Mn(Ⅱ) and Co(Ⅱ) with the oxygen atoms of hydroxyl and carbonyl groups,nitrogen of tertiary amine and imino *** imino and tertiary amine groups mainly dominate the *** reproducibility of the adsorbents indicates they can be regenerated by 5% thiourea and 0.5 mol/L HNO_(3) solution efficiently.

关键词： Adsorption Schiff base PAMAM dendrimer DFT calculation

侵犯肾窦或肾周脂肪的肾透明细胞癌临床特征及术后生存影响因素分析

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解放军医学院学报 2020年第9期41卷 885-888,904页

作者：孙松梅刘姝白旭黄庆波袁静张晓晶李林王海屹解放军医学院北京100853 解放军总医院第二医学中心健康医学科北京100853 北京大学医学人文学院北京100191 解放军总医院第一医学中心影像诊断科北京100853 解放军总医院第一医学中心泌尿外科北京100853 解放军总医院第一医学中心病理科北京100853 解放军总医院医学创新研究部医院管理研究所北京100853

目的探讨侵犯肾窦和(或)肾周脂肪的肾透明细胞癌的临床特征,并分析患者术后生存影响因素。方法收集2012年12月1日-2019年8月9日解放军总医院第一医学中心通过MR检查发现侵犯肾窦或肾周脂肪并经手术病理证实的肾透明细胞癌患者的临床和... 详细信息

目的探讨侵犯肾窦和(或)肾周脂肪的肾透明细胞癌的临床特征,并分析患者术后生存影响因素。方法收集2012年12月1日-2019年8月9日解放军总医院第一医学中心通过MR检查发现侵犯肾窦或肾周脂肪并经手术病理证实的肾透明细胞癌患者的临床和病理资料,以log-rank检验和多因素Cox比例风险回归进行生存分析,探索影响患者全因死亡的影响因素。结果174例患者纳入分析,平均年龄58.1±11.4岁,其中女性29例,男性145例,在1.5~86.2个月的随访期内,136例存活,38例死亡。生存时间25%分位数为50.3个月。单因素log-rank检验显示,肿瘤直径、侵犯部位、有无静脉癌栓和病理Fuhrman核分级影响患者总生存率且有统计学意义(P均<0.05)。多元Cox回归显示,肿瘤直径≥6.8 cm(HR:3.94;95%CI:1.78~8.71)、侵犯肾周脂肪(HR:0.33;95%CI:0.12~0.91)、发生静脉癌栓(HR:2.06,95%CI:1.00~4.26)是影响患者生存的独立因素。结论本研究发现肿瘤直径大于6.8 cm、侵犯肾窦和发生静脉癌栓为影响侵犯肾窦和(或)肾周脂肪的肾透明细胞癌患者生存的独立危险因素。

关键词：肾透明细胞癌肾窦/肾周脂肪侵犯肾癌手术治疗生存分析

肾脏囊性病变2019版Bosniak分类中MRI标准的观察者重测信度分析

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中华放射学杂志 2022年第10期56卷 1121-1128页

作者：白旭孙松梅康欢欢李林许伟赵春刚朴勇男王英王小娜于梅艳王美凤贾凯强郭爱桃叶慧义王海屹解放军总医院第五医学中心放射科北京100039 解放军总医院第二医学中心放射诊断科北京100853 解放军总医院第一医学中心放射诊断科北京100853 解放军总医院医学创新研究部医院管理研究所北京100853 达州市中心医院放射科达州635099 珲春市中医医院医学影像科珲春133300 山东大学附属济南市中心医院医学影像中心济南250013 首都医科大学附属北京中医医院放射科北京100010 解放军总医院第六医学中心放射诊断科北京100048 解放军火箭军特色医学中心放射科北京100088 解放军总医院第三医学中心病理科北京100039

目的探讨肾脏囊性病变(CRM)2019版Bosniak分类中MRI标准的观察者重测信度,分析病灶病理性质、大小及阅片者经验对重测信度的影响。方法回顾性连续收集2009年1月至2019年6月于解放军总医院第一医学中心行常规肾脏增强MRI并获得手术病理... 详细信息

目的探讨肾脏囊性病变(CRM)2019版Bosniak分类中MRI标准的观察者重测信度,分析病灶病理性质、大小及阅片者经验对重测信度的影响。方法回顾性连续收集2009年1月至2019年6月于解放军总医院第一医学中心行常规肾脏增强MRI并获得手术病理结果的207例CRM患者,共207个病灶。基于2019版Bosniak分类系统的MRI标准,8名不同年资的放射科医师在对患者病理信息均不知情的前提下,对所有CRM间隔1个月进行两次独立评估。采用组内相关系数(ICC)衡量8名阅片者对所有病灶以及不同病理性质(良性及恶性)、不同大小(最大径≤40 mm及>40 mm)亚组的重测信度,计算并比较4名高年资(工作经验≥10年)及4名低年资(工作经验40 mm的120个。基于2019版Bosniak分类MRI标准,对全部病灶,8名阅片者单独两次评估的重测信度ICC为0.776~0.888,整体重测信度ICC为0.848(95%CI 0.821~0.872),高、低年资阅片者重测信度ICC分别为0.853(95%CI 0.824~0.880)、0.843(95%CI 0.811~0.871),差异无统计学意义(Z=0.85,P=0.374)。全部阅片者对良性病变的ICC为0.827,恶性病变为0.654,差异有统计学意义(Z=2.80,P=0.005);最大径≤40 mm的病变的ICC为0.770,>40 mm的为0.876,差异有统计学意义(Z=-2.36,P=0.018)。对不同病理性质及不同大小的CRM亚组中,高、低年资阅片者重测信度差异均无统计学意义(P均>0.05)。结论2019版Bosniak分类中MRI标准对CRM的阅片者重测信度佳,且不受阅片者工作经验影响;不同病理性质及不同大小病灶间重测信度存在差异,但均达良好以上水平。

关键词：磁共振成像肾脏囊性病变 Bosniak分类重测信度

Chinese expert consensus on the diagnosis and treatment of balanoposthitis

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Chinese Medical Journal 2024年第13期137卷 1519-1521页

作者： Li Zhang Amer A.A.Abdulrahman Hao Guo Jia’an Zhang Xinghua Gao Weihua Pan Gang Wang Jinhua Xu Yuling Shi Liuqing Chen Hongxiang Chen songmei Geng Yuping Ran Hongwei Wang Xiaoyong Man Jianmin Chang Furen Zhang Litao Zhang Guangwen Yin Jianzhong Zhang Wei Lai Zhibin Niu Hongkun Jiang Haibo Liu Yaolong Chen Jianjian Wang Department of Dermatology The First Hospital of China Medical UniversityShenyangLiaoning 110001China Key Laboratory of Immunodermatology Ministry of Education and NHCNational Joint Engineering Research Center for Theranostics of Immunological Skin DiseasesShenyangLiaoning 110001China Department of Dermatology Chinese Academy of Medical Science and Peking Union Medical CollegeNanjingJiangsu 210042China Department of Dermatology Second Affiliated Hospital of Naval Medical UniversityShanghai 200003China Department of Dermatology Xijing HospitalFourth Military Medical UniversityXi’anShaanxi 710032China Department of Dermatology Huashan HospitalFudan UniversityShanghai 200040China Department of Dermatology Shanghai Skin Disease HospitalTongji University School of MedicineShanghai 200443China Department of Dermatology Wuhan No.1 HospitalWuhanHubei 430022China Department of Dermatology Huazhong University of Science and Technology Union Shenzhen HospitalShenzhenGuangdong 518052China Department of Dermatology Second Affiliated Hospital of Xi’an Jiaotong UniversityXi’anShaanxi 710004China Department of Dermatovenereology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Dermatology Huadong HospitalFudan UniversityShanghai 200040China Department of Dermatology Second Affiliated HospitalZhejiang University School of MedicineHangzhouZhejiang 310009China Department of Dermatology Beijing HospitalBeijing 100730China Shandong Provincial Hospital for Skin Diseases&Shandong Provincial Institute of Dermatology and Venereology Shandong First Medical University&Shandong Academy of Medical SciencesJinanShandong 250061China Department of Dermatology Tianjin Academy of Traditional Chinese Medicine Affiliated HospitalTianjin 300120China Department of Dermatology The First Affiliated Hospital of Zhengzhou UniversityZhengzhouHenan 450052China Department of Dermatology Peking University People’s HospitalBeijing 100044 China Department of Dermatology Third Affi

Balanoposthitis(BP),a common male genitalia inflammation,is managed by clinicians from different specialties,including urology,pediatrics,dermatology,and *** to this diverse array of clinicians involved,there exists a lack of consistent,evidence-based recommendations for *** development of the consensus engaged 19 representative hospitals and it adhered to rigorous protocols,encompassing international registration(IPGRP-2021CN003)and the application of evidence grading criteria and recommendation standards[Appendix S1,Supplementary File,http://***/CM9/C42].Over the period from December 2020 to October 2022,consensus on 12 clinical issues was reached through comprehensive evidence searches and two iterations of Delphi surveys[Supplementary File,http://***/CM9/C42].

关键词： Delphi diagnosis rigorous

Efficient gene transfection of suspension cells by highly branched poly(β-amino ester)

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Chinese Chemical Letters 2023年第7期34卷 176-181页

作者： Delu Che Chenfei Wang Zhili Li Kaixuan Wang Shuaiwei sun Xinyue Zhang Yi Li Zhengju Chen Lei Guo Yajing Hou Dezhong Zhou songmei Geng Department of Dermatology the Second Hospital Affiliated to Xi'an Jiaotong UniversityXi'an 710061China School of Chemical Engineering and Technology Xi'an Jiaotong UniversityXi'an 710049China Infectious Disease Department the Second Xiangya Hospital of Central South UniversityChangsha 410011China Pooling Medical Research Institutes Hangzhou 310053China Department of Pharmacy Shaanxi Provincial People's HospitalXi'an 710068China

Suspension cells play a crucial role in many biological processes. However, compared to adherent cells, it is particularly challenging to introduce exogenous genes into suspension cells to regulate their biological functions with non-viral gene vectors, mainly due to the low cellular uptake and endosomal escape of polyplexes. Herein, to improve the interactions of polyplexes with cellular membranes, we design and synthesize highly branched poly(β-amino ester)(HPAE) via an “A2 + B4 + C2” Michael addition *** show that branching significantly increases DNA condensation of HPAE, cellular uptake and endosomal escape of HPAE/DNA polyplexes. In mast cells(MCs), HPAE exhibits up to 80-fold higher gene transfection efficiency compared to the corresponding linear poly(β-amino ester)(LPAE) and the leading commercial gene transfection reagents PEI25k, jetPEI, and Lipofectamine 3000, without causing obvious cytotoxicity. Our study establishes a reliable non-viral platform for efficient gene transfection of suspension cells.

关键词： Non-viral vector Highly branched poly(β-amino ester) Gene transfection High transfection efficiency Suspension cells Mast cells

血脂异常和丙氨酸氨基转移酶升高对高尿酸血症患病的交互作用

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中国慢性病预防与控制 2024年第1期32卷 38-42页

作者：卢双艳普惠婕陈洁李梦启张梅刁翌李贵涛周佳王松梅孙承欢叶爱芳毛勇昆明医科大学公共卫生学院云南省昆明650500 云南省安宁市中医医院健康管理中心云南省安宁650300

目的探讨血脂异常和丙氨酸氨基转移酶(ALT)升高的交互作用对高尿酸血症(HUA)患病的影响,为HUA的防治提供科学依据。方法于2020年5月—2021年6月,采用多阶段分层随机抽样法抽取安宁市4725名45~95岁居民为调查对象,进行问卷调查、体格检... 详细信息

目的探讨血脂异常和丙氨酸氨基转移酶(ALT)升高的交互作用对高尿酸血症(HUA)患病的影响,为HUA的防治提供科学依据。方法于2020年5月—2021年6月,采用多阶段分层随机抽样法抽取安宁市4725名45~95岁居民为调查对象,进行问卷调查、体格检查和实验室检测。采用SAS 9.4软件进行t检验、秩和检验、χ^(2)检验、单因素和多因素logistic回归分析。采用多因素logistic回归相乘模型和相加模型分析血脂异常和ALT升高的交互作用对HUA患病的影响。结果4725名调查对象中,HUA患者1681例(35.58%),血脂异常患者1667例(35.28%),ALT升高者397例(8.40%),血脂异常与ALT升高共患率为3.70%(175/4725)。多因素logistic回归分析结果显示,调整混杂因素后,血脂异常(OR=2.328,95%CI:1.775~3.053)和ALT升高(OR=2.060,95%CI:1.363~3.114)均与HUA患病高风险相关(P<0.01)。交互作用分析显示,血脂异常与ALT升高对于HUA患病不存在相乘交互效应(OR=1.870,95%CI:0.943~3.710);但存在相加交互效应,有血脂异常合并ALT升高人群的HUA患病风险是无血脂异常且无ALT升高人群的6.079倍(OR=6.079,95%CI:4.459~8.287)。调整混杂因素后,交互作用相对超额危险度比、交互作用归因比、交互作用指数和纯因子归因交互作用百分比分别为3.392(95%CI:1.521~5.264)、55.800%(95%CI:40.700%~70.900%)、3.011(95%CI:1.921~4.721)和66.787%(95%CI:43.972%~72.238%)。结论血脂异常和ALT升高对HUA患病可能存在相加交互效应,改善血脂与控制ALT水平可能会协同预防HUA的发生。

关键词：血脂异常丙氨酸氨基转移酶高尿酸血症交互作用