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Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis:A multicenter,randomized,double-blind,placebo-controlled phase 2b trial

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Chinese Medical Journal 2024年第2期137卷 200-208页

作者： Yan Zhao Jianzhong zhang Bin Yang Jingyi Li Yangfeng Ding Liming Wu Litao zhang Jinyan Wang Xiaohong Zhu furen zhang Xiaohua Tao Yumei Li Chunlei zhang Linfeng Li Jianyun Lu Qingchun Diao Qianjin Lu Xiaoyong Man Fuqiu Li Xiujuan Xia Hao Cheng Yingmin Jia Guoqing Zhao Jinchun Yan Bo Chen Department of Dermatology Peking University People’s HospitalBeijing 100044China Department of Dermatology Dermatology HospitalSouthern Medical UniversityGuangzhouGuangdong 510091China Department of Dermatology West China HospitalSichuan UniversityChengduSichuan 610041China Department of Dermatology Shanghai Skin Disease HospitalInstitute of PsoriasisTongji University School of MedicineShanghai 200443China Department of Dermatology Affiliated Hangzhou First People’s HospitalZhejiang University School of MedicineHangzhouZhejiang 310006China Department of Dermatology Tianjin Academy of Traditional Chinese Medicine Affiliated HospitalTianjin 300120China Department of Dermatology Ningbo No.2 HospitalNingboZhejiang 315010China Department of Dermatology The Wuxi Second Affiliated Hospital of Nanjing Medical UniversityWuxiJiangsu 214002China Shandong Provincial Hospital for Skin Diseases&Shandong Provincial Institute of Dermatology and Veneorology Shandong First Medical University&Shandong Academy of Medical SciencesJinanShandong 250022China Center for Plastic&Reconstructive Surgery Department of DermatologyZhejiang Provincial People’s Hospital(Affiliated People’s HospitalHangzhou Medical College)HangzhouZhejiang 310014China Department of Dermatology Affiliated Hospital of Jiangsu UniversityZhenjiangJiangsu 212001China Department of Dermatology Peking University Third HospitalBeijing 100191China Department of Dermatology Beijing Friendship HospitalCapital Medical UniversityBeijing 100050China Department of Dermatology The Third Xiangya Hospital of Central South UniversityChangshaHunan 410013China Department of Dermatology Chongqing Traditional Chinese Medicine HospitalChongqing 400011China Hunan Key Laboratory of Medical Epigenomics Department of DermatologyThe Second Xiangya Hospital of Central South UniversityChangshaHunan 410011China Department of Dermatology The Second Affiliated HospitalZhejiang University School of MedicineHangzhouZhejiang 310009China Departme

Background:Atopic dermatitis(AD)affects approximately 10%of adults ***310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 *** trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe ***:This multicenter,randomized,double-blind,placebo-controlled,phase 2b trial was conducted in 21 medical institutions in China from February to November *** 120 eligible patients were enrolled and randomized(1:1:1)to receive subcutaneous injections of 300 mg CM310,150 mg CM310,or placebo every 2 weeks for 16 weeks,followed by an 8-week follow-up *** primary endpoint was the proportion of patients achieving≥75%improvement in the Eczema Area and Severity Index(EASI-75)score from baseline at week *** and pharmacodynamics were also ***:At week 16,the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups(70%[28/40]for high-dose and 65%[26/40]for low-dose)than that in the placebo group(20%[8/40]).The differences in EASI-75 response rate were 50%(high ***,95%CI 31%-69%)and 45%(low ***,95%CI 26%-64%),with both P values<***310 at both doses also significantly improved the EASI score,Investigator’s Global Assessment score,daily peak pruritus Numerical Rating Scale,AD-affected body surface area,and Dermatology Life Quality Index compared with ***310 treatment reduced levels of thymus and activation-regulated chemokine,total immunoglobulin E,lactate dehydrogenase,and blood *** incidence of treatment-emergent adverse events(TEAEs)was similar among all three groups,with the most common TEAEs reported being upper respiratory tract infection,atopic dermatitis,hyperlipidemia,and *** severe adverse events were deemed to be attributed to ***:CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tol

关键词： CM310 Moderate-to-severe atopic dermatitis Interleukin-4 receptor alpha Adults

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

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

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度普利尤单抗治疗结节性痒疹1例

中华皮肤科杂志 2024年第1期57卷 69-70页

作者：张帆刘红张福仁山东第一医科大学附属皮肤病医院山东省皮肤病医院山东省皮肤病性病防治研究所济南250022

患者男,65岁,因躯干、四肢丘疹、结节伴瘙痒4年就诊.患者4年前无明显原因出现全身瘙痒,搔抓后出现皮疹,瘙痒渐加重,影响睡眠.3年前曾诊断为"湿疹",予雷公藤、糖皮质激素口服(具体剂量不详)、中药等治疗,效果不佳,遂就诊.既往史:糖尿病1... 详细信息

患者男,65岁,因躯干、四肢丘疹、结节伴瘙痒4年就诊.患者4年前无明显原因出现全身瘙痒,搔抓后出现皮疹,瘙痒渐加重,影响睡眠.3年前曾诊断为"湿疹",予雷公藤、糖皮质激素口服(具体剂量不详)、中药等治疗,效果不佳,遂就诊.既往史:糖尿病10余年,胰岛素治疗,空腹血糖6~7mmol/L.无特应性皮炎、过敏性鼻炎、哮喘史,无类似家族史.体检:各系统无明显异常.

关键词：结节性痒疹特应性皮炎哮喘史具体剂量过敏性鼻炎搔抓糖皮质激素雷公藤

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以咖啡牛奶斑为表现的Ⅰ型神经纤维瘤病2例

中华皮肤科杂志 2024年第4期57卷 363-364页

作者：李洪达孙乐乐刘红张福仁山东大学济南250061 山东省皮肤病医院济南250012

例1男,6月龄,自出生时躯干、四肢多发咖啡牛奶斑。皮肤科检查:背部、前胸、腋窝大片咖啡牛奶斑(直径>15mm),四肢散在≥6片咖啡牛奶斑(直径>5mm)(图1)。余系统检查无异常。患者父母均正常,非近亲结婚,患者无兄弟姊妹,无家族史。

关键词：非近亲结婚咖啡牛奶斑 Ⅰ型神经纤维瘤病患者父母腋窝四肢 6月龄

长期使用传统免疫抑制剂治疗皮肤病的不良反应比较

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中国麻风皮肤病杂志 2024年第5期40卷 311-316页

作者：王艺赵晴糜自豪刘红张福仁山东第一医科大学附属皮肤病医院山东济南250022 山东省皮肤病性病防治研究所山东济南250022

目的:比较患者长期(>12周)使用各传统免疫抑制剂后出现的不良反应。方法:收集2019年1月至2023年10月期间长时间(>12周)使用甲氨喋呤、环磷酰胺、环孢素、吗替麦考酚酯和沙利度胺药物的患者检查资料,对血常规、肝功能、肾功能实验室检查... 详细信息

目的:比较患者长期(>12周)使用各传统免疫抑制剂后出现的不良反应。方法:收集2019年1月至2023年10月期间长时间(>12周)使用甲氨喋呤、环磷酰胺、环孢素、吗替麦考酚酯和沙利度胺药物的患者检查资料,对血常规、肝功能、肾功能实验室检查进行回顾性分析。结果:共1507例使用传统免疫抑制剂患者纳入分析,其中甲氨喋呤1142例,环磷酰胺135例,环孢素67例,吗替麦考酚酯66例,沙利度胺97例,不良反应发生率分别为:38.18%,56.30%,44.30%,27.27%,22.39%。最常见的不良反应依次为肝功能损伤(24.22%),肾功能损伤(12.61%)和骨髓抑制(9.69%)。患者使用免疫抑制剂引起的不良反应发生率与用药时长存在相关性。结论:长期服用传统免疫抑制剂可导致不良反应的发生,最常引起不良反应的药物为环磷酰胺。因此,对于长期服用此类药物的患者应进行定期监测。

关键词：传统免疫抑制剂不良反应骨髓抑制肝功能损伤肾功能损伤

误诊为持久性隆起性红斑的海分枝杆菌感染一例

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中国麻风皮肤病杂志 2024年第6期40卷 425-427页

作者：于越乾暴芳芳刘红张福仁山东第一医科大学附属皮肤病医院山东济南250022 山东省皮肤病性病防治研究所山东济南250022

患者,女,48岁。左膝结节16个月。患者曾在外院接受伊曲康唑及氨苯砜治疗9个月,无效。患者在我院通过皮肤组织分枝杆菌培养和定量聚合酶链反应(qPCR)测序技术诊断为海分枝杆菌感染,口服利福平和克拉霉素治疗4个月,皮损明显好转。患者从... 详细信息

患者,女,48岁。左膝结节16个月。患者曾在外院接受伊曲康唑及氨苯砜治疗9个月,无效。患者在我院通过皮肤组织分枝杆菌培养和定量聚合酶链反应(qPCR)测序技术诊断为海分枝杆菌感染,口服利福平和克拉霉素治疗4个月,皮损明显好转。患者从出现皮肤症状到诊断为海分枝杆菌感染的时间为16个月,提醒皮肤科临床医生应注意海分枝杆菌感染的非典型临床表现。

关键词：海分枝杆菌感染持久性隆起性红斑误诊

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累及皮肤和肌腱的难治性海分枝杆菌感染一例

中国麻风皮肤病杂志 2024年第5期40卷 352-354页

作者：张欣然赵晴于长平周桂芝张福仁山东大学山东济南250000 山东第一医科大学附属皮肤病医院山东济南250022 山东省皮肤病性病防治研究所山东济南250022

患者,男,53岁。右上肢结节半年。皮肤科查体:右上肢见多发暗红色丘疹、结节,部分结节破溃,可见脓血性分泌物,伴右手肿胀,皮温正常,轻度压痛。皮肤组织病理检查符合感染性肉芽肿;组织分枝杆菌培养为海分枝杆菌;海分枝杆菌qPCR(组织)为阳... 详细信息

患者,男,53岁。右上肢结节半年。皮肤科查体:右上肢见多发暗红色丘疹、结节,部分结节破溃,可见脓血性分泌物,伴右手肿胀,皮温正常,轻度压痛。皮肤组织病理检查符合感染性肉芽肿;组织分枝杆菌培养为海分枝杆菌;海分枝杆菌qPCR(组织)为阳性,B超提示右手指伸肌腱腱鞘炎,结合临床表现及实验室检查诊断为海分枝杆菌感染。给予米诺环素、克拉霉素治疗2个月,效果欠佳,结合药敏结果调整方案为利福平、克拉霉素、多西环素、氨苯砜治疗,5个月后右上肢丘疹、结节基本消失。

关键词：海分枝杆菌感染性肉芽肿

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三例麻风畸残病例延迟发现原因分析

中国麻风皮肤病杂志 2024年第7期40卷 488-490页

作者：槐鹏程初同胜刘殿昌刘健张福仁山东第一医科大学附属皮肤病医院山东济南250022 山东省皮肤病性病防治研究所山东济南250022

本文对3例麻风畸残病例延迟发现原因进行了分析,患者1在神经内科多次误诊,在治疗效果不佳的情况下,连续十几年未再就诊,直至出现溃疡畸残;患者2独居、智障,发病后一直未就诊,4年后出现畸残;患者3在神经科误诊5年后出现畸残。3例畸残病... 详细信息

本文对3例麻风畸残病例延迟发现原因进行了分析,患者1在神经内科多次误诊,在治疗效果不佳的情况下,连续十几年未再就诊,直至出现溃疡畸残;患者2独居、智障,发病后一直未就诊,4年后出现畸残;患者3在神经科误诊5年后出现畸残。3例畸残病例的发现过程提示,应面向鳏寡孤独或智障人员开展麻风线索调查,同时加强神经科医师麻风防治知识的培训,促进麻风患者的早发现。

关键词：麻风畸残线索调查神经科培训