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Anzupgo®的疗效与安全性已获多项全球III期研究验证。DELTA 1和DELTA 2研究共纳入960名慢性手部湿疹患者[1,2]，均达成主要终点及所有次要终点[1,2,3]，证实其疗效显著优于赋形剂[1,2,3]，研究结果发表于国际权威医学期刊《柳叶刀》[4]；后续DELTA 3开放性拓展试验进一步证明，该药52周长期应用的安全性及疗效持续性[5]，为临床使用提供坚实数据支撑。
慢性手部湿疹创新药落地大湾区，Anzupgo®首方为患者带来新希望
瘙痒、疼痛且反复发作，慢性手部湿疹让患者深陷疾病阴霾。作为常见多发的炎症性皮肤病，患者手部会出现红斑、丘疹、水疱、渗液、脱屑甚至开裂，常年受瘙痒和疼痛困扰。病程超3个月或每年复发至少两次，即可判定为慢性手部湿疹。数据显示，其患病率约4.7%，每20人中就有1人受此困扰，且女性比例高于男性[6]。其中，职业接触致病者超半数，医务人员、办公室人员及频繁湿手作业群体等均为高发人群[7]。疾病引发的瘙痒、疼痛与频繁复发，严重影响患者生活质量，还波及职业与心理状态，导致工作效率下降、经济负担加重。
传统疗法存在缺口，创新药物助力患者回归正常生活。中山陈星海中西医结合医院皮肤科主任梁国雄指出：“目前治疗主要依赖外用糖皮质激素、系统用药和物理治疗，但患者获益有限。慢性手部湿疹病因复杂、病程长、易复发，诊断与治疗存在挑战，急需更具针对性、安全有效的方案，帮助患者快速缓解症状、长期维持疗效并减少复发。而我国内地此前尚无专门针对该病的获批治疗药物。”
Anzupgo®（德戈替尼乳膏）作为首个专门针对中重度慢性手部湿疹成人患者（皮质类固醇治疗应答不充分或不适合接受皮质类固醇治疗）的外用药物，通过抑制整个JAK家族（JAK1、JAK2、JAK3和TYK2），阻止JAK-STAT信号激活——该信号在慢性手部湿疹发病机制中起关键作用[7]。梁国雄表示：“多项临床研究证实了德戈替尼乳膏在缓解炎症、改善皮肤症状方面的突出表现。依托‘港澳药械通’政策，大湾区居民能更快用上这款创新药，相信能切实提升患者长期生活质量。”
“港澳药械通”政策是粤港澳大湾区医疗协同发展的重要举措，自2020年11月发布以来已落地近五年，为大湾区乃至全国患者提供了更便捷的医疗资源获取渠道。华润广东医药有限公司作为政策落地重要参与方，有力保障了此次创新药首方顺利开出，助力患者获得更多元优质的治疗选择。
利奥中国总经理殷晓峰表示：“慢性手部湿疹长期困扰众多人群。作为全球首款专门针对该病的泛JAK抑制剂，德戈替尼乳膏过去一年已陆续在欧盟、英国、瑞士、美国等市场获批上市，疗效与安全性获全球临床数据验证。此次在中山陈星海中西医结合医院开出大湾区首方，是利奥中国的重要里程碑，意味着中国慢性手部湿疹患者可通过大湾区指定医院获得诊断和创新治疗，为他们带来切实福音。”
参考资料：
[1.] ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 1). Identifier: NCT04871711. https://clinicaltrials.gov/ct2/show/NCT04872101.
[2.] ClinicalTrials.gov. National Library of Medicine (U.S.). Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2). Identifier: NCT04872101. https://clinicaltrials.gov/ct2/show/NCT04872101.
[3.] Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet 2024; published online July 18. https://doi.org/10.1016/S0140-6736(24)01027-
[4.] Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet 2024; published online July 18. https://doi.org/10.1016/S0140-6736(24)01027-4..
[5.] ClinicalTrials.gov. National Library of Medicine (U.S.). Open-label Multi-site Extension Trial in Subjects Who Completed the DELTA 1 or DELTA 2 Trials (DELTA3). Identifier: NCT04949841 https://clinicaltrials.gov/ct2/show/NCT04949841.
[6.] Apfelbacher C, Bewley A, Molin S, et al. Prevalence of chronic hand eczema in adults: a cross-sectional survey of over 60 000 respondents from the general population of Canada, France, Germany, Italy, Spain and the UK. Br J Dermatol. 2025;192(6):1047-1054. doi:10.1093/bjd/ljaf020
[7.] Apfelbacher C, Molin S, Weisshaar E, et al. Characteristics and provision of care in patients with chronic hand eczema: updated data from the CARPE registry. Acta Derm Venereol. 2014;94(2):163-167. doi:10.2340/00015555-1632
[8.] Dubin C, Del Duca E, Guttman-Yassky E. Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges. Ther Clin Risk Manag. 2020;16:1319-1332. Erratum in: Ther Clin Risk Manag. 2021 Mar 18;17:233.
[9.] Lee GR, Maarouf M, Hendricks AK, Lee DE, Shi VY. Current and emerging therapies for hand eczema. Dermatol Ther. 2019;32(3):e12840.
[10.] Lynde C, Guenther L, Diepgen TL, et al. Canadian hand dermatitis management guidelines. J Cutan Med Surg. 2010;14(6):267-284. Erratum in: J Cutan Med Surg. 2011 Nov-Dec;15(6):360
[11.] Diepgen TL, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015 Jan;13(1):e1–22.
[12.] Bissonnette R, Diepgen TL, Elsner P, et al. Redefining treatment options in chronic hand eczema (CHE). J Eur Acad Dermatol Venereol. 2010;24 Suppl 3:1-20.
[13.] Apfelbacher C, Bewley A, Molin S, et al. Prevalence of Chronic Hand Eczema in adults: A cross-sectional multi-national study of 60,000 respondents in the general population. Presented at the 2024 European Society of Contact Dermatitis (ESCD) congress; September 04-07 2024; Dresden, Germany. Poster presentation #3
[14.] Thyssen JP, Schuttelaar MLA, Alfonso JH, et al. Guidelines for diagnosis, prevention, and treatment of hand eczema. Contact Dermatitis. 2022;86(5):357-378.
[15.] Grant L, Seiding Larsen L, Burrows K, et al. Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists. Adv Ther. 2020;37(2):692-706.
[16.] Cortesi PA, Scalone L, Belisari A, et al. Cost and quality of life in patients with severe chronic hand eczema refractory to standard therapy with topical potent corticosteroids. Contact Dermatitis. 2014;70(3):158-168.
[17.] Voorberg AN, Loman L, Schuttelaar MLA. Prevalence and Severity of Hand Eczema in the Dutch General Population: A Cross-sectional, Questionnaire Study within the Lifelines Cohort Study. Acta Derm Venereol. 2022;102:adv00626.
