度普利尤单抗治疗中、重度特应性皮炎的快速卫生技术评估  

Rapid health technology assessment of dupilumab for the treatment of moderate to severe atopic dermatitis

作　　者：迪力努尔·艾尼 张珊滋 龚福凯 吴建华[1,2] Dilinuer AINI;ZHANG Shanzi;GONG Fukai;WU Jianhua(Xinjiang Uygur Autonomous Region People’s Hospital,Urumqi 830001,China;Institute of Clinical Pharmacy of Xinjiang Uygur Autonomous Region,Urumqi 830001,China)

机构地区：[1]新疆维吾尔自治区人民医院,乌鲁木齐830001 [2]新疆维吾尔自治区临床药学研究所,乌鲁木齐830001

出　　处：《西北药学杂志》2025年第2期205-211,共7页Northwest Pharmaceutical Journal

基　　金：国医药教育协会2023年《临床用药卫生技术评估》专项课题(编号:2023WSJSPGZXKT-48)。

摘　　要：目的对度普利尤单抗治疗中、重度特应性皮炎(atopic dermatitis,AD)的有效性、安全性和经济性进行快速卫生技术评估,为临床治疗提供循证依据。方法计算机检索Pubmed、Embase、the Cochrane Library、中国知网(CNKI)、万方(Wangfang Data)、维普(VIP)、中国生物医学文献数据库(SinoMed)以及国内外相关卫生技术评估(health technology assessment,HTA)机构官方网站,检索时限为各数据库自建库起至2023年10月31日,仅纳入度普利尤单抗治疗中重度AD的卫生技术评估、系统评价(systematic review,SR)/Meta分析以及经济学研究。由2名研究者独立筛选文献、提取资料和质量评价,对数据结果进行定性分析。结果共纳入文献8篇,6篇SR/Meta分析、2篇药物经济学研究。有效性研究结果显示,与安慰剂相比,度普利尤单抗能够显著降低湿疹面积及严重程度指数评分(eczema area and severity index,EASI)、特应性皮炎积分指数(scoring atopic dermatitis,SCORAD)、瘙痒数字评分[(numerical rating scale,NRS)以及焦虑抑郁评分,同时能有效提高研究者整体评估(investigator global assessment,IGA)]、皮肤病生活质量评分(dermatology life quality index,DLQI),从而提升患者的心理状态和生活质量。安全性研究结果显示,度普利尤单抗使用后相较于其他药物组会增加结膜炎、鼻咽炎、头痛、上呼吸道感染等的发生率,但不良反应较轻,患者可耐受。目前已有研究的对照组大多为安慰剂,因此在与常规治疗对比分析上存在一定局限性。经济学研究结果显示,与其他治疗组相比,度普利尤单抗具有较好的经济性和成本效果优势,可增加生存年数(life years,LY)和质量调整生命年(quality-adjusted lifeyears,QALY)。结论度普利尤单抗在中、重度特应性皮炎患者的临床治疗中有较好的有效性、安全性和经济性。Objective To evaluate the efficacy,safety and economic aspects of dupilumab in the treatment of moderate to severe atopic dermatitis(AD),and to provide evidence-based recommendations for clinical practice.Methods A comprehensive literature search was conducted using PubMed,Embase,the Cochrane Library,CNKI,Wangfang Data,VIP,SinoMed,and relevant health technology assessment(HTA)websites and databases.The search period extended from their inception dates to October 31,2023,and including HTA reports,systematic reviews(SR)/Meta-analyses,and economic studies related to dupilumab in the treatment of AD.Two researchers independently screened the literature,extracted the data and assessed the quality of the data.Results A total of 8 papers,6 SR/Meta-analyses and 2 economic studies were included.Compared with placebo,dupilumab significantly reduced the scores of the eczema area and severity index(EASI),scoring atopic dermatitis(SCORAD),and numerical rating scale(NRS),while significantly increasing the scores of the investigator global assessment(IGA)and dermatology life quality index(DLQI),thereby enhancing the patients’mental health and quality of life.Safety studies have shown that compared with other drug groups,the use of dupilumab increased the incidence of conjunctivitis,nasopharyngitis,headache,and upper respiratory tract infection,etc.,but the adverse reactions were generally mild and well-tolerated by patients.At present,most of the control groups in existing studies used placebo,so there were certain limitations in the comparison analysis with conventional treatment.Compared with other treatment groups,dupilumab has better economic and cost-effectiveness,which can increase the life years and quality-adjusted life years.Conclusion Dupilumab is effective,safe and economical in the treatment of moderate to severe atopic dermatitis.

关 键 词：度普利尤单抗 特应性皮炎 有效性 安全性 经济性 快速卫生技术评估 

分 类 号：R969.3[医药卫生—药理学]