特应性皮炎治疗药物疗效指标设计的科学考量  

Scientific considerations on the design of drug therapeutic efficacy indicators for the treatment of atopic dermatitis

作　　者：杨靖怡 葛玉梅 钱思源 翟云 赵聪 韵文萍 谢松梅 YANG Jing-yi;GE Yu-mei;QIAN Si-yuan;ZHAI Yun;ZHAO Cong;YUN Wen-ping;XIE Song-mei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2023年第19期1930-1934,共5页Chinese Journal of New Drugs

摘　　要：目的:探讨特应性皮炎治疗药物疗效指标设计的科学考虑。方法:通过调研国内外新药临床试验进展、相关指南和文献,讨论特应性皮炎治疗药物临床试验中疗效指标的科学设计。结果与结论:特应性皮炎治疗药物疗效指标设计,通常应对症状、体征、生活质量及病情长期控制情况等进行综合评价,主要疗效指标应能够反映临床获益且与治疗目标相一致。以患者为中心的评估量表设计、验证和应用在药物疗效的科学评价中至关重要且仍存挑战。Objective:To discuss the scientific considerations on the design of drug therapeutic efficacy indicators for the treatment of atopic dermatitis.Methods:By investigating the progress of global clinical trials of new drugs,relevant guidelines and the literatures,the scientific design of efficacy indicators in clinical trials of atopic dermatitis was discussed.Results and Conclusion:Generally,the design of drug efficacy indicators for the treatment of atopic dermatitis should comprehensively evaluate the symptoms,signs,quality of life and long⁃term control of the disease.The main efficacy indicators should reflect the clinical benefits and remain consistent with the treatment objectives.The design,validation and application of patient⁃centered assessment scale are crucial,and are still challenging in the scientific evaluation of drug efficacy.

关 键 词：特应性皮炎 治疗药物 疗效指标 评价量表 

分 类 号：R976[医药卫生—药品]