光化性角化病试验中病变反应率的应用。
Use of Lesion Response Rate in Actinic Keratosis Trials.
作者信息
Szeimies Rolf-Markus, Atanasov Petar, Bissonnette Robert
机构信息
Department of Dermatology and Allergology, Vest Clinic, Recklinghausen, Germany.
Amaris, London, UK.
出版信息
Dermatol Ther (Heidelb). 2016 Dec;6(4):461-464. doi: 10.1007/s13555-016-0145-2. Epub 2016 Sep 19.
Abstract
UNLABELLED
Complete patient clearance is often required by regulatory agencies for the approval of treatments for actinic keratosis (AK). However, an increasing number of clinicians have challenged the use of this measure in clinical practice and its interpretation. It has been argued that complete patient clearance often underestimates the clinical benefit of a drug and is influenced by a number of key confounding factors, such as number and distribution of lesions, at baseline. Lesions response rate is one alternative which has been suggested as more relevant due to its applicability to clinical practice and closer reflection of the clinical value of the drug. This paper provides an updated perspective on the topic and details the current thinking on the role of complete clearance and lesion response rate in the context of AK.
FUNDING
Galderma.
摘要
未标注
监管机构通常要求完全清除患者的光化性角化病（AK）病变，才能批准相关治疗。然而，越来越多的临床医生对这一指标在临床实践中的应用及其解读提出了质疑。有人认为，完全清除患者病变往往低估了药物的临床益处，且受到一些关键混杂因素的影响，如基线时病变的数量和分布。病变反应率是另一种指标，因其适用于临床实践且更能反映药物的临床价值，被认为更具相关性。本文提供了关于该主题的最新观点，并详细阐述了在光化性角化病背景下，完全清除和病变反应率作用的当前看法。
资助
高德美公司。
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