特应性皮炎(AD)是一种慢性复发性皮肤病。虽然没有明确的治疗方法,适当的治疗可以控制病情。生物药物的出现导致需要明确定义疾病的严重程度和治疗反应。因此,定义临床医生报告的疾病严重程度和患者报告的严重程度的标准化结果列表至关重要。迄今为止,缺乏可靠的标准来定义对治疗和治疗失败的反应。
本系统综述根据临床医生报告的疾病严重程度和患者报告的结果来定义治疗目标。参考已发表的中重度AD临床试验。这些目标在日常临床实践中的应用将确保更好地选择可用的治疗方案,从而提高患者的护理质量。
进行了系统的文献检索,以确定2000年1月至2020年10月之间发表的关于中度至重度成人AD的随机对照临床试验(RCT)的治疗目标。
总共,14项研究符合资格标准。就临床医生报告的疾病严重程度而言,最广泛使用的工具是异位性皮炎评分(SCORAD),其次是湿疹面积严重程度评分(EASI)和研究者全球评估(IGA)。对于作为随机对照试验疗效结果的疾病严重程度量表,最大的标准化和可重复性是EASI评分提高至少50%,IGA评分比基线降低≥2级.从患者的角度来看,最广泛使用的工具是皮肤病学生活质量指数(DLQI),数字率量表(NRS)-瘙痒和面向患者的湿疹测量评分(POEM)。就患者报告的随机对照试验疗效结果而言,一个数字DLQI,据报道,NRS-瘙痒和POEM评分比基线改善至少4分。
本系统综述强调了专家之间合作以确定和优化治疗结果的必要性。尽管在协调成果措施方面取得了相当大的进展,在2008年“湿疹协调结果措施”(HOME)倡议的基础上,我们的结果表明该终点仍然是未满足的需求。基于文献数据,我们提出了一种用于日常临床实践的最小治疗目标算法,旨在激发关于如何进一步改善AD患者护理的讨论。
Atopic dermatitis (AD) is a chronically relapsing skin disease. Although a definitive cure is not available, appropriate treatment can control the disease. The advent of biologic drugs has led to the need for a clear definition of the disease severity and treatment response. A standardized list of outcomes that defines clinician-reported disease severity and patients\' reported severity are therefore essential. Solid criteria to define the response to treatment and treatment failure are lacking to date.
This systematic
review defines treatment goals in terms of clinician-reported disease severity and patient-reported outcomes, referring to the published moderate-to-severe AD clinical trials. The application of these goals in daily clinical practice will ensure a better selection of available treatment options, thus increasing patient quality of care.
A systematic literature search was performed to identify the treatments goals of randomized controlled clinical trials (RCTs) on moderate-to-severe adult AD published between January 2000 and October 2020.
In total, 14 studies met the eligibility criteria. The most widely used tools in terms of clinician-reported disease severity were the Scoring of Atopic Dermatitis (SCORAD) followed by the Eczema Area Severity Score (EASI) and Investigator Global Assessment (IGA). For disease severity scales as efficacy outcome in RCTs, the greatest standardization and reproducibility was for improvement of at least 50% in EASI score and IGA score reduction of ≥2 grades from baseline. The most widely used tools from the patients\' perspective were the Dermatology Life Quality Index (DLQI), Numeric Rate Scale (NRS)-itch and Patient Oriented Eczema Measure Score (POEM). In terms of patients\' reported efficacy outcomes in RCTs, a numerical DLQI, NRS-itch and POEM score improvement of at least 4 points from baseline was reported.
This systematic
review highlights the need for collaboration between experts in order to define and optimize treatment outcomes. Despite considerable progress in harmonizing outcome measures, promoted by the foundation of the Harmonizing Outcome Measures for Eczema (HOME) initiative in 2008, our results demonstrate that this endpoint is still an unmet need. Based on the literature data we propose a minimum treatment goal algorithm for use in daily clinical practice aimed at stimulating a discussion on how the care of AD patients could be further improved.