Professor of Internal Medicine, Dermatology Section, Northeastern Ohio Medical University, Rootstown, OH, USA.
J Dermatolog Treat. 2012 Feb;23(1):26-34. doi: 10.3109/09546634.2011.643221. Epub 2012 Jan 4.
Acne has a significant negative impact on quality of life (QoL): lack of self-confidence, depressive symptoms and suicidal thoughts. The objective was to assess the impact of an initial and continued therapy in severe acne patients through patient-related outcomes (PRO).
In two sequential double-blind randomized studies, patients received either adapalene 0.1% and benzoyl peroxide 2.5% (A-BPO) or vehicle, associated with doxycycline 100 mg for 12 weeks. Patients having obtained at least a good improvement according to investigator global assessment were re-randomized for a 24-week therapy with A-BPO or vehicle. PROs were assessed using the Acne-QoL and a patient treatment satisfaction questionnaire.
QoL was improved at week 12 in all domains with a significant difference for the Acne-symptoms domain (p < 0.001) in favor of the A-BPO regimen. Additional 24-week A-BPO treatment showed a sustained improvement, significant (p < 0.001) for all domains except for Acne-symptoms. In the vehicle arm, QoL significantly worsened for all domains (p < 0.03). At weeks 12 and 36, a significantly higher proportion of patients receiving A-BPO vs. vehicle reported high satisfaction for five out of six treatment satisfaction items.
The early and sustained improvement of these PROs is correlated to the fast onset of action of A-BPO, the treatment effectiveness and a good safety profile.
痤疮对生活质量(QoL)有重大负面影响:缺乏自信、抑郁症状和自杀念头。目的是通过患者相关结局(PRO)评估严重痤疮患者初始和持续治疗的影响。
在两项连续的双盲随机研究中,患者接受了阿达帕林 0.1%和过氧化苯甲酰 2.5%(A-BPO)或赋形剂联合多西环素 100mg 治疗 12 周。根据研究者总体评估获得至少良好改善的患者被重新随机分为 A-BPO 或赋形剂治疗 24 周。使用痤疮生活质量问卷(Acne-QoL)和患者治疗满意度问卷评估 PROs。
所有领域的 QoL 在第 12 周均得到改善,A-BPO 方案在痤疮症状领域具有显著差异(p<0.001)。另外 24 周的 A-BPO 治疗显示出持续改善,除痤疮症状外,所有领域均具有统计学意义(p<0.001)。在赋形剂组中,所有领域的 QoL 均显著恶化(p<0.03)。在第 12 和 36 周,接受 A-BPO 治疗的患者报告对治疗满意度六个项目中的五个项目的高满意度比例显著高于接受赋形剂治疗的患者。
这些 PROs 的早期和持续改善与 A-BPO 的快速起效、治疗效果和良好的安全性特征相关。