Gubanova Elena, Haddad Tabet May, Bergerova Yvonne, Moiseieva Olena, Chemeris Andrey, Sanches Elena, Sharova Alisa, Rodriguez Pose Luisa, Raymond Romain, Prygova Inna, Carlisle Ian
Vallex Med Clinic of Preventive Medicine, Moscow National University of Food Production, Starokaluzhskoe Shosse, 62, Moscow, Russian Federation, 117630.
Dr Haddad Clinics, Beirut, Lebanon.
Aesthetic Plast Surg. 2018 Dec;42(6):1672-1680. doi: 10.1007/s00266-018-1200-4. Epub 2018 Aug 17.
Although the short- and long-term effectiveness of abobotulinumtoxinA (Dysport/Azzalure) for glabellar line (GL) treatment is well established, reporting of subject satisfaction over repeat treatment cycles is limited. The APPEAL study aimed to assess subject satisfaction with long-term GL treatment with abobotulinumtoxinA in a real-life setting.
APPEAL was a noninterventional, prospective, longitudinal study in subjects administered ≥ 3 abobotulinumtoxinA injection cycles for moderate-to-severe GL, according to routine clinical practice. Subjects completed a satisfaction questionnaire at 3 weeks (± 7 days) after each cycle. Primary endpoint included subjects' overall satisfaction with GL after three injection cycles. Secondary endpoints included satisfaction after Cycles 1 and 2 and factors associated with satisfaction after each cycle. Physician satisfaction was also assessed after Cycles 1 and 3.
Of 150 subjects enrolled, 135 completed the overall subject satisfaction questionnaire after Cycle 3. At 3 weeks after Cycle 3, 99.3% of subjects were 'very satisfied' (74.1%) or 'satisfied' (25.2%) with GL. Levels of subject satisfaction and associated factors after Cycles 1 and 2 were as large and significant as after Cycle 3 (83-100%, depending on question). Physicians' satisfaction with GL appearance, facial expression, and overall satisfaction was almost complete after the first injection (≥ 97.4%) and unanimous after the third (100%).
In the APPEAL study, overall satisfaction was high after three abobotulinumtoxinA injection cycles for GL based on both subjects' (99.3%) and physicians' (100.0%) assessments. High levels of subject satisfaction reported after Cycle 1 were maintained with repeated injections. No new safety signals were observed.
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 . Trial registration NCT02353897.
尽管a型肉毒毒素（丽舒妥/阿佐脲）治疗眉间纹（GL）的短期和长期疗效已得到充分证实，但关于重复治疗周期中受试者满意度的报告却很有限。 APPEAL研究旨在评估在现实生活环境中，受试者对a型肉毒毒素长期治疗眉间纹的满意度。
APPEAL是一项非干预性、前瞻性、纵向研究，根据常规临床实践，对接受过≥3个周期a型肉毒毒素注射治疗中重度眉间纹的受试者进行研究。受试者在每个周期后的3周（±7天）完成一份满意度调查问卷。主要终点包括三个注射周期后受试者对眉间纹的总体满意度。次要终点包括第1和第2周期后的满意度以及每个周期后与满意度相关的因素。在第1和第3周期后也评估了医生的满意度。
在纳入的150名受试者中，135名在第3周期后完成了总体受试者满意度调查问卷。在第3周期后的3周，99.3%的受试者对眉间纹“非常满意”（74.1%）或“满意”（25.2%）。第1和第2周期后受试者的满意度水平及相关因素与第3周期后一样高且具有显著性（83%-100%，取决于问题）。医生对眉间纹外观、面部表情和总体满意度在首次注射后几乎完全满意（≥97.4%），在第三次注射后一致满意（100%）。
在APPEAL研究中，根据受试者（99.3%）和医生（100.0%）的评估，三个周期的a型肉毒毒素注射治疗眉间纹后总体满意度较高。第1周期后报告的高受试者满意度在重复注射后得以维持。未观察到新的安全信号。
证据水平IV：本杂志要求作者为每篇文章指定证据水平。有关这些循证医学评级的完整描述，请参阅目录或在线作者指南www.springer.com/00266 。试验注册号NCT02353897。
