Department of Dermatology, Andreas Sygros Skin Hospital, Athens, Greece.
HeaDS S.A, Athens, Greece.
Int J Dermatol. 2020 Jun;59(6):690-697. doi: 10.1111/ijd.14879. Epub 2020 Apr 17.
Actinic keratosis (AK) is a chronic, precancerous skin disease. Various treatments options exist, including ingenol mebutate gel. The aim of this study was to compare its effectiveness and tolerability as well as the impact of therapy on patients' quality of life in standard clinical practice.
A multicenter study was carried out involving a 12-month follow-up period. A sample of 440 patients was included. Medical history details were recorded. Effectiveness, compliance to treatment, quality of life (EQ-5D-5L), and treatment satisfaction questionnaire for medication (TSQM-9) at week 8 were assessed.
Of the total 440 patients, 428 (97.3%) attended at 8 weeks assessment. The number of patients with complete clearance was 337 (78.7%). EQ VAS score was significantly increased (P < 0.001). As far as TSQM-9 is concerned, patients with complete clearance reported statistically significantly higher satisfaction in effectiveness, convenience, and global satisfaction. At the 12-month follow-up visit, 323 patients (95.8%) retained their clearance status. Nineteen patients did not apply the ingenol mebutate gel on consecutive days. For these patients, the complete clearance rate was 42.1%, while for those who were treated on consecutive days, the complete clearance rate was 80.6%. None of our patients developed skin cancer.
This study supports that ingenol mebutate is effective for the treatment of AK with a good safety profile. It significantly improves quality of life. Limited adherence to treatment might be associated with reduced effectiveness.
光化性角化病（AK）是一种慢性、癌前皮肤病。有多种治疗选择，包括 ingenol 咪喹莫特凝胶。本研究旨在比较其在标准临床实践中的有效性和耐受性，以及对患者生活质量的影响。
进行了一项为期 12 个月的随访的多中心研究。纳入了 440 例患者。记录了病史细节。在第 8 周评估了疗效、治疗依从性、生活质量（EQ-5D-5L）和药物治疗满意度问卷（TSQM-9）。
在总共 440 例患者中，428 例（97.3%）在第 8 周接受了评估。337 例（78.7%）患者完全清除。EQ VAS 评分显著升高（P<0.001）。就 TSQM-9 而言，完全清除的患者在疗效、方便性和总体满意度方面的报告满意度明显更高。在 12 个月的随访中，323 例患者（95.8%）保留了他们的清除状态。19 例患者未连续使用 ingenol 咪喹莫特凝胶。对于这些患者，完全清除率为 42.1%，而对于连续接受治疗的患者，完全清除率为 80.6%。我们的患者均未发生皮肤癌。
本研究支持 ingenol 咪喹莫特凝胶治疗 AK 有效，安全性良好。它显著改善了生活质量。治疗依从性有限可能与疗效降低有关。
