Klinik für Dermatologie, Venerologie und Allergologie, St. Josef-Hospital, Bochum, Germany.
Centre for Cell Biology and Cutaneous Research, Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, U.K.
Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15.
Ingenol mebutate (IngMeb) and diclofenac sodium (DS) are approved treatments for actinic keratosis (AK).
To compare the efficacy and safety of IngMeb 0·015% gel with DS 3% gel (NCT02406014).
Patients with 4-8 visible, discrete AK lesions on the face/scalp in a 25 cm contiguous area of skin were randomized 1:1 to IngMeb once-daily for three consecutive days or DS twice-daily for 90 days. Patients with AK lesions at Week 8 following IngMeb were offered a second IngMeb course. Primary end point was complete clearance of AK lesions (AKCLEAR 100) at end of first treatment course (Week 8, IngMeb; Week 17, DS). Secondary end points included AKCLEAR 100 at end of last treatment course and Week 17; adverse events (AEs) were assessed at these time points. Patients completed treatment satisfaction questionnaires for medication (TSQM; Week 17).
AKCLEAR 100 at end of first treatment course was higher with IngMeb (34%) vs. DS (23%; P = 0·006). AKCLEAR 100 at end of last IngMeb course (53%) and Week 17 (45%) was higher than DS (both P < 0·001). The most frequent AE was application-site erythema (IngMeb 19%; DS 12%). Treatment-related AE (TRAE) duration was shorter with IngMeb. TRAE withdrawals were lower for IngMeb (2%) vs. DS (6%). TSQM scores for global satisfaction (P < 0·001) and effectiveness (P = 0·002) were higher with IngMeb, as was dosing instruction adherence (≥ 90% vs. 70%).
AKCLEAR 100, patient treatment satisfaction and effectiveness were significantly higher with IngMeb compared with DS, demonstrating superiority of IngMeb for AK treatment on face/scalp.
Ingenol 咪泊三醇（IngMeb）和双氯芬酸钠（DS）均已获批用于治疗光化性角化病（AK）。
比较 IngMeb 0.015%凝胶与 DS 3%凝胶的疗效和安全性（NCT02406014）。
在面部/头皮 25cm 连续皮肤区域内有 4-8 个可见、离散 AK 病变的患者，按 1:1 随机分为 IngMeb 组（每天一次，连续 3 天）或 DS 组（每天两次，共 90 天）。在 IngMeb 治疗 8 周后 AK 病变未清除的患者可接受第二次 IngMeb 治疗。主要终点为首次治疗结束时 AK 病变完全清除（AKCLEAR 100）（第 8 周，IngMeb；第 17 周，DS）。次要终点包括末次治疗结束和第 17 周时的 ACKLEAR 100；这些时间点评估不良事件（AE）。患者在第 17 周时完成药物治疗满意度问卷（TSQM）。
首次治疗结束时 IngMeb 组的 ACKLEAR 100 更高（34%），而 DS 组为 23%（P=0.006）。末次 IngMeb 治疗结束时（53%）和第 17 周时（45%）的 ACKLEAR 100 更高（均 P<0.001）。最常见的 AE 是用药部位红斑（IngMeb 19%；DS 12%）。IngMeb 的治疗相关 AE（TRAE）持续时间更短。IngMeb 的 TRAE 停药率更低（2%），而 DS 组为 6%。IngMeb 组的全球满意度（P<0.001）和疗效（P=0.002）评分更高，用药依从性（≥90%）也更高。
与 DS 相比，IngMeb 治疗 AK 的 ACKLEAR 100、患者治疗满意度和疗效均显著更高，表明 IngMeb 在面部/头皮 AK 治疗方面具有优越性。
