Siller Greg, Gebauer Kurt, Welburn Peter, Katsamas Janelle, Ogbourne Steven M
Siller Medical Pty Ltd and Dermatology Group, The University of Queensland, Queensland, Australia.
Australas J Dermatol. 2009 Feb;50(1):16-22. doi: 10.1111/j.1440-0960.2008.00497.x.
The sap of the plant Euphorbia peplus is a traditional remedy for skin conditions, including actinic keratosis. The active constituent of the sap is ingenol mebutate (ingenol-3-angelate), formerly known as PEP005. This randomized, double-blind, vehicle-controlled, phase IIa study investigated the safety (and secondarily the efficacy) of two applications of ingenol mebutate gel in 58 patients with biopsy-confirmed actinic keratosis. Five preselected lesions were treated with ingenol mebutate gel, 0.0025%, 0.01% or 0.05%, or vehicle gel, on days 1 and 2 (Arm A) or days 1 and 8 (Arm B). There were no significant differences in tolerability or efficacy between Arms A and B. Treatment was well tolerated. The most common local skin responses were dose-related erythema, flaking/scaling/dryness and scabbing/crusting. Efficacy was greatest with ingenol mebutate gel, 0.05%, which resulted in complete clinical clearance of 71% of treated lesions (P < 0.0001 vs vehicle gel). In addition, 67% of patients treated with ingenol mebutate gel, 0.05% had clinical clearance of at least four of five treated lesions (P = 0.0185 vs vehicle gel). Ingenol mebutate gel is being developed as a short-course topical therapy for actinic keratosis and non-melanoma skin cancer.
泽漆的汁液是治疗包括光化性角化病在内的皮肤病的传统药物。该汁液的活性成分是斑蝥素甲酯（ingenol-3-当归酸酯），以前称为PEP005。这项随机、双盲、赋形剂对照的IIa期研究调查了58例经活检确诊为光化性角化病的患者使用两次斑蝥素甲酯凝胶的安全性（其次是疗效）。在第1天和第2天（A组）或第1天和第8天（B组），对五个预先选定的皮损分别使用0.0025%、0.01%或0.05%的斑蝥素甲酯凝胶或赋形剂凝胶进行治疗。A组和B组在耐受性或疗效方面没有显著差异。治疗耐受性良好。最常见的局部皮肤反应与剂量相关，包括红斑、脱屑/鳞屑/干燥和结痂。0.05%的斑蝥素甲酯凝胶疗效最佳，可使71%的治疗皮损实现临床完全清除（与赋形剂凝胶相比，P<0.0001）。此外，接受0.05%斑蝥素甲酯凝胶治疗的患者中有67%的人其五个治疗皮损中至少有四个实现了临床清除（与赋形剂凝胶相比，P = 0.0185）。斑蝥素甲酯凝胶正在开发成为一种用于治疗光化性角化病和非黑色素瘤皮肤癌的短疗程局部治疗药物。
