外用皮质类固醇对 1 至 3 级光化性角化病（AK）经 ingenol mebutate 治疗后的炎症或疗效无影响：一项随机临床试验。

Topical corticosteroid has no influence on inflammation or efficacy after ingenol mebutate treatment of grade I to III actinic keratoses (AK): A randomized clinical trial.

机构信息

Department of Dermatology, Bispebjerg University Hospital, University of Copenhagen, Copenhagen, Denmark.

出版信息

J Am Acad Dermatol. 2016 Apr;74(4):709-15. doi: 10.1016/j.jaad.2015.11.034. Epub 2016 Jan 22.

DOI:10.1016/j.jaad.2015.11.034

PMID:26810403

Abstract

BACKGROUND

Ingenol mebutate (IngMeb) is approved for treatment of actinic keratoses (AK) and may cause unpredictable local skin responses (LSR).

OBJECTIVES

We sought to investigate whether IngMeb-induced LSR, pain, and pruritus could be alleviated with a topical glucocorticoid and, further, to assess efficacy, cosmetic outcome, and patient satisfaction in patients with severe photodamage.

METHODS

In this blinded, randomized controlled clinical trial, patients with multiple AK and field cancerization of the face or scalp were treated in 2 areas with IngMeb (0.015%) daily for 3 days. After finalized IngMeb treatment, 1 area was randomized to receive topical clobetasol propionate (0.05%) twice daily for 4 days. Assessments included LSR (0-24; days 1, 4, 8, 15, 57), pain (0-10) and pruritus (0-3; days 1-15), AK clearance (days 15, 57), and cosmetic outcome (0-3; day 57).

RESULTS

Clobetasol propionate application had no influence on LSR (P = .939), pain (P = .500), pruritus (P = .312), or AK cure rate (P = .991). Overall, IngMeb cleared 86% of all AK lesions, exerting a therapeutic effect on all AK severity grades; cure rates were 88%, 70%, and 60% for grade I, II, and III AK, respectively. Skin texture improved significantly in remedied areas (2.0 vs 1.0; P < .001); no hypopigmentation, hyperpigmentation, or scarring were observed.

LIMITATIONS

These results do not provide safety and efficacy beyond 2 months of follow-up.

CONCLUSION

Application of clobetasol propionate does not alleviate IngMeb-induced LSR after 3 days of IngMeb treatment.

摘要

背景

Ingenol 咪泊他丁（IngMeb）已获准用于治疗光化性角化病（AK），并可能导致不可预测的局部皮肤反应（LSR）。

目的

我们旨在研究 IngMeb 诱导的 LSR、疼痛和瘙痒是否可以通过局部糖皮质激素缓解，并进一步评估严重光损伤患者的疗效、美容效果和患者满意度。

方法

在这项双盲、随机对照临床试验中，多名患有 AK 和面部或头皮区域癌前病变的患者在 2 个区域接受每日 IngMeb（0.015%）治疗 3 天。完成 IngMeb 治疗后，1 个区域随机接受丙酸氯倍他索（0.05%）每日 2 次治疗 4 天。评估包括 LSR（0-24；第 1、4、8、15 和 57 天）、疼痛（0-10）和瘙痒（0-3；第 1-15 天）、AK 清除率（第 15 和 57 天）和美容效果（0-3；第 57 天）。

结果

丙酸氯倍他索的应用对 LSR（P =.939）、疼痛（P =.500）、瘙痒（P =.312）或 AK 治愈率（P =.991）均无影响。总体而言，IngMeb 清除了所有 AK 病变的 86%，对所有 AK 严重程度等级均具有治疗作用；I 级、II 级和 III 级 AK 的治愈率分别为 88%、70%和 60%。治疗区域的皮肤质地显著改善（2.0 比 1.0；P <.001）；未观察到色素减退、色素沉着或瘢痕。