咪喹莫特 5%乳膏与双氯芬酸 3%凝胶治疗面部或头皮光化性角化病的长期临床疗效：两项随机对照试验的汇总分析。

Long-term clinical outcomes of imiquimod 5% cream vs. diclofenac 3% gel for actinic keratosis on the face or scalp: a pooled analysis of two randomized controlled trials.

机构信息

Department of Dermatology and Venereology, Otto-von-Guericke University, Magdeburg, Germany.

Centroderm Clinic, Wuppertal, Germany.

出版信息

J Eur Acad Dermatol Venereol. 2020 Jan;34(1):82-89. doi: 10.1111/jdv.15868. Epub 2019 Sep 12.

DOI:10.1111/jdv.15868

PMID:31407414

Abstract

BACKGROUND

Actinic keratosis (AK) is an early in situ epidermal cancer which can progress to invasive squamous cell carcinoma (SCC). Imiquimod 5% cream (IMIQ) and diclofenac 3% gel (DIC) are frequently used to treat AK; however, their long-term effects following repeated treatment cycles have never been compared.

OBJECTIVE

To compare IMIQ and DIC in the treatment of AK with respect to the risk of change to grade III AK or invasive SCC, after 3 years.

METHODS

Data were pooled from two randomized, active-controlled, open-label, multicentre, multinational, phase IV studies (Clinicaltrials.gov NCT00777127/NCT01453179), with two parallel groups. Studies were conducted between 2008 and 2015 and were almost identical in design. Patients eligible for inclusion were immunocompetent adults with 5-10 visible AK lesions on the face/scalp and grade I/II AK. The primary endpoint was inhibition of histological change to grade III AK or invasive SCC in the study treatment area, observed until month 36. Patients applied either IMIQ or DIC for a maximum of six treatment cycles.

RESULTS

In total, 479 patients (IMIQ 242; DIC 237) were included in the full analysis set. Histological change to grade III AK or invasive SCC was observed until month 36 in 13 (5.4%) patients treated with IMIQ, compared with 26 (11.0%) patients treated with DIC (absolute risk difference -5.6% [95% confidence interval -10.7%, -0.7%]). Time to histological change was greater in the IMIQ group than the DIC group (P = 0.0266). Frequency of progression to invasive SCC was lower with IMIQ than with DIC at all time points. Initial clearance rate was higher in the IMIQ group compared with the DIC group, while recurrence rate was lower. Both treatments were well tolerated.

CONCLUSIONS

Over 3 years, IMIQ was superior to DIC in clearing AK lesions and preventing histological change to grade III AK or invasive SCC and recurrence.

摘要

背景

光化性角化病（AK）是一种早期原位表皮癌，可进展为侵袭性鳞状细胞癌（SCC）。咪喹莫特 5%乳膏（IMIQ）和双氯芬酸 3%凝胶（DIC）常用于治疗 AK；然而，它们在多次治疗周期后的长期效果从未被比较过。

目的

比较 IMIQ 和 DIC 在治疗 AK 方面的效果，观察 3 年后 AK 进展为 3 级或 SCC 的风险。

方法

数据来自两项随机、阳性对照、开放标签、多中心、多国、四期研究（Clinicaltrials.gov NCT00777127/NCT01453179），分为两组。这些研究于 2008 年至 2015 年进行，设计几乎相同。纳入的患者为免疫功能正常的成年人，面部/头皮有 5-10 个可见 AK 病变，且 AK 为 1 级/2 级。主要终点是在研究治疗区域观察到组织学变化抑制至 3 级 AK 或 SCC 的发生率，直至第 36 个月。患者最多接受 6 个治疗周期的 IMIQ 或 DIC 治疗。

结果

共有 479 例患者（IMIQ 242 例，DIC 237 例）被纳入全分析集。13 例（5.4%）接受 IMIQ 治疗的患者在第 36 个月时观察到组织学变化为 3 级 AK 或 SCC，而 26 例（11.0%）接受 DIC 治疗的患者发生组织学变化（绝对风险差异-5.6%[95%置信区间-10.7%，-0.7%]）。与 DIC 组相比，IMIQ 组的组织学变化时间更长（P=0.0266）。在所有时间点，IMIQ 组的 SCC 进展发生率均低于 DIC 组。与 DIC 组相比，IMIQ 组的初始清除率更高，复发率更低。两种治疗方法均耐受良好。