■光化性角化病(AK)是癌前病变,发育不良,由慢性阳光照射引起的表皮病变可能进展为鳞状细胞癌。采用蓝光光动力疗法(ALA-PDT)的氨基乙酰丙酸20%溶液先前已被证明优于载体加PDT(VEH-PDT)治疗面部AKs,头皮,和上肢。
■我们报告了ALA-PDT的详细患者满意度数据。
■患者对ALA-PDT与VEH-PDT的满意度以及患者报告的ALA-PDT与先前AKs治疗的可接受性进行了三个随机评估,成人车辆对照研究(两个II期和一个III期)。II期研究中的患者在头皮和/或面部接受治疗,III期研究中的患者在上肢接受了治疗。
■共有234、166和269名患者参加了两项II期研究和一项III期研究,分别;总的来说,79.8%的患者为男性。ALA-PDT的总体治疗满意度为79%至88%,相比之下,VEH-PDT为35%至56%。患者通常认为ALA-PDT与以前的治疗相当或更可接受。包括冷冻疗法,5-氟尿嘧啶,咪喹莫特,以前的PDT,和手术。上肢接受ALA-PDT或VEH-PDT的患者比例相似,副作用/不良事件(AE),和副作用/AE的持续时间是可接受的。
■大多数患者是男性,没有进行统计学比较。
■患者普遍对ALA-PDT治疗面部AKs感到满意,头皮,和上肢,并认为ALA-PDT等于或比以前的治疗更可接受。
■ClinicalTrials.gov:NCT01475955;NCT02239679;NCT02137785。
UNASSIGNED: Actinic keratoses (AKs) are precancerous, dysplastic, epidermal lesions caused by chronic sun exposure that may progress to squamous cell carcinoma. Aminolevulinic acid 20% solution with blue light photodynamic therapy (ALA-PDT) has previously been shown to be superior to vehicle plus PDT (VEH-PDT) for treatment of AKs of the face, scalp, and upper extremities.
UNASSIGNED: We report detailed patient satisfaction data for ALA-PDT.
UNASSIGNED: Patient satisfaction for ALA-PDT versus VEH-PDT and patient-reported acceptability of ALA-PDT versus previous treatments for AKs were assessed in three randomized, vehicle-controlled studies (two Phase II and one Phase III) in adults. Patients in the Phase II studies were treated on the scalp and/or face, and those in the Phase III study were treated on the upper extremities.
UNASSIGNED: A total of 234, 166, and 269 patients were enrolled in the two Phase II studies and one Phase III study, respectively; overall, 79.8 percent of patients were male. Overall treatment satisfaction ranged from 79 to 88 percent for ALA-PDT, compared to 35 to 56 percent for VEH-PDT. Patients generally considered ALA-PDT to be equivalent to or more acceptable than prior treatments, including cryotherapy, 5-fluorouracil, imiquimod, previous PDT, and surgery. Similar proportions of patients receiving ALA-PDT or VEH-PDT on the upper extremities considered in-office time, side effects/adverse events (AEs), and duration of side effects/AEs to be acceptable.
UNASSIGNED: The majority of patients were male, and no statistical comparisons were conducted.
UNASSIGNED: Patients were generally satisfied with ALA-PDT for the treatment of AKs of the face, scalp, and upper extremities and considered ALA-PDT to be equal to or more acceptable than previous treatments.
UNASSIGNED: ClinicalTrials.gov: NCT01475955; NCT02239679; NCT02137785.