光动力疗法治疗高级别鳞状上皮内病变:一项随机对照试验OA

Background:Ablative/excisional surgery is the recommended therapy for cervical high-grade squamous intra-epithelial lesions(HSILs)but is associated with cervical damage and elevated risk of complications uponsubsequent pregnan-cies.Methods:This multicenter,randomized,controlled trial compared APL-1702(2-g ointment containing 5％hexamin-olevulinate;photoactivated at 125 J/cm2)versus placebo in adult women with cervical HSILs(randomization ratio:2:1).Upon completion of 6-month treatment,patients in the APL-1702 group entered into a 6-month extension phase with observa-tion only.The primary efficacy endpoint was treatment response,as defined by normal histology or low-grade squamous intra-epithelial lesion histology plus human papillomavirus(HPV)clearance,at 6 months in a modified intent-to-treat population.Results:A total of 402 women were enrolled.The 6-month response rate was 41.1％(104/253)in the APL-1702 group ver-sus 21.7％(28/129)in the placebo group(P<0.001).HPV16/18 clearance rate was 31.4％(49/156)and 15.4％(12/78)in the APL-1702 and placebo groups,respectively(P=0.011).The rate of treatment-emergent adverse events was 56.8％(151/266)and 56.0％(75/134)in the APL-1702 and placebo groups,respectively.At the end of the 6-month extension pe-riod,54.9％(56/102)of the patients who responded at end of the 6-month treatment period maintained a response.Conclu-sion:APL-1702 significantly increased the 6-month response rate in patients with cervical HSIL versus placebo control,with a favourable safety profile.