Feasibility of 5-fluorouracil and imiquimod for the topical treatment of cervical intraepithelial neoplasias (CIN) 2/3.
Feasibility of 5-fluorouracil and imiquimod for the topical treatment of cervical intraepithelial neoplasias (CIN) 2/3.
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5-氟尿嘧啶和咪喹莫特局部治疗宫颈上皮内瘤变（CIN）的可行性2/3。
DOI：
10.1002/ijgo.14983
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Rahangdale,Lisa
中科院分区：
文献类型：
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作者：
Desravines,Nerlyne;Hsu,Chiu-Hsieh;Mohnot,Sopan;Sahasrabuddhe,Vikrant;House,Margaret;Sauter,Edward;O'Connor,Siobhan;Bauman,JulieE;Chow,H-HSherry;Rahangdale,Lisa
目的探讨外用5‐氟尿嘧啶（5‐FU）和咪喹莫特治疗宫颈上皮内瘤变（CIN） 2/3的可行性（以耐受性和安全性衡量）和疗效。方法本前瞻性先导研究纳入18-45岁p16+ CIN 2/3的女性。参与者在第1、3、5和7周自行应用5% 5 - FU，在第2、4、6和8周由医生应用咪喹莫特进行8周交替治疗。通过症状日记和临床检查收集不良事件（ae）。可行性通过研究干预的耐受性和安全性（ae）来衡量。耐受性评估为能够应用50%或更多治疗剂量的参与者人数。安全性结果计算为经历“特定不良事件”的参与者数量，定义为可能、可能或肯定相关的2级或更严重的不良事件或1级生殖器不良事件（水疱、溃疡或脓疱）持续超过5天。通过组织学检查确定干预的有效性，并在治疗后进行高危人乳头瘤病毒（hrHPV）检测。结果13例患者年龄中位数为27±2.9岁。11名（84.61%）参与者使用了50%或更多的治疗。所有参与者报告为1级ae；6例（46.15%）报告2级ae；0例报告3/4级ae。3名（23.08%）参与者有明确的ae。在完成50%或以上治疗剂量的患者中，有10名（90.91%）患者的组织学回归正常或CIN 1，在研究结束时，有7名（63.63%）患者的hr - HPV检测呈阴性。结论5‐FU/咪喹莫特临床治疗CIN 2/3是可行的，有初步疗效。局部治疗作为辅助或替代手术治疗CIN 2/3需要进一步研究。
ObjectivesTo determine the feasibility (as measured by tolerability and safety) and efficacy of topical 5‐fluorouracil (5‐FU) and imiquimod for the treatment of cervical intraepithelial neoplasia (CIN) 2/3.MethodsThis pilot prospective study was conducted in women aged 18–45 years with p16+ CIN 2/3. Participants underwent an 8‐week alternating regimen of self‐applied 5% 5‐FU on weeks 1, 3, 5, and 7 and physician‐applied imiquimod on weeks 2, 4, 6, and 8. Adverse events (AEs) were collected by symptom diary and clinical exam. Feasibility was measured by tolerability and safety (AEs) of the study intervention. Tolerability was assessed as the number of participants able to apply 50% or more of the treatment doses. The safety outcome was calculated as the number of participants who experienced “specified AEs” defined as possibly, probably, or definitely related grade 2 or worse AE or grade 1 genital AEs (blisters, ulcerations, or pustules) lasting more than 5 days. The efficacy of the intervention was determined by histology and high‐risk human papillomavirus (hrHPV) testing was done after treatment.ResultsThe median age of the 13 participants was 27 ± 2.9 years. Eleven (84.61%) participants applied 50% or more of the treatment. All participants reported grade 1 AEs; 6 (46.15%) reported grade 2 AEs; and 0 reported grade 3/4 AEs. Three (23.08%) participants had specified AEs. Histologic regression to normal or CIN 1 among those completing 50% or more of the treatment doses was observed in 10 (90.91%) participants, and 7 (63.63%) tested negative for hr‐HPV at the end of the study.ConclusionsTopical treatment for CIN 2/3 with 5‐FU/imiquimod is feasible, with preliminary evidence of efficacy. Topical therapies need further investigation as adjuncts or alternatives to surgical therapy for CIN 2/3.