以温敏凝胶为基质注入尿道的光动力疗法治疗男性尿道尖锐湿疣的疗效观察

Clinical outcomes of photodynamic therapy combined thermosensitive gel intraurethal injection for male urethral condyloma acuminatum

背景尖锐湿疣是由人乳头瘤病毒感染引起的一种性传播疾病,男性尿道生理解剖结构特殊,传统的冷冻和激光治疗难以去除尿道内的尖锐湿疣。光动力疗法损伤小、重复性好,适用于尿道内尖锐湿疣的治疗。目前光动力治疗常用的给药方法是采用棉拭子浸泡于药物凝胶后,将棉拭子填入尿道后湿敷疣体。目的观察以温敏凝胶为基质注入尿道方式的5-氨基酮戊酸光动力疗法(5-aminolevulinic acid photodynamic therapy,5-ALA-PDT)治疗男性尿道内尖锐湿疣的临床疗效。方法将2016年1月-2020年12月解放军总医院第一医学中心皮肤科门诊接诊的尿道尖锐湿疣患者随机分为温敏凝胶注入组和温敏凝胶棉拭子湿敷组。温敏凝胶注入组采用以温敏凝胶为基质的20%5-ALA直接注入尿道合适深度(比疣体位置深1 cm),保持3 h;温敏凝胶棉拭子湿敷组以温敏凝胶为基质的20%5-ALA棉拭子填入尿道湿敷患处及周围1 cm范围,保持3 h。两组均用635 nm半导体激光照射,每个光斑照射的能量密度为100~120 J/cm^(2)。照光时间20~30 min,矫正功率80 mW/cm^(2)。每7~10 d治疗1次,连续治疗3~5次。治疗后于10 d、1个月、3个月进行随访,观察疣体清除率、复发率和不良反应。结果共纳入44例尿道尖锐湿疣患者,温敏凝胶注入组和温敏凝胶棉拭子湿敷组每组各22例,年龄分别为29.3±6.3(19~42)岁和30.1±7.3(19~44)岁,差异无统计学意义(P>0.05)。温敏凝胶注入组和温敏凝胶棉拭子湿敷组3次治疗后疣体完全清除率分别为86.3%和72.7%(P=0.457),5次治疗后疣体完全清除率分别为95.5%和90.9%(P=1.000),3个月后复发率分别为9.5%和10%(P=1.000),差异均无统计学意义。治疗后两组均有轻度或中度尿痛,偶有轻微痒感,温敏凝胶注入组痛感更轻。两组无系统不良反应。结论以温敏凝胶为基质直接注入尿道的5-ALA-PDT治疗尿道尖锐湿疣经济有效,患者舒适度好,值得临床推广。

Background Condyloma acuminatum is a sexually transmitted disease caused by human papillomavirus infection.The male urethra has a special physiological and anatomical structure,thus it is difficult to remove condyloma acuminatum in the urethra by traditional freezing and laser treatment.Photodynamic therapy is suitable for the treatment of condyloma acuminatum in urethra due to its small damage and good repeatability.At present,the commonly used drug delivery method of photodynamic therapy is to soak the cotton swab in the drug gel,fill the cotton swab into the urethra and make wet compress for the wart.Objective To observe the effect of 5-aminolevulinic acid photodynamic therapy(5-ALA-PDT)with thermosensitive gel as matrix injected into urethra for treatment of condyloma acuminatum in male urethra.Methods From January 2016 to December 2020,patients with urethral condyloma acuminatum were randomly divided into thermosensitive gel injection group and thermosensitive gel cotton swab wet compress group.In the injection group,20%of 5-aminolevulinic acid based on thermosensitive gel was directly injected into the urethra at a suitable depth(1 cm deeper than the wart),and the drug was maintained for 3 hours;In the cotton swab wet compress group,20%of 5-ALA cotton swabs with thermosensitive gel as the matrix were filled into the affected area and around the 1 cm range of urethral with wet compress for 3 hours;Both the two groups were irradiated with 635 nm semiconductor laser,with the energy density between 100-120 J/cm^(2),the irradiation time of 20-30 min/spot and the correction power was 80mw/cm^(2).All patients were treated once every 7-10 days for 3-5 times continuously.After 10 days,one month and three months of treatment,the complete clearance rate,recurrence rate and side effects in the two groups were observed.Results Totally 44 patients were enrolled,with 22 cases in each group.The patients aged 29.3±6.3(range,19-42)years in the thermosensitive gel injection group,and 30.1±7.3(range,19-44)years in the thermosensitive gel cotton swab wet compress group(P>0.05).Follow up lasted for 3 months.The complete clearance rate of the thermosensitive gel injection group and the thermosensitive gel cotton swab wet compress group was 86.3%and 72.7%after 3 times of treatment(P=0.457),and 95.5%and 90.9%after 5 times of treatment(P=1.000);The recurrence rate was 9.5%and 10%(P=1.000).After treatment,there was mild to moderate urination pain and occasional slight itching,and the pain was milder in the thermosensitive gel injection group.No systemic adverse reactions occurred.Conclusion 5-ALA-PDT by injecting the thermosensitive gel into urethra as the photosensitizer carrier is effective,economical and comfortable for the treatment of male urethral condyloma acuminatum,which is worthy of clinical generalization.