20%氨基酮戊酸光动力治疗外阴尖锐湿疣量效关系临床研究

目的 比较在固定敷药面积的前提下外用不同剂量20%盐酸氨基酮戊酸溶液（ALA）进行光动力疗法（ALA-PDT）治疗外阴尖锐湿疣的安全性与疗效。 方法 随机、开放、两个剂量组平行对照的多中心临床研究，就诊的尖锐湿疣患者按随机号分配进入A组或B组，A组外用0.5 ml 20% ALA，B组外用0.25 ml 20% ALA，敷药范围的直径均为2 cm，外用聚乙烯薄膜封包，胶布固定。3 h后使用红光照射，能量密度80 ～ 120 J/cm2。两组均7 ～ 10 d重复治疗1次，共治疗3次。每次治疗后进行疗效评价和不良反应观察，末次治疗后第1、4、8、12、24周进行随访，观察复发率。 结果 3个中心共入组尖锐湿疣患者88例，其中81例完成全部治疗（A组45例，B组36例），A组总疣体数为55个，B组为49个。治疗3次后A组疣体清除率为98.18%，B组为85.71%，两组差异有统计学意义（χ2 = 5.67，P < 0.05）；痊愈率分别为97.77%和80.55%，差异有统计学意义（χ2 = 6.66，P < 0.05）。治疗结束后第12周，A组复发率为9.09%（4/44），B组为35.71%（10/28），差异有统计学意义（χ2 = 7.74，P < 0.01）。不良反应A、B两组分别为33.33%、30.55%，差异无统计学意义（χ2 = 0.07，P > 0.05），不良反应有局部红肿、疼痛、糜烂，均在1 ～ 5 d内自行缓解。 结论 固定敷药面积时，外用0.5 ml 20% ALA-PDT疗法治疗外阴尖锐湿疣疗效优于0.25 ml，复发率显著降低，同时不良反应未见明显增加。

Topical 20% 5-aminolevulinic acid-based photodynamic therapy for the treatment of condyloma acuminatum of the vulva: a multicenter,randomized clinical evaluation of dose-response relationship

Huang Dan*, Ju Mei, Qian Yihong, Zhou Pingyu, Tang Zengqi, Yang Xifang, Zhang Xiaohua, Guo Qing, Chen Kun, Gu Heng. *Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical Collage, Nanjing 210042, China Corresponding authors: Chen Kun, Email: kunchen181@aliyun.com; Ju Mei, jumeiweng@163.com 【Abstract】 Objective To compare the safety and efficacy of two doses of topical 20% 5-aminolevulinic acid （ALA） in photodynamic therapy（PDT） for condyloma acuminatum of the vulva on the premise that the area to be topically treated is fixed. Methods An open, randomized, parallel-group controlled clinical trial was performed in three institutions in eastern China. Patients with condyloma acuminatum of the vulva were randomly divided into two groups according to a random number table: group A and group B applying 0.5 ml and 0.25 ml of 20% ALA solution, respectively, to an area measuring 2 cm in diameter followed by polyethylene film coating and adhesive tape fixation. All the patients were treated for three times with an interval of 7 － 10 days. Efficacy was evaluated and adverse reactions were recorded after each treatment, and follow-up was scheduled on week 1, 4, 8, 12 and 24 after the last treatment for the observation of recurrence rate. Results A total of 88 patients with genital condyloma acuminatum were enrolled in this trail, and 81 patients completed all the treatment, including 45 patients with 55 warts in group A and 36 patients with 49 warts in group B. After 3 times of treatment, significant differences were observed in wart clearance rate （98.18% vs. 85.71%, χ2 = 5.67, P < 0.05） and cure rate （97.77% vs. 80.55%, χ2 = 6.66, P < 0.05）. The overall recurrence rate during 12 weeks after the last treatment was significantly lower in group A than in group B（9.09% （4/44） vs. 35.71% （10.28） , χ2 = 7.74, P < 0.01）. Adverse reactions mainly included local swelling, pain and erosion, and all spontaneously subsided within 1 to 5 days. Further more, no significant difference was observed in the occurrence rate of adverse reactions between group A and B （33.33% vs. 30.55%, P > 0.05）. Conclusions Given that the area to be topically treated is fixed, 0.5 ml of 20% ALA is superior to 0.25 ml of 20% ALA in the photodynamic treatment of condyloma acuminatum of the vulva with favorable efficacy, reduced recurrence and similar adverse reactions.