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

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

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（AIJA—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0．5ml 20％ALA，B组外用0．25ml 20％ALA，敷药范围的直径均为2cm，外用聚乙烯薄膜封包，胶布固定。3h后使用红光照射，能量密度80～120．1／cm2。两组均7～10d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个中心共人组尖锐湿疣患者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（r=5．67，P〈0．05）；痊愈率分别为97．77％和80．55％，差异有统计学意义（r=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（r=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（r=0．07，P〉0．05），不良反应有局部红肿、疼痛、糜烂，均在1～5d内自行缓解。结论固定敷药面积时，外用0．5ml 20％ALA—PDT疗法治疗外阴尖锐湿疣疗效优于0．25ml，复发率显著降低，同时不良反应未见明显增加。

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%, X2 = 5.67, P 〈 0.05） and cure rate （97.77% vs. 80.55%, X2 = 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）, x2 = 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.