中华皮肤科杂志 ›› 2007, Vol. 40 ›› Issue (2): 67-70.

• 论著 •    下一篇

外用盐酸氨基酮戊酸光动力疗法治疗尖锐湿疣多中心随机对照研究

涂平1, 郑和义2, 顾恒3, 徐金华4, 王秀丽5, 陈伟1, 李军2, 陈昆3, 陆小年4, 王宏伟5, 朱学骏1   

  1. 1. 北京大学第一医院皮肤科 100034;
    2. 中国医学科学院、中国协和医科大学北京协和医院皮肤科;
    3. 中国医学科学院、中国协和医科大学皮肤病研究所;
    4. 复旦大学附属华山医院皮肤科;
    5. 上海市皮肤病性病医院
  • 收稿日期:2006-04-12 发布日期:2007-02-15

Topical 5-aminolevulinic acid photodynamic therapy for the treatment of condyloma acuminatum:a multicenter,randomized,CO2 laser-controlled trial

TU Ping1, ZHENG He-yi2, GU Heng3, XU Jin-hua4, WANG Xiu-li5, CHEN Wei1, LI Jun2, CHEN Kun3, LU Xiao-nian4, WANG Hong-wei5, ZHU Xue-jun1   

  1. Department of Dermatology, Peking University First Hospital, Beijing 100034, China
  • Received:2006-04-12 Published:2007-02-15

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摘要： 目的 观察外用盐酸氨基酮戊酸光动力疗法(ALA-PDT)治疗尖锐湿疣的安全性与疗效.方法 随机、开放、CO2激光平行对照的多中心临床研究,分为ALA-PDT试验组和CO2激光对照组,疗程最多3周.末次治疗后第1周进行疗效评价,第4、8和12周观察复发率.治疗前及末次治疗后1周进行实验室检查,并观察不良反应.结果 5个中心共入组尖锐湿疣患者453例,其中442例完成全部随访(试验组331例,对照组111例).在末次治疗后1周,试验组和对照组疣体清除率分别为98.42%和100%(P>0.05),两组男性尿道口部位的疣体清除率分别为99.43%和100%(P>0.05).试验组治疗后总复发率(10.77%)较对照组(33.33%)显著降低(P<0.0001),其中男性尿道口部位的疣体复发率在试验组和对照组分别为10.53%和36.36%,差异亦有统计学意义(P<0.0001).试验组及对照组均未发生系统不良反应.局部不良反应发生率在试验组为7.67%,主要为轻微糜烂;对照组53.57%,主要为溃疡、疼痛,其中瘢痕14例次.试验组不良反应发生率明显低于对照组,差异有统计学意义(P<0.0001).结论 外用ALA-PDT疗法治疗尖锐湿疣治愈率高,复发率低,安全性好.特别适用于男性尿道口尖锐湿疣的治疗.

关键词: 尖锐湿疣, 氨基酮戊酸, 光化学疗法, 随机对照试验

Abstract: Objective To evaluate the safety and efficacy of topical 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in the treatment of condyloma acuminatum.Methods This multicenter,randomized,open,parallel,CO2 laser-controlled clinical trial was conducted at 5 research sites in China.Patients with condyloma acuminatum were randomly assigned to the ALA-PDT group or the CO2 laser (control) group in an allocation ratio of 3:1.The treatment was repeated weekly if necessary,but no more than 3 times.The primary efficacy endpoint was the wart clearance rate 1 week after the last treatment.The recurrence rate was evaluated at weeks 4,8,and 12 after the treatment ended.The laboratory examinations were performed before and at the end of the treatment.Results A total of 453 patients with condyloma acuminatum were enrolled in the clinical trial.Of these,442 (97.57%) patients completed the trial (331 in the ALA-PDT group,and 111 in the control group).At 1 week after the last treatment,98.42% and 100% of the base line warts were eliminated in the ALA-PDT group and the control group,respectively (P>0.05).The clearance rate of condylomata acuminata at male urethral orifice was 99.43% in the ALA-PDT group and 100% in the control group (P>0.05).The overall recurrence rate calculated for the whole follow-up period was significantly lower in the ALA-PDT group than in the control group (10.77% vs 33.33%,P<0.0001),and the recurrence of condyloma acuminatum at male urethra orifice was also significantly decreased in the ALA-PDT group than in the control group (10.53% vs 36.36%,P<0.0001).There was no systemic adverse event in either group.The incidence of local adverse events was significantly lower in the ALA-PDT group than in the control group (7.67% vs.53.57%,P<0.0001).The main adverse event in the ALA-PDT group was mild erosion,whereas the adverse events in the control group were more common and severe,including pain,ulcer,and even scarring (n=14).Conclusions The results confirm that topical ALA-PDT is a safe and effective treatment with low recurrence rate for condyloma acuminatum,especially for this condition at urethral orifice.

Key words: Condylomata acuminata, Aminolevulinic acid, Photochemotherapy, Randomized controlled trials