5-aminolevulinic Acid-photodynamic Therapy For 50 Patients With Condyloma Acuminatum

Objective:Condyloma acuminatum(CA) is one of the sexually transmitted disease(STD) infected by human papilloma virus(HPV).Its incidence is the second place in STDs and elevates year by year. This study is to evaluate the effects of ALA- PDT and traditional physical treatment including electrotome and cryotherapy for CA, and observe the reactions of therapeutic region continually, in order to supply some useful clinical information for using ALA-PDT more effectively in the future.Methods:The study involved 100 cases whose clinical diagnosis was CA with positive results of Acetic -acidin-white in the 2nd hospital of HeBei Medical university from 2007-7 to 2008-2.The cases were all male and the size of lesion was from 0.2×0.2cm to 2.0×2.0cm .The patients' ages were from 21 to 60 years old and the average age was 35 years old. The course of disease was from 3 months to 3 years. All patients agreed to have a treatment ether ALA-PDT or traditional physical treatment.100 cases was separated to 2 groups by the order of their visiting. Fifty cases were treated by ALA- PDT and the other 50 cases were treated by traditional physical treatment. 3 cases were observed continually of the reaction on therapeutic region in this study. The two groups had no significant difference statistically (P>0.05) in age,sex,course,size of lesion, they had comparability.1 ALA-PDT group1.1 ALA was produced by ShangHai FuDanzhangjiang company, it's common name is 5-aminolevulinic acid.20%ALA solution was prepared not long before using on the area of lesion.1.2 ALA-PDT device was provided by ShangHai FuDanzhangjiang company produced by GuXi province GuiLin City XingDa photoelectricity medical device company limited. Its type is XD₆35AB, the output wavelength is 635nm,the work rate is 0-300mw.1.3 The approach of ALA-PDT: First, wet compressing in the lesion using fresh 20%ALA solution and then wafering it by using plastic film.3 hours later, irradiating the lesion with PDT device. The energy was about 100-150J/cm2. Then repeating the treatment in 7-10 days until the lesion has been eliminated.2 traditional physical treatment group2.1 Using electrotome if the lesion was bigger than 0.5cm in diameter or the number of the lesion was more than 3. Otherwise, using cryotherapy.2.2 Electrotome device was produced by Peking photoelectricity institute, work rate is 10W. The treatment would be finished while every lesion has been cleared.2.3 Cryotherapy treatment was overlaying the lesion with–196 ℃liquid nitrogen,then the lesion would be cooling and turned to white,after the colour recovering from white to the normal skin colour, then repeating the operation once.3 Therapeutic effect judgement: complete remission: the lesion has been eliminated completely; part remission: the lesion has been eliminated more than 50%; Did not respond: the lesion has been eliminated less than 50% or the lesion has no marked change.4 follow-ups: follow up the complete remission cases every week from the day finished the last treatment to the next 3 months.5 Using spss11.0 software for statistics analysis by chi-square test6 observing continually the reaction of the rapeutic regionThree cases by ALA-PDT were observed continually of the reaction of therapeutic region. According to records, the time frequency of observation was before treatment, right after treatment. And then during the first 24 hours, an inspection was made in every two hours, and the next 48 hours, an inspection, in every four hours. The observation lasted 3 days in all or until the lesion has been eliminated. A detail record with a photo was made for every inspection. All the photo was taken in the same room, light condition, patient's position, gesture and same camera SONY type DC50 in order to make all the photo had better comparability.Results: 1 The therapeutic effect of ALA-PDT group compared with traditional physical treatment. The complete remission was 49 of 50 (98%) for ALA- PDT and 50 of 50 (100%) for traditional physical treatment, respectively. 19(38%) cases in ALA-PDT group reached complete remission only by having treatment once and other 22(44%) cases by twice, 4(8%) cases by three times, 4(8%) cases by four times. One (2%) case was ineffective. All the cases in traditional physical treatment had treatment only once reaching complete remission. According to chi-square test, complete remission x2=1.0(P>0.05) There was no statistically significance. So there was no difference in complete remission of the two groups. Once complete remission rate x2=44.93(P<0.005), there was statistically significance. So the once complete remission rate of the traditional physical treatment was higher than that of ALA- PDT.2 The recurrence after treatment: There was one case of ALA-PDT group out of the study for not response to the treatment. There wasn't another one losing visit in the other 99 cases. Recurrence rate of traditional physical treatment was 32.0% and 14.3% for ALA- PDT. According to chi-square test,x2=4.35(P<0.05), there was statistically significance, so the recurrence rate by ALA- PDT was much lower than that by traditional physical treatment.3 According to the result of continual observation, the reaction of therapeutic region could be classified into 3 clinical phases: edema-necrosis phase, atrophy-erosion-fall off phase and recovery phase.Conclusions:According to the result of comparison of ALA-PDT and traditional physical treatment, the once complete remission rate of traditional physical treatment was higher than that of ALA- PDT. However, the recurrence rate of ALA- PDT was much lower than that of traditional physical treatment and there was no difference in complete remission of the two groups. According to the continual observation, the reaction of therapeutic region could be classified into 3 clinical phases: edema-necrosis phase, atrophy-erosion-fall off phase and recovery phase.