CAJ | 학술논문

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.3h后使用红光照射,能量密度80～ 120 J/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(x2=5.67,P＜0.05);痊愈率分别为97.77％和80.55％,差异有统计学意义(x2=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(x2=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(x2=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0.5 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.
목적 비교재고정부약면적적전제하외용불동제량20％염산안기동무산용액(ALA)진행광동력요법(ALA-PDT)치료외음첨예습우적안전성여료효.방법 수궤、개방、량개제량조평행대조적다중심림상연구,취진적첨예습우환자안수궤호분배진입A조혹B조,A조외용0.5 ml 20％ ALA,B조외용0.25 ml 20％ALA,부약범위적직경균위2 cm,외용취을희박막봉포,효포고정.3h후사용홍광조사,능량밀도80～ 120 J/cm2.량조균7～10d중복치료1차,공치료3차.매차치료후진행료효평개화불량반응관찰,말차치료후제1、4、8、12、24주진행수방,관찰복발솔.결과 3개중심공입조첨예습우환자88례,기중81례완성전부치료(A조45례,B조36례),A조총우체수위55개,B조위49개.치료3차후A조우체청제솔위98.18％,B조위85.71％,량조차이유통계학의의(x2=5.67,P＜0.05);전유솔분별위97.77％화80.55％,차이유통계학의의(x2=6.66,P＜ 0.05).치료결속후제12주,A조복발솔위9.09％(4/44),B조위35.71％(10/28),차이유통계학의의(x2=7.74,P＜ 0.01).불량반응A、B량조분별위33.33％、30.55％,차이무통계학의의(x2=0.07,P＞ 0.05),불량반응유국부홍종、동통、미란,균재1 ～5d내자행완해.결론 고정부약면적시,외용0.5 ml 20％ ALA-PDT요법치료외음첨예습우료효우우0.25 ml,복발솔현저강저,동시불량반응미견명현증가.
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.