ALA-PDT治疗轻中度宫颈上皮内瘤样病变伴高危型HPV感染临床观察  

Clinical Observation of ALA-PDT of Mild and Moderate Cervical Intraepithelial Neoplasia with High-risk Type HPV Infection

作　　者：王喜英[1] 孟健[2] 冯育洁[3] 王健[1] 白吉[3] 穆雅琴[1] 刘丽华[1] 张海燕[1] 赵富玺[1] 

机构地区：[1]山西大同大学医学院微生物与免疫学研究所,山西大同037009 [2]山西大同大学医学院解剖教研室,山西大同037009 [3]大同市第三人民医院皮肤科,山西大同037008

出　　处：《中国皮肤性病学杂志》2017年第9期975-977,共3页The Chinese Journal of Dermatovenereology

基　　金：大同市科技攻关项目(2016101)

摘　　要：目的评价5-氨基酮戊酸光动力疗法(ALA-PDT)治疗宫颈上皮内瘤样病变(CIN)1/2伴高危型人乳头状瘤病毒(HR-HPV)感染的临床疗效和安全性,探讨ALA治疗的最佳浓度。方法将入选的120例CIN1/2伴HR-HPV感染患者随机分为4组,分别予ALA浓度为20%,10%和5%及安慰剂治疗。3~6个月后根据皮肤活检、巴氏涂片和HPV检测结果评估治疗效果。结果治疗3~6个月后,安慰剂组与不同浓度ALA组中CIN1患者的有效率差异均无统计学意义(不同浓度ALA组vs安慰剂组,P均>0.05),20%ALA组中CIN2患者的有效率显著高于安慰剂组患者的有效率,且差异有统计学意义(56.25%vs 95.00%,P<0.01)。治疗6个月后,20%ALA组中CIN2患者HPV 16/18阴转率为85.00%,安慰剂组CIN2患者阴转率为31.25%,差异有统计学意义(P<0.01)。结论 20%ALAPDT可以治疗CIN2,还可以清除HR-HPV。Objective To investigate the efficacy and safety of 5-aminolevulinic acid photodynamic therapy（ALA-PDT） and the optimal concentration for women with cervical intraepithelial neoplasia （CIN） 1/2 with high risk human papillomavirus （HR-HPV） infection. Methods This was a randomized, placebo controlled study that included a total number of 120 women with CIN 1/2 based on local pathology. Patients received topical treatments of ALA 20% , 10% , 5% and placebo ointment and were evaluated for response after 3 - 6 months based on biopsy, Papanieolaou test and HPV test. Results In the CIN1 populations there were no statistically significant differences in the number of responders in the ALA dose groups compared to placebo group at any time point（ different concentration ALA group vs. placebo group, all P 〉 0. 05 ）. A clear dose effect with a statistically significant response in the ALA 20% group of 95.00% compared to 56. 25% in the placebo group （ P 〈 0. 01 ） was observed at 3 months in women with CIN2, including an encouraging 85.00% clearance of HPV 16/18 compared to 31.25 % in the placebo group at 6 months （P 〈 0. 01 ）. Conclusion The 20% ALA-PDT is a novel therapy that shows promise in the treatment of CIN2 including the clearance of HPV, but not of CIN1.

关 键 词：宫颈上皮内瘤样病变1/2 5-氨基酮戊酸光动力疗法 高危型人乳头状瘤病毒 

分 类 号：R751.05[医药卫生—皮肤病学与性病学]