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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 evaluate the clinical efficacy and safety of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) in the treatment of cervical intraepithelial neoplasia (CIN) 1/2 with high-risk human papilloma virus (HR-HPV) Explore the best concentration of ALA treatment. Methods A total of 120 patients with CIN1 / 2 HR-HPV infection were randomly divided into 4 groups, which were treated with 20%, 10% and 5% ALA and placebo respectively. After 3 to 6 months according to skin biopsy, Pap smear and HPV test results to assess the therapeutic effect. Results After 3 to 6 months of treatment, there was no significant difference in the effective rate between placebo group and CIN1 group in different concentrations of ALA group (ALA vs placebo group, all P> 0.05), in 20% ALA group The effective rate of CIN2 patients was significantly higher than that of placebo patients (56.25% vs 95.00%, P <0.01). After 6 months of treatment, the negative rate of HPV 16/18 in CIN2 patients was 85.00% in 20% ALA group and 31.25% in placebo group, the difference was statistically significant (P <0.01). Conclusions 20% ALAPDT can treat CIN2 and HR-HPV can be eliminated.