局部 5-氨基酮戊酸光动力疗法（5-ALA-PDT）与手术治疗高级别阴道上皮内瘤变的对比研究。
Comparative study of topical 5-aminolevulinic acid photodynamic therapy (5-ALA-PDT) and surgery for the treatment of high-grade vaginal intraepithelial neoplasia.
机构信息
Department of Gynecology, Affiliation Hospital of The First Affiliated Hospital of Zhengzhou University, 450003, China.
Department of Gynecology, Affiliation Hospital of The First Affiliated Hospital of Zhengzhou University, 450003, China.
出版信息
Photodiagnosis Photodyn Ther. 2022 Sep;39:102958. doi: 10.1016/j.pdpdt.2022.102958. Epub 2022 Jun 16.
OBJECTIVE
To compare the clinical efficacy and safety of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) and local surgical excision in the treatment of high-grade vaginal intraepithelial neoplasia (VAIN).
METHODS
This was a retrospective study of a single center. Patients with biopsy-proven high-grade VAIN were counseled on the option of excision or ALA-PDT. After treatment patients were followed up at 3, 6 and 12 months and every 6 months afterwards. Clinical data of two groups were analyzed.
RESULTS
Sixty patients were treated with ALA-PDT and 40 patients underwent excision surgery. The clinical characteristics of patients in the two groups were similar. The mean ages of patients treated with ALA-PDT and local surgical excision were 41.93+13.08 (18-70) and 43.25+11.64 (22-61) years old, respectively. The treatment times of PDT for patients in the ALA-PDT group were 5.48±1.41 (2-8) times. At 3-6 months after treatment, the overall complete remission (CR) rate was 93.33% (56/60) in PDT group and 82.5% (33/40) in local surgical excision group. In PDT group, a 12- and 24-month follow-up, the total HPV clearance rate was 68.97% and 77.55%, respectively. At 12-month and 2-year follow-up after local surgical excision, the total HPV clearance rate was 60% and 64.52%, respectively. Further analysis showed that the clinical efficacy was comparable between the two treatments. Patients over 45 years old exhibited a lower HPV clearance rate (P<0.05) than those under 45 years old. It was also observed that persistent HPV infection is a major risk factor for persistent disease. Further comparative analyses showed no significant difference in the CR rate and treatment times between VAINII and VAINIII in ALA-PDT group. Moreover, 4 patients (11.36%) developed recurrent lesions during follow-up after ALA-PDT, whereas 3 patients (8.33%) in the local excision group developed recurrent lesions. In addition, there was no significant difference in the recurrent rate between two groups.
CONCLUSIONS
ALA-PDT shows similar efficacy and less side effects compared to local surgical excision.
目的
比较 5-氨基酮戊酸光动力疗法（ALA-PDT）与局部手术切除治疗高级别阴道上皮内瘤变（VAIN）的临床疗效和安全性。
方法
这是一项单中心回顾性研究。对经活检证实为高级别 VAIN 的患者进行切除或 ALA-PDT 治疗的选择咨询。治疗后，患者在 3、6 和 12 个月以及此后每 6 个月进行随访。分析两组患者的临床资料。
结果
60 例患者接受 ALA-PDT 治疗，40 例患者接受局部手术切除。两组患者的临床特征相似。ALA-PDT 组和局部手术切除组患者的平均年龄分别为 41.93+13.08（18-70）岁和 43.25+11.64（22-61）岁。ALA-PDT 组 PDT 治疗次数为 5.48±1.41（2-8）次。治疗后 3-6 个月，ALA-PDT 组的总完全缓解（CR）率为 93.33%（56/60），局部手术切除组为 82.5%（33/40）。在 ALA-PDT 组的 12 个月和 2 年随访中，HPV 清除率分别为 68.97%和 77.55%。在局部手术切除组的 12 个月和 2 年随访中，HPV 清除率分别为 60%和 64.52%。进一步分析表明，两种治疗方法的临床疗效相当。45 岁以上患者的 HPV 清除率（P<0.05）低于 45 岁以下患者。持续性 HPV 感染也是持续性疾病的主要危险因素。进一步的对比分析显示，ALA-PDT 组中 VAINII 和 VAINIII 的 CR 率和治疗次数无显著差异。此外，ALA-PDT 组有 4 例（11.36%）患者在随访期间出现复发病变，而局部切除组有 3 例（8.33%）患者出现复发病变。此外，两组的复发率无显著差异。
结论
ALA-PDT 与局部手术切除相比，具有相似的疗效和较少的副作用。
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