氨基酮戊酸光动力疗法治疗硬化萎缩性苔藓的疗效观察

Clinical efficacy of 5-aminolevulinic acid-based photodynamic therapy for the treatment of lichen sclerosus et atrophicus

目的观察氨基酮戊酸光动力疗法治疗女阴硬化萎缩性苔藓的疗效和安全性。方法采用开放性，非对照性临床研究，受试者每两周进行1次氨基酮戊酸光动力治疗，治疗2～4次，于治疗前，治疗后2、4、8周各随访1次，进行疗效和安全性评价。结果共有38例女阴硬化萎缩性苔藓的患者纳入疗效分析。治疗结束后，总有效率为81．6％（31／38）。症状／体征总分在治疗后第2、4、8周分别为17．6±10．18、11．6±8．35、7．6±5．93，均明显低于治疗前（29．3±9．17），经t检验，差异均有统计学意义（t值分别为5．26、8．80、12．22，均P〈0．01）。其他疗效评估指标包括皮损面积、白斑、萎缩、糜烂，皲裂、瘙痒评分，在治疗后第2．4、8周（萎缩自第8周开始）均较治疗前改善明显，差异均有统计学意义（均P〈0．05）。氨基酮戊酸光动力疗法不良反应主要表现为治疗局部皮肤灼热感，其中16％（6／38）的患者在第1次治疗时诉疼痛明显。结论氨基酮戊酸光动力疗法治疗女阴硬化萎缩性苔藓，起效快，疗效确切。

Objective To estimate the efficacy and safety of 5-aminolevulinic acid-based photodynamic therapy （ALA-PDT） in the treatment of lichen sclerosus et atrophicus of the vulva. Methods An open and non- controlled clinical study was performed. Forty-two patients were enrolled in this study and received ALA-PDT once every two weeks for 2 to 4 times. Follow-up visits were arranged at 2, 4 and 8 weeks after initiation of treatment, and patients were evaluated at the baseline （before treatment） and all the follow-up time points for the efficacy and safety of treatment. Results Finally, 38 patients completed the trial and 4 patients were lost to follow up. The total response rate was 81.6% （31/38） at the end of the treatment. The average symptom and sign score in these patients was significantly lower at 2, 4 and 8 weeks after initiation of treatment than that before treatment （17.6 ＋ 10.18, 11.6 ~ 8.35 and 7.6 ~ 5.93 vs. 29.3 ＋ 9.17, t = 5.26, 8.80, 12.22, respectively, all P 〈 0.01）. A significant improvement was also observed in the other aspects, such as skin lesion area, hypopigmentation, erosion/rhagades and itching score at 2, 4 and 8 weeks, as well as in skin atrophy at 8 weeks after initiation of treatment compared with those before treatment （all P 〈 0.05）. Local burning sensation was the main adverse reaction to ALA-PDT, and 16% （6/38） of these patients complained of severe pain during the first treatment. Conclusion ALA-PDT shows favorable efficacy in patients with lichen sclerosus et atrophicus of the vulva with a rapid onset of action.