探讨应用高强度聚焦超声(high intensity focused ultrasound, HIFU)治疗女性外阴上皮内非瘤样病变(鳞状上皮增生、硬化性苔癣和硬化性苔癣合并鳞状上皮细胞增生)的方法及疗效。

选择2006年7月至2009年10月，在本院妇科门诊就诊被确诊为外阴上皮内非瘤样病变接受高强度聚焦超声治疗的262例患者，及同期接受单纯药物治疗的56例患者为研究对象。将262例患者随机分为单纯HIFU治疗组(A组，n＝72)，HIFU＋局部药物治疗组(B组，n＝190)，将同期接受单纯药物治疗的同类患者，纳入对照组(n＝56)。三组患者年龄，病变程度、病理学分型等比较，差异无显著意义(P>0.05)。对所有患者进行治疗方法探索和随访，设立"外阴瘙痒评分法"、"外阴白色病变面积计算法"、"四象限比较法"和"四度外阴皮肤弹性评估法"判别客观疗效(本研究遵循的程序符合本院人体试验委员会所制定的伦理学标准，得到该委员会批准，分组征得受试对象本人的知情同意，并与之签署临床研究知情同意书)。

A，B组治疗方法对控制各类外阴上皮内非瘤样病变瘙痒症状疗效满意，与对照组比较，差异有显著意义(P<0.05)，以B组疗效最佳。B组治疗后，瘙痒症状消失率达83.2%(158/190)。A，B组白色病变治疗有效率均为100.0%，A组治愈率为66.7%(48/72)，B组为72.1%(137/190)。B组外阴白色病变区域由(15.21±8.56) cm²减小至(6.68±3.11) cm²。A，B组治疗后，白色病变区面积减小与对照组比较，差异有显著意义(P<0.01)，B组治愈率高于A组。A，B组治疗后，对外阴皮肤弹性恢复的疗效也显著优于对照组(P<0.05)。

高强度聚焦超声对于女性外阴上皮内非瘤样病变的瘙痒症状、白色病变区域面积减小和恢复外阴皮肤弹性有良好疗效，并具有治疗方便、安全无创等优势。对女性外阴上皮内非瘤样病变，应依据病变类型和程度选择治疗方案。

To investigate therapeutic methods and effects of high intensity focused ultrasound (HIFU) on the treatment of nonneoplasia epithelial disorders of skin and mucosa of vulva, including squamous hyperplasia of the vulva (SHL), lichen sclerosus of the vulva (LSV) and lichen sclerosus complexed with squamous hyperplasia of vulva (LSCSH).

From July 2006 to October 2009, 262 patients with nonneoplasia epithelial disorders of skin and mucosa of vulva were divided into two groups: group A (n=72, treated by HIFU only) and group B (n=190, treated by HIFU+ drugs). Meanwhile, another 56 patients with same disease who were treated by drugs only were recurited into control group (n=56). There were no statistically significant difference on age, degree of lesions, and pathological classification among three groups (P>0.05). The study protocol was approved by the Ethical Review Board of Investigation in Human Being of Jinan Military General Hospital. Informed consent was obtained from all participants.

The curative effect rates of relieving-pruritus, lichen sclerosus and vulvar leucoplakia in group A and group B were better than those of control group (P<0.05), and the curative rate of the group B was the best, and after the treatment, disappearance of pruritus was 83.2%(158/190). The effective rates of white lesion in both group A and B were 100.0%, and the cure rate of group A and group B were 66.7%(48/72) and 72.1%(137/190), respectively. The region of vulvar white lesion reduced from (15.21±8.56)cm² to (6.68±3.11)cm² in group B. There was significant difference of reduction of vulvar white lesion region between group A, B and control group (P<0.05).

High intensity focused ultrasound was a simple, safe, fast, effective and repeatable method for the treatment of nonneoplasia epithelial disorders of skin and mucosa of vulva, especially relieving-pruritus, lichen sclerosus and vulvar leucoplakia.