袁媛, 王爽, 钟丽珍, 李冬晴, 谢小花, 张晓玲. 聚焦超声联合康妇凝胶治疗女性外阴硬化性苔藓的临床研究. 2026. biomedRxiv.202604.00177
聚焦超声联合康妇凝胶治疗女性外阴硬化性苔藓的临床研究
通讯作者: 袁媛, Sfbyuany986@163.com
DOI:10.12201/bmr.202604.00177
Clinical Study on the Efficacy of Focused Ultrasound Combined with Kangfu Gel in Treating Vulvar Lichen Sclerosus in WomenYuan Yuan; Wang Shuang; Zhong Lizhen; Li Dongqing; Xie Xiaohua; Zhang Xiaoling△
Department of Gynecology, Jiangxi Maternal and Child Health Hospital, Nanchang, Jiangxi 330006, China
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摘要:【摘要】目的 观察聚焦超声联合康妇凝胶用于女性外阴硬化性苔藓(vulvar lichen sclerosus,VLS)的治疗效果及安全性,为临床方案优化提供参考。方法 选取2024年1月-2025年6月江西省妇幼保健院妇科门诊确诊的VLS患者120例,采用随机数字表法分为观察组与对照组,每组各60例。对照组仅接受聚焦超声治疗,观察组接受聚焦超声治疗后联合康妇凝胶外涂。分别于治疗前、治疗后6个月评估两组患者的临床症状体征(采用Cattaneo评分)、生活质量及不良事件发生情况,并比较综合疗效。结果 治疗后6个月,两组临床症状评分均较治疗前显著下降(P < 0.05),且观察组各症状评分均低于对照组(P < 0.05)。观察组在SF-36各维度评分改善方面均优于对照组(P < 0.05)。观察组不良事件发生率为3.33%,显著低于对照组的26.67%(P < 0.05)。治疗6个月后,观察组总体疗效显著优于对照组(Z=2.978, P<0.05)。结论 聚焦超声联合康妇凝胶治疗女性VLS,能更显著地缓解临床症状、提升生活质量、减少不良反应并提高整体疗效,具备良好的临床推广价值。
Abstract: Abstract Objective To observe the therapeutic efficacy and safety of focused ultrasound combined with Kangfu Gel in the treatment of female vulvar lichen sclerosus (VLS), and to provide a reference for optimizing clinical regimens. Methods A total of 120 patients diagnosed with VLS at the Gynecology Outpatient Clinic of Jiangxi Provincial Maternal and Child Health Hospital from January 2024 to June 2025 were enrolled. They were randomly divided into an observation group and a control group using a random number table method, with 60 cases in each group. The control group received focused ultrasound treatment alone, while the observation group received focused ultrasound treatment followed by topical application of Kangfu Gel. Clinical symptoms and signs (assessed by Cattaneo score), quality of life, and adverse events were evaluated before treatment and at 6 months after treatment, and the overall therapeutic efficacy was compared between the two groups. Results At 6 months after treatment, the clinical symptom scores in both groups decreased significantly compared with those before treatment (P < 0.05), and all symptom scores in the observation group were lower than those in the control group (P < 0.05). The observation group showed greater improvements in all dimensions of the SF-36 score than the control group (P < 0.05). The incidence of adverse events in the observation group was 3.33%, which was significantly lower than that in the control group (26.67%, P < 0.05). After 6 months of treatment, the overall efficacy in the observation group was significantly better than that in the control group (Z = 2.978, P < 0.05). Conclusion Focused ultrasound combined with Kangfu Gel in the treatment of female VLS can more significantly alleviate clinical symptoms, improve quality of life, reduce adverse reactions, and enhance overall efficacy, demonstrating good potential for clinical promotion.
Key words: Vulvar Lichen Sclerosus; Focused Ultrasound; Kangfu Gel提交时间:2026-04-29
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序号 提交日期 编号 操作 1 2026-04-14 10.12201/bmr.202604.00177V1
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