• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

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

DOI: 10.12201/bmr.202604.00177
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    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

    Submit time: 29 April 2026

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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  • ID Submit time Number Download
    1 2026-04-14

    10.12201/bmr.202604.00177V1

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Wang Shuang, Zhong Lizhen, Li Dongqin, Xie Xiaohua, Zhang Xiaoling. 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. 2026. biomedRxiv.202604.00177

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