新型温控射频治疗女性产后阴道松弛症的前瞻性随机对照研究  

Prospective Randomized Controlled Clinical Study on the Efficacy of A Novel Temperature-Controlled Radiofrequency Treatment for Postpartum Vaginal Laxity

作　　者：邵辉 王璐[1] 陈鹿嘉 董芮嘉 汤洁莹 廖雪吟 杨建民[1] 李薇薇[1] SHAO Hui;WANG Lu;CHEN Lu-jia;DONG Rui-jia;TANG Jie-ying;LIAO Xue-yin;YANG Jian-min;LI Wei-wei(Department of Plastic Surgery,Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University,Beijing 102218,China)

机构地区：[1]清华大学附属北京清华长庚医院整形外科,清华大学临床医学院,102218

出　　处：《国际妇产科学杂志》2024年第5期509-514,共6页Journal of International Obstetrics and Gynecology

摘　　要：目的:探讨新型温控射频对产后阴道松弛症的临床疗效与安全性。方法:选取2022年6月-2023年6月于清华大学附属北京清华长庚医院收治的43例产后阴道松弛症患者为研究对象,随机分为2组,试验组(21例)接受新型温控射频治疗,对照组(22例)接受假开机治疗(无温度及能量)。通过比较治疗前后女性性功能指数量表(female sexual function index,FSFI)、女性性困扰诊断量表修订版(female sexual distress scale-revised,FSDS-R)、阴道松弛问卷(vaginal laxity questionnaire,VLQ)以及性生活满意度问卷(sexual satisfaction questionnaire,SSQ)的主观评分,结合对小阴唇基底边长、外阴着色和弹性等指标的客观评估,综合评价射频治疗的临床疗效与安全性。结果:试验组患者首次治疗后第18周较基线的FSFI总分改变值(△T)的均值为(8.72±3.94)分,对照组(△C)为(-0.03±1.28)分,2组平均FSFI总分改变值的差值(△T-△C)为8.75分,95%CI为6.889~10.613分,组间差值的95%CI下限大于0,试验组FSFI评分优于对照组(t=4.810,P<0.001)。两因素重复测量方差分析结果显示,FSFI评分的时间主效应(F时间=24.156,P时间<0.001)、组别主效应(F组别=12.754,P组别=0.001)、时间×组别的交互作用(F时间×组别=25.689,P时间×组别<0.001)均有统计学意义。以组别为自变量的干预效应表明,治疗6、10、18周后,试验组FSFI评分高于对照组,差异有统计学意义(均P<0.05)。以时间为自变量的时间效应表明,治疗后各时间点的FSFI评分均高于治疗前,且治疗6、10、18周后的FSFI评分均高于治疗3周后,差异有统计学意义(均P<0.05);而治疗6、10、18周后的FSFI评分比较,差异无统计学意义(均P>0.05)。治疗10、18周后,试验组FSDS-R评分、小阴唇基底边长均低于对照组,SSQ评分高于对照组,差异有统计学意义(均P<0.05)。治疗3、6、10、18周后,试验组VLQ评分、指测阴道松弛改善程度及外阴状态均优于对照组,差异均Objective:To investigate the clinical efficacy and safety of a novel temperature-controlled radiofrequency(TCRF)treatment for postpartum vaginal laxity.Methods:A total of 43 female patients with postpartum vaginal laxity,treated at Beijing Tsinghua Changgung Hospital,affiliated with Tsinghua University from June 2022 to June 2023,were selected for this study.The patients were randomly divided into two groups:the experimental group(21 patients)received the novel TCRF treatment,while the control group(22 patients)received a sham treatment(no temperature or energy applied).Clinical efficacy and safety were comprehensively evaluated by comparing subjective scores from the female sexual function index(FSFI),female sexual distress scale-revised(FSDS-R),vaginal laxity questionnaire(VLQ),and sexual satisfaction questionnaire(SSQ)before and after treatment,alongside objective assessments of labia minora basal length,vulvar pigmentation,and elasticity.Results:At the 18th week after the first treatment,the mean change in total FSFI score(△T)in the experimental group was 8.72±3.94 points,while in the control group(△C),it was-0.03±1.28 points.The mean difference in FSFI score change between the two groups(△T-△C)was 8.75 points,with a 95%CI of 6.889-10.613 points,indicating that the lower limit of the 95%CI for the difference between the two groups was greater than 0.The experimental group showed a significant improvement in FSFI scores compared to the control group(t=4.810,P<0.001).Two-factor repeated measures ANOVA demonstrated that the main effects of time(Ftime=24.156,Ptime>0.001),group(Fgroup=12.754,Pgroup=0.001),and the interaction between time and group(Ftime×group=25.689,Ptime×group>0.001)was statistically significant.Intervention effects,with group as the independent variable,indicated that FSFI scores in the experimental group were significantly higher than those in the control group at 6,10,and 18 weeks post-treatment (all P<0.05). Time effect analysis, with time as the independent variable, showed that

关 键 词：射频疗法 病人满意度 阴道松弛症 盆底功能障碍性疾病 温控射频 无创治疗 

分 类 号：R714.6[医药卫生—妇产科学]