重组Ⅲ型人源化胶原蛋白冻干纤维治疗阴道松弛症随机对照临床试验研究  

Randomized controlled clinical trial of recombinant humanized typeⅢcollagen freeze-dried fibers for the treatment of vaginal laxity.

作　　者：陈梦捷 张三元[2] 徐迎亚 钟晓翠 胡丽娜[1] 董晓静[1] CHEN Meng-jie;ZHANG San-yuan;XU Ying-ya;ZHONG Xiao-cui;HU Li-na;DONG Xiao-jing(Department of the Obstetrics and Gynecology,the Second Affiliated Hospital of Chongqing Medical University,Chongqing 400010,China;Department of the Obstetrics and Gynecology,the First Hospital of Shanxi Medical Universi-ty,Taiyuan 030001,China)

机构地区：[1]重庆医科大学附属第二医院妇产科,重庆400010 [2]山西医科大学第一医院妇产科,山西太原030001

出　　处：《中国实用妇科与产科杂志》2024年第6期665-668,共4页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：太原市科技局2023年度“双百攻关行动”第一批“揭榜挂帅”项目(2024TYJB0149)。

摘　　要：目的探讨重组Ⅲ型人源化胶原蛋白冻干纤维在治疗阴道松弛症中的临床疗效及安全性。方法2022年6月至2023年3月在重庆医科大学附属第二医院和山西医科大学第一医院确诊的84例阴道松弛症患者纳入研究,随机分为研究组[采用重组Ⅲ型人源化胶原蛋白冻干纤维联合医用Ⅲ型胶原阴道凝胶(加载产品)治疗,42例]和对照组(采用医用Ⅲ型胶原阴道凝胶治疗,42例)。比较两组患者治疗前后阴道松弛分度量化评分改善率、女性性功能指数(FSFI)评分、阴道松弛问卷(VLQ)评分、盆底肌评估总分及不良反应发生率等指标的差异。结果治疗结束后4周研究组阴道松弛量化评分改善率为88.10%(37/42),显著高于对照组(30.95%,13/42),差异有统计学意义(P<0.001)。去除加载产品后研究组的有效率为57.14%。研究组FSFI评分改善及VLQ评分改善显著优效于对照组(P<0.05)。其中在性活动时阴道润滑性、性交痛(改善)、性生活满意度和主观性唤起能力4个方面,研究组改善情况均优于对照组。研究组与对照组在安全性方面无明显差异,均无严重不良事件发生。结论重组Ⅲ型人源化胶原蛋白冻干纤维经阴道注射治疗阴道松弛症具有较好的疗效及安全性。Objective To investigate the clinical efficacy and safety of recombinant humanized typeⅢcollagen freezedried fibers in the treatment of vaginal laxity.Methods From June 2022 to March 2023,84 patients diagnosed with vagi⁃nal laxity in the Second Affiliated Hospital of Chongqing Medical University and the First Hospital of Shanxi Medical University were enrolled in this study.They were randomly divided into the experimental group(recombinant typeⅢhu⁃manized collagen freeze-dried fiber added with typeⅢcollagen vaginal gel,n=42)and the control group(typeⅢcolla⁃gen vaginal gel,n=42).The improvement rate of vaginal laxity grading quantitative score,female sexual function index,vaginal laxity questionnaire score,pelvic floor muscle evaluation score,and the incidence of adverse reactions were com⁃pared between the two groups before and after treatment.Results Four weeks after the treatment,the improvement rate of vaginal laxity quantitative score in the experimental group was 88.10%(37/42),significantly higher than that in the control group(30.95%,13/42,P<0.001).The effective rate of the experimental group after minus the loaded product was 57.14%.The improvement of FSFI score and VLQ score in the experimental group was significantly superior to that in the control group(P<0.05).Among them,the vaginal lubrication during sexual activity,dyspareunia(improvement),sexual life satisfaction,and subjective arousal ability,the improvement in the experimental group was better than that in the con⁃trol group.There was no statistical difference in safety between the experimental group and the control group,and no seri⁃ous adverse events occurred.Conclusion Recombinant humanized typeⅢcollagen freeze-dried fibers by vagi⁃nal injection is an effective method for the treatment of vaginal laxity with good safety.

关 键 词：重组Ⅲ型人源化胶原蛋白 阴道松弛症 随机对照 

分 类 号：R711.73[医药卫生—妇产科学]