Randomized controlled clinical trial of recombinant humanized type Ⅲ collagen freeze-dried fibers for the treatment of vaginal laxity
CHEN Meng-jie
ZHANG San-yuan
XU Ying-ya
ZHONG Xiao-cui
HU Li-na
DONG Xiao-jing
Abstract：Objective To investigate the clinical efficacy and safety of recombinant humanized type Ⅲ collagen freeze-dried 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 type Ⅲ hu-manized collagen freeze-dried fiber added with type Ⅲ collagen vaginal gel,n=42)and the control group(type Ⅲ colla-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 type Ⅲ collagen freeze-dried fibers by vagi-nal injection is an effective method for the treatment of vaginal laxity with good safety.
Keywords：recombinant humanized type Ⅲ collagenvaginal laxityrandomized control
Publication Date：2024-06-02
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：4( 665-668 )