重组Ⅲ型人源化胶原蛋白阴道凝胶治疗阴道干涩临床研究  

Clinical research in recombinant human type Ⅲ collagen-derived vaginal gel in the treatment of vaginal dryness

作　　者：董晓静[1] 郭雪桃[2] 游爽 刘丽[1] 仇丽霞[3] 朱赟 陆路[5] 胡丽娜[1] DONG Xiao-jing;GU Xue-tao;YOU Shuang;LIU Li;QIU Li-xia;ZHU Yun;LU Lu;HU Li-na(The Second Affiliated Hospital of Chongqing Medical University,Chongqing 400010,China;不详)

机构地区：[1]重庆医科大学附属第二医院妇产科,重庆400010 [2]山西医科大学附属第一医院,山西太原030001 [3]山西医科大学,山西太原030001 [4]中国科学院生物物理研究所生物大分子国家实验室,北京100101 [5]复旦大学上海医学院公共卫生临床中心教育部医学分子病毒学重点实验室,上海200032

出　　处：《中国实用妇科与产科杂志》2022年第6期657-660,共4页Chinese Journal of Practical Gynecology and Obstetrics

基　　金：高等学校学科创新引智计划([2016]404号);重庆医科大学附属第二医院“宽仁英才”项目(13-003-003)。

摘　　要：目的 探讨重组Ⅲ型人源化胶原蛋白阴道凝胶治疗阴道干涩的临床疗效和安全性。方法 将2014年1月至5月重庆医科大学附属第二医院和山西医科大学附属第一医院收治的80例阴道干涩患者随机分为两组,分别给予重组Ⅲ型人源化胶原蛋白阴道凝胶(研究组,2g/次)和透明质酸衍生物阴道凝胶(对照组,3g/次)治疗,隔日1次,共10次。比较治疗前后及两组之间阴道干燥指数、阴道p H值、外阴阴道刺痛、性交疼痛、症状缓解时间以及总体疗效。结果 符合研究方案且完成研究者,研究组38例,对照组38例。治疗后研究组干燥指数增加3分、增加了33.3%,有效率为63.2%;对照组增加2分、增加了27.3%、有效率为39.5%,两组间差异有统计学意义(P<0.05)。两组治疗对pH值均无影响。治疗后外阴阴道干涩刺痛、性交疼痛症状均有改善,两组间差异无统计学意义(P>0.05)。研究组对疗效满意度的主观评价中,满意及非常满意的比例为63.1%,对照组为24.7%,差异有统计学意义(P<0.05)。结论 重组Ⅲ型人源化胶原蛋白阴道凝胶可安全、有效地缓解阴道干涩症状,尤其适用于不宜使用激素治疗的患者。Objective To evaluate the clinical efficacy and safety of recombinant human type Ⅲ collagen-derived vaginal gel in the treatment of vaginal dryness.Methods A total of 80 women suffering vaginal dryness who are treated in the Second Affiliated Hospital of Chongqing Medical University and the first hospital of Shanxi medical university form Jan 2014 to May 2014 were divided into two groups,40 were treated with recombinant human typeⅢcollagenderived vaginal gel(study group,2g per time)and 40 with hyaluronic acid vaginal gel(control group,3g per time)every other day for a total of 10 times.The index of vaginal dryness,vaginal p H,vulvar and vaginal sting,dyspareunia,symptomatic relief time and total effect were compared between the two groups before and after treatment.Results Finally 76 patients were enrolled in this study,each group with 38.The index of vaginal dryness was increased 3 points which was increased by 33.3%and the effectiveness was 63.2%in study group.The index of vaginal dryness was increased 2 points,which was increased by 27.3%and the effectiveness was 39.5%in control group(P<0.05).The vaginal p H had no changed after treatment in the two groups.The vulvar and vaginal sting and dyspareunia were relieved in the two groups after treatment.There was no statistic difference(P>0.05).Satisfaction evaluation was higher in study group(63.1%)than in control group(24.7%)(P<0.05).Conclusion Recombinant human typeⅢcollagenderived vaginal gel is effective and safe in relieving symptoms of vaginal dryness,and it is especially suitable for vaginal dryness women who are unsuitable for estrogen therapy.

关 键 词：绝经 阴道干涩 阴道凝胶 重组Ⅲ型人源化胶原蛋白 透明质酸衍生物阴道凝胶 

分 类 号：R711.73[医药卫生—妇产科学]