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自交联透明质酸凝胶与宫内节育器预防不孕患者宫腔粘连的比较:一项随机临床试验

Comparison of Autocross-Linked Hyaluronic Acid Gel and Intrauterine Device for Preventing Intrauterine Adhesions in Infertile Patients: A Randomized Clinical Trial.

作者信息

Wang Yu-Qing, Song Xiao-Hua, Wu She-Ling, Huang Yu-Zhen, Yan Lei, Li Chang-Zhong

机构信息

School of medicine, Shandong University, Shandong, China.

Center for Reproductive Medicine, Reproductive Hospital Affiliated to Shandong University, Shandong, China.

出版信息

Gynecol Minim Invasive Ther. 2020 Apr 28;9(2):74-80. doi: 10.4103/GMIT.GMIT_103_19. eCollection 2020 Apr-Jun.

Abstract

OBJECTIVES

The objective of this study is to evaluate the efficacy of autocross-linked hyaluronic acid (HA) compared with intrauterine device (IUD) for preventing intrauterine adhesions (IUAs) in infertile patients after hysteroscopic adhesiolysis.

MATERIALS AND METHODS

A randomized clinical trial (ChiCTR-IOR-16007746). Upon completion of adhesiolysis, 3 ml of HA gel was placed into the uterine cavity in Group A; 3 ml of HA gel and an IUD were placed in Group B; and only an IUD was placed in Group C. A second hysteroscopic examination was performed in all patients at approximately 1 month postoperatively for the evaluation of IUA. The primary outcome measure was the effective rate of IUA prevention based on the American Fertility Society (AFS) scoring system.

RESULTS

Eighty-nine women were randomly distributed into two groups for intention to treat with 30 patients in Group A, 24 patients in Group B, and 35 patients in Group C. Patients were scored and stratified into three degrees and were enrolled using the simple random sampling method. The three groups were well balanced. There were no significant differences in age, endometrial thickness, the previous number of pregnancy, and the distribution of adhesion categories across mild, moderate, and severe between the three groups. The effective rate of IUA prevention, the AFS score after therapy, and the percentage improvements of Chinese score and AFS score before and after surgery were statistically significant difference between Groups A and C. The clinical pregnancy rate in Group A was higher than those in Groups B and C, but the difference was not statistically significant.

CONCLUSION

HA gel has an advantage over an IUD in reducing IUA recurrence and decreasing adhesions.

摘要

目的

本研究旨在评估自交联透明质酸(HA)与宫内节育器(IUD)相比,在宫腔镜粘连松解术后预防不孕患者宫腔粘连(IUA)的疗效。

材料与方法

一项随机临床试验(ChiCTR-IOR-16007746)。粘连松解完成后,A组将3ml HA凝胶注入宫腔;B组将3ml HA凝胶和一枚IUD置入宫腔;C组仅置入一枚IUD。所有患者在术后约1个月进行第二次宫腔镜检查以评估IUA。主要结局指标是基于美国生育协会(AFS)评分系统的IUA预防有效率。

结果

89名女性被随机分为两组进行意向性治疗,A组30例,B组24例,C组35例。对患者进行评分并分层为三度,采用简单随机抽样方法纳入。三组均衡性良好。三组在年龄、子宫内膜厚度、既往妊娠次数以及轻度、中度和重度粘连类别分布方面无显著差异。A组和C组在IUA预防有效率、治疗后AFS评分以及手术前后中文评分和AFS评分的改善百分比方面存在统计学显著差异。A组的临床妊娠率高于B组和C组,但差异无统计学意义。

结论

HA凝胶在降低IUA复发和减少粘连方面优于IUD。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4170/7354758/0858763349d0/GMIT-9-74-g001.jpg

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