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壳聚糖联合宫内节育器预防宫腔镜粘连松解术后宫腔粘连:一项目标试验模拟研究。

Chitosan combined with intrauterine device prevents intrauterine adhesions after hysteroscopic adhesiolysis: A target trial emulation study.

机构信息

Department of Gynecology, The Fourth Hospital of Shijiazhuang, Shijiazhuang, China.

Department of Obstetrics, The Fourth Hospital of Shijiazhuang, Shijiazhuang, China.

出版信息

J Obstet Gynaecol Res. 2023 Jun;49(6):1571-1578. doi: 10.1111/jog.15629. Epub 2023 Mar 4.

DOI:10.1111/jog.15629
PMID:36869641
Abstract

AIM

To compare the efficacy of chitosan and intrauterine device (IUD) combination with an IUD alone in patients with intrauterine adhesions (IUAs) who underwent hysteroscopic adhesiolysis.

METHODS

This retrospective study assessed 303 patients with moderate-to-severe IUA (American Fertility Society [AFS] score ≥5) who underwent hysteroscopic adhesiolysis between January 2018 and December 2020. Using observational data under a cohort design, we emulated a target trial with two treatment arms: chitosan plus IUD and IUD alone groups. Second-look hysteroscopy was performed in all patients 3 months after the initial hysteroscopy. The primary outcome was improved adhesion assessed using the AFS scoring system.

RESULTS

The baseline characteristics were balanced between the two groups. The second hysteroscopy revealed significantly better AFS scores in group A than in group B (values: 3 [1-4] vs. 4 [2-6], p < 0.001; change: 63% [50%-80%] vs. 44% [33%-67%], p < 0.001, respectively). Significantly better menstruation conditions (improved rate: 66% vs. 49%, p = 0.004) and endometrial thickness (mean: 7.0 mm vs. 6.0 mm, p < 0.001) were also observed in group A than in group B. Moreover, group A showed a significantly higher 1-year clinical pregnancy rate (40% vs. 28%, p = 0.037) and better quality of life (p < 0.001) than group B.

CONCLUSIONS

Chitosan and IUD combination showed better efficacy in reducing adhesions and improving clinical outcomes in patients with moderate-to-severe IUA after hysteroscopic adhesiolysis.

摘要

目的

比较宫腔粘连(IUAs)患者宫腔镜粘连松解术后应用壳聚糖与单纯宫内节育器(IUD)治疗的疗效。

方法

本回顾性研究纳入了 2018 年 1 月至 2020 年 12 月期间接受宫腔镜粘连松解术的 303 例中重度宫腔粘连(美国生殖医学学会[AFS]评分≥5)患者。采用队列设计下的观察性数据,我们模拟了一个具有两个治疗组的目标试验:壳聚糖+IUD 组和 IUD 组。所有患者在初次宫腔镜检查后 3 个月进行二次宫腔镜检查。主要结局为使用 AFS 评分系统评估粘连改善情况。

结果

两组患者的基线特征平衡。A 组第二次宫腔镜检查的 AFS 评分明显优于 B 组(分值:3[1-4] vs. 4[2-6],p<0.001;变化:63%[50%-80%] vs. 44%[33%-67%],p<0.001)。A 组的月经情况(改善率:66% vs. 49%,p=0.004)和子宫内膜厚度(平均值:7.0mm vs. 6.0mm,p<0.001)也明显优于 B 组。此外,A 组 1 年临床妊娠率(40% vs. 28%,p=0.037)和生活质量(p<0.001)明显优于 B 组。

结论

与单纯 IUD 相比,宫腔粘连松解术后应用壳聚糖与 IUD 联合治疗中重度宫腔粘连可减少粘连,改善临床结局。

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