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Study question

研究问题

To compare the effectiveness of levonorgestrel-releasing intrauterine system (LNG-IUS 52mg) with hysteroscopic niche rep in the reduction of niche-related postmenstrual spotting.

比较左炔诺孕酮宫内缓释系统（LNG-IUS 52mg）与宫腔镜下子宫憩室切除术在治疗子宫瘢痕憩室相关的月经后点滴状出血的疗效。

Summary answer

答案总结

In women with niche-related postmenstrual spotting, LNG-IUS did not more often reduce spotting days with 50% at 6th month than hysteroscopic niche rep.

在有憩室相关的月经后点滴状出血的患者中，LNG-IUS治疗后6个月后在缩短出血时间（减少50%的出血时间）方面并没有优于宫腔镜子宫憩室切除术。

What is known already

既往已知

Both Levonorgestrel intrauterine system (LNG-IUS) and hysteroscopic niche rep are widely implemented to reduce niche-related postmenstrual spotting. The study aimed to compare the effectiveness of LNG-IUS 52mg with hysteroscopic niche rep in the reduction of niche-related postmenstrual spotting.

LNG-IUS和宫腔镜子宫憩室切除术是两种已广泛应用于治疗憩室相关的月经后点滴状出血的方法，本研究旨在比较两者的疗效。

Study design, size, duration

研究设计、样本量、时长

A randomised, open-label, controlled trial conducted at one medical center in Shanghai, China. From September 2019 to January 2022, we randomised 208 women to LNG-IUS (N = 104) or hysteroscopic niche rep (N = 104).The primary outcome was reduction of postmenstrual spotting at 6th month after randomisation, defined as percentage of women with a reduction of at least 50% in spotting days from baseline. Efficacy and safety were assessed by an intention-to-treat analyses.

在上海的一家医疗中心进行的一项开放标签的随机对照试验。研究纳入2019年9月至2022年1月间的208例患者，将其随机分为两组，LNG-IUS组（N=104）和宫腔镜组（N=104）。主要结局为治疗后6个月月经后点滴状出血的减少情况（与治疗前相比点滴状出血天数减少50%的比例），采用意向性治疗分析评估疗效和安全性。

Participants/materials, setting, methods

研究对象、设计、方法

Women with symptoms of postmenstrual spotting after CS, with a niche depth of at least 2 mm and residual myometrium of at least 2.2mm on Magnetic Resonance Imaging (MRI), and no intention to conceive within the next year were randomly assigned to treatment with LNG-IUS 52mg or a hysteroscopic niche rep.

剖宫产术后出现月经后点滴状出血，MRI检查提示憩室深度＞2mm，局部浆肌层厚度不小于2.2mm，术后无生育意向的女性，随机分为两组，LNG-IUS组和宫腔镜组。

Main results and the role of chance

主要结果和几率

At 6th month follow-up, a 50% reduction of spotting had occurred in 78.4% (80/102) women in the LNG-IUS group and 73.1% (76/104) women in the hysteroscopic niche rep group (RR = 1.07, [95%CI 0.92-1.25]; P = 0.370). Spotting reduced over time (Ptrend=0.001), with a stronger reduction in the LNG-IUS group (P = 0.001), while there was also a significant interaction between time and treatment (P = 0.007). From nine months onwards, reduction of spotting occurred significantly more after LNG-IUS than hysteroscopic niche rep (9th month 89.2% vs. 72.1%, RR = 1.24, [95% CI 1.08-1.42]; 12th month 90.2% vs. 70.2%, RR = 1.29, [95% CI 1.12-1.48]).

Moreover, compared with the hysteroscopic niche rep group, the LNG-IUS group had significantly fewer postmenstrual spotting days and total bleeding days from six months onwards (all P < 0.001), and less pelvic pain from three months onwards (all P < 0.010).

Intervention-related complications were not reported in any of the groups. During follow-up, eleven (10.8%) women reported hormonal related side-effects and two (2.0%) women had spontaneous partial expulsion in the LNG-IUS group, while in the hysteroscopic niche rep group three unintended pregnancies were reported.

随访6个月，LNG-IUS组18.4%（80/102）的患者出血减少50%，而宫腔镜组为73.1%（76/104）（RR=1.07，95%CI 0.92-1.25；P=0.370）。治疗持续时间与疗效之间有明显的交互性，随着时间的推移（Ptrend=0.001），LNG-IUS组出血减少更为明显（P=0.001）。治疗后9个月，LNG-IUS减少出血较宫腔镜更为明显（9个月时，89.2% vs 72.1%，RR=1.24，95%CI 1.08-1.42；12个月时，90.2% vs 70.2%，RR=1.29，95%CI 1.12-1.48）。

此外与宫腔镜组相比，LNG-IUS组在治疗后6个月月经后点滴状出血天数及月经出血总天数方面均明显减少（P＜0.001），治疗后3个月，盆腔痛率减少（P＜0.010）。

两组均未发生治疗相关的并发症。在随访过程中，LNG-IUS组中11例出现激素相关的副作用，2例出现环位下移。宫腔镜组，3例意外妊娠。

Limitations, reasons for caution

局限性

Due to the nature of the intervention, it was not possible to blind participants and gynaecologists for treatment allocation.The cut-off value chosen for our primary outcome and the moment of assessment for our primary endpoint can both be debated.

由于治疗本身的特定，在治疗方法分配时，无论对患者还是医生都无法完全做到盲法。对于主要结局的截断值以及主要结局评估时间，均值得探讨。

Wider implications of the findings

研究意义

LNG-IUS provides an alternative treatment for women with niche-related gynaecological symptoms and no active desire to become pregnant.

对于有子宫憩室相关的月经后点滴状出血症状，且无再次生育意向的患者，LNG-IUS是一种可供选择的替代治疗方法。

文章来源：

Y Wang, X He, Y Tian, L Xie, B Mol, J Huirne, Z Jian, P-751 Comparing levonorgestrel intrauterine system versus hysteroscopic niche rep in women with postmenstrual spotting related to a niche in the uterine caesarean scar, Human Reproduction, Volume 38, Issue Supplement_1, June 2023, dead093.054, https://doi.org/10.1093/humrep/dead093.054