Department of Gynecology and Obstetrics, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Gynecology and Obstetrics, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
BMC Med. 2024 Sep 16;22(1):395. doi: 10.1186/s12916-024-03608-4.
Transcervical resection of adhesions (TCRA) is the standard treatment for intrauterine adhesion (IUA). Previous studies have shown that postoperative oral estrogen or an intrauterine physical barrier could reduce the recurrence of IUA by promoting the proliferation of the endometrium or inhibiting the reformation of adhesions. Our team designed an intrauterine stent that can release estrogen within the uterine cavity slowly. In this study, we aimed to investigate the efficacy and safety of the estrogen-releasing intrauterine system in preventing the recurrence of moderate to severe IUA.
This was a multicenter prospective randomized controlled 2-arm parallel trial that included patients who were diagnosed with moderate to severe IUA and who received TCRA. A total of 250 patients were randomly assigned, at a 1:1 ratio, to receive the intrauterine estrogen-releasing system or a Foley catheter balloon combined with oral estrogen therapy after surgery. The primary outcome was the rate of adhesion reduction in the two groups. The secondary outcomes included endometrial thickness at the ovulation period, menstrual improvement rates, and other reported adverse events during follow-up.
The average daily drug release amount for all the tested stents was 0.21 mg/day. At 60 days postoperatively, the rate of adhesion reduction was significantly greater in the experimental group than in the control group (93.33% vs. 58.56%, p < 0.001). The endometrium of the experimental group was thicker than that of the control group (p < 0.001). Consistently, the rate of improvement in menstruation was greater in the experimental group than in the control group (p = 0.010). No grade 3-4 adverse events were found in the two groups during the 1-year follow-up.
In the cohort of patients with moderate to severe IUA, the intrauterine estrogen-releasing system was more effective at reducing adhesion than traditional oral estrogen combined with an intrauterine Foley catheter after TCRA. This novel intrauterine system provides a new option for the management of IUA after surgery.
The registration number is NCT04972032. Date of registration: August 15, 2021.
经宫颈粘连切除术（TCRA）是治疗宫腔粘连（IUA）的标准治疗方法。先前的研究表明，术后口服雌激素或宫腔内物理屏障可以通过促进子宫内膜增殖或抑制粘连再形成来降低 IUA 的复发率。我们的团队设计了一种可以在宫腔内缓慢释放雌激素的宫内支架。在这项研究中，我们旨在研究雌激素释放宫内系统预防中重度 IUA 复发的疗效和安全性。
这是一项多中心前瞻性随机对照 2 臂平行试验，纳入了诊断为中重度 IUA 并接受 TCRA 的患者。将 250 例患者按 1:1 比例随机分为两组，术后分别接受宫内雌激素释放系统或 Foley 导管球囊联合口服雌激素治疗。主要结局是两组粘连减少率。次要结局包括排卵期间的子宫内膜厚度、月经改善率以及随访期间其他报告的不良事件。
所有测试支架的平均日药物释放量为 0.21mg/天。术后 60 天，实验组粘连减少率明显高于对照组（93.33% vs. 58.56%，p<0.001）。实验组的子宫内膜比对照组厚（p<0.001）。同样，实验组的月经改善率也高于对照组（p=0.010）。两组在 1 年随访期间均未发现 3-4 级不良事件。
在中重度 IUA 患者队列中，与 TCRA 后传统口服雌激素联合宫腔内 Foley 导管相比，宫内雌激素释放系统在减少粘连方面更有效。这种新型宫内系统为术后 IUA 的管理提供了一种新的选择。
注册号为 NCT04972032。注册日期：2021 年 8 月 15 日。
