[Potential of new self-crosslinked hyaluronic acid gel on the recovery of endometrium after artificial abortion: a multicenter, prospective randomized controlled trial].
C Y Li, L R Teng, Q Lin, L P Zhao, Y X Zhu, X Mi, Z N Wang, X Y Wang, L S Zhang, D Han, L L Ma, W P Bai, J M Wang, J Ni, H P Shen, Q F Chen, H M Xu, C C Ren, J Jiang, G Y Liu, P Peng, X Y Liu
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引用次数: 0
Abstract
Objective: To evaluate the impact of self-crosslinked hyaluronic acid (SCH) gel on endometrium recovery after artificial abortion. Methods: A multicenter, prospective randomized controlled trial was conducted across 18 hospitals from December 2021 to February 2023, involving 382 women who underwent artificial abortion. Participants were randomly allocated to receive either treatment with SCH gel (SCH group) or no treatment (control group) in a 1∶1 ratio. The primary outcome was endometrium thickness in 14 to 18 days after the first postoperative menstruation. Secondary outcomes included changes in menstrual volume during the first postoperative menstruation, menstruation resumption within 6 postoperative weeks, time to menstruation resumption, duration of the first postoperative menstruation, and incidence of dysmenorrhea. Results: Baseline characteristics of participants were comparable between the two groups (all P>0.05), with 95.3% (182/191) in SCH group and 92.7% (177/191) in the control group completed the study. The postoperative endometrial thickness in SCH group was significantly greater than that in the control group [(9.78±3.15) vs (8.95±2.32) mm; P=0.005]. SCH group also had significantly fewer participants with reduced menstrual volume [23 cases (12.6%, 23/182) vs 31 cases (17.5%, 31/177); P=0.038]. Although SCH group experienced less dysmenorrhea during the first postoperative menstrual period, this difference was not statistically significant [28.5% (51/179) vs 37.1% (65/175); P=0.083]. Outcomes were similar between SCH group and the control group regarding the proportion of participants who resumed menstruation within 6 weeks postoperatively, time to menstruation resumption, and duration of the first postoperative menstruation (P=0.792, 0.485, and 0.254, respectively). No serious adverse events were observed during the study period, and no adverse events were attributed to SCH gel treatment. Conclusion: The application of SCH gel after artificial abortion is safe and might aid in the recovery of the endometrium.
目的:评估自交联透明质酸凝胶对人工流产后子宫内膜恢复的影响:评估自交联透明质酸(SCH)凝胶对人工流产后子宫内膜恢复的影响。方法:在 18 家医院开展一项多中心、前瞻性随机对照试验:2021年12月至2023年2月期间,在18家医院开展了一项多中心、前瞻性随机对照试验,共有382名女性接受了人工流产。参与者按1∶1的比例随机分配接受SCH凝胶治疗(SCH组)或不接受治疗(对照组)。主要结果是术后第一次月经来潮后14至18天的子宫内膜厚度。次要结果包括术后首次月经期间月经量的变化、术后6周内月经恢复情况、月经恢复时间、术后首次月经持续时间和痛经发生率。研究结果两组参与者的基线特征具有可比性(P均大于0.05),SCH组95.3%(182/191)和对照组92.7%(177/191)的参与者完成了研究。SCH组术后子宫内膜厚度明显高于对照组[(9.78±3.15) mm vs (8.95±2.32) mm; P=0.005]。SCH组中月经量减少的人数也明显少于对照组[23例(12.6%,23/182) vs 31例(17.5%,31/177);P=0.038]。虽然SCH组在术后第一次月经期间出现痛经的人数较少,但这一差异在统计学上并不显著[28.5%(51/179) vs 37.1%(65/175);P=0.083]。在术后6周内恢复月经的参与者比例、恢复月经的时间以及术后首次月经持续时间方面,SCH组与对照组的结果相似(P分别为0.792、0.485和0.254)。研究期间未观察到严重不良事件,也没有不良事件归因于SCH凝胶治疗。结论人工流产后使用SCH凝胶是安全的,可能有助于子宫内膜的恢复。