新型自交联透明质酸钠凝胶对人工流产手术后子宫内膜修复的影响一项多中心前瞻性随机对照研究

Potential of new self-crosslinked hyaluronic acid gel on the recovery of endometrium after artificial abortion:a multicenter,prospective randomized controlled trial

李春颖 ¹滕莉荣 ¹林青 ²赵丽萍 ³朱云霞 ⁴米鑫 ⁵王贞娜 ⁵王晓晔 ⁶张李松 ⁷韩丹 ⁸马丽丽 ⁹白文佩 ¹⁰王建梅 ¹¹倪俊 ¹²沈会平 ¹³陈勤芳 ¹⁴许洪梅 ¹⁵任琛琛 ¹⁶江静 ¹⁷刘冠媛 ¹⁸彭萍 ¹刘欣燕¹

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作者信息

1. 中国医学科学院北京协和医院妇产科,北京 100730
2. 首都医科大学附属北京友谊医院妇产科,北京 100050
3. 北京市大兴区妇幼保健院妇女保健部,北京 102600
4. 首都医科大学附属北京佑安医院产科,北京 100069
5. 北京市顺义区妇幼保健院生殖调节科,北京 101300
6. 北京大学第三医院妇产科,北京 100191
7. 首都医科大学附属复兴医院妇科,北京 100038
8. 首都医科大学附属北京天坛医院妇产科,北京 100070
9. 北京市大兴区人民医院妇产科,北京 102600
10. 首都医科大学附属北京世纪坛医院妇科,北京 100038
11. 天津医科大学第二医院计划生育科,天津 300211
12. 北京市海淀医院妇产科,北京 100080
13. 北京市海淀区妇幼保健院计划生育服务指导科,北京 100080
14. 中国福利会国际和平妇幼保健院计划生育科,上海 200030
15. 北京丰台医院妇产科,北京 100071
16. 郑州大学第三附属医院妇科,郑州 450052
17. 河北医科大学第二医院妇产科,石家庄 050000
18. 首都医科大学附属北京朝阳医院妇产科,北京 100020
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摘要

目的评估人工流产手术后应用自交联透明质酸钠(SCH)凝胶对子宫内膜修复的影响.方法本研究为多中心、前瞻性随机对照试验.纳入2021年12月至2023年2月期间18家医院的382例接受人工流产手术的妇女.以交叉设计随机化生成分配表并制作随机分配信封,全部受试者按照随机信封以1∶1比例分配至SCH组(接受SCH凝胶治疗)、对照组(未接受SCH凝胶治疗),均为191例.主要疗效指标为术后首次月经结束后第14～18天的子宫内膜厚度,次要疗效指标包括术后6周内是否月经复潮、月经复潮时间、术后首次月经的经量变化(与术前比较)、术后首次月经经期天数以及痛经情况.结果两组受试者的基线特征差异均无统计学意义(P均＞0.05);382例受试者中,共有359例[SCH组182例(95.3％,182/191)、对照组177例(92.7％,177/191)]完成了本研究的统计学分析.SCH组受试者人工流产手术后子宫内膜厚度显著大于对照组[分别为(9.78±3.15)、(8.95±2.32)mm;P=0.005].SCH组经量减少的发生率也明显低于对照组[分别为12.6％(23/182)、17.5％(31/177);P=0.038].尽管SCH组术后首个月经期间痛经情况较少,但两组比较,差异无统计学意义[分别为28.5％(51/179)、37.1％(65/175);P=0.083].在术后6周内月经复潮的例数、月经复潮时间和经期天数方面,两组之间分别比较均无显著差异(P均＞0.05).研究期间未观察到严重不良事件,且无任何归因于SCH凝胶治疗的不良事件.结论人工流产手术后应用SCH凝胶是安全的,并有助于促进子宫内膜的修复.

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.

关键词

透明质酸/流产,人工/子宫内膜/随机对照试验/自交联透明质酸钠凝胶

Key words

Hyaluronic acid/Abortion,induced/Endometrium/Randomized controlled trial/Self-crosslinked hyaluronic acid gel

引用本文复制引用

出版年

2024

中华妇产科杂志

中华医学会

中华妇产科杂志

CSTPCDCSCD北大核心

影响因子：2.752

ISSN：0529-567X

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