近日，美国加州大学圣地亚哥健康中心Charles W. Nager及其研究团队探讨了阴道网片子宫固定术与子宫骶韧带悬吊阴道子宫切除术对子宫阴道脱垂患者的治疗效果。这一研究成果于2019年9月17日发表在国际顶尖医学期刊《美国医学会杂志》上。

2013年4月至2015年2月，美国盆底疾病网络的9个临床中心进行了一项随机、优越性临床试验，招募了183名患症状性阴道子宫脱垂的绝经后妇女，平均年龄为66岁，将其随机分为两组，93名行阴道网片子宫固定术，90名行子宫骶韧带悬吊阴式子宫切除术。采用生存模型对治疗失败的综合结局进行评估，包括脱垂再治疗、处女膜外脱垂和有脱垂症状。

术后36个月，子宫固定术组患者的失败率为26%，子宫切除术组为38%，校正风险比为0.62。子宫固定术组的平均手术时间为111.5分钟，显著短于子宫切除术组（156.7分钟）。子宫固定术组中有8%的患者发生网片暴露，12周后，1%发生肉芽组织，3%缝合线暴露；子宫切除术组中有7%的患者术中发生输尿管扭结，12周后，11%发生肉芽组织，21%缝合线暴露。

虽然阴道网片子宫固定术与子宫骶韧带悬吊阴道子宫切除术相比，并没有显著降低子宫阴道脱垂患者再脱垂的复发率，但其疗效的置信区间很宽，还需进一步研究来评估阴道网片子宫固定术是否比子宫切除术更有效。

据悉，子宫阴道脱垂最常采用顶端缝合悬吊阴道子宫切除术，经阴道网片子宫固定术是一种替代选择。

附：英文原文

Title: Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse: A Randomized Clinical Trial

Author: Charles W. Nager, Anthony G. Visco, Holly E. Richter, Charles R. Rardin, Rebecca G. Rogers, Heidi S. Harvie, Halina M. Zyczynski, Marie Fidela R. Paraiso, Donna Mazloomdoost, Scott Grey, Amaanti Sridhar, Dennis Wallace

Issue&Volume: Vol 322 No 11

Abstract: 

Importance  Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option.

Objective  To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy.

Design, Setting, Participants  At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018.

Interventions  Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension.

Main Outcomes and Measures  The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate.

Results  A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, −45.2 [95% CI, −57.7 to −32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%).

Conclusions and Relevance  Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension.

DOI: 10.1001/jama.2019.12812

Source: https://jamanetwork.com/journals/jama/article-abstract/2749873