Karp Deborah R, Jean-Michel Marjorie, Johnston Yasmin, Suciu Gabriel, Aguilar Vivian C, Davila G Willy
Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA 30322, USA.
Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):211-5. doi: 10.1097/SPV.0b013e31825e6401.
To evaluate the use and effect of early administration of vaginal estrogen via a continuous low-dose estradiol vaginal ring placed immediately after pelvic reconstructive surgery.
This was a randomized controlled trial of 65 postmenopausal women undergoing vaginal reconstructive surgery. The subjects were randomly assigned to receive an estradiol-releasing vaginal ring, placebo vaginal ring, or control without vaginal ring for 12 weeks immediately after vaginal reconstructive surgery. The primary outcome was tissue quality based on vaginal maturation 3 months postoperatively. Secondary outcome measures were subjective and objective signs of atrophy; vaginal pH; the presence of granulation tissue, microscopic inflammation, and major healing abnormalities; and the ability to tolerate an intravaginal ring.
At 12 weeks, the estradiol ring group had a significantly improved maturation value (P<0.01) and objective atrophy assessment (P<0.01) compared with the placebo ring and control arms. Granulation tissue was increased in the placebo ring arm (P<0.01). Subjective atrophy scores did not differ among the groups (P=0.39).
Early administration of vaginal estrogen after vaginal surgery via an estradiol-releasing ring is feasible and results in improved markers of tissue quality postoperatively compared to placebo and controls.
评估盆腔重建手术后立即放置持续低剂量雌二醇阴道环早期给予阴道雌激素的使用情况及效果。
这是一项针对65名接受阴道重建手术的绝经后女性的随机对照试验。受试者在阴道重建手术后立即被随机分配接受释放雌二醇的阴道环、安慰剂阴道环或不使用阴道环,为期12周。主要结局是术后3个月基于阴道成熟度的组织质量。次要结局指标包括萎缩的主观和客观体征;阴道pH值;肉芽组织、微观炎症和主要愈合异常的存在情况;以及耐受阴道环的能力。
在12周时,与安慰剂环组和对照组相比,雌二醇环组的成熟度值显著改善(P<0.01),客观萎缩评估也显著改善(P<0.01)。安慰剂环组的肉芽组织增多(P<0.01)。各组间主观萎缩评分无差异(P=0.39)。
与安慰剂和对照组相比,阴道手术后通过释放雌二醇的环早期给予阴道雌激素是可行的,且术后组织质量指标得到改善。