Department of Pediatrics, Obstetrics and Reproductive Medicine, Section of Obstetrics and Gynecology, University of Siena, Siena, Italy.
Steroids. 2012 Apr;77(5):528-33. doi: 10.1016/j.steroids.2012.01.017. Epub 2012 Feb 1.
This randomized, double blind, placebo-controlled study compared the usefulness of danazol 400mg vaginally versus 600mg orally in women as a preoperative preparation for hysteroscopic surgery. Ninety-one fertile women were randomly allocated to Group A (46 patients received 400mg of danazol placed into the posterior vaginal fornix and three oral tablets of commercially available folic acid as a placebo), and Group B [45 women treated with 600mg of danazol orally (200mg three times daily) and two vaginal tablets of Lactobacillus rhamnosus as a placebo]. The patients underwent an operative hysteroscopy, transvaginal sonography, blood tests, and a histological assay. A visual analog scale (VAS) score to compute the degree of the surgeon's satisfaction was used. The outcome measures were as follows: an evaluation of the changes in the endometrial thickness, the prevalence of endometrial atrophy, changes in the blood tests, any collateral effects, the degree of difficulty and view, the duration of the surgical procedure, any complications during the operative hysteroscopy and associated side effects, and the surgeon's satisfaction with the endometrial preparation. The vaginal administration route was associated with a more pronounced effect on the endometrial thickness. Significantly more patients receiving vaginal danazol (45/46) had a hypotrophic endometrium than those receiving oral danazol (37/45, P<0.01). In addition, the patients receiving danazol vaginally had a shorter operating time, lower infusion volume, fewer side effects, and a higher surgeon satisfaction. Vaginal danazol adequately prepares the endometrium for an operative hysteroscopy by thinning the endometrium effectively with few side effects and little impact on the metabolic parameters.
这项随机、双盲、安慰剂对照研究比较了阴道给予丹那唑 400mg 与口服 600mg 对宫腔镜手术前准备的有效性。91 名生育期妇女被随机分为 A 组(46 例患者阴道后穹窿放置 400mg 丹那唑和三片市售叶酸作为安慰剂)和 B 组[45 例患者口服 600mg 丹那唑(每日 200mg,分 3 次)和两片阴道用鼠李糖乳杆菌作为安慰剂]。患者接受宫腔镜手术、经阴道超声检查、血液检查和组织学检查。采用视觉模拟评分(VAS)计算医生满意度。观察指标包括:子宫内膜厚度变化、子宫内膜萎缩发生率、血液检查变化、任何不良反应、手术难度和视野、手术时间、宫腔镜手术过程中的任何并发症及相关副作用、以及医生对子宫内膜准备的满意度。阴道给药途径对子宫内膜厚度的影响更明显。接受阴道丹那唑治疗的患者(46 例中有 45 例)子宫内膜萎缩的发生率显著高于接受口服丹那唑治疗的患者(45 例中有 37 例,P<0.01)。此外,接受阴道丹那唑治疗的患者手术时间更短、输液量更少、副作用更少、医生满意度更高。阴道丹那唑通过有效减少子宫内膜厚度,很少有副作用,对代谢参数影响小,充分准备子宫内膜进行宫腔镜手术。