Phupong Vorapong, Sophonsritsuk Areepan, Taneepanichskul Surasak
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.
Contraception. 2006 Mar;73(3):253-6. doi: 10.1016/j.contraception.2005.09.012. Epub 2005 Nov 16.
The purpose of this study is to evaluate the effects of tranexamic acid and placebo on controlling irregular uterine bleeding secondary to Norplant use.
A prospective randomized, double-blind, placebo-controlled trial was conducted. Sixty-eight Norplant users who had irregular bleeding were randomly allocated into two groups. A total of 34 users received tranexamic acid 500 mg twice a day for 5 days; the placebo was given to the other 34 users in the same manner. The total number of days of bleeding and spotting and the percentage of women whose irregular uterine bleeding was stopped was analyzed at the end of weeks 1 and 4.
In the follow-up period (4 weeks after the initial treatment), a bleeding-free interval of > 20 days was found in 58.8% of the subjects treated with tranexamic acid and in 76.5% treated with placebo (p = .12). The percentage of subjects whose irregular uterine bleeding stopped during week 1 after the initial treatment was significantly higher in the tranexamic acid group than those in the placebo group (64.7% vs. 35.3%, p = .015). The mean number of bleeding/spotting days was not significantly different between the groups (15.4 vs. 12.7 days, p = .182).
Tranexamic acid for 5 days appears to be an effective treatment for irregular uterine bleeding associated with Norplant use only while it is being used. However, treatment for 5 days does not seem to provide long-term benefit.
本研究旨在评估氨甲环酸和安慰剂对控制左炔诺孕酮皮下埋植剂使用后所致不规则子宫出血的效果。
进行了一项前瞻性随机双盲安慰剂对照试验。68名有不规则出血的左炔诺孕酮皮下埋植剂使用者被随机分为两组。34名使用者每天两次服用500毫克氨甲环酸,共5天;另外34名使用者以相同方式服用安慰剂。在第1周和第4周结束时,分析出血和点滴出血的总天数以及不规则子宫出血停止的女性百分比。
在随访期(初始治疗后4周),氨甲环酸治疗组58.8%的受试者和安慰剂治疗组76.5%的受试者出现了>20天的无出血间隔(p = 0.12)。初始治疗后第1周内不规则子宫出血停止的受试者百分比,氨甲环酸组显著高于安慰剂组(64.7%对35.3%,p = 0.015)。两组间出血/点滴出血天数的平均值无显著差异(15.4天对12.7天,p = 0.182)。
氨甲环酸治疗5天似乎仅在用药期间对左炔诺孕酮皮下埋植剂相关的不规则子宫出血有效。然而,治疗5天似乎未提供长期益处。