Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-5509, USA.
Am J Obstet Gynecol. 2011 Oct;205(4):319.e1-7. doi: 10.1016/j.ajog.2011.05.015. Epub 2011 May 14.
We sought to assess the efficacy and safety of 2 dosing regimens of a novel, oral tranexamic acid formulation (Lysteda; Ferring Pharmaceuticals Inc, Parsippany, NJ) in women with cyclic heavy menstrual bleeding.
This was a multicenter, double-blind, placebo-controlled, randomized, parallel-group trial for 3 menstrual cycles (n = 304). Women with mean menstrual blood loss (MBL) of ≥ 80 mL/cycle were randomized to receive either 1.95 g/d or 3.9 g/d of tranexamic acid or placebo for up to 5 days of menstrual bleeding. Primary efficacy endpoints were mean MBL reduction from baseline, mean MBL reductions that were considered "meaningful" by subjects, and mean MBL reductions from baseline > 50 mL/cycle. Adverse events (AEs) were also assessed.
Only the 3.9 g/d group met all 3 primary efficacy endpoints. AEs did not significantly differ among the 3 groups. There were no serious study-related AEs.
The 3.9-g/d dose met all 3 primary efficacy endpoints, whereas the 1.95 g/d dose met 2 primary efficacy endpoints. Both doses were well tolerated.
评估新型口服氨甲环酸制剂（Lysteda；辉凌制药公司，新泽西州帕西帕尼）两种给药方案在治疗女性周期性月经过多中的疗效和安全性。
这是一项为期 3 个月经周期（n = 304）的多中心、双盲、安慰剂对照、随机、平行组试验。平均月经失血量（MBL）≥ 80 mL/周期的女性随机接受 1.95 g/d、3.9 g/d 的氨甲环酸或安慰剂治疗，最多 5 天的月经出血。主要疗效终点为从基线的平均 MBL 减少、受试者认为“有意义”的平均 MBL 减少和从基线的平均 MBL 减少 > 50 mL/周期。还评估了不良事件（AE）。
只有 3.9 g/d 组达到了所有 3 个主要疗效终点。3 组间的不良事件无显著差异。无严重与研究相关的不良事件。
3.9 g/d 剂量达到了所有 3 个主要疗效终点，而 1.95 g/d 剂量达到了 2 个主要疗效终点。两种剂量均耐受良好。
