氨甲环酸治疗月经过多：一项随机对照试验。
Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial.
机构信息
From the Carolina Women's Research and Wellness Center, Durham, North Carolina; Xanodyne Pharmaceuticals, Inc., Newport, Kentucky; the Department of Obstetrics and Gynecology, University of Kentucky, Lexington, Kentucky; the New Age Medical Research Corporation, Miami, Florida; the Cleveland Clinic Fertility Center, Canfield, Ohio; the Department of Obstetrics and Gynecology, Danderyds Hospital, Stockholm, Sweden; the University of Alabama at Birmingham, Birmingham, Alabama; The Center for Women's Health & Wellness, LLC, Plainsboro, New Jersey; the University of Miami, Miami, Florida; the University of Washington, Seattle, Washington; and ARSTAT Analysis, Flemington, New Jersey.
出版信息
Obstet Gynecol. 2010 Oct;116(4):865-875. doi: 10.1097/AOG.0b013e3181f20177.
OBJECTIVE
To assess the efficacy and safety of an oral formulation of tranexamic acid for the treatment of heavy menstrual bleeding.
METHODS
Adult women with heavy menstrual bleeding (mean menstrual blood loss 80 mL or more per cycle) were enrolled in a double-blind, placebo-controlled study. After two pretreatment menstrual cycles, women were randomized to receive tranexamic acid 3.9 g/d or placebo for up to 5 days per menstrual cycle through six cycles. To meet the prespecified three-component primary efficacy end point, mean reduction in menstrual blood loss from baseline with tranexamic acid treatment needed to be 1) significantly greater than placebo, 2) greater than 50 mL, and 3) greater than a predetermined meaningful threshold (36 mL or higher). Health-related quality of life was measured using a validated patient-reported outcome instrument.
RESULTS
Women who received tranexamic acid (n=115) met all three primary efficacy end points: first, a significantly greater reduction in menstrual blood loss of -69.6 mL (40.4%) compared with -12.6 mL (8.2%) in the 72 women who received placebo (P<.001); reduction of menstrual blood loss exceeding a prespecified 50 mL; and last, reduction of menstrual blood loss considered meaningful to women. Compared with women receiving placebo, women treated with tranexamic acid experienced significant improvements in limitations in social or leisure and physical activities, work inside and outside the home, and self-perceived menstrual blood loss (P<.01). The majority of adverse events were mild to moderate in severity, and the incidence of gastrointestinal adverse events was comparable with placebo.
CONCLUSION
In this study, a new oral tranexamic acid treatment was well tolerated and significantly improved both menstrual blood loss and health-related quality of life in women with heavy menstrual bleeding.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00386308.
LEVEL OF EVIDENCE
I.
目的
评估氨甲环酸口服制剂治疗月经过多的疗效和安全性。
方法
本双盲、安慰剂对照研究纳入了月经过多的成年女性（平均月经失血量每周期 80 毫升或更多）。在两个预处理月经周期后，女性被随机分配至接受氨甲环酸 3.9 g/d 或安慰剂治疗，最多每周期 5 天，共 6 个周期。为达到预设的三组分主要疗效终点，氨甲环酸治疗的月经失血量从基线的平均减少量需要满足以下 3 个条件：1）显著大于安慰剂，2）大于 50 毫升，3）大于预定的有意义阈值（36 毫升或更高）。采用经过验证的患者报告结局量表评估健康相关生活质量。
结果
接受氨甲环酸治疗的 115 名女性均达到了所有三个主要疗效终点：首先，与接受安慰剂的 72 名女性相比，月经失血量的显著减少量为-69.6 毫升（40.4%），而安慰剂组为-12.6 毫升（8.2%）（P<.001）；其次，月经失血量减少量超过预定的 50 毫升；最后，减少的月经失血量被女性认为有意义。与接受安慰剂的女性相比，接受氨甲环酸治疗的女性在社会或休闲活动、体力活动、家庭内外工作以及自我感知的月经失血量方面的限制显著改善（P<.01）。大多数不良事件的严重程度为轻度至中度，胃肠道不良事件的发生率与安慰剂相当。
结论
在这项研究中，一种新的氨甲环酸口服治疗方法耐受性良好，可显著减少月经过多女性的月经失血量并改善其健康相关生活质量。
临床试验注册
ClinicalTrials.gov，www.clinicaltrials.gov，NCT00386308。
证据水平
I。
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