氨甲环酸与炔诺酮治疗排卵型月经过多的多中心前瞻性研究

A multlcenter prospective randomized open comparative study on the treatment of ovulatory menorrhagia with tranexamic acid and norethisterone in China

目的比较氨甲环酸与炔诺酮治疗排卵型月经过多患者的有效性和安全性。方法2004年7月至2006年12月，自中国4个城市5个教学医院妇科门诊收集经筛查证实为排卵型月经过多的患者131例，按随机表法分为氨甲环酸组（70例）和炔诺酮组（61例），氨甲环酸组患者于月经周期第1～5天口服氨甲环酸1g，每天3次，炔诺酮组患者于月经周期第19～26天口服炔诺酮5mg，每天2次，均连续2个周期。两组患者停药后均随诊1个周期。观察两组患者治疗前后经期失血量[MBL，以绘图失血评估表（PBAC）评估]、经期长度、生活质量的变化及其安全性。结果共128例患者完成研究，其中氨甲环酸组69例，炔诺酮组59例。两组患者第1、2个周期PBAC总分均显著降低，经期缩短，患者的生活质量显著改善，差异均有统计学意义（P〈0．05）。氨甲环酸组第1、2个周期PBAC总分下降的百分率（分别为35％、44％）均高于炔诺酮组（分别为17％、34％），差异均有统计学意义（P〈0．05）。第2个周期治疗有效率氨甲环酸组（41％，28／69）高于炔诺酮组（24％，14／59），差异有统计学意义（P=0．04）。氨甲环酸组第1个周期生活质量的改善显著高于炔诺酮组，差异有统计学意义（P=0．03）。两组之间血红蛋白含量变化比较，差异均无统计学意义（P〉0．05）。氨甲环酸组至少出现1次不良反应患者的百分率（19％，13／69）显著少于炔诺酮组（35％，19／54），差异有统计学意义（P=0．04），第2个周期、随诊周期愿意继续用药患者的百分率氨甲环酸组分别为94％（63／67）、79％（48／61），均显著高于炔诺酮组[分别为79％（44／56）、59％（30／51）]，差异均有统计学意义（P：0．01、0．02）。结论与黄体期口服炔诺酮相比，经期第1～5天口服氨甲环酸3g／d能更有效地使排卵型月经过多患者的MBL减少，生活质量改善，患者的接受性较高。

Objective To compare the efficacy and safety of tranexamic acid （TA） and norethisterone （NET） for the treatment of patients with ovulatory menorrhagia in China. Methods One hundred and thirty one patients with proven ovulatory menorrhagia from gynecologic clinics of 5 teaching hospitals located in 4 different cities in China were enrolled during Jul 2004 to Dec 2006. Among them 128 completed the study. Patients were randomly divided into two therapeutic regimen groups： TA 1 g thrice daily during menstrual cycle days（D） 1 -5, 69 cases; or NET 5 mg twice daily on D19 -26, 59 cases. The drugs were administered for 2 consecutive cycles, then withdrawn and patients were followed-up for 1 more cycle. Data on menstrual blood loss [ estimated by pictorial blood assessment chart （PBAC） ], length of menstrual periods, quality of life （QOL） evaluated by a 6 item health-related questionnaire were collectedbefore, during each cycle and were compared. Results Both treatments led to significant decreases of mean PBAC scores and shorter duration of menstrual periods, and improved the QOL ranking during the two treatment cycles. The mean percentages of PBAC decrements in the TA first and second cycles were significantly greater than those in the NET corresponding cycles（35% vs 17%, P=0. 004; 44% vs 34%, P =0. 04 respectively）. The success rate of TA second cycle was higher than that of the NET second cycle （41% vs 24%, P =0. 04）. Improvement of QOL ranking in the TA first cycle was also significantly better than those in the NET first cycle （ P = 0. 03 ）. The percentage of patients with at least 1 adverse event in TA group（ 19% ） was significantly lower than that in NET group （35%, P = 0. 04 ）. Patients＇ willingness to continue the treatment in the TA second and follow-up cycles （94% ,79% respectively） were significantly higher than those in the corresponding cycles of NET groups （ 79%, 59% respectively ; P = 0. 01, P = 0. 02）. Condusion The regimen of TA 3 g daily during menstrual days 1 - 5 is a more effective and tolerable treatment than luteal phase norethisterone for patients with ovulatory menorrhagia.