Preston J T, Cameron I T, Adams E J, Smith S K
Department of Obstetrics and Gynaecology, University of Cambridge, Rosie Maternity Hospita, UK.
Br J Obstet Gynaecol. 1995 May;102(5):401-6. doi: 10.1111/j.1471-0528.1995.tb11293.x.
To compare the efficacy and safety of tranexamic acid and norethisterone in the treatment of ovulatory menorrhagia.
A randomised, double-blind, placebo controlled study.
University Department of Obstetrics and Gynaecology, Addenbrooke's Hospital, Cambridge.
One hundred and three women complaining of heavy periods with a regular cycle recruited directly from general practitioners within the hospital catchment area and from consultants' gynaecology clinics.
There were forty-six women on placebo with confirmed ovulatory menorrhagia, defined as menstrual blood loss greater than 80 ml/cycle and mid-luteal serum progesterone concentration greater than 9 nmol/l). Twenty-one received norethisterone (5 mg twice a day on days 19 and 26) and 25 received tranexamic acid (1 g four times daily on days 1 to 4) for two cycles.
Menstrual blood loss was measured using the alkaline haematin method. Haematological assessments were made both at the beginning and at the end of the study, questionnaires were given to assess subjective endpoints, and patients were asked to report any adverse events during all cycles.
Tranexamic acid reduced mean menstrual blood loss by 45%, from 175 ml to 97 ml (95% CI for the difference in menstrual blood loss 52 to 108, P < 0.0001), norethisterone increased mean blood loss by 20% from 173 ml to 208 ml (95% CI for the difference in menstrual blood loss -64 to 2, P = 0.26). Fourteen (56%) women who received tranexamic acid achieved a mean menstrual loss of less than 80 ml per cycle during treatment, but only two (9.5%) who received norethisterone achieved this mean menstrual loss. There were no serious adverse events reported for either drug.
Tranexamic acid is a safe and effective form of medical therapy in women with menorrhagia and is highly likely to normalise blood loss in women losing 80 to 200 ml prior to treatment. Norethisterone at this dose is not effective therapy for ovulatory menorrhagia.
比较氨甲环酸和炔诺酮治疗排卵型月经过多的疗效及安全性。
一项随机、双盲、安慰剂对照研究。
剑桥阿登布鲁克医院大学妇产科。
103名抱怨月经量大且周期规律的女性，她们直接从医院服务区域内的全科医生以及妇科顾问诊所招募而来。
46名确诊为排卵型月经过多的女性服用安慰剂（定义为月经失血量大于80毫升/周期且黄体中期血清孕酮浓度大于9纳摩尔/升）。21名女性服用炔诺酮（第19天和第26天每天两次，每次5毫克），25名女性服用氨甲环酸（第1至4天每天四次，每次1克），均治疗两个周期。
采用碱性高铁血红素法测量月经失血量。在研究开始和结束时进行血液学评估，发放问卷以评估主观终点，并要求患者报告所有周期中的任何不良事件。
氨甲环酸使平均月经失血量减少45%，从175毫升降至97毫升（月经失血量差异的95%置信区间为52至108，P<0.0001）；炔诺酮使平均失血量增加20%，从173毫升增至208毫升（月经失血量差异的95%置信区间为-64至2，P = 0.26）。接受氨甲环酸治疗的14名（56%）女性在治疗期间平均月经失血量低于80毫升/周期，但接受炔诺酮治疗的只有2名（9.5%）女性达到此平均月经失血量。两种药物均未报告严重不良事件。
氨甲环酸是治疗月经过多女性的一种安全有效的药物治疗形式，很有可能使治疗前失血量在80至200毫升的女性的失血量恢复正常。此剂量的炔诺酮对排卵型月经过多无效。
