Karnash S L, Granger C B, White H D, Woodlief L H, Topol E J, Califf R M
Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710, USA.
J Am Coll Cardiol. 1995 Dec;26(7):1651-6. doi: 10.1016/0735-1097(95)00386-x.
The purpose of this study was to examine the clinical implications of administering thrombolytic therapy to menstruating women with acute myocardial infarction.
Although anecdotal case reports have suggested that thrombolytic therapy is safe during menstruation, the risk of increased bleeding in menstruating women receiving such therapy is poorly defined.
We identified menstruating women who received thrombolytic therapy by soliciting information on all North American women enrolled in the GUSTO-I trial and then collected additional information about them with use of a one-page data form. We compared the characteristics and outcomes of these women with other GUSTO-I patient populations, including all North American women below the median age of menopause, all women and all patients.
The median age of the 12 menstruating women was 46 years; 75% were cigarette smokers. The median hospital stay was 7 days, 2 fewer than the overall stay in GUSTO-I. None of these women died or had a stroke or severe bleeding. Three patients (25%) had moderate bleeding (vaginal in two patients [66%]) that required transfusion compared with 11% of all GUSTO-I patients and all North American premenopausal women (p = 0.13) and 17% of all female GUSTO-I patients (p = 0.47). Because of the small sample size of 12 women, the power was low (0.37) to detect the observed difference in moderate bleeding. The median nadir hematocrit was 33% in the menstruating women compared with 34% in the premenopausal women and all women. The median time from symptom onset to treatment for the 12 women was 3.7 h, which was 0.9 h longer than the overall median in the trial (p = 0.09).
Although there was no statistically significant increase in bleeding risk during menstruation, this fact may be a result of low statistical power rather than a lack of effect. Thus, the results suggest that there may be a clinically significant increase in the risk of moderate bleeding. Nevertheless, the GUSTO-I experience is consistent with the concept that the lifesaving benefit of thrombolytic therapy for acute myocardial infarction should generally not be withheld because of active menstruation.
本研究旨在探讨对患有急性心肌梗死的月经期女性进行溶栓治疗的临床意义。
尽管有个别病例报告表明溶栓治疗在月经期间是安全的，但接受此类治疗的月经期女性出血增加的风险仍不明确。
我们通过收集参与GUSTO-I试验的所有北美女性的信息，确定了接受溶栓治疗的月经期女性，然后使用一页式数据表格收集她们的其他信息。我们将这些女性的特征和结局与其他GUSTO-I患者群体进行了比较，包括所有年龄低于绝经中位数的北美女性、所有女性和所有患者。
12名月经期女性的中位年龄为46岁；75%为吸烟者。中位住院时间为7天，比GUSTO-I的总体住院时间少2天。这些女性中无一死亡、发生中风或严重出血。3名患者（25%）出现中度出血（2名患者[66%]为阴道出血），需要输血，而所有GUSTO-I患者和所有北美绝经前女性中这一比例为11%（p = 0.13），所有GUSTO-I女性患者中这一比例为17%（p = 0.47）。由于只有12名女性的样本量较小，检测到中度出血差异的效能较低（0.37）。月经期女性的最低血红蛋白中位数为33%，而绝经前女性和所有女性为34%。这12名女性从症状发作到治疗的中位时间为3.7小时，比试验中的总体中位数长0.9小时（p = 0.09）。
尽管月经期间出血风险没有统计学上的显著增加，但这一事实可能是由于统计效能低而非缺乏影响。因此，结果表明中度出血风险可能有临床意义的增加。然而，GUSTO-I的经验与以下观念一致，即一般不应因处于月经期而拒绝给予急性心肌梗死患者溶栓治疗带来的挽救生命的益处。
