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氨甲环酸对择期剖宫产患者失血的有效性:随机临床试验

Effectiveness of tranexamic acid on blood loss in patients undergoing elective cesarean section: randomized clinical trial.

作者信息

Abdel-Aleem H, Alhusaini T K, Abdel-Aleem M A, Menoufy M, Gülmezoglu A M

机构信息

Department of Obstetrics and Gynecology, Women's Health Centre , Assiut , Egypt and.

出版信息

J Matern Fetal Neonatal Med. 2013 Nov;26(17):1705-9. doi: 10.3109/14767058.2013.794210. Epub 2013 May 10.

Abstract

OBJECTIVE

Cesarean section is associated with more blood loss than vaginal delivery. This could increase the risk of morbidity and mortality especially among anemic women. The objective of the trial is to assess the possible effect of tranexamic acid on blood loss during and after elective cesarean section.

METHODS

We conducted a randomized controlled trial at Women's Health Hospital, Assiut University, Assiut, Egypt. All pregnant women with singleton fetus planned to have elective cesarean section at ≥37 wks gestation were randomized to receive 1 g tranexamic acid slowly intravenously over 10 min before elective cesarean section group or not. Blood loss was measured during and for two hours after operation. Any side effects, complications, medications, changes in vital signs and duration of hospital stay were recorded. This study is registered, number ACTRN12612000313831.

RESULTS

Seven hundred and forty women were randomized (373 in study group and 367 in control group). Mean total blood loss was 241.6 (SE 6.77) ml in the tranexamic acid group versus 510 (SE 7.72) ml in the control group. The mean drop in hematocrit and hemoglobin levels were statistically significantly lower in the tranexamic acid group than in the control group. There were no statistically or clinically significant differences in other outcomes.

CONCLUSIONS

Pre-operative use of tranexamic acid is associated with reduced blood loss during and after elective cesarean section. This could be of benefit for anemic women or those who refuse blood transfusion.

摘要

目的

剖宫产比阴道分娩失血更多。这可能会增加发病和死亡风险,尤其是在贫血女性中。该试验的目的是评估氨甲环酸对择期剖宫产术中及术后失血的可能影响。

方法

我们在埃及阿斯尤特大学阿斯尤特妇女健康医院进行了一项随机对照试验。所有计划在妊娠≥37周时进行择期剖宫产的单胎孕妇被随机分为两组,一组在择期剖宫产术前10分钟内缓慢静脉注射1克氨甲环酸,另一组不注射。在手术期间及术后两小时测量失血量。记录任何副作用、并发症、用药情况、生命体征变化及住院时间。本研究已注册,注册号为ACTRN12612000313831。

结果

740名女性被随机分组(研究组373名,对照组367名)。氨甲环酸组的平均总失血量为241.6(标准误6.77)毫升,而对照组为510(标准误7.72)毫升。氨甲环酸组的血细胞比容和血红蛋白水平的平均下降在统计学上显著低于对照组。其他结局在统计学或临床上无显著差异。

结论

择期剖宫产术前使用氨甲环酸与术中及术后失血减少有关。这可能对贫血女性或拒绝输血的女性有益。

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