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氨甲环酸预防剖宫产产后出血:一项双盲随机临床试验。

Tranexamic acid for the prevention of postpartum hemorrhage after cesarean section: a double-blind randomization trial.

机构信息

Department of Anesthesiology, Daqing Oilfield General Hospital, Daqing 163001, People's Republic of China.

出版信息

Arch Gynecol Obstet. 2013 Mar;287(3):463-8. doi: 10.1007/s00404-012-2593-y. Epub 2012 Oct 13.

DOI:10.1007/s00404-012-2593-y
PMID:23064441
Abstract

OBJECT

Our purpose in conducting this study was to determine the efficacy of tranexamic acid (TXA) in reducing blood loss in patients after cesarean section (CS).

METHOD

A randomized, double-blind, case-controlled study was conducted on 174 primipara undergoing CS. 88 of them given 10 mg/kg TXA immediately before CS were compared with 86 others to whom TXA was not given. Blood loss was calculated from blood collected and measured during two periods: the first period was from placental delivery to end of CS and the second from the end of CS to 2 h postpartum. Vital signs such as BP, HR, RP, hemoglobin, platelet count, postoperative PT and PPT were tested in the two groups.

RESULTS

Blood loss in the period between the end of CS and 2 h postpartum was significantly lower (p < 0.01) in the TXA group (46.6 ± 42.7) than in the control group (84.7 ± 80.2). The quantity of total blood from placental delivery to 2 h postpartum was also significantly reduced (p = 0.02) in the TXA group (379.2 ± 160.1) than in the control group (441.7 ± 189.5). However, the amount of blood loss in the period from placental delivery to the end of CS did not differ between the TXA and control groups (p = 0.17). PPH stopped in 65 women (75.6 %) in the control group and in 81 (92.0 %) in the TXA group (p < 0.01). No significant abnormal vital signs were observed after TXA administration. Mild, transient side effects occurred more often in the TXA group than in the control group.

CONCLUSION

Treatment with TXA is effective in reducing blood loss in patients undergoing CS. Although the study was not adequately powered to address safety issues, the observed side effects were mild and transient.

摘要

目的

本研究旨在评估氨甲环酸(TXA)在剖宫产(CS)患者中减少出血量的效果。

方法

采用随机、双盲、病例对照研究,对 174 例行 CS 的初产妇进行研究。其中 88 例在 CS 前即刻给予 10mg/kgTXA,与 86 例未给予 TXA 的患者进行比较。通过收集和测量两个时期的血液来计算出血量:第一个时期是从胎盘娩出到 CS 结束,第二个时期是从 CS 结束到产后 2 小时。对两组患者的血压(BP)、心率(HR)、呼吸频率(RP)、血红蛋白(Hb)、血小板计数、术后 PT 和 PPT 等生命体征进行检测。

结果

TXA 组 CS 结束至产后 2 小时的出血量明显低于对照组(46.6±42.7)(p<0.01)。从胎盘娩出到产后 2 小时的总出血量也明显减少(TXA 组 379.2±160.1,对照组 441.7±189.5,p=0.02)。然而,TXA 组和对照组从胎盘娩出到 CS 结束的时间段的出血量无差异(p=0.17)。对照组有 65 例(75.6%)产妇的 PPH 停止,TXA 组有 81 例(92.0%)(p<0.01)。TXA 给药后未见明显异常生命体征。TXA 组的轻度、短暂的不良反应发生率高于对照组。

结论

TXA 治疗可有效减少 CS 患者的出血量。虽然本研究在安全性问题上的效力不足,但观察到的不良反应轻微且短暂。

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