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静脉注射氨甲环酸能否减少全阴道闭合术时的失血量?一项随机双盲安慰剂对照试验。

Does Intravenous Tranexamic Acid Reduce Blood Loss at the Time of Total Colpocleisis? A Randomized Double-Blind Placebo-Controlled Trial.

作者信息

McDermott Colleen D, Lovatsis Danny, Wang Stella, Huszti Ella, Wadsworth Kristin

机构信息

Division of Urogynecology (Drs. McDermott, Lovatsis, and Wadsworth), Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.

Division of Urogynecology (Drs. McDermott, Lovatsis, and Wadsworth), Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.

出版信息

J Minim Invasive Gynecol. 2025 Jun;32(6):555-561. doi: 10.1016/j.jmig.2025.01.005. Epub 2025 Jan 13.

DOI:10.1016/j.jmig.2025.01.005
PMID:39814219
Abstract

STUDY OBJECTIVE

To determine the efficacy of intravenous (IV) tranexamic acid (TXA) in reducing blood loss and blood transfusion among women undergoing total colpocleisis.

DESIGN

Double-blind, randomized, placebo-controlled trial.

SETTING

Tertiary academic urogynecology practice.

PARTICIPANTS

Consenting women undergoing total colpocleisis (±midurethral sling) for treatment of posthysterectomy pelvic organ prolapse.

INTERVENTIONS

Participants were randomly assigned to a single dose of 1gram TXA or placebo after anesthesia induction. Primary outcome measures were the differences in preoperative hemoglobin (hgb) and hematocrit (hct) compared to those measured 24 hours after surgery. Secondary outcomes included the difference in intraoperative blood loss and the need for blood transfusion during hospital stay. Safety outcomes were assessed 6 weeks postoperatively.

MAIN RESULTS

Thirty participants completed the study (TXA: 14; placebo: 16). Preoperative variables were similar between groups. Intraoperative outcomes were also comparable, and all surgeries were completed under general anesthesia. No significant differences were observed in any blood loss outcomes between groups (TXA versus placebo differences: hgb 3.2g/dL versus 2.6g/dL, p = .41; hct 0.09 versus 0.08, p = .25; intraoperative blood loss 340mL versus 405mL, p = .58). One patient in the TXA group received a blood transfusion 1 day after surgery due to medically significant anemia. There were no significant adverse events related to the study intervention in the TXA group.

CONCLUSION

This study showed no statistically significant differences in blood loss outcomes with the use of IV TXA at the time of total colpocleisis (±midurethral sling). While TXA administration showed no advantage regarding blood loss, it demonstrated no significant adverse effects. This study reinforces judicious use of TXA at the time of colpocleisis rather than using it prophylactically.

摘要

研究目的

确定静脉注射氨甲环酸(TXA)在减少全阴道封闭术女性患者失血及输血方面的疗效。

设计

双盲、随机、安慰剂对照试验。

地点

三级学术性泌尿妇科诊所。

参与者

同意接受全阴道封闭术(± 中段尿道吊带术)以治疗子宫切除术后盆腔器官脱垂的女性。

干预措施

参与者在麻醉诱导后被随机分配接受一剂1克的TXA或安慰剂。主要结局指标为术前血红蛋白(hgb)和血细胞比容(hct)与术后24小时测量值的差异。次要结局包括术中失血量差异及住院期间输血需求。术后6周评估安全性结局。

主要结果

30名参与者完成了研究(TXA组:14名;安慰剂组:16名)。两组术前变量相似。术中结局也具有可比性,所有手术均在全身麻醉下完成。两组在任何失血结局方面均未观察到显著差异(TXA组与安慰剂组差异:hgb为3.2g/dL对2.6g/dL,p = 0.41;hct为0.09对0.08,p = 0.25;术中失血量为340mL对405mL,p = 0.58)。TXA组有1名患者因具有临床意义的贫血在术后1天接受了输血。TXA组未出现与研究干预相关的显著不良事件。

结论

本研究表明,在全阴道封闭术(± 中段尿道吊带术)时使用静脉注射TXA在失血结局方面无统计学显著差异。虽然TXA给药在失血方面未显示出优势,但也未显示出显著不良反应。本研究强调在阴道封闭术时应明智地使用TXA,而非预防性使用。

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