静脉注射氨甲环酸与直肠米索前列醇减少腹部子宫肌瘤切除术出血量的疗效和安全性。一项随机比较研究

Hesham Gouda, A. Ragab, Khaled M. Kholaif
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In the three groups the following outcomes were reached : the estimated blood loss (EBL) during open myomectomy, need for intra and post operative blood transfusion, operative time, myomectomy time, postoperative hematocrit and hemoglobin, drop in postoperative hemoglobin , drop in hematocrit, side effects of TXA and oxytocin including and post operative stay in days. Interventions: Group (A) (Tranexamic Acid group): Women received TXA as a single bolus intravenous injection of 15 mg/ kg (maximum 1 g) slowly over 10 min 20 min before skin incision. Group (B) (Misoprostol group): Women received two tablet of (200 microgram) misoprostol (Cytotec) rectally 1hr before starting of operation.. Group (C) (placebo group): Women received 500 ml saline infusion at a rate of 120 ml/h before and during the operation. 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引用次数: 0

摘要

目的:本研究的目的是比较直肠米索前列醇与静脉注射氨甲环酸(TXA)在减少切开子宫肌瘤切除术术中出血量方面的疗效和安全性。设计:随机比较研究。从2021年4月到2021年9月。方法:对75例符合入选标准的子宫肌瘤患者行子宫肌瘤切除术。患者按1:1:1的分配比例随机分为三组。每组编号为A、B、C (A组为氨甲环酸,B组为催产素,C组为对照组),每组25例。三组均获得以下结果:切开子宫肌瘤切除术时估计失血量(EBL)、术中及术后输血需求、手术时间、子宫肌瘤切除术时间、术后红细胞压积和血红蛋白、术后血红蛋白下降、红细胞压积下降、TXA和催产素的副作用包括及术后停留天数。干预措施:A组(氨甲环酸组):女性接受TXA单次静脉注射,剂量为15mg / kg(最大1g),在皮肤切开前20分钟缓慢注射,持续10分钟。B组(米索前列醇组):术前1小时口服米索前列醇(Cytotec) 2片(200微克)。C组(安慰剂组):术前和术中以120 ml/h的速率输注生理盐水500 ml。结果:术中输血需求;统计分析目前的结果显示氨甲环酸组和米索前列醇组之间无显著差异(无需病例)。另一方面,与对照组33(66.0%)有极显著差异(p= <0.001)。此外,关于术后输血的需要;氨甲环酸分别显著高于米索前列醇组6(12.0%)、对照组0(0.0%)和对照组3 (6.0%)(p = 0.042)。术中出血量(ml);统计分析当前结果显示氨甲环酸组与米索前列醇组(229.35±41.05)、(225.80±44.82)差异无统计学意义。对照组术中出血量(680.35±189.39)显著高于对照组(p = <0.001)。关于术后停留时间(天);统计分析当前结果显示氨甲环酸组与米索前列醇组(1.34±0.48)比(1.32±0.47)无显著性差异。另一方面,对照组的住院时间为1.56±0.54 (p = 0.030)。结论:与安慰剂相比,术前静脉注射氨甲环酸和直肠米索前列醇在减少术中出血量、术中及术后输血次数、术后住院时间、手术时间和子宫肌瘤切除术时间等方面均有显著效果。关于手术和子宫肌瘤切除时间(分钟);统计分析当前结果显示氨甲环酸组与米索前列醇组(68.50±10.98 vs 68.60±10.83)、(23.38±1.86 vs 22.34±1.67)差异无统计学意义。对照组(85.70±24.45)和(27.74±2.93)时间分别显著高于对照组(p = <0.001和0.001)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Efficacy and Safety of Intravenous Tranexamic Acid Versus Rectal Misoprostol in Reducing Blood Loss During Abdominal Myomectomy. A Randomized Comparative Study
Aim: The aim of the study is to compare the efficacy and safety of rectal Misoprostol versus IV Tranexamic acid (TXA) in reducing intraoperative blood loss during open myomectomy. Design: A randomized comparative study. the period from April 2021 September 2021. Methods: A total of 75 patients with uterine fibroid fulfilling the inclusion criteria were scheduled for abdominal myomectomy. Patients were randomized and allocated into one of three groups with a 1:1:1 allocation ratio. The groups were coded as A,B,C (group A for tranexamic acid ,group B for oxytocin and group C for control) (n=25 per group). In the three groups the following outcomes were reached : the estimated blood loss (EBL) during open myomectomy, need for intra and post operative blood transfusion, operative time, myomectomy time, postoperative hematocrit and hemoglobin, drop in postoperative hemoglobin , drop in hematocrit, side effects of TXA and oxytocin including and post operative stay in days. Interventions: Group (A) (Tranexamic Acid group): Women received TXA as a single bolus intravenous injection of 15 mg/ kg (maximum 1 g) slowly over 10 min 20 min before skin incision. Group (B) (Misoprostol group): Women received two tablet of (200 microgram) misoprostol (Cytotec) rectally 1hr before starting of operation.. Group (C) (placebo group): Women received 500 ml saline infusion at a rate of 120 ml/h before and during the operation. Results: Regarding need for intraoperative blood transfusion; statistical analysis of current results showed that there was no significant difference between tranexamic acid and misoprostol groups (no cases needed). On the other hand there was highly significant difference with control group 33 (66.0%) (p= <0.001). Also, Regarding need for postoperative blood transfusion; tranexamic acid was significantly higher than misoprostol and control groups 6 (12.0%) vs. 0 (0.0%) vs. 3 (6.0%) respectively ( p = 0.042). Regarding intraoperative blood loss (ml); statistical analysis of current results showed that there was no significant difference between tranexamic acid and misoprostol groups 229.35 ± 41.05 and 225.80 ± 44.82. On the other hand there was highly significant higher intraoperative blood loss in control group 680.35 ±189.39 ( p = <0.001). Regarding post-operative stay (days); statistical analysis of current results showed that there was no significant difference between tranexamic acid and misoprostol groups 1.34 ± 0.48 vs. 1.32 ± 0.47. On the other hand there was highly significant longer stay in control group 1.56 ± 0.54 ( p = 0.030). Conclusion: In women undergoing abdominal myomectomies, preoperative intravenous tranexamic acid and rectal misoprostol were very effective in reducing intraoperative blood loss, need for intra and postoperative blood transfusion, post-operative stay and operation and myomectomy time compared with placebo. Regarding operation and myomectomy time (mins); statistical analysis of current results showed that there was no significant difference between tranexamic acid and misoprostol groups 68.50 ± 10.98 vs. 68.60 ± 10.83 and 23.38 ± 1.86 vs. 22.34 ± 1.67. On the other hand there was highly significant longer time in control group 85.70 ± 24.45 and 27.74 ± 2.93 ( p = <0.001 and 0.001) respectively.
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