Intravenous Tranexamic Acid Combined With Intramyometrial Desmopressin During Laparoscopic Myomectomy: A Randomized Double-Blind Placebo-Controlled Trial
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引用次数: 0
Abstract
Objective
To evaluate whether intravenous tranexamic acid combined with intramyometrial desmopressin reduces perioperative blood loss during laparoscopic myomectomy.
Design
A prospective, randomized, double-blind, placebo-controlled trial.
Setting
A tertiary university hospital.
Patients
One hundred women undergoing laparoscopic myomectomy for symptomatic uterine fibroids were included in the study. Patients with suspected malignancy, thromboembolic disease, significant systemic illness, abnormal coagulation, anticoagulant use, body mass index ≥30 kg/m², or concomitant surgical procedures were excluded.
Interventions
Participants were randomized to receive intravenous tranexamic acid 1 g (n = 50) or placebo (normal saline; n = 50). All patients received intramyometrial desmopressin (30 mcg diluted in 100 mL normal saline).
Measurements and Main Results
Median estimated blood loss did not differ significantly between the tranexamic acid and placebo groups (150 mL vs 100 mL; p = .269). Transfusion rates were similar (10% vs 6%; p = .715). Postoperative hemoglobin levels were comparable between groups (p = .505). Surgeon-rated operative difficulty scores were significantly higher in Group I than in Group II (median score: 6 vs 5, p = .016). Multivariable regression identified myoma number (B = 19.09 mL per myoma; 95% CI: 8.31–29.86; p = .001) and myoma diameter (B = 2.02 mL per cm; 95% CI: 0.18–3.85; p = .032) as independent predictors of blood loss. Increasing age was independently associated with blood transfusion risk (odds ratio 1.18; 95% CI: 1.00–1.38; p = .044).
Conclusion
Tranexamic acid was safe but did not significantly reduce estimated blood loss or the need for transfusion compared with the placebo. Routine combined use is not supported; however, further evaluation in patients with a higher myoma burden may be warranted.
目的:评价静脉注射氨甲环酸联合子宫内膜去氨加压素能否减少腹腔镜子宫肌瘤切除术围手术期的出血量。设计:前瞻性、随机、双盲、安慰剂对照试验。环境:三级大学医院。参与者:100名因症状性子宫肌瘤接受腹腔镜子宫肌瘤切除术的妇女被纳入研究。排除疑似恶性肿瘤、血栓栓塞性疾病、重大全身性疾病、凝血异常、使用抗凝剂、体重指数≥30 kg/m²或伴有外科手术的患者。干预措施:参与者随机接受静脉注射氨甲环酸1g (n = 50)或安慰剂(生理盐水,n = 50)。所有患者均接受子宫内膜去氨加压素(30mcg,用100ml生理盐水稀释)。结果:氨甲环酸组和安慰剂组的中位估计失血量无显著差异(150 mL vs 100 mL; p = 0.269)。输血率相似(10% vs 6%; p = 0.715)。术后两组间血红蛋白水平具有可比性(p = 0.505)。手术难度评分I组明显高于II组(中位评分:6 vs 5, p = 0.016)。多变量回归确定肌瘤数量(B = 19.09 mL /肌瘤;95% CI 8.31-29.86; p = 0.001)和肌瘤直径(B = 2.02 mL / cm; 95% CI 0.18-3.85; p = 0.032)是失血的独立预测因子。年龄增加与输血风险独立相关(优势比1.18;95%可信区间1.00-1.38;p = 0.044)。结论:氨甲环酸是安全的,但与安慰剂相比,并没有显著减少估计失血量或输血需求。不支持常规联合使用;然而,对肌瘤负担较高的患者进行进一步评估可能是有必要的。
期刊介绍:
The Journal of Minimally Invasive Gynecology, formerly titled The Journal of the American Association of Gynecologic Laparoscopists, is an international clinical forum for the exchange and dissemination of ideas, findings and techniques relevant to gynecologic endoscopy and other minimally invasive procedures. The Journal, which presents research, clinical opinions and case reports from the brightest minds in gynecologic surgery, is an authoritative source informing practicing physicians of the latest, cutting-edge developments occurring in this emerging field.