Arantes Guilherme C, Pereira Rui Manoel R, de Melo Daniela B, Alonso Nivaldo, Duarte Maria do Carmo M B
Department of Plastic Surgery of the Professor Fernando Figueira Integral Medicine Institute (Instituto de Medicina Integral Prof. Fernando Figueira), Recife, Pernambuco (PE), Brazil.
Plastic Surgery of the Professor Fernando Figueira Integral Medicine Institute (Instituto de Medicina Integral Prof. Fernando Figueira) (Head: Prof. Rui Manoel R. Pereira), Recife, PE, Brazil.
J Craniomaxillofac Surg. 2017 May;45(5):642-648. doi: 10.1016/j.jcms.2016.12.021. Epub 2016 Dec 30.
Few data are available regarding blood loss during cleft palate surgery. This study assessed the effect of using tranexamic acid in the reduction of intraoperative bleeding.
A double-blind, randomized clinical trial compared intraoperative bleeding and the incidence of oronasal fistulas after palatoplasties in a control group that was given placebo and an intervention group that was given 10 mg/kg tranexamic acid followed by a continuous infusion of 1 mg/kg/h of the same until the end of surgery. Patients who underwent primary palatoplasty with no known or suspected coagulation disorders at our institution during the study period were included in the study.
70 patients were allocated, 66 received the intervention. Blood loss was reduced by 11.9%, without statistical significance. The incidence of fistulas in the intervention and control groups was 12.9% and 18.75%, respectively. The reduction of 5.8% (CI 95%: 12%-23.8%) was not significant.
The reduction of intraoperative blood loss was lower than expected and not statistically significant; a larger sample is needed to confirm the observed reduction. The drug did not seem to have negative effects on flap viability.
关于腭裂手术中失血情况的数据较少。本研究评估了使用氨甲环酸减少术中出血的效果。
一项双盲随机临床试验比较了在接受安慰剂的对照组和接受10mg/kg氨甲环酸然后以1mg/kg/h持续输注直至手术结束的干预组中，腭裂修复术后的术中出血情况及口鼻瘘发生率。在研究期间，于我们机构接受初次腭裂修复术且无已知或疑似凝血障碍的患者被纳入研究。
70例患者被分配入组，66例接受了干预。失血量减少了11.9%，无统计学意义。干预组和对照组的瘘发生率分别为12.9%和18.75%。5.8%（95%CI：12%-23.8%）的降低无统计学意义。
术中失血量的减少低于预期且无统计学意义；需要更大样本量来证实所观察到的减少情况。该药物似乎对皮瓣存活没有负面影响。
