Obesity and Digestive Diseases Unit, Medica Sur Clinic and Foundation, Mexico City, Mexico.
PLoS One. 2011;6(7):e22581. doi: 10.1371/journal.pone.0022581. Epub 2011 Jul 27.
Intraoperative blood loss is a frequent complication of hepatic resection and orthotopic liver transplantation. Recombinant activated coagulation factor VII (rFVIIa) is a coagulation protein that induces hemostasis by directly activating factor X. There is no clear information about the prophylactic value of rFVIIa in hepatobiliary surgery, specifically in liver resection and orthotopic liver transplantation. The aim of this study was to assess the effect of rFVIIa prophylaxis to prevent mortality and bleeding resulting from hepatobiliary surgery.
Relevant randomized trials were identified by searching The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index. Randomized clinical trials comparing different rFVIIa prophylactic schemas against placebo or no intervention to prevent bleeding in hepatobiliary surgery were included. Adults undergoing liver resection, partial hepatectomy, or orthotopic liver transplantation were included. Dichotomous data were analyzed calculating odds ratios (ORs) and 95% confidence intervals (CIs). Continuous data were analyzed calculating mean differences (MD) and 95% CIs.
Four randomized controlled trials were included. There were no significant differences between rFVIIa and placebo for mortality (OR 0.96; 95% CI 0.35-2.62), red blood cell units (MD 0.32; 95% CI -0.08-0.72) or adverse events (OR 1.55; 95% CI 0.97-2.49).
The available information is limited, precluding the ability to draw conclusions regarding bleeding prophylaxis in hepatobiliary surgery using rFVIIa. Although an apparent lack of effect was observed in all outcomes studied, further research is needed.
术中出血是肝切除术和原位肝移植的常见并发症。重组活化凝血因子 VII(rFVIIa)是一种凝血蛋白,通过直接激活因子 X 诱导止血。关于 rFVIIa 在肝胆手术中的预防价值,特别是在肝切除和原位肝移植中,尚无明确信息。本研究旨在评估 rFVIIa 预防用于预防肝胆手术出血的效果。
通过在 Cochrane 图书馆、MEDLINE、EMBASE 和科学引文索引中搜索相关随机试验,确定了相关的随机试验。纳入了比较不同 rFVIIa 预防方案与安慰剂或无干预措施预防肝胆手术出血的随机临床试验。纳入接受肝切除术、部分肝切除术或原位肝移植的成年人。二项数据采用优势比(OR)和 95%置信区间(CI)进行分析。连续数据采用平均差异(MD)和 95%CI 进行分析。
纳入了四项随机对照试验。rFVIIa 与安慰剂在死亡率(OR 0.96;95%CI 0.35-2.62)、红细胞单位(MD 0.32;95%CI -0.08-0.72)或不良事件(OR 1.55;95%CI 0.97-2.49)方面均无显著差异。
目前的信息有限,无法得出关于使用 rFVIIa 预防肝胆手术出血的结论。尽管在所有研究的结局中均观察到明显缺乏效果,但仍需要进一步研究。