Tianjin Union Hospital, Department of Orthopedics, Tianjin 300121, PR China; Tianjin Medical University, Tianjin 30070, PR China.
Tianjin Medical University, Tianjin 30070, PR China.
Int J Surg. 2014;12(2):95-102. doi: 10.1016/j.ijsu.2013.11.011. Epub 2013 Dec 4.
A systematic review of randomized controlled trials was conducted to examine the efficacy of fibrin sealants for the reduction of postoperative blood loss and allogeneic red blood cell transfusion in total knee arthroplasty (TKA).
Studies published through May 2013 were identified from PubMed, Embase, the Cochrane library, ScienceDirect, and other databases. Two independent reviewers assessed the quality of methodology using the Grade of Recommendations Assessment, Development and Evaluation approach and extracted data from literature. The mean difference (MD) of blood loss, hemoglobin loss, and risk ratios (RR) of transfusion rate and adverse events in the fibrin-treated and placebo groups were pooled throughout the study. The relevant data were analyzed using Stata 11.0 software.
Eight studies were included in the review, with a total sample size of 558 patients. The drainage blood loss [MD = -354.02 mL, 95% confidence interval (CI) (-500.87 to -207.18); P < 0.05], reduction in calculated total blood loss [MD = -402.12, 95% CI (-599.16 to -205.08); P < 0.05], hemoglobin loss [MD = -0.86 g/dL, 95% CI (-1.10 g/dL to -0.61 g/dL); P < 0.05], and transfusion rate [RR = 0.62, 95% CI (0.45-0.86); P < 0.05] were all significantly reduced following treatment with fibrin sealants. There were no significant differences in the incidence of adverse events [RR = 0.69, 95% CI (0.32-1.59); P > 0.05] among the study groups.
The results of the present meta-analysis suggest that fibrin sealants for patients undergoing TKA may reduce blood loss and maintain higher hemoglobin levels, particularly when fibrin sealants are used at higher dosage. Furthermore, fibrin sealants do not increase the risk of postoperative deep vein thrombosis, superficial infection, pulmonary embolism, and hematoma. Further evaluation is required to confirm our findings before fibrin sealants can be used in patients undergoing TKA.
II.
系统评价随机对照试验,以评估纤维蛋白密封剂在全膝关节置换术(TKA)中减少术后失血和异体红细胞输血的效果。
通过 PubMed、Embase、Cochrane 图书馆、ScienceDirect 和其他数据库,检索截至 2013 年 5 月发表的研究。两位独立的评审员使用推荐评估、制定和评价方法(Grade of Recommendations Assessment, Development and Evaluation approach)评估方法学质量,并从文献中提取数据。从纤维蛋白治疗组和安慰剂组汇总失血、血红蛋白损失和输血率及不良反应的风险比(RR)的平均值差异(MD)。使用 Stata 11.0 软件分析相关数据。
共纳入 8 项研究,总计 558 例患者。引流失血量[MD=-354.02ml,95%置信区间(CI)(-500.87 至 -207.18);P<0.05]、计算总失血量[MD=-402.12ml,95%CI(-599.16 至 -205.08);P<0.05]、血红蛋白损失[MD=-0.86g/dl,95%CI(-1.10g/dl 至 -0.61g/dl);P<0.05]和输血率[RR=0.62,95%CI(0.45-0.86);P<0.05]均显著降低。研究组间不良反应发生率[RR=0.69,95%CI(0.32-1.59);P>0.05]无显著差异。
本荟萃分析结果表明,纤维蛋白密封剂可减少 TKA 患者的失血量并维持较高的血红蛋白水平,特别是在高剂量使用纤维蛋白密封剂时。此外,纤维蛋白密封剂并不增加术后深静脉血栓形成、浅表感染、肺栓塞和血肿的风险。在纤维蛋白密封剂可用于 TKA 患者之前,需要进一步评估以确认我们的发现。
II 级。