Li Zhi-Jun, Fu Xin, Tian Peng, Liu Wen-Xing, Li Yao-Min, Zheng Yong-Fa, Ma Xin-Long, Deng Wei-Min
Department of Orthopedics, Tianjin Medical University General Hospital, Tianjin, 300054, People's Republic of China,
Knee Surg Sports Traumatol Arthrosc. 2015 Jul;23(7):2019-25. doi: 10.1007/s00167-014-2898-4. Epub 2014 Feb 12.
Fibrin sealant (FS) comprises a mixture of fibrinogen and thrombin that controls bleeding, reduces blood transfusions, improves tissue healing and shortens postoperative recovery time after various surgical procedures. However, no single study has been large enough to definitively determine whether fibrin sealant is safe and effective. We report a meta-analysis of randomized controlled trials (RCTs) evaluating the efficacy and safety of fibrin sealant in total knee arthroplasty.
Articles published before August, 2012 were identified from PubMed, Embase, The Cochrane Library and other internet databases. Relevant journals and the recommendations of expert panels were also searched manually. We included only high-quality RCTs. Two independent reviewers searched and assessed the literature. Relevant data were analysed using RevMan 5.0.
Seven RCTs met the inclusion criteria. Use of fibrin sealant significantly reduced haemoglobin decline mean difference (MD = -0.72), 95 % confidence interval [95 % CI (-0.83, -0.62), p < 0.00001], postoperative drainage volume [MD = -354.53, 95 % CI (-482.43, -226.63), p < 0.00001], the proportion of patients requiring blood transfusion risk differences [RD = -0.27, 95 % CI (-0.45, -0.08), p = 0.006] and the incidence of wound haematoma [RD = -0.11, 95 % CI (-0.22, -0.00), p = 0.04]. There were no significant differences in deep vein thrombosis, pulmonary embolism, infection rate or other complications between groups.
Use of fibrin sealant in total knee arthroplasty was effective and safe, reduced haemoglobin decline, postoperative drainage volume, incidence of haematoma and need for blood transfusion, and did not increase the risk of complications. Due to the limited quality of the evidence currently available, more high-quality RCTs are required.
II.
纤维蛋白密封剂(FS)由纤维蛋白原和凝血酶的混合物组成,可控制出血、减少输血、促进组织愈合并缩短各种外科手术后的术后恢复时间。然而,尚无单一研究规模足够大到能明确确定纤维蛋白密封剂是否安全有效。我们报告一项对评估纤维蛋白密封剂在全膝关节置换术中疗效和安全性的随机对照试验(RCT)的荟萃分析。
从PubMed、Embase、Cochrane图书馆及其他网络数据库中检索2012年8月之前发表的文章。还手动检索了相关期刊及专家小组的建议。我们仅纳入高质量的RCT。两名独立的审阅者检索并评估文献。使用RevMan 5.0分析相关数据。
七项RCT符合纳入标准。使用纤维蛋白密封剂显著降低了血红蛋白下降均值差(MD = -0.72),95%置信区间[95%CI(-0.83,-0.62),p < 0.00001]、术后引流量[MD = -354.53,95%CI(-482.43,-226.63),p < 0.00001]、需要输血的患者比例风险差[RD = -0.27,95%CI(-0.45,-0.08),p = 0.006]以及伤口血肿发生率[RD = -0.11,95%CI(-0.22,-0.00),p = 0.04]。两组之间在深静脉血栓形成、肺栓塞、感染率或其他并发症方面无显著差异。
在全膝关节置换术中使用纤维蛋白密封剂是有效且安全的,可减少血红蛋白下降、术后引流量、血肿发生率及输血需求,且不会增加并发症风险。由于目前现有证据质量有限,需要更多高质量的RCT。
II级。