脊柱手术中应用氨甲环酸的有效性和安全性荟萃分析

摘要

目的 通过荟萃分析对抗纤溶药氨甲环酸(TXA)在减少脊柱外科手术失血量的有效性和安全性进行评价.方法 计算机检索数据库PubMed、EMBase、Cochrane Library、CNKI、维普中文科技期刊数据库中关于TXA对脊柱外科手术失血量影响的临床随机对照双盲研究,并结合手工查阅所有检出文献和相关综述的参考文献作为补充资料,截止到2009年11月.采用RevMan 4.2软件进行统计学分析,TXA组与安慰剂组总失血量和总输血量采用加权均数差(WMD)评价,输血率、深静脉血栓发生率采用优势比(OR)评价.结果 共纳入前瞻性随机对照双盲研究4篇,样本总量295例.荟萃分析结果显示,与安慰剂组相比,TXA能够显著减少脊柱外科手术患者总失血量[WMD为-523.74,95%CI为(-778.92～-268.56),P＜0.01]和输血量[WMD为-242.28,95%CI为(-394.02～-90.54),P=0.002],降低输血率[OR为0.57,95%CI为(0.34～0.93),P=0.020],而深静脉血栓发生率无明显差异.结论 静脉应用TXA能够显著减少脊柱外科手术总失血量和输血量,降低输血率,而不增加术后深静脉血栓的发生率.%Objective To assess the effectiveness and safety of using tranexamic acid(TXA) in reducing blood loss in spine surgery through a meta-analysis. Methods Literatures before November 2009 were identified from the PubMed, EMBase, Cochrane library, CNKI and VIP databases. Relevant journals or conference proceedings were also searched manually. This study only enrolled high quality (Jadad scores ≥3 ) randomized controlled trials (RCTs) . Two independent reviewers searched and assessed the literatures. Weighted mean difference (WMD) of blood loss and blood transfusions, odds ratio (OR) of transfusion rate and of deep vein thrombosis (DVT) rate in TXA-treated group versus placebo group were calculated across the studies. The statistical analysis were conducted by the software of RevMan 4. 2. Results Four double-blinded RCTs met the inclusion criteria for meta-analysis. The total sample size of these studies was 295. The use of TXA significantly reduced total blood loss [ WMD = -523.74, 95% CI ( - 778.92, - 268.56), P ＜ 0. 01 ], blood volumes of transfusion [ WMD = - 242. 28, 95% CI( - 394. 02,- 90. 54), P = 0. 002 ] and proportion of patients requiring blood transfusion [ OR = 0. 57, 95% CI (0. 34,0. 93 ), P = 0. 020 ], while did not raise the risk of DVT, as compared with placebo group. Conclusions This meta-analysis indicates that the use of TXA infusion for patients undergoing spine surgery is effective in reducing total blood loss, transfusion volumes and the rate of transfusion, yet doesn't raise the risk of postoperative DVT.