氨甲环酸应用于膝关节置换术随机对照安慰剂试验的Meta分析

Exploration on the safety and effectiveness of using tranexamic acid in the total knee arthroplasty

目的探讨全膝关节置换术中使用氨甲环酸(TA)的安全性和有效性。方法计算机检索PubMed、The Cochrane Library、中国期刊全文数据库(CNKI)、中文科技期刊全文数据库(VIP)和万方数据库(WANFANG),查找所有在膝关节置换术中比较TA和安慰剂的随机对照试验(RCT),检索时限均为建库至2011年12月31日。同时手检纳入文献的参考文献。按纳入、排除标准由两人独立进行RCT的筛选、资料提取和质量评价后,采用RevMan5.1.6软件进行Meta分析,并采用GRADE系统进行证据质量评价。结果共纳入15个研究,950例患者。Meta分析结果显示:(1)总失血量:使用TA可以显著减少患者的总失血量[SMD=-478.48,95%CI(-640.31,-316.64),P<0.00001];(2)接受输血的人数:TA可以减少患者29%的输血率[SMD=0.15,95%CI(0.10,0.22),P<0.00001];(3)术后输血量:TA可以减少患者术后输血量[SMD=-1.42,95%CI(-1.75,-1.09),P<0.00001];(4)术后深静脉血栓(DVT)的发生率:TA组患者与对照组患者DVT的发生率无差异[SMD=0.70,95%CI(0.29,1.74),P=0.43];(5)术后肺栓塞(PE)的发生情况:TA组患者与对照组患者PE的发生率无差异[SMD=0.57,95%CI(0.13,2.42),P=0.44]。基于系统评价结果,采用GRADE系统推荐分级方法评价证据质量及推荐等级,结果显示,证据水平均为低级。结论 TA和安慰剂相比,可以减少患者总失血量、输血率和术后输血量,不会增高术后DVT和PE发生率,安全性高;但因原始研究的质量均较低,建议临床上审慎选择使用;需要更多高质量、大样本的RCT进一步论证。

Objective To explore the safety and effectiveness of using tranexamic acid in the total knee arthroplasty.Methods Such databases as PubMed,The Cochrane Library,China journal full-text database(CNKI),Chinese science and technology periodical full-text database(VIP)and WANFANG were searched from their establishment to December 31,2011 for collecting the randomized controlled trials(RCTs)about tranexamic acid vs.placebo for all in the total knee arthroplasty.After study selection,assessment and data extraction conducted by two reviewers independently,meta-analyses were performed by using the RevMan 5.1.6 software.The level of evidence was assessed by using the GRADE system.Results Fifteen studies involving 950 patients were included.The results of meta-analyses showed that:(1)Total blood loss:Using TA can significantly reduce the patient's total blood loss[SMD=-478.48,95% CI(-640.31,-316.64),P<0.000 01];(2)The number of received blood transfusions:TA can reduce 29% of the rate of blood transfusion patients accept the number of blood transfusion[SMD=0.15,95% CI(0.10,0.22),P<0.000 01];(3)Accept the number of blood transfusion:TA can reduce quantity of patients postoperative blood transfusion[SMD=-1.42,95% CI(-1.75,-1.09),P<0.000 01];(4)The incidence of postoperative DVT:There was no significant difference in the incidence of DVT between the patients of TA and control groups [SMD=0.70,95% CI(0.29,1.74),P=0.43];(5)After the happening situation of PE:There was no significant difference in the incidence of PE between the patients of TA and control groups [SMD=0.57,95% CI(0.13,2.42),P=0.44].Based on GRADE system,all the evidence was at level C.Conclusions Compared with placebo,TA can reduce patients total blood loss,blood transfusion rate and postoperative blood transfusion amount,and can not increase postoperative DVT and PE incidence rate and high safety.Due to the poor quality of the original studies,a prudent choice is suggested;and more high-quality,large-sample studies are need.