Chinese Journal of Tissue Engineering Research ›› 2021, Vol. 25 ›› Issue (15): 2430-2436.doi: 10.3969/j.issn.2095-4344.3821
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Efficacy and safety of tranexamic acid and epsilon-aminocaproic acid in reducing perioperative blood loss during total knee arthroplasty: a meta-analysis
Chen Wang, Feng Shuo, Zhang Yu, Chen Xiangyang
- The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221002, Jiangsu Province, China
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Received:2020-06-28Revised:2020-07-03Accepted:2020-07-31Online:2021-05-28Published:2021-01-05 -
Contact:Chen Xiangyang, MD, Chief physician, Associate professor, Master’s supervisor, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221002, Jiangsu Province, China -
About author:Chen Wang, Master candidate, The Affiliated Hospital of Xuzhou Medical University, Xuzhou 221002, Jiangsu Province, China
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Cite this article
Chen Wang, Feng Shuo, Zhang Yu, Chen Xiangyang. Efficacy and safety of tranexamic acid and epsilon-aminocaproic acid in reducing perioperative blood loss during total knee arthroplasty: a meta-analysis [J]. Chinese Journal of Tissue Engineering Research, 2021, 25(15): 2430-2436.
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2.1 文献检索结果及质量评价 从6个电子数据库(Cochrane图书馆、PubMed、Web of Science、中国知网、万方、维普)中提取了相关文献1 215篇。使用Endnote X9软件删除重复项后，还剩下681篇；阅读题目和摘要进行初筛，排除了503篇不相关的文献；剩余178篇，根据纳入和排除标准排除文献146篇；仔细阅读其余的32篇文章，通过浏览文献中的参考文献，纳入了0个其他的研究；由于以下原因排除了另外25篇文章：没有进行对比(n=11)，没有需要的数据(n=8)，综述(n=4)，其他(n=2)。最后1990年至2020年6月之间发表的7项研究符合纳入标准[9-15]，纳入荟萃分析。详细的文献筛选过程见图1。表1详细列出了纳入文献的一般特征。 "
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7项研究总计3 464例患者(氨甲环酸 = 1 508例，ε-氨基己酸 = 1 956例)。其中4项为随机对照研究[9，12，14-15]，Cochrane偏倚风险评估为低风险(图2，3)；3项为回顾性对照研究[10-11，13]，研究质量由纽卡斯尔-渥太华量表评估，其中2项为高质量研究，1项为中等质量研究(表2)。纳入文献的样本量至少为32例，最多为820例；随访时间为1-3个月不等。"
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4项随机对照试验研究均描述了随机序列的产生和分配隐瞒，均描述了双盲；文献中对失访和报告等偏倚进行了详细的报道，并将其归类为低风险偏倚；对测量和其他偏倚描述的较差。3项队列研究的文献质量采用纽卡斯尔-渥太华量表进行评价，结果显示非随机对照试验偏倚风险相对较低。 2.2 Meta分析结果 2.2.1 总失血量 4项研究(共733例患者)比较了两种药物使用后的总失血量[9，12-13，15]，森林图显示两者差异无统计学异质性(I2=44%，P=0.15)，采用固定效应模型。结果证明两种药物之间差异有显著性意义，氨甲环酸组的总失血量少于ε-氨基己酸组(WMD=-0.44，95%CI：-0.59至-0.30，P < 0.000 01)，见图4。 "
2.2.2 术中失血量 3项研究(共428例患者)比较了两种药物使用后的术中失血量[12，14-15]，森林图显示两者差异无统计学异质性(I2=35%，P=0.22)，采用固定效应模型。结果证明两种药物之间差异无显著性意义(WMD=-2.49，95%CI：-7.77-2.78，P=0.35)，见图5。 "
2.2.3 红细胞容积损失量 2项研究(共332例患者)比较了两种药物使用后的红细胞容积损失量[12，14]，森林图显示两者差异有统计学异质性(I2=95%， P < 0.000 01)，采用随机效应模型。结果证明两种药物之间差异无显著性意义(WMD=-0.87，95%CI：-1.96-0.22，P= 0.12)，见图6。"
2.2.4 红细胞压积下降量 2项研究(共159例患者)比较了两种药物使用后的红细胞压积下降量[9，15]，森林图显示两者差异有统计学异质性(I2=62%，P=0.11)，采用随机效应模型。结果证明两种药物之间差异无显著性意义(WMD=-0.41，95%CI：-1.90-1.07，P=0.59)，见图7。"
2.2.5 血红蛋白下降量 4项研究(共 1 734例患者)比较了两种药物使用后的血红蛋白下降量[9，11，14-15]，森林图显示两者差异无统计学异质性(I2=43%，P=0.15)，采用固定效应模型。结果证明两种药物之间差异有显著性意义，氨甲环酸组血红蛋白下降量小于ε-氨基己酸组(WMD=-0.19，95%CI：-0.26至-0.12，P < 0.000 01)，见图8。"
2.2.6 单位红细胞输血量 2项研究(共479例患者)比较了两种药物使用后的单位红细胞输血量[13，15]，森林图显示两者差异无统计学异质性(I2=0%，P= 0.57)，采用固定效应模型。结果证明两种药物之间差异有显著性意义，氨甲环酸组单位红细胞输血量小于ε-氨基己酸组(WMD=0.14，95%CI：0.04-0.42，P=0.000 6)，见图9。"
2.2.7 每例患者单位输血量 3项研究(共2 653例患者)比较了两种药物使用后每例患者的单位输血量[9-11]，森林图显示两者差异有统计学异质性(I2= 56%，P=0.11)，采用随机效应模型。结果证明两种药物之间差异无显著性意义(WMD=0.00，95%CI：-0.05-0.06，P = 0.94)，见图10。"
2.2.8 输血人数 5项研究(共2 890例患者)比较了两种药物使用后的输血人数[9-11，14-15]，森林图显示两者差异无统计学异质性(I2=9%，P=0.35)，采用固定效应模型。结果证明两种药物之间差异无显著性意义(WMD=1.31，95%CI：0.94-1.83，P=0.11)，见图11。"
2.2.9 引流管引流量 2项研究(共237例患者)比较了两种药物使用后的引流管引流量[14-15]，森林图显示两者差异有统计学异质性(I2=99%，P < 0. 000 01)，采用随机效应模型。结果证明两种药物之间差异无显著性意义(WMD=-2.11，95%CI：-5.73-1.52，P=0.25)，见图12。"
2.2.10 住院时间 3项研究(共1 769例患者)比较了两种药物使用后的住院时间[11-12，14]，森林图显示两者差异无统计学异质性(I2=0%，P=0.77)，采用固定效应模型。结果证明两种药物之间差异无显著性意义(WMD=-0.01，95%CI： -0.11-0.08，P=0.80)，见图13。"
2.2.11 止血带时间 2项研究(共280例患者)比较了两种药物使用后的止血带时间[12，15]，森林图显示两者差异无统计学异质性(I2=0%，P=0.94)，采用固定效应模型。结果证明两种药物之间差异无显著性意义(WMD=1.23，95%CI： -2.73-5.20，P=0.54)，见图14。"
2.2.12 手术时间 3项研究(共353例患者)比较了两种药物使用后的手术时间[9，12，15]，森林图显示两者差异无统计学异质性(I2=0%，P=0.39)，采用固定效应模型。结果证明两种药物之间差异无显著性意义(WMD=1.42，95%CI： -2.23-5.07，P=0.45)，见图15。"
2.2.13 肺部并发症 2项研究(共332例患者)比较了两种药物使用后的肺部并发症[12，14]，森林图显示两者差异有统计学异质性(I2=63%，P=0.10)，采用随机效应模型。结果证明两种药物之间差异无显著性意义(WMD=1.30，95%CI：0.06-28.39，P=0.87)，见图16。"
2.2.14 心脏并发症 3项研究(共424例患者)比较了两种药物使用后的心脏并发症[12，14-15]，森林图显示两者差异无统计学异质性(I2=0%，P=0.77)，采用固定效应模型。结果证明两种药物之间差异无显著性意义(WMD=2.33，95%CI：0.59-9.12，P=0.23)，见图17。"
2.2.15 再入院人数 2项研究(共2 586例患者)比较了两种药物使用后的再入院人数[10-11]，森林图显示两者差异无统计学异质性(I2=0%，P=0.96)，采用固定效应模型。结果证明两种药物之间差异无显著性意义(WMD=0.94，95%CI：0.59-1.49，P=0.79)，见图18。"
2.3 发表偏倚评价 采用Review Manager 5.3软件进行发表偏倚检验。以纳入研究最多的输血率一项做漏斗图，并把输血率分为随机对照试验组和非随机对照试验组做亚组分析，漏斗图中的6个点大致对称分布，表明发布偏倚对结果的影响较小，见图19。"
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