Efficacy and safety of intravenous tranexamic acid in the operative treatment of calcaneal fractures: a meta-analysis

doi:10.3969/j.issn.2095-4344.1190

Abstract

Abstract:

BACKGROUND: The use of tranexamic acid in calcaneal fracture surgery can reduce the intraoperative and postoperative blood loss, reduce the incidence of incision complications, but cannot increase the rate of thrombosis. However, the clinical studies of tranexamic acid used in calcaneal fracture at home and abroad are few, and the small-sampled and low-quality trials lead to different results and poor credibility.

OBJECTIVE: To evaluate the efficacy and safety of intravenous tranexamic acid in calcaneal fracture surgery by meta-analysis.

METHODS:The Cochrane Library, Embase, PubMed, CNKI, VIP and WanFang databases were searched, and high-quality prospective randomized controlled studies using tranexamic acid in calcaneal fracture surgery were collected. Quality evaluation and data extraction in the included literatures were conducted. Meta-analysis was performed on intraoperative blood loss, postoperative drainage volume, postoperative hemoglobin, postoperative coagulation function (prothrombin time and activated partial thromboplastin time), incision complications and vascular adverse events in the tranexamic acid group and the normal saline group using RevMan 5.3 software provided by the Cochrane system.

RESULTS AND CONCLUSION: Seven articles were enrolled, including one in English and six in Chinese. There were 469 patients in total, 234 in the tranexamic acid group and 235 in the normal saline group. Meta-analysis results showed that: (1) The intraoperative blood loss and postoperative drainage volume in the tranexamic acid group were lower than those in the normal saline group [MD=-14.54, 95%CI (-25.08, -1.00), P=0.04; MD=-106.41, 95%CI (-134.91, -77.91), P < 0.000 01]. (2) The postoperative hemoglobin value in the tranexamic acid group was significantly higher than that in the normal saline group [SMD=1.21, 95%CI (0.38, 2.24), P=0.004]. (3) There was no significant difference in the prothrombin time or activated partial thromboplastin time postoperatively between two groups [MD=0.30, 95%CI (-0.09, 0.68), P=0.13; MD=1.08, 95%CI (-0.17, 2.33), P=0.09]. (4) The incidence of complications in the tranexamic acid group was lower than that in the normal saline group [RR=0.26, 95%CI (0.15, 0.42), P < 0.000 01]. No significant difference was found in the incidence of postoperative gastrointestinal bleeding, deep vein thrombosis, or acute coronary syndrome [RR=1.22, 95%CI (0.39, 3.83), P=0.74]. To conclude, tranexamic acid can effectively reduce the blood loss in the operation of calcaneal fracture, reduce the postoperative incision complications, and does not increase the incidence of postoperative deep vein thrombosis and other related vascular events. Tranexamic acid is safe and effective in calcaneal fracture surgery.

Key words: randomized controlled trials, tranexamic acid, calcaneal fracture, blood loss, incision complications, thrombosis, postoperative drainage volume, deep vein thrombosis, acute coronary syndrome, meta-analysis

CLC Number:

R453

Zhang Shuai, Ge Wenlong, Li Chang, Han Shichong, Wang Gang, Ren Wenjun. Efficacy and safety of intravenous tranexamic acid in the operative treatment of calcaneal fractures: a meta-analysis[J]. Chinese Journal of Tissue Engineering Research, 2019, 23(20): 3268-3274.

Figures/Tables 3

2.2.4 术后凝血功能检测有5篇文献报告了术后凝血酶原时间(PT)[6，11-14]，各项研究之间存在统计学异质性(P=0.07，I2=54%)，见图7A，逐个剔除纳入的研究后再重新进行分析，结果显示剔除“雷萌2017”研究后，各项研究之间无统计学异质性(P=0.60，I2=0%)，采用固定效应模型进行Meta分析后且各组间结果有统计学意义，说明异质性的来源与“雷萌2017”该项研究差异性较大有关。结果显示：氨甲环酸组与生理盐水组在术后凝血酶原时间值的差异无统计学意义[MD=0.30，95%CI(-0.09，0.68)，P=0.13]，氨甲环酸组术后凝血酶原时间值与生理盐水组相似，无明显差异，见图7B。有6篇文献报告了术后APTT值[6，11-14，16]，各项研究之间无明显统计学异质性(P=0.40，I2=2%)，采用固定效应模型进行Meta分析。结果显示：氨甲环酸组与生理盐水组术后APTT值的差异无统计学意义[MD=1.08，95%CI(-0.17，2.33)，P=0.09]。氨甲环酸对凝血系统因子的功能无影响，不增加血栓形成的风险，见图8。 2.2.5 切口并发症发生率有6篇文献报告了术后切口相关并发症的发生例数[6，11，13-16]，各研究之间无明显统计学异质性(P=0.97，I2=0%)，采用固定效应模型进行Meta分析。结果显示：氨甲环酸组与生理盐水组的术后切口并发症发生率比较差异有统计学意义[RR=0.26，95%CI(0.15，0.42)，P < 0.000 01]，氨甲环酸组术后切口并发症发生率显著低于生理盐水组，见图9。 2.2.6 血管不良事件发生率有2项研究报告了术后血管相关事件的发生率[6，12]，研究间无明显统计学异质性(P= 0.36，I2=0%)，采用固定效应模型进行Meta分析。结果显示：氨甲环酸组与生理盐水组在术后血管事件发生率方面的差异无统计学意义[RR=1.22，95%CI(0.39，3.83)， P=0.74]，使用氨甲环酸并不增加血管不良事件的发生率，见图10。 2.3 异质性和敏感性分析 Meta分析结果显示术后引流量的异质性较高，逐个剔除各项研究后再次进行Meta分析，结果仍显示出较高的异质性，且各组间结果有统计学意义，说明关于术后引流量方面此次Meta分析的结果较为可靠，通过重新阅读全文认为术后引流量异质性的来源可能与各个研究间引流量统计时间差异有关；该Meta分析结果示术后血红蛋白水平的异质性较高，逐个剔除纳入的研究后再重新进行分析，结果仍显示出较高的异质性，且各组间结果有统计学意义，说明关于术后血红蛋白水平方面此次分析的结果较为可靠，异质性的来源可能与各个研究间统计单位差异有关。 2.4 发表偏倚分析使用RevMan软件对文献进行Meta分析时可使用漏斗图进行发表偏倚评价，但Meta分析纳入的研究数不应少于10篇文献，否则会因为纳入的研究数少而导致漏斗图的检验能力下降，以致无法判断不对称性的真实性。而此次研究仅纳入7篇文献，因而未进行发表偏倚漏斗图分析。 "

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