重组人可溶性血栓调节蛋白治疗脓毒症合并弥散性血管内凝血临床疗效的Meta分析

Clinical efficacy of recombinant human soluble thrombomodulin in sepsis-induced disseminated intravascular coagulation:a meta-analysis

目的系统评价重组人可溶性血栓调节蛋白(rhTM)治疗脓毒症合并弥散性血管内凝血(DIC)的临床疗效。方法检索PubMed、Embase、Cochrane Library、Sinomed、中国知网、万方数据库、维普数据库自建库至2022年7月发表的关于rhTM治疗脓毒症合并DIC患者的临床研究。对照组使用肝素、安慰剂治疗或空白对照;试验组使用rhTM治疗。由2名研究人员独立筛选文献、数据提取及质量评价后,使用RevMan 5.4软件进行Meta分析。结果共纳入7篇文献、合计1913例患者,其中试验组937例,对照组976例。Meta分析显示,试验组患者28 d病死率显著低于对照组[相对危险度(RR)=0.83,95%置信区间(CI)(0.71,0.97),Z=2.40,P=0.02],DIC缓解率显著高于对照组[RR=1.34,95%CI(1.09,1.66),Z=2.75,P=0.006],而两组患者间不良事件数比较差异没有统计学意义[RR=1.01,95%CI(0.58,1.75),Z=0.02,P=0.98]。结论rhTM能够降低脓毒症合并DIC患者的28 d病死率,提高DIC缓解率,且不会增加不良事件的发生,具有较好的临床使用价值。

Objective To systematically evaluate the clinical efficacy of recombinant human soluble thrombomodulin(rhTM)in sepsis-induced disseminated intravascular coagulation(DIC).Methods Clinical studies on rhTM for the treatment of sepsis-induced DIC were searched in PubMed,Embase,Cochrane Library,Sinomed,China National Knowledge Infrastructure,Wanfang database and VIP database published up to July 2022.The control group was treated with heparin,placebo or blank control.The experimental group was treated with rhTM.Two reviewers independently screened articles,extracted data and evaluated the quality of included studies.The RevMan 5.4 software was used to perform meta-analysis.Results Seven clinical studies involving 1913 patients were included,with 935 patients in the experimental group and 978 patients in the control group.Meta-analysis showed that the 28-day mortality in the experimental group was much lower than that in the control group[relative risk(RR)=0.83,95%confidence interval(CI)(0.71,0.97),Z=2.40,P=0.02],the remission rate of DIC was much higher[RR=1.34,95%CI(1.09,1.66),Z=2.75,P=0.006],and no significant difference in the number of adverse events was found between the two groups[RR=1.01,95%CI(0.58,1.75),Z=0.02,P=0.98].Conclusion rhTM can reduce the 28-day mortality and improve the remission rate of DIC in patients with sepsis-induced DIC,and it does not increase the occurrence of adverse events,showing good clinical application value.