背景:弥散性血管内凝血(DIC)综合征是一种高度致命的疾病,其特征是多器官损伤的并发症。虽然联合抗凝血酶(AT)和重组血栓调节蛋白(rTM)对DIC综合征的影响以前已经研究过,结果不一致且无定论。因此,我们对AT和rTM联合给药治疗脓毒性DIC进行了系统评价,以使用随机效应分析模型研究联合治疗优于AT或rTM单药治疗的优越性.
方法:我们搜索了电子数据库,包括Medline,Cochrane中央控制试验登记册,Scopus,和Igaku-ChuoZasshi(ICHU-SHI)日本中央医学网从成立到2022年1月。包括评估AT和rTM组合的功效的研究。主要结果是全因死亡率,与单药治疗相比,次要结局是严重出血并发症的发生.根据每个主要研究的报告结果,我们以95%置信区间(CI)呈现了合并比值比(OR)或风险比(HR)。
结果:我们分析了7项纳入的临床试验,所有这些都是观察性研究.与单一疗法相比,联合疗法与28天死亡率较低无显著的有利关联(HR0.67[0.43-1.05],或0.73[0.45-1.18])。I2值分别为60%和72%,分别,表明高度异质性。作为次要结果,两组出血并发症相似(合并OR1.11[0.55-2.23],I2值55%)。
结论:尽管本分析的结果无法证实AT和rTM联合治疗对感染性DIC的统计学意义,在改善死亡率方面显示出有希望的效果。出血发生率低,临床可行。需要进一步的研究才能得出更多的结论性结果。
背景:本研究已在大学医院医学信息网络(UMIN)临床试验注册(UMINID:000049820)中注册。
BACKGROUND: Disseminated intravascular coagulation (DIC) syndrome is a highly lethal condition characterized by the complication of multiple organ damage. Although the effects of combined antithrombin (AT) and recombinant
thrombomodulin (rTM) on DIC syndrome have previously been examined, the results are inconsistent and inconclusive. Therefore, we conducted a systematic
review on the combined administration of AT and rTM for the treatment of septic DIC to investigate the superiority of the combination therapy over either AT or rTM monotherapy using a random-effects analysis model.
METHODS: We searched electronic databases, including Medline, Cochrane Central Register of Controlled Trials, Scopus, and Igaku-Chuo Zasshi (ICHU-SHI) Japanese Central
Review of Medicine Web from inception to January 2022. Studies assessing the efficacy of combined AT and rTM were included. The primary outcome was all-cause mortality, and the secondary outcome was occurrence of serious bleeding complications compared to monotherapy. We presented the pooled odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CI) depending on reporting results in each primary study.
RESULTS: We analyzed seven enrolled clinical trials, all of which were observational studies. Combination therapy had a non-significant favorable association with lower 28-day mortality compared to monotherapy (HR 0.67 [0.43-1.05], OR 0.73 [0.45-1.18]). The I2 values were 60% and 72%, respectively, suggesting high heterogeneity. As a secondary outcome, bleeding complications were similar between the two groups (pooled OR 1.11 [0.55-2.23], I2 value 55%).
CONCLUSIONS: Although the findings in this analysis could not confirm a statistically significant effect of AT and rTM combination therapy for septic DIC, it showed a promising effect in terms of improving mortality. The incidence of bleeding was low and clinically feasible. Further research is warranted to draw more conclusive results.
BACKGROUND: This study was registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN ID: 000049820).