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抗凝血酶III(ATIII)替代疗法用于脓毒症和/或术后并发症患者:一项对照双盲、随机、多中心研究。

Antithrombin III (ATIII) replacement therapy in patients with sepsis and/or postsurgical complications: a controlled double-blind, randomized, multicenter study.

作者信息

Baudo F, Caimi T M, de Cataldo F, Ravizza A, Arlati S, Casella G, Carugo D, Palareti G, Legnani C, Ridolfi L, Rossi R, D'Angelo A, Crippa L, Giudici D, Gallioli G, Wolfler A, Calori G

机构信息

Department of Hematology, Ospedale Niguarda, Milano, Italy.

出版信息

Intensive Care Med. 1998 Apr;24(4):336-42. doi: 10.1007/s001340050576.

DOI:10.1007/s001340050576
PMID:9609411
Abstract

BACKGROUND

ATIII is decreased in sepsis and/or shock and its baseline value correlates with mortality. The efficacy of ATIII therapy on mortality was assessed in a selected group of patients admitted to the intensive care unit (ICU) in a double-blind, randomized, multicenter study.

METHODS

120 patients admitted to the ICU with an ATIII concentration < 70% were randomized to receive ATIII (total dose 24000 units) or placebo treatment for 5 days; 56 patients had septic shock.

RESULTS

ATIII concentrations in the treated group remained constant throughout the treatment period (range 97-102%). The Kaplan-Meier analysis showed no difference in overall survival between the two groups: 50 and 46% for ATIII and placebo, respectively. Septic shock and hemodynamic support were unbalanced in the two groups at admission. Therefore the Cox analysis was carried out after adjusting for these two variables. Treatment with ATIII decreases the risk of death with an odds ratio (OR) of 0.56. Of the covariates analyzed, septic shock and the baseline multiple organ failure score were negatively associated with survival and plasma activity level was positively associated with survival with an OR of 0.97 for each 1% increase in the ATIII plasma concentration at baseline.

CONCLUSIONS

The results of ATIII treatment in this population of patients suggests that replacement therapy reduces mortality in the subgroup of septic shock patients only.

摘要

背景

脓毒症和/或休克时抗凝血酶III(ATIII)水平降低,其基线值与死亡率相关。在一项双盲、随机、多中心研究中,对一组入住重症监护病房(ICU)的患者评估了ATIII治疗对死亡率的疗效。

方法

120名入住ICU且ATIII浓度<70%的患者被随机分为接受ATIII(总剂量24000单位)或安慰剂治疗5天;56名患者患有感染性休克。

结果

治疗组的ATIII浓度在整个治疗期间保持恒定(范围97 - 102%)。Kaplan - Meier分析显示两组总体生存率无差异:ATIII组和安慰剂组分别为50%和46%。两组入院时感染性休克和血流动力学支持情况不均衡。因此,在对这两个变量进行调整后进行Cox分析。ATIII治疗使死亡风险降低,比值比(OR)为0.56。在分析的协变量中,感染性休克和基线多器官功能衰竭评分与生存率呈负相关,血浆活性水平与生存率呈正相关,基线时ATIII血浆浓度每增加1%,OR为0.97。

结论

该患者群体中ATIII治疗的结果表明,替代治疗仅降低感染性休克患者亚组的死亡率。

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Intensive Care Med. 1998 Jul;24(7):663-72. doi: 10.1007/s001340050642.
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