Antithrombin III (ATIII) replacement therapy in patients with sepsis and/or postsurgical complications: a controlled double-blind, randomized, multicenter study
Antithrombin III (ATIII) replacement therapy in patients with sepsis and/or postsurgical complications: a controlled double-blind, randomized, multicenter study
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DOI：
10.1007/s001340050576
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发表时间：
1998-04-01
影响因子：
38.9
通讯作者：
Calori, G
中科院分区：
文献类型：
--
作者：
Baudo, F;Caimi, TM;Calori, G
背景：ATIII 在败血症和/或休克时降低，其基线值与死亡率相关。在一项双盲、随机、多中心研究中，在选定的一组入住重症监护病房 (ICU) 的患者中评估了 ATIII 治疗对死亡率的疗效。方法：120 名入住 ICU 且 ATIII 浓度 < 70% 的患者随机接受 ATIII（总剂量 24 000 单位）或安慰剂治疗，为期 5 天； 56 名患者出现感染性休克。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 分析显示两组之间的总生存率没有差异：ATIII 组和安慰剂组分别为 50% 和 46%。入院时两组感染性休克和血流动力学支持不平衡。因此，在调整这两个变量后进行了 Cox 分析。 ATIII 治疗可降低死亡风险，比值比 (OR) 为 0.56。在分析的协变量中，脓毒性休克和基线多器官衰竭评分与生存呈负相关，血浆活性水平与生存呈正相关，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，替代疗法仅降低脓毒性休克患者亚组的死亡率。
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 24 000 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.