IgMA-enriched immunoglobulin in neutropenic patients with sepsis syndrome and septic shock: A randomized, controlled, multiple-center trial*

医学 感染性休克 败血症 内科学 中性粒细胞减少症 死亡率 胃肠病学 外科 化疗
作者
Marcus Hentrich,Karl Fehnle,Helmut Ostermann,Joachim Kienast,Oliver A. Cornely,Christoph Salat,Ralf Übelacker,Dieter Buchheidt,Gerhard Behre,Wolfgang Hiddemann,Xaver Schiel
出处
期刊:Critical Care Medicine [Ovid Technologies (Wolters Kluwer)]
卷期号:34 (5): 1319-1325 被引量:73
标识
DOI:10.1097/01.ccm.0000215452.84291.c6
摘要

To evaluate the effect of intravenous IgMA-enriched immunoglobulin (ivIGMA) therapy on mortality in neutropenic patients with hematologic malignancies and sepsis syndrome or septic shock.Multiple-center, prospective randomized, controlled study.Six university hospitals in Germany.Patients were 211 neutropenic patients with sepsis syndrome or septic shock after chemotherapy for severe hematologic disorders between 1992 and 1999.Patients received 1300 mL of ivIGMA (7.8 g IgM, 7.8 g IgA, and 49.4 g IgG) infused intravenously within a period of 72 hrs or human albumin according to the same schedule as ivIGMA.All-cause mortality at 28 days, sepsis-related mortality at 28 days, all-cause mortality at 60 days, mortality from septic shock, and mortality from microbiologically proven Gram-negative sepsis and septic shock were recorded. Immunoglobulin had no benefit over human albumin. The 28-day mortality rate was 26.2% and 28.2% in the ivIGMA and control patients, respectively (difference, 2.0% [95% confidence interval, -10.2 to 14.2 percentage points]). Likewise, the 60-day mortality rate did not differ between both arms (29.6% vs. 34.7% in the ivIGMA and control patients, respectively). Mortality rates in patients with sepsis syndrome (17.1% vs. 16.7%) and septic shock (51.9% vs. 54.8%) were also found to be similar between both groups.Intravenous ivIGMA had no beneficial effects in neutropenic patients with hematologic malignancies and sepsis syndrome and septic shock.
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