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首页> 外文期刊>Critical care : >Early treatment with IgM-enriched intravenous immunoglobulin does not mitigate critical illness polyneuropathy and/or myopathy in patients with multiple organ failure and SIRS/sepsis: a prospective, randomized, placebo-controlled, double-blinded trial
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Early treatment with IgM-enriched intravenous immunoglobulin does not mitigate critical illness polyneuropathy and/or myopathy in patients with multiple organ failure and SIRS/sepsis: a prospective, randomized, placebo-controlled, double-blinded trial

机译：富含IgM的静脉内免疫球蛋白的早期治疗不能缓解多器官功能衰竭和SIRS /败血症患者的重症多发性神经病和/或肌病：一项前瞻性，随机，安慰剂对照，双盲试验

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IntroductionCritical illness polyneuropathy and/or myopathy (CIPNM) is a severe complication of critical illness. Retrospective data suggest that early application of IgM-enriched intravenous immunoglobulin (IVIG) may prevent or mitigate CIPNM. Therefore, the primary objective was to assess the effect of early IgM-enriched IVIG versus placebo to mitigate CIPNM in a prospective setting.MethodsIn this prospective, randomized, double-blinded and placebo-controlled trial, 38 critically ill patients with multiple organ failure (MOF), systemic inflammatory response syndrome (SIRS)/sepsis, and early clinical signs of CIPNM were included. Patients were randomly assigned to be treated either with IgM-enriched IVIG or placebo over a period of three days. CIPNM was measured by the CIPNM severity sum score based on electrophysiological stimulation of the median, ulnar, and tibial nerves on days 0, 4, 7, 14 and on the histological evaluation of muscle biopsies on days 0 and 14 and ranged from 0 (no CIPNM) to 8 (very severe CIPNM).ResultsA total of 38 critically ill patients were included and randomized to receive either IgM-enriched IVIG (n = 19) or placebo (n = 19). Baseline characteristics were similar between the two groups. CIPNM could not be improved by IVIG treatment, represented by similar CIPNM severity sum scores on day 14 (IVIG vs. placebo: 4.8 ± 2.0 vs. 4.5 ± 1.8; P = 0.70). CIPNM severity sum score significantly increased from baseline to day 14 (3.5 ± 1.6 vs. 4.6 ± 1.9; P = 0.002). After an interim analysis the study was terminated early due to futility in reaching the primary endpoint.ConclusionsEarly treatment with IVIG did not mitigate CIPNM in critically ill patients with MOF and SIRS/sepsis.Trial registrationClinicaltrials.gov: NCT01867645
机译：简介重症多发性神经病和/或肌病（CIPNM）是重症的严重并发症。回顾性数据表明，尽早使用富含IgM的静脉免疫球蛋白（IVIG）可以预防或减轻CIPNM。因此，主要目的是评估前瞻性研究中早期富集IgM的IVIG与安慰剂在缓解CIPNM方面的作用。方法在该前瞻性，随机，双盲和安慰剂对照试验中，38例多器官功能衰竭的重症患者（ MOF），全身性炎症反应综合征（SIRS）/败血症和CIPNM的早期临床体征均包括在内。在三天内将患者随机分配接受富含IgM的IVIG或安慰剂治疗。 CIPNM的严重程度总和评分是根据CIPNM严重度总分来衡量的，该分数基于第0、4、7、14天的正中，尺神经和胫神经的电生理刺激，以及第0和14天的肌肉活检组织学评估，范围为0（无CIPNM）到8（非常严重的CIPNM）。结果总共纳入38名危重患者，并随机接受富含IgM的IVIG（n = 19）或安慰剂（n = 19）。两组之间的基线特征相似。 IVIG治疗不能改善CIPNM，在第14天时具有类似的CIPNM严重程度总分（IVIG与安慰剂：4.8±2.0对4.5±1.8; P = 0.70）。从基线到第14天，CIPNM严重性总分显着提高（3.5±1.6 vs. 4.6±1.9; P = 0.002）。经过中期分析后，该研究由于未能达到主要终点而提前终止了研究结论结论对于患有MOF和SIRS /脓毒症的危重患者，早期用IVIG治疗并不能减轻CIPNM的临床试验临床注册.NCT01867645

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