Intravenous immunoglobulin G therapy in streptococcal toxic shock syndrome:: A European randomized, double-blind, placebo-controlled trial
Intravenous immunoglobulin G therapy in streptococcal toxic shock syndrome:: A European randomized, double-blind, placebo-controlled trial
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DOI：
10.1086/376630
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发表时间：
2003-08-01
影响因子：
11.8
通讯作者：
Norrby-Teglund, A
中科院分区：
文献类型：
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作者：
Darenberg, J;Ihendyane, N;Norrby-Teglund, A
采用多中心、随机、双盲、安慰剂对照试验，评价静脉注射大剂量多特异性免疫球蛋白G（IVIG）连续治疗链球菌中毒性休克综合征（STSS）的疗效和安全性。由于患者招募缓慢，该试验提前终止，结果来自21名入组患者（10名IVIG接受者和11名安慰剂接受者）。主要终点是28天的死亡率，安慰剂组的死亡率高出3.6倍。IVIG组在第2天（P = .02）和第3天（P = .04）脓毒症相关器官衰竭评估评分显著降低。此外，IVIG组治疗后血浆中抗自体分离物表达的超抗原的中和活性显著增加（P = 0.03）。虽然在主要终点中没有达到统计学显著性，但该试验为IVIG作为STSS的有效持续治疗提供了进一步的支持。
The efficacy and safety of high-dose intravenous polyspecific immunoglobulin G (IVIG) as adjunctive therapy in streptococcal toxic shock syndrome (STSS) were evaluated in a multicenter, randomized, double-blind, placebo-controlled trial. The trial was prematurely terminated because of slow patient recruitment, and results were obtained from 21 enrolled patients (10 IVIG recipients and 11 placebo recipients). The primary end point was mortality at 28 days, and a 3.6-fold higher mortality rate was found in the placebo group. A significant decrease in the sepsis-related organ failure assessment score at days 2 (P = .02) and 3 (P = .04) was noted in the IVIG group. Furthermore, a significant increase in plasma neutralizing activity against superantigens expressed by autologous isolates was noted in the IVIG group after treatment (P = .03). Although statistical significance was not reached in the primary end point, the trial provides further support for IVIG as an efficacious adjunctive therapy in STSS.