研究动态
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免疫球蛋白预防可防止小儿急性淋巴细胞白血病因发烧入院:多中心随机试验的结果。

Immunoglobulin prophylaxis prevents hospital admissions for fever in pediatric acute lymphoblastic leukemia: results of a multicenter randomized trial.

发表日期:2024 Aug 08
作者: Kirsten A Thus, Hester A De Groot-Kruseman, Pauline Winkler-Seinstra, Marta Fiocco, Heidi Segers, Cor Van den Bos, Inge M Van der Sluis, Wim J E Tissing, Margreet A Veening, Christian Michel Zwaan, Cornelis M Van Tilburg, Rob Pieters, Marc Bierings
来源: HAEMATOLOGICA

摘要:

感染会导致急性淋巴细胞白血病 (ALL) 治疗期间的大量发病率,其中适应性免疫系统受到严重影响,导致血清免疫球蛋白水平下降。本试验的目的是调查 ALL 儿科患者静脉注射免疫球蛋白 (IVIG) 预防是否可以防止因发热入院。这项随机对照试验是荷兰国家多中心 ALL 研究的子试验。年龄为 1-19 岁的中危 (MR) ALL 患者被随机分为两组,接受 IVIG 预防(每三周给予 0.7 g/kg IVIG,从诊断后第 22 天开始)或明确的护理标准(对照组)。 2012 年 10 月至 2019 年 3 月期间,91 名患者 (51%) 被随机分配至 IVIG 预防组,86 名患者 (49%) 被分配至对照组。 IVIG 预防组有 206 例因发热入院,而对照组有 271 例 (p=0.011)。 IVIG 预防与菌血症无关。然而,与对照组相比,IVIG 预防与因血培养阴性发烧而入院的人数显着减少相关(N=113 vs 200,p. 1)。
Infections lead to substantial morbidity during treatment of acute lymphoblastic leukemia (ALL) in which the adaptive immune system gets severely affected, leading to declining serum immunoglobulin levels. The aim of this trial was to investigate whether intravenous immunoglobulin (IVIG) prophylaxis in pediatric patients with ALL prevents admissions for fever. This randomized controlled trial was a subtrial of the national Dutch multicenter ALL study. Patients aged 1-19 years with medium risk (MR) ALL were randomized into two groups receiving either IVIG prophylaxis (0.7 g/kg IVIG given every three weeks, starting day 22 after diagnosis) or well defined standard of care (control group). Between October 2012 until March 2019, 91 (51%) patients were randomly assigned to IVIG prophylaxis and 86 (49%) to the control arm. In the IVIG prophylaxis group there were 206 admissions for fever versus 271 in the control group (p=0.011). IVIG prophylaxis was not associated with bacteremia. However, IVIG prophylaxis was associated with significantly less admissions for fever with negative blood cultures compared to the control group (N=113 versus 200, p.