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

We performed a trial to investigate whether intravenous immunoglobulin (IVIG) prophylaxis in pediatric patients with ALL could prevent admissions for fever.

我们进行了一项试验，以调查静脉注射免疫球蛋白（IVIG）预防措施是否能预防儿童ALL患者的发热住院。

This randomized controlled trialwas a subtrial of the national Dutch multicenter ALL study.

这项随机对照试验是荷兰全国多中心急性淋巴细胞白血病（ALL）研究的一个子试验。

Patients aged 1-19 years with medium-risk ALL were randomized into two groups receiving either IVIG prophylaxis (0.7 g/kg IVIG given every 3 weeks, starting on day 22 after diagnosis) or well-defined standard of care (control group).

年龄在1至19岁之间，中危ALL患者被随机分为两组，一组接受IVIG预防治疗（从诊断后第22天开始，每3周给予0.7 g/kg的IVIG），另一组接受明确的标准治疗（对照组）。

Between October 2012 and March 2019, 91 (51%) patients were randomly assigned to IVIG prophylaxis and 86 (49%) to the control arm.

2012年10月至2019年3月期间，91名（51%）患者被随机分配到IVIG预防组，86名（49%）患者被分配到对照组。

In the IVIG prophylaxis group there were 206 admissions for fever versus 271 in the control group (P=0.011).

在IVIG预防组中，共有206次因发热住院，而在对照组中为271次（P=0.011）。

IVIG prophylaxis was not associated with bacteremia.

IVIG预防治疗与菌血症的发生无相关性。

However, there were significantly fewer admissions for fever with negative blood cultures in the IVIG prophylaxis group than in the control group (113 vs. 200, P<0.001).

然而，在IVIG预防治疗组中，因发热且血液培养阴性的住院次数显著少于对照组（113比200，P<0.001）。

The difference in number of admissions for fever was observed specifically during maintenance treatment (100 vs. 166, P<0.001) resulting in fewer courses of antibiotic treatment (78 vs. 137, P<0.001) and fewer cases of chemotherapy adaptation (72 vs. 134, P<0.001).

在维持治疗期间，发热住院次数的差异特别明显（100比166，P<0.001），导致抗生素治疗疗程减少（78比137，P<0.001）和化疗调整病例减少（72比134，P<0.001）。

In conclusion, in pediatric patients with medium-risk ALL, IVIG prophylaxis was associated with significantly fewer admissions for fever with negative blood cultures during maintenance treatment, resulting in fewer courses of antibiotic treatment and fewer chemotherapy adaptations.

总之，在中危急性淋巴细胞白血病（ALL）的儿科患者中，IVIG预防治疗与维持治疗期间因发热且血培养阴性而住院次数显著减少有关，从而减少了抗生素治疗疗程和化疗调整的次数。