Thus Kirsten A, De Groot-Kruseman Hester A, Winkler-Seinstra Pauline, Fiocco Marta, Segers Heidi, Van den Bos Cor, Van der Sluis Inge M, Tissing Wim J E, Veening Margreet A, Zwaan Christian Michel, Van Tilburg Cornelis M, Pieters Rob, Bierings Marc
Princess Máxima Center for Pediatric Oncology, Utrecht.
Mathematical Institute Leiden University, Leiden University, Leiden, The Netherlands; Department of Biomedical Data Science, Section Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands; Princess Máxima Center for Pediatric Oncology, Utrecht.
Haematologica. 2025 Jan 1;110(1):47-54. doi: 10.3324/haematol.2024.285428.
Infections lead to substantial morbidity during the treatment of acute lymphoblastic leukemia (ALL) in which the adaptive immune system is severely affected, leading to declining serum immunoglobulin levels. We performed a trial to investigate whether intravenous immunoglobulin (IVIG) prophylaxis in pediatric patients with ALL could prevent 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 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). Between October 2012 and 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, 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). 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). 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.
在急性淋巴细胞白血病（ALL）的治疗过程中，感染会导致严重的发病情况，因为适应性免疫系统会受到严重影响，导致血清免疫球蛋白水平下降。我们进行了一项试验，以研究在患有ALL的儿科患者中静脉注射免疫球蛋白（IVIG）预防是否能预防因发热而住院。这项随机对照试验是荷兰全国多中心ALL研究的一个子试验。年龄在1至19岁的中危ALL患者被随机分为两组，一组接受IVIG预防（诊断后第22天开始，每3周静脉注射0.7 g/kg IVIG），另一组接受明确界定的标准治疗（对照组）。在2012年10月至2019年3月期间，91名（51%）患者被随机分配接受IVIG预防，86名（49%）被分配到对照组。IVIG预防组有206次因发热住院，而对照组为271次（P = 0.011）。IVIG预防与菌血症无关。然而，IVIG预防组血培养阴性的发热住院次数明显少于对照组（113次对200次，P < 0.001）。发热住院次数的差异在维持治疗期间尤为明显（100次对166次，P < 0.001），导致抗生素治疗疗程减少（78次对137次，P < 0.001），化疗调整情况减少（72次对134次，P < 0.001）。总之，在患有中危ALL的儿科患者中，IVIG预防与维持治疗期间血培养阴性的发热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情况。
