PMID- 31929600 OWN - NLM STAT- MEDLINE DCOM- 20200415 LR - 20200415 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 15 IP - 1 DP - 2020 TI - Predictive factors of first dosage intravenous immunoglobulin-related adverse effects in children. PG - e0227796 LID - 10.1371/journal.pone.0227796 [doi] LID - e0227796 AB - BACKGROUND: Intravenous immunoglobulin (IVIG) therapy is used in the treatment of various diseases, and IVIG-related adverse effects (IVIG-AEs) vary from mild to severe. However, the mechanisms underlying IVIG-AEs and the potential predictive factors are not clear. This study investigated whether certain IVIG-AEs can be predicted before IVIG administration. STUDY DESIGN AND METHODS: This retrospective cohort study at the Division of Neurology, Saitama Children's Medical Center included patients enrolled from 2008 to 2018 who were < 18 years old and received IVIG for the first time. IVIG-AEs were classified according to the Common Terminology Criteria for Adverse Events version 5.0. RESULTS: A total of 104 patients fulfilled the inclusion criteria. The rate of IVIG-AEs was 37.5% (39/104). The most frequent IVIG-AEs were fever (41.0% [16/39]) and headache (38.5% [15/39]). AEs were below grade 2 in all except one patient and there were no grade 4 AEs. High serum total protein (TP) level was significantly related to the occurrence of IVIG-AEs (odds ratio, 14.8; 95% confidence interval, 2.4-90.5; P < 0.01). The optimal cutoff TP level was 6.7 g/dL. Although low WBC count and immunoglobulin G level may be predictive risk factors of IVIG-AEs, it was not confirmed in this study. CONCLUSION: IVIG-AEs occurred in 37.5% of cases, and most were mild. TP was the best predictive risk factor of IVIG-AEs before IVIG administration. These results may aid in elucidating the mechanism underlying IVIG-AEs. FAU - Kubota, Jun AU - Kubota J AUID- ORCID: 0000-0002-1891-4746 AD - Division of Neurology, Saitama Children's Medical Center, Saitama, Japan. AD - Department of Pediatrics, The Jikei University School of Medicine, Tokyo, Japan. FAU - Hamano, Shin-Ichiro AU - Hamano SI AD - Division of Neurology, Saitama Children's Medical Center, Saitama, Japan. AD - Department for Child Health and Human Development, Saitama Children's Medical Center, Saitama, Japan. FAU - Daida, Atsuro AU - Daida A AD - Division of Neurology, Saitama Children's Medical Center, Saitama, Japan. FAU - Hiwatari, Erika AU - Hiwatari E AD - Division of Neurology, Saitama Children's Medical Center, Saitama, Japan. AD - Department of Pediatrics, The Jikei University School of Medicine, Tokyo, Japan. FAU - Ikemoto, Satoru AU - Ikemoto S AD - Department for Child Health and Human Development, Saitama Children's Medical Center, Saitama, Japan. FAU - Hirata, Yuko AU - Hirata Y AD - Division of Neurology, Saitama Children's Medical Center, Saitama, Japan. FAU - Matsuura, Ryuki AU - Matsuura R AD - Division of Neurology, Saitama Children's Medical Center, Saitama, Japan. FAU - Hirano, Daishi AU - Hirano D AD - Department of Pediatrics, The Jikei University School of Medicine, Tokyo, Japan. LA - eng PT - Journal Article DEP - 20200113 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Immunoglobulins, Intravenous) SB - IM MH - Child MH - Child, Preschool MH - Exanthema/chemically induced MH - Female MH - Fever/chemically induced MH - Headache/chemically induced MH - Humans MH - Immunoglobulins, Intravenous/administration & dosage/*adverse effects MH - Incidence MH - Infant MH - Male MH - Nausea/chemically induced MH - Protective Factors MH - Retrospective Studies MH - Vomiting/chemically induced PMC - PMC6957294 COIS- The authors have declared that no competing interest exist. EDAT- 2020/01/14 06:00 MHDA- 2020/04/16 06:00 PMCR- 2020/01/13 CRDT- 2020/01/14 06:00 PHST- 2019/08/29 00:00 [received] PHST- 2019/12/29 00:00 [accepted] PHST- 2020/01/14 06:00 [entrez] PHST- 2020/01/14 06:00 [pubmed] PHST- 2020/04/16 06:00 [medline] PHST- 2020/01/13 00:00 [pmc-release] AID - PONE-D-19-24367 [pii] AID - 10.1371/journal.pone.0227796 [doi] PST - epublish SO - PLoS One. 2020 Jan 13;15(1):e0227796. doi: 10.1371/journal.pone.0227796. eCollection 2020.