1.Analysis of specific risks and long-term toxicities of BCR-ABL1 TKIs in pediatric patients with hematological malignancies
Luping WEN ; Fan XIA ; Ziqiong LIAO ; Benjie ZHOU ; Hui CHEN
China Pharmacy 2026;37(8):1050-1055
OBJECTIVE To analyze the specific risks and long-term toxicities of four BCR-ABL1 tyrosine kinase inhibitors (TKIs)(imatinib, dasatinib, nilotinib, and bosutinib) in pediatric patients with hematological malignancies. METHODS Adverse drug event (ADE) reports submitted to the the United States FDA Adverse Event Reporting System (FAERS) from January 2012 to December 2024, with imatinib, dasatinib, nilotinib, and bosutinib as the primary suspect drugs, were collected. Data mining was performed using the reporting odds ratio method and proportional reporting ratio method. ADE terms were classified and summarized by system organ class (SOC) and preferred term (PT) according to the Medical Dictionary for Drug Regulatory Activities (MedDRA, version 26.0). Meanwhile, the ADE reports were divided by age into the adult group (≥18 years) and the pediatric group (<18 years) to compare the differences in ADE between the two groups. RESULTS A total of 1 512 pediatric ADE reports were included: 993 for imatinib, 391 for dasatinib, 112 for nilotinib, and 16 for bosutinib. Among the reported ADEs, the patients were mainly aged 12-<18 years; the reports mainly originated from the United States, France, and Japan; and the primary indications were chronic myeloid leukemia and acute lymphoblastic leukemia. A total of 5 256 ADE signals were mined, among which 235 were positive signals, involving 1 103 PT across 27 SOC. The top five PT ranked by the number of positive signals were nausea, febrile neutropenia, abdominal pain, neutropenia, and anemia. The top two SOC were general disorders and administration site conditions, and gastrointestinal disorders. Compared with the adult group, the pediatric group had relatively higher proportions of events related to infections and infestations as well as blood and lymphatic system disorders. Pediatric long-term toxicity signals primarily included growth retardation, accompanied by signals related to endocrine system abnormalities and bone metabolism abnormalities. Specific signals included imatinib-associated septic shock, dasatinib-associated chylothorax, and nilotinib-associated electrocardiographic QT interval prolongation. CONCLUSIONS When pediatric patients use BCR-ABL1 TKIs, priority monitoring of infection risk and hematologic parameters is required, along with long-term follow-up of height, endocrine, and bone metabolism parameters. Targeted screening and management of drug-specific signals should be performed to ensure the long-term safety of pediatric medication.
2.Influence of Mode of Delivery on Children’s Attention Deficit Hyperactivity Disorder and Childhood Intelligence
Min XU ; Xuemei YU ; Benjie FAN ; Guimei LI ; Xinxin JI
Psychiatry Investigation 2023;20(8):714-720
Objective:
To investigate whether differences exist in attention deficit hyperactivity disorder (ADHD) and intelligence between children born by cesarean delivery and those born by vaginal delivery.
Methods:
This retrospective study included singleton children that were born between January 2013 and December 2014. The Chinese version of the Conners’ Parent Rating Scale–Revised (CPRS-48) was required on the probability of psychological and behavioral problems. The China–Wechsler Intelligence Scale for Children (C-WIRS) was used for evaluation of crystallized intelligence and Raven’s Standard Progressive Matrices for evaluation of fluid intelligence.
Results:
A total of 10,568 valid questionnaires were obtained. CPRS-48 ADHD index and detection rate were higher in cesarean delivery group than those in vaginal delivery group. Cesarean delivery groups had a lower performance intelligence quotient score according to C-WISC.
Conclusion
Children born by cesarean delivery were more likely to have a risk of ADHD and a lower performance intelligence quotient compared with those born by vaginal delivery.

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