PDF(Pubmed)
Abstract：
UNASSIGNED: High-intensity chemotherapy can cause life-threatening complications in pediatric patients. Therefore, this study investigated safety and efficacy of long-acting pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF; Jinyouli®) in children undergoing high-intensity chemotherapy.
UNASSIGNED: Treatment-naive patients received post-chemotherapy PEG-rhG-CSF as primary prophylaxis for two cycles. The primary endpoints were drug-related adverse events (AEs) and bone pain scores. Secondary endpoints included grade 3-4 neutropenia, duration of neutropenia recovery, absolute neutrophil count changes, febrile neutropenia (FN), reduced chemotherapy intensity, antibiotic usage, and AE severity. The cost-effectiveness of PEG-rhG-CSF was compared with that of rhG-CSF (Ruibai®).
UNASSIGNED: Here, 307 and 288 patients underwent one and two PEG-rhG-CSF cycles, respectively. Ninety-one patients experienced drug-related AEs, primarily bone pain (12.7%). Moreover, Grade 3-4 neutropenia and FN were observed. Median FN durations were 3.0 days in both cycles. No drug-related delays were observed during chemotherapy. One patient experienced grade 4 neutropenia-induced reduction in chemotherapy intensity during cycle 2. In total, 138 patients received antibiotics. PEG-rhG-CSF exhibited superior cost-effectiveness compared to rhG-CSF.
UNASSIGNED: Our findings indicate that PEG-rhG-CSF is safe, efficient, and cost-effective in pediatric patients undergoing high-intensity chemotherapy, providing preliminary evidence warranting further randomized controlled trials.
UNASSIGNED: Treatment-naive patients received post-chemotherapy PEG-rhG-CSF as primary prophylaxis for two cycles. The primary endpoints were drug-related adverse events (AEs) and bone pain scores. Secondary endpoints included grade 3-4 neutropenia, duration of neutropenia recovery, absolute neutrophil count changes, febrile neutropenia (FN), reduced chemotherapy intensity, antibiotic usage, and AE severity. The cost-effectiveness of PEG-rhG-CSF was compared with that of rhG-CSF (Ruibai®).
UNASSIGNED: Here, 307 and 288 patients underwent one and two PEG-rhG-CSF cycles, respectively. Ninety-one patients experienced drug-related AEs, primarily bone pain (12.7%). Moreover, Grade 3-4 neutropenia and FN were observed. Median FN durations were 3.0 days in both cycles. No drug-related delays were observed during chemotherapy. One patient experienced grade 4 neutropenia-induced reduction in chemotherapy intensity during cycle 2. In total, 138 patients received antibiotics. PEG-rhG-CSF exhibited superior cost-effectiveness compared to rhG-CSF.
UNASSIGNED: Our findings indicate that PEG-rhG-CSF is safe, efficient, and cost-effective in pediatric patients undergoing high-intensity chemotherapy, providing preliminary evidence warranting further randomized controlled trials.
摘要：
■高强度化疗可在儿科患者中引起危及生命的并发症。因此,这项研究调查了长效聚乙二醇化重组人粒细胞集落刺激因子(PEG-rhG-CSF;Jinyouli®)在接受高强度化疗的儿童中的安全性和有效性.
■未接受治疗的患者接受化疗后PEG-rhG-CSF作为两个周期的初级预防。主要终点是药物相关不良事件（AEs）和骨痛评分。次要终点包括3-4级中性粒细胞减少症，中性粒细胞减少症恢复的持续时间，绝对中性粒细胞计数变化，发热性中性粒细胞减少症（FN），化疗强度降低，抗生素的使用，和AE严重程度。比较了PEG-rhG-CSF与rhG-CSF(Ruibai®)的成本效益。
■这里，307和288例患者接受了一个和两个PEG-rhG-CSF周期，分别。91名患者出现药物相关的不良事件，主要为骨痛（12.7%）。此外，观察到3-4级中性粒细胞减少和FN。在两个周期中,平均FN持续时间为3.0天。在化疗期间没有观察到药物相关的延迟。在第2周期中，一名患者经历了4级中性粒细胞减少症诱导的化疗强度降低。总的来说,138例患者接受抗生素治疗。与rhG-CSF相比,PEG-rhG-CSF表现出优异的成本效益。
■我们的研究结果表明PEG-rhG-CSF是安全的，高效,并且在接受高强度化疗的儿科患者中具有成本效益，提供了进一步随机对照试验的初步证据.
■未接受治疗的患者接受化疗后PEG-rhG-CSF作为两个周期的初级预防。主要终点是药物相关不良事件（AEs）和骨痛评分。次要终点包括3-4级中性粒细胞减少症，中性粒细胞减少症恢复的持续时间，绝对中性粒细胞计数变化，发热性中性粒细胞减少症（FN），化疗强度降低，抗生素的使用，和AE严重程度。比较了PEG-rhG-CSF与rhG-CSF(Ruibai®)的成本效益。
■这里，307和288例患者接受了一个和两个PEG-rhG-CSF周期，分别。91名患者出现药物相关的不良事件，主要为骨痛（12.7%）。此外，观察到3-4级中性粒细胞减少和FN。在两个周期中,平均FN持续时间为3.0天。在化疗期间没有观察到药物相关的延迟。在第2周期中，一名患者经历了4级中性粒细胞减少症诱导的化疗强度降低。总的来说,138例患者接受抗生素治疗。与rhG-CSF相比,PEG-rhG-CSF表现出优异的成本效益。
■我们的研究结果表明PEG-rhG-CSF是安全的，高效,并且在接受高强度化疗的儿科患者中具有成本效益，提供了进一步随机对照试验的初步证据.
