持续输注粒细胞集落刺激因子在儿童肿瘤性疾病中与中性粒细胞恢复的优势相关。
完整摘要 · 中文译文
引言:强化化疗的使用显著改善了癌症患者的总生存期(OS)和无复发生存期(RFS)。然而,这也增加了化疗所致中性粒细胞减少症(CIN)的风险。粒细胞集落刺激因子(G-CSF)常用于加速中性粒细胞恢复,但关于不同G-CSF给药途径优越性的研究有限。 材料与方法:本研究为一项随机、前瞻性、单中心研究。共纳入28名受试者,按1:1比例随机分配至试验组和对照组。研究结束时,20例符合统计学分析条件。主要终点为从中性粒细胞减少发生至中性粒细胞稳定恢复的持续时间。次要终点包括安全性特征、7天急诊返院率以及感染或发热事件的发生情况。 结果:静脉滴注(IVD)组从CIN至中性粒细胞恢复的平均时间为6.2天,静脉推注(IVI)组为7.6天(P = 0.0068)。两组平均差异为1.4天。IVD组发热性中性粒细胞减少症(FN)的发生率显著低于IVI组(15% vs. 50%,P = 0.0407)。两组不良事件(AEs)相当。 结论:G-CSF经静脉滴注途径给药可使中性粒细胞恢复更快,并降低FN风险。所有可评价的不良事件在两组间相当。这些结果提示静脉滴注途径可能是一个更优的选择。 或优化伴有CIN的癌症患者的支持治疗。
完整摘要 · 英文原文
INTRODUCTION: The use of intensified chemotherapy has significantly improved overall survival (OS) and relapse-free survival (RFS) in cancer patients. However, it also increases the risk of chemotherapy-induced neutropenia (CIN). Granulocyte colony-stimulating factor (G-CSF) is commonly used to hasten neutrophil recovery, but limited research has focused on the superiority of different routes of G-CSF administration. MATERIALS AND METHODS: This was a randomized, prospective, single-institution study. Twenty-eight participants were enrolled and randomly assigned to experimental and control arms in a 1:1 ratio. At the end of the study, 20 cases were eligible for statistical analysis. The primary endpoint was the duration from the onset of neutropenia to steady neutrophil recovery. Secondary endpoints included the safety profile, 7-day emergency return rate, and the occurrence of infectious or febrile events. RESULTS: The mean duration from CIN to neutrophil recovery was 6.2 days in the intravenous drip (IVD) group and 7.6 days in the intravenous injection (IVI) group (P = 0.0068). The mean difference between the two groups was 1.4 days. A significantly lower incidence of febrile neutropenia (FN) was observed in the IVD group compared to the IVI group (15% vs. 50%, P = 0.0407). Adverse effects (AEs) were comparable between the two groups. CONCLUSIONS: The IVD route of G-CSF administration leads to faster neutrophil recovery and reduces the risk of FN. All evaluable AEs are comparable between the two groups. These findings suggest that the IVD route may be a preferable option for optimizing supportive care in cancer patients with CIN.