Staber P B, Holub R, Linkesch W, Schmidt H, Neumeister P
Division of Hematology, Medical University Graz, Graz, Austria.
Bone Marrow Transplant. 2005 May;35(9):889-93. doi: 10.1038/sj.bmt.1704927.
Infectious complications are frequent events in patients undergoing high-dose cytotoxic chemotherapy with subsequent autologous peripheral blood stem cell transplantation (PBSCT). To evaluate whether a single subcutaneous injection of pegfilgrastim (6 mg) is as safe and effective as daily filgrastim (5 mug/kg/day), 60 consecutive autologous stem cell transplantations performed for various haematological malignancies have been analysed. In total, 24 patients undergoing 30 consecutive PBSCT received a single subcutaneous injection of 6 mg pegfilgrastim on day 5 after transplantation and were compared retrospectively with 30 patients receiving 5 mug/kg/day of filgrastim starting from day 7 post transplantation. The mean duration of grade 4 neutropenia in the pegfilgrastim and filgrastim groups was 8.3 and 9.5 days, respectively (P=0.047). The results of the two groups were not significantly different for incidence of febrile neutropenia and toxicity profile. However, duration of febrile neutropenia (1.6 vs 3.0 days) and total days of fever (1.73 vs 4.1) were different (P=0.017 and 0.003, respectively), favouring the pegfilgrastim arm. Consequently, a higher incidence of transplants with documented infectious complications associated with the filgrastim group could be observed (56 vs 26%) (P=0.02). A single injection of pegfilgrastim administered at day 5 post transplant shows comparable safety and efficacy profiles to daily injections of filgrastim.
感染性并发症是接受大剂量细胞毒性化疗并随后进行自体外周血干细胞移植(PBSCT)患者中的常见事件。为了评估单次皮下注射聚乙二醇化非格司亭(6毫克)是否与每日注射非格司亭(5微克/千克/天)一样安全有效,分析了连续60例因各种血液系统恶性肿瘤进行的自体干细胞移植。总共,24例接受连续30次PBSCT的患者在移植后第5天接受了单次皮下注射6毫克聚乙二醇化非格司亭,并与30例从移植后第7天开始接受5微克/千克/天非格司亭治疗的患者进行了回顾性比较。聚乙二醇化非格司亭组和非格司亭组4级中性粒细胞减少的平均持续时间分别为8.3天和9.5天(P = 0.047)。两组在发热性中性粒细胞减少的发生率和毒性方面没有显著差异。然而,发热性中性粒细胞减少的持续时间(1.6天对3.0天)和发热总天数(1.73天对4.1天)有所不同(分别为P = 0.017和0.003),聚乙二醇化非格司亭组更具优势。因此,可以观察到非格司亭组记录的与感染性并发症相关的移植发生率更高(56%对26%)(P = 0.02)。移植后第5天单次注射聚乙二醇化非格司亭显示出与每日注射非格司亭相当的安全性和有效性。