The phase Ⅱ report of clinical trials on efficacy and tolerability of domestic rhG-CSF in preventing leucopenia caused by chemotherapy
HOU Mei
YAN Xi
QIU Meng
LI Lu
WANG Qi-xia
ZHANG Li-jian
LIN Jiang-tao
SHI Jing
Abstract：Objective:To observe the phase Ⅱ of clinical trials on efficacy and tolerability of domestic rhG-CSF in preventing leucopenia caused by chemotherapy.Methods:The multicenter study was conducted in 69 patients with malignancies.They were randomized to receive cycles A and B therapy or cycles B and A therpay.In cycle A therapy,patients were treated with chemotherapy plus rhG-CSF and in cycle B therapy,they were treated with chemotherapy alone.The changes in WBC(white blood cell) and ANC (absolute neutrophil count) in cycle A and B therapy were compared.Results:Shortening duration of leucopenia and neutropenia were more pronounce in cycle A therapy than in cycle B therapy.The minimum value of WBC and ANC were higher in cycle A therapy than in cycle B therapy.The incidence of delaying chemotherapy due to leucopenia was obviously lower in cycle A therapy.The side effect for domestie rhG-GSF,including pain and scleroma at injection site,weakness,and fever,were mild.Conclusion:The results indicated that the domestic rhG-CSF was able to alleviate the degree of leucopenia and neutropenia and to shorten the duration of leucopenia and neutropenia caused by chemotherapy with mild toxicity.
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Publication Date：2001-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 279-282 )