[重组人G-CSF治疗非霍奇金淋巴瘤化疗所致中性粒细胞减少的双盲交叉临床试验]。

Nihon Gan Chiryo Gakkai shi Pub Date : 1990-10-20
A Oyama, K Ota, S Asano, F Takaku, Y Yoshida, Y Uzuka, M Omine, S Furusawa, O Takatani, U Sawada
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引用次数: 0

摘要

对46例接受非霍奇金淋巴瘤强化化疗的患者进行了一项由中国仓鼠卵巢细胞产生的重组人粒细胞集落刺激因子(rG-CSF)的双盲、安慰剂对照、交叉临床试验。每例患者接受2个周期的CHOP治疗。rG-CSF(2微克/千克/天)或其安慰剂从化疗开始后2天开始,以交叉方式皮下给予每位患者14天。rG-CSF在最低点显著增加绝对中性粒细胞计数(ANC),并减少ANC低于1,000/mm3的天数,以及ANC大于或等于2,000/mm3的恢复天数。骨髓检查显示rG-CSF治疗后骨髓细胞数量明显增加。在安慰剂周期中观察到12次感染发作,而在rG-CSF周期中观察到6次感染发作。未观察到严重的副作用。我们得出结论,rG-CSF对非霍奇金淋巴瘤强化化疗引起的中性粒细胞减少症有效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[A double-blind, cross-over clinical trial of recombinant human G-CSF on neutropenia induced by chemotherapy for non-Hodgkin's lymphoma].

A double-blind, placebo-controlled, cross-over clinical trial of recombinant human granulocyte colony-stimulating factor (rG-CSF), produced by Chinese hamster ovary cells, was conducted in 46 patients receiving intensive chemotherapy for non-Hodgkin's lymphoma. Each patient received 2 cycles of CHOP therapy. rG-CSF (2 micrograms/kg/day) or its placebo was given subcutaneously to each patient for 14 days from 2 days after initiation of the chemotherapy, in a cross-over fashion. rG-CSF significantly increased the absolute neutrophil counts (ANC) at nadir, and reduced the number of days with ANC less than 1,000/mm3 and also the number of days for recovery to ANC greater than or equal to 2,000/mm3. Bone marrow examination showed a significant increase in the number of myeloid cells after rG-CSF treatment. 12 infective episodes were observed during placebo cycles, while 6 infective episodes were observed during rG-CSF cycles. No serious side effects were observed. We concluded that rG-CSF was effective in neutropenia induced by intensive chemotherapy for non-Hodgkin's lymphoma.

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