摘要
目的：观察国产重组人粒细胞／巨噬细胞集落刺激因子（ｒｈＧＭＣＳＦ）对化疗病人血白细胞下降的防治作用及其不良反应。方法：共７０例癌症病人，包括肺癌、非霍奇金氏淋巴瘤、头颈部癌、乳腺癌、胃癌等病种，按照３：１分别入国产ｒｈＧＭＣＳＦ及进口ｒｈＧＭＣＳＦ组，采取自身交叉对照的方法，每例病人化疗２疗程，其中一疗程加国产或进口ｒｈＧＭＣＳＦ作为治疗组疗程，而另一相同化疗疗程不加ｒｈＧＭＣＳＦ作为对照组疗程，比较治疗组及对照组白细胞（ＷＢＣ）及中性粒细胞（ＡＮＣ）的变化，并观察不良反应。同时与进口品进行初步的比较。结果：治疗组疗程加用国产ｒｈＧＭＣＳＦ，ＷＢＣ下降（＜４０×１０９／Ｌ）、ＡＮＣ下降（＜２０×１０９／Ｌ）持续天数均明显低于对照组疗程（６７天比１０６天，３２５天比６９天），且ＡＮＣ最低点亦高于对照组，因ＡＮＣ下降而延迟下一疗程化疗的发生率明显低于对照组（１１３％ｖｓ４９％），与进口ｒｈＧＭＣＳＦ的临床疗效基本一致。国产ｒｈＧＭＣＳＦ的不良反应多为ＩＩ级的发热、骨骼肌肉疼痛、皮疹、局部硬结，患者能耐受，与进口产品的不良反应无差异。结论：国产ｒｈＧＭＣＳＦ可缩短化疗后ＷＢＣ下降?
Objective: To evaluate
the effect of the domestic product of rhGM CSF in prevention of leucopenia caused by cancer
chemotherapy, and to observe the side effects of the drug. Methods: 70 patients with
malignancies, including lung cancer, non Hodgkin's lymphoma, head and neck cancer, breast
cancer, stomach cancer and other kinds of cancer, were treated by combination chemotherapy.
All the patients were divided into the domestic rhGM CSF group and the importing rhGM CSF
group by the ratio of 3:1 Each patient received two cycles of chemotherapy,nomely, the trial
cycle and the control cycle. In the trial cycle, domestic rhGMCSF was administrated following
chemotherapy.In the control cycle, rhGmCSF was not used. The change of white blood cell
(WBC)count and absolute neutrophil count (ANC) between the trial cycle and the control cycle
was compared. We also contrasted the effects and toxicity of the domestic versus imported
products. Results: The duration of leucopenia (WBC< 40109/L) and neutropenia (ANC< 20109/L)
was obviously shorter in the trial cycle than that in the control cycle, which was 67 vs 106, and
325 vs 69 days respectively. The nadir of ANC following chemotherapy in the trial group was
higher than that in the control cycle. The incidence of delaying next chemotherapy was
obviously lower in the trial cycle. The effects of the domestic rhGM CSF were similar to the
imported products. The side effect of domestic product of rhGM CSF including fever, chill,
skeleton and muscle pain,rashes and local thickness on injection site rosis. All of them were
mild to moderate. The frequencies of side effect were not significanty different between the
domestic and the importied products. Conclusion: The results demonstrated that the domestic
product of rhGM CSF was able to shorten the duration of leucopenia and neutropenia and to
alleviate the degree of leucopenia caused by chemotherapy. The toxicity was tolerable.
出处
《癌症》
SCIE
CAS
CSCD
北大核心
1999年第3期324-326,共3页
Chinese Journal of Cancer
