[关键词]
[摘要]
观察rhGM-CSF(重组人粒细胞 巨噬细胞集落刺激因子)预防和治疗肿瘤化疗所致白细胞(WBC)和中性粒细胞(ANC)减少的临床疗效和毒性反应。方法:采用随机自身交叉对照临床研究的方法,对64例病人进行化疗和rhGM-CSF治疗, 每一例病人连续观察2个周期。AB组病人第1周期为治疗组(A周期),采用化疗加rhGM-CSF治疗,第2周期为对照组(B周期),采用单纯化疗;BA组病人第1周期为对照组(B周期)采用单纯化疗,第2周期为治疗组(A周期)采用化疗加rhGM-CSF治疗。结果: 59例病人可评价疗效,治疗组WBC和ANC下降持续天数明显少于对照组,同时,WBC和ANC最低值也高于对照组,并且最低值时的中位化疗序日也比对照组明显提前,第21天时,治疗组WBC和ANC数值明显高于对照组,化疗延迟的例数治疗组明显少于对照组。结论: rhGM-CSF对化疗所致的白细胞和中性粒细胞减少具有明显的预防和治疗作用,保证化疗如期进行,不良反应可以耐受。
[Key word]
[Abstract]
To evaluate the efficacy and tolerability of rhGMCSF in prevention of neutropenia caused by chemotherapy of cancer patients. Methods: A muticenter, randomized, match and crossover clinical study was conducted. 64 enrolled patients were randomized into AB and BA groups and each patient received two cycles of combination chemotherapy. Zesults: 59 patients were evaluted for clinical efficacy. rhGM-CSF significantly increased the number of WBC and ANC at the stage of nadir. The period when the patients, rhGM-CSF also resulted in a hastening recovery from leucopenia and neutropenia. Conclusion: The administration of rhGM-CSF ensures the implement of sheduled combination chemotherapy. The main side effects such as fever, osteomyalgia, skin rash were generally tolerable.
[中图分类号]
[基金项目]