rhGM-CSF预防肿瘤化疗所致白细胞减少的随机对照临床研究

A Randomized and Controlled Study of rhGM-CSF on Leucopenia Induced by Chemotherapy on Cancer Patients

目的：观察ｒｂＧＭ－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。

Objective: To evaluate the efficacy and tolerability of rhGM-CSF in prevention of neutropenia caused by chemothera- py 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.Results: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 administraton of rhTM-CSF ensures the implement of sheduled combination chemotherapy. The main side effects such as fever, osteomyalgia,skin rash were generally tolerable.