重组人粒细胞集落刺激因子预防化疗后粒细胞减少的Ⅱ期临床试验

Phase II clinical trials on recombinant human granulocyte colony stimulating factor in prevention of neutropenia after chemotherapy

目的：评价重组人粒细胞集落刺激因子（ｒｈＧ－ＣＳＦ）对预防恶性肿瘤化疗后粒细胞减少的作用及不良反应。方法：６２例恶性肿瘤病人随机分入ＡＢ和ＢＡ２组。Ａ为治疗周期，即化疗结束４８ｈ开始，ｒｈＧ＿ＣＳＦ５μｇ／ｋｇ，ｓｃ，ｑｄ×７～１５ｄ；Ｂ为空白对照周期。自化疗开始隔日查血常规１次，观察中性粒细胞（Ｎｅｕ）绝对值及白细胞（ＷＢＣ）的变化。结果：治疗周期于ｒｈＧ＿ＣＳＦ注射２４ｈ后，ＷＢＣ及Ｎｅｕ绝对值迅速上升，４８ｈ出现第１个高峰，ｄ８出现第２个高峰，而对照周期化疗后ＷＢＣ和Ｎｅｕ绝对值逐渐下降，始终低于治疗周期。ＷＢＣ和Ｎｅｕ的最低值（ＷＢＣ＜４．０×１０９／Ｌ，Ｎｅｕ绝对值＜２．０×１０９／Ｌ）的持续时间，以及化疗后ｄ２１ＷＢＣ＜４．０×１０９／Ｌ的病例数在治疗周期和对照周期间差异有显著意义（Ｐ＜０．０５）。骨痛和感冒症状发生率分别为２１％和１６％，注射部位局部反应、皮疹、发热少见。结论：ｒｈＧ＿ＣＳＦ可以促进化疗病人ＷＢＣ和Ｎｅｕ的恢复，耐受性良好，可以作为肿瘤化疗中提高剂量强度的有效的辅助药。

AIM: To evaluate the efficacy and adverse reaction of rhG_CSF in chemotherapy induced neutropenia. METHODS: Sixty_Two patients with malignancies confirmed by pathology or cytology were enrolled. All the patients were divided into group AB or BA at random by self_control cross over test. At 48 h after chemotherapy, rhG_CSF was given 5 g/kg daily for 7_15 d in group A. In group B, the patients received chemotherapy alone without rhG_CSF as control. Blood routine examination was taken every other day from the start of chemotherapy. The changes of absolute neutrophil count(ANC) and leukocyte WBC counts were observed. RESULTS: In the trial group, ANC increased rapidly with the first peak after 48 h of rhG_CSF injection. The second peak occurred at the d 8. In the control group, the ANC and WBC count decreased gradually, lower than that of the trial group all the time. There was a difference between the trial and control groups ( P <0.05). On the nadir of WBC count and ANC, the duration of WBC<4.0109/L, ANC<2.0109/L, and the number of patients with WBC<4.0109/L on the d 21 after chemotherapy. The rates of bone pain and influenza symptom were 21% and 16%, respectively. Local response of injection and rash, fever were infrequent. CONCLUSION: rhG_CSF plays an important role in accelerating the recovery of WBC and ANC induced by chemotherapy. The patients are well tolerances. We can suggest that rhG_CSF is a favorably adjuvant drug in the high dose intensive chemotherapy.