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[摘要]
评价rhG-CSF(粒生素)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:入组总数63例,均为病理或细胞学证实的恶性肿瘤。采用自身交叉方法将患者随机分入AB和BA两组。A为治疗周期,即化疗用药结束48 h开始,每日1次皮下注射rhG-CSF 5 μg/kg,连续用药7~14 d。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(ANC)及白细胞(WBC)的变化。结果: 治疗组于rhG-CSF注射24 h后,WBC及ANC迅速上升,48 h出现第1个高峰,第10天出现第2个高峰,而对照组化疗后,WBC和ANC逐渐下降,始终低于治疗组。WBC、ANC的最低值、WBC<4.0×10 9/L、ANC<2.0×10 9/L的持续时间,以及化疗后第21天WBC<4.0×10 9/L的病例数在治疗组和对照组间差异有显著性( P <0.05)。结论: rhG-CSF可以促进化疗患者WBC和ANC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辅助药。
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[Abstract]
To evaluate the efficacy and side effects of rhG-CSF (recombinant human granulocyte colony stimulating factor) in chemotherapy induced neutropenia. Methods: 63 cases with malignacies confirmed by pathology or cytology were enrolled. All patients were divided into group AB or BA at randomly self-control cross-over test. At the time of 48 hours after chemotherapy, rhG-CSF was given at a dose of 5 μg?kg -1 ?d -1 for 7 to 14 days 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 change of absolute neutrophil and neukocyte counts were observed. Results: In the trial group, neutrophil count increased rapidly with the first peak after 48 hours of rhG-CSF injection. The second peak occurred on the tenth day. In the control group, the absolute neutrophil and leukocyte counts decreased gradually, lower than that of the trial group all the time. There is a significant difference between the trial and control groups (P<0.05) on the nadir of WBC and ANC counts, the duration of WBC<4.0×10 9/L and ANC<2.0×10 9/L, and the number of patients with WBC<4.0×10 9/L on the twenty-first day after chemotherapy. The rates of bone pain and local response of injection were 25.8% and 27.4% respectively. Influenzal symptom was infrequent. Conclusion: rhG-CSF plays an important role in accelerating the recovery of leukocyte and absolute neutrophil induced by chemotherapy. The patients were well toleranced. It is suggested that rhG-CSF be a favourably adjuvant drug in the high dose intensive chemotherapy.
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