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[目的]评价InstitutoSidusS.A.生物公司生产的若美斯(rhG CSF)对防治化疗后粒细胞减少症的作用及不良反应。[方法]采用随机分组的方法 ,将34例患者分为AB组和BA组。AB组第一周期(A周期)化疗48h后加用G CSF ,第二周期为空白对照周期(B周期) ,仅单独使用化疗 ;BA组与上相反。rhG CSF在化疗药物末次给药后48h起 ,5μg/kg,皮下注射 ,每日1次。同时观察患者血中白细胞(WBC)值及中性粒细胞(ANC)值变化。[结果]运用rhG CSF支持后的研究组和对照组相比 ,化疗后WBC值<1×109/L,2×109/L,3×109/L ,4×109/L的持续平均天数明显减少(P<0.05,P<0.01)。ANC值<0.5×109/L,1.0×109/L,1.5×109/L ,2.0×109/L的持续平均天数也明显减少(P<0.05,P<0.01) ,并能减少感染和运用其他抗生素的几率 ,用药后白细胞值及中性粒细胞值在d2 出现第1个高峰、d8 出现第2个高峰。rhG CSF对血小板无明显影响。不良反应表现为 :30%的病人出现轻中度的骨骼肌疼痛 ,6%出现轻度乏力 ,6%出现轻度局部注射痛 ,一般不需特殊处理 ,易于耐受。[结论]rhG CSF可以促进化疗病人WBC和ANC的恢复 ,安全性好 ,可作为化疗提高剂量的辅助用药。
[Objective] To evaluate the effects and adverse reactions of rhG CSF produced by Institut Sidus S.A. in the prevention and treatment of neutropenia after chemotherapy. [Methods] 34 patients were divided into AB group and BA group by randomized grouping method. The first cycle of AB group (A cycle) 48h after the addition of G CSF, the second cycle of the blank control cycle (B cycle), only chemotherapy alone; BA group and the opposite. rhG CSF 48h after the last dose of chemotherapy drugs, 5μg / kg, subcutaneous injection, once daily. At the same time, we observed the change of white blood cell (WBC) and neutrophil (ANC) in the patients. [Results] Compared with the control group, the mean continuous days of WBC values <1 × 109 / L, 2 × 109 / L, 3 × 109 / L and 4 × 109 / L after rhG CSF support were significantly higher Decrease (P <0.05, P <0.01). The mean number of days with ANC values <0.5 × 109 / L, 1.0 × 109 / L, 1.5 × 109 / L and 2.0 × 109 / L also decreased significantly (P <0.05, P <0.01) The chances of antibiotics, white blood cells and neutrophils after treatment, the first peak appeared in the d2, d8 appeared the second peak. rhG CSF had no significant effect on platelets. Adverse reactions manifested as: 30% of patients with mild to moderate skeletal muscle pain, mild fatigue occurred in 6%, 6% of mild local injection pain, generally do not need special treatment, easy to tolerate. [Conclusion] rhG CSF can promote the recovery of WBC and ANC in chemotherapy patients. It has good safety and can be used as adjuvant to increase the dose of chemotherapy.