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目的 (1)观察重组人粒细胞集落刺激因子(G-CSF)和重组人促红细胞生长素(EPO)单用或联合应用对大鼠脑缺血再灌注(I/R)后的保护作用。(2)探讨临床应用G-CSF和EPO治疗急性脑梗死的疗效及安全性。方法 (1)大鼠实验:72只大鼠制备局灶性I/R模型,分为G-CSF组(给予G-CSF)、EPO组(给予EPO)和对照组(均n=24),各组又分为1 d、7 d、14 d、28 d,共4个亚组(均n=6)。于再灌注后不同时间点进行神经功能评分及梗死面积检测。(2)临床试验:72例急性脑梗死患者随机分为治疗组(36例)和对照组(36例)。两组均按急性脑梗死常规方法治疗,治疗组在此基础上分别添加G-CSF(GCSF亚组,12例)、EPO(EPO亚组,12例)和G-CSF+EPO联合(G-CSF+EPO亚组,12例)治疗。采用美国国立卫生研究院脑卒中量表(NIHSS)和改良Rankin量表进行评分。结果 (1)大鼠实验:再灌注后14和28 d,两组神经功能评分均高于对照组(P<0.05),梗死面积均明显小于对照组(P<0.05)。(2)临床试验:治疗后1、7和14 d各组NIHSS评分和改良Rankin量表评分比较差异无显著性(P>0.05)。与对照组比较,治疗后28 d、3个月、6个月、1年、2年各治疗亚组NIHSS评分、改良Rankin量表评分均显著好转(P<0.05或P<0.01)。G-CSF+EPO亚组疗效明显优于G-CSF亚组和EPO亚组(P<0.05)。治疗后14d,治疗组与对照组比较脑梗死体积差异无显著性(P>0.05);治疗后28 d各亚组脑梗死体积均明显小于对照组,差异有统计学意义(P<0.05或P<0.01)。G-CSF、EPO治疗期间未出现明显不良反应。结论 G-CSF、EPO能明显改善大鼠的神经功能症状、减小梗死面积,对大鼠I/R损伤有保护作用。G-CSF和EPO单药或联合治疗急性脑梗死患者耐受性良好,可改善临床预后。
Objective (1) To observe the protective effects of recombinant human granulocyte colony-stimulating factor (G-CSF) and recombinant human erythropoietin (EPO) on the protection of rats after cerebral ischemia-reperfusion (I / R). (2) To investigate the clinical efficacy and safety of G-CSF and EPO in the treatment of acute cerebral infarction. Methods Rats (72 rats) were divided into G-CSF group (G-CSF group), EPO group (EPO group) and control group (all n = 24) Each group was divided into 1 d, 7 d, 14 d, 28 d, a total of 4 subgroups (all n = 6). Neurological scores and infarct size were measured at different time points after reperfusion. (2) Clinical trial: 72 patients with acute cerebral infarction were randomly divided into treatment group (36 cases) and control group (36 cases). G-CSF (GCSF subgroup, 12 cases), EPO (EPO subgroup, 12 cases) and G-CSF + EPO combined with G-CSF were respectively added into the two groups according to the routine method of acute cerebral infarction. CSF + EPO subgroup, 12 cases). The NIH Stroke Scale (NIHSS) and the modified Rankin scale were used for scoring. Results (1) In rats, the neurological scores of both groups were significantly higher than those of the control group (P <0.05) at 14 and 28 days after reperfusion. The infarct size was significantly smaller than that of the control group (P <0.05). (2) Clinical trial: There was no significant difference in NIHSS score and modified Rankin scale score between the two groups at 1, 7 and 14 days after treatment (P> 0.05). Compared with the control group, the NIHSS score and the modified Rankin scale score of 28th, 3rd, 6th, 1th and 2th year after treatment were significantly improved (P <0.05 or P <0.01). The efficacy of G-CSF + EPO subgroup was significantly better than G-CSF subgroup and EPO subgroup (P <0.05). At 14 days after treatment, there was no significant difference in the volume of cerebral infarction between the treatment group and the control group (P> 0.05). After 28 days of treatment, the volume of cerebral infarction in each subgroup was significantly smaller than that of the control group (P <0.05 or P <0.01). G-CSF, EPO treatment did not appear significant adverse reactions. Conclusion G-CSF and EPO can significantly improve neurological function, reduce infarct size and protect rat I / R injury. Patients with acute cerebral infarction treated with G-CSF and EPO alone or in combination are well tolerated and improve clinical outcomes.