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重组人促红细胞生成素改善重度创伤性脑损伤患者的功能恢复:一项随机、双盲和对照临床试验。

Recombinant human erythropoietin improves functional recovery in patients with severe traumatic brain injury: A randomized, double blind and controlled clinical trial.

作者信息

Li Zhong-Min, Xiao Yi-Lei, Zhu Jian-Xin, Geng Feng-Yang, Guo Chuan-Jun, Chong Zong-Lei, Wang Le-Xin

机构信息

Department of Neurosurgery, Liaocheng People's Hospital of Taishan Medical University, Liaocheng, Shandong, 252000, PR China.

School of Biomedical Sciences, Charles Sturt University, Wagga Wagga, NSW 2678, Australia.

出版信息

Clin Neurol Neurosurg. 2016 Nov;150:80-83. doi: 10.1016/j.clineuro.2016.09.001. Epub 2016 Sep 3.

Abstract

OBJECTIVE

To investigate the short-term effect of recombinant human erythropoietin (EPO) on patients with severe traumatic brain injury.

METHODS

One hundred and fifty-nine patients with severe traumatic brain injury were randomly divided into EPO (n=79) and control group (n=80). EPO group was treated with subcutaneous injection of EPO (100 units/kg) on day 1, 3, 6, 9 and 12 following the brain injury. Glasgow outcome scores (GOS) were used to evaluate the outcomes three months after the treatment. Serum neuron specific enolase (NSE) and S-100β protein were measured within the first three months after treatment.

RESULTS

In the end, 146 patients (75 of the EPO group and 71 of the control group) completed the trial. Three months after the treatment, Good recovery was found in 33.3% of the EPO and 12.6% of the control group patients (p<0.05). Serum NSE and S-100β protein were decreased gradually in both groups after treatment, but their levels in the EPO group were lower than that of control group (p<0.05). There was no statistically significant difference in blood pressure, hemoglobin levels, pneumonia, sepsis or thromboembolic events between the two groups three months after the treatment (p>0.05).

CONCLUSION

Treatment with five doses of recombinant human erythropoietin is associated with an improved functional recovery in patients with severe traumatic brain injury. This treatment does not seem to increase the risk of thromboembolic events or severe infections.

摘要

目的

探讨重组人促红细胞生成素(EPO)对重度创伤性脑损伤患者的短期影响。

方法

159例重度创伤性脑损伤患者被随机分为EPO组(n = 79)和对照组(n = 80)。EPO组在脑损伤后的第1、3、6、9和12天接受皮下注射EPO(100单位/千克)治疗。采用格拉斯哥预后评分(GOS)评估治疗三个月后的预后。在治疗后的前三个月内检测血清神经元特异性烯醇化酶(NSE)和S - 100β蛋白。

结果

最终,146例患者(EPO组75例,对照组71例)完成试验。治疗三个月后,EPO组33.3%的患者恢复良好,对照组为12.6%(p < 0.05)。治疗后两组血清NSE和S - 100β蛋白均逐渐下降,但EPO组的水平低于对照组(p < 0.05)。治疗三个月后,两组在血压、血红蛋白水平、肺炎、败血症或血栓栓塞事件方面无统计学显著差异(p > 0.05)。

结论

五剂重组人促红细胞生成素治疗可改善重度创伤性脑损伤患者的功能恢复。这种治疗似乎不会增加血栓栓塞事件或严重感染的风险。

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