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荟萃分析与试验序贯分析在促红细胞生成素治疗创伤性脑损伤中的疗效和安全性:一种新的范式。

Meta-Analysis with Trial Sequential Analysis on the Efficacy and Safety of Erythropoietin in Traumatic Brain Injury: A New Paradigm.

机构信息

Department of Neurosurgery, All India Institute of Medical Sciences, New Delhi, India.

Department of Surgery, All India Institute of Medical Sciences, New Delhi, India.

出版信息

World Neurosurg. 2020 Oct;142:465-475. doi: 10.1016/j.wneu.2020.05.142. Epub 2020 May 22.

DOI:10.1016/j.wneu.2020.05.142
PMID:32450313
Abstract

OBJECTIVE

Erythropoietin (EPO) has been shown to be beneficial in traumatic brain injury (TBI). We have attempted to quantitatively synthesize the findings of current randomized controlled trials (RCTs) in this meta-analysis and analyzed the need for further trials using trial sequential analysis (TSA).

METHODS

A systematic search was performed in PubMed, the Cochrane Library databases, and Google Scholar for RCTs until December 2019 evaluating the role of EPO in patients with TBI. Seven RCTs were finally included in the quantitative analysis. TSA was done to evaluate the need for further studies.

RESULTS

The pooled estimate demonstrated that EPO significantly reduced mortality at 6 months (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.43-0.97; P = 0.04) but not in hospital mortality (OR, 0.84; 95% CI, 0.31-2.32; P = 0.74). There was no significant difference in the rate of favorable outcomes with EPO (OR, 1.58; 95% CI, 0.84-2.99; P = 0.16). The rate of deep vein thrombosis (RD, -0.02; 95% CI, -0.06 to 0.02; P =0.41) was also not found to be significantly different in the 2 groups. TSA showed that the accrued information is insufficient to make any definitive conclusions.

CONCLUSIONS

EPO seems to be beneficial in terms of reducing 6-month mortality, however, its effect on in-hospital mortality, neurologic outcomes, and risk of deep vein thrombosis fails to reach statistical significance. TSA suggests a need for large trials to evaluate the role of EPO in patients with TBI in a more systematic way.

摘要

目的

促红细胞生成素(EPO)已被证明对创伤性脑损伤(TBI)有益。我们试图通过荟萃分析定量综合目前随机对照试验(RCT)的结果,并使用试验序贯分析(TSA)分析进一步试验的必要性。

方法

在 PubMed、Cochrane 图书馆数据库和 Google Scholar 中进行了系统检索,以评估 RCT 中 EPO 在 TBI 患者中的作用,检索截至 2019 年 12 月。最终有 7 项 RCT 纳入定量分析。进行 TSA 以评估进一步研究的必要性。

结果

汇总估计表明,EPO 显著降低了 6 个月时的死亡率(比值比 [OR],0.65;95%置信区间 [CI],0.43-0.97;P=0.04),但不能降低住院死亡率(OR,0.84;95% CI,0.31-2.32;P=0.74)。EPO 组的良好结局率无显著差异(OR,1.58;95% CI,0.84-2.99;P=0.16)。两组深静脉血栓形成(RD,-0.02;95% CI,-0.06 至 0.02;P=0.41)的发生率也无显著差异。TSA 表明,累积的信息不足以得出任何明确的结论。

结论

EPO 似乎在降低 6 个月死亡率方面有益,但其对住院死亡率、神经结局和深静脉血栓形成风险的影响尚未达到统计学意义。TSA 表明需要进行大型试验,以更系统的方式评估 EPO 在 TBI 患者中的作用。

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