Liu T S, Yin Z H, Yang Z H, Wan L N
Pediatrics, and Traditional Chinese Medicine; PKU Care Zibo Hospital, Zibo, China.
Eur Rev Med Pharmacol Sci. 2021 Mar;25(5):2318-2326. doi: 10.26355/eurrev_202103_25264.
Previous systematic review has shown the safety and efficiency of EPO (erythropoietin) for neonatal hypoxic-ischemic encephalopathy (HIE). To date, the evidence is limited that EPO is beneficial to therapeutic hypothermia as an adjuvant. There has not a brief discussion about the neuroprotection effects of EPO without hypothermia. To evaluate the long-term prognosis of HIE treated with EPO alone, we carried out this study that can be a supplement to the previous meta-analysis.
7 databases (including PubMed, EMBASE, Cochrane, CKNI, CBM, WanFang, and VIP) and the ClinicalTrials.gov were retrieved from inception to 1 March 2020. The inclusion criteria were RCTs with EPO treatment without hypothermia. The outcomes were tested by using the Bayley Scales of Infant Development (BSID), including the Bayley Mental Development Index Score (MDI) and the Bayley Psychomotor Development Index Score (PDI). This meta-analysis was done to compare the Risk Ratio (RR) for the scores of BSID less than 70 after over 6 months of follow-up.
11 RCTs (1099 newborns) were included, excluding deaths and lost visits, and 917 patients finally were performed the statistical analysis. In neonatal HIE infants, investigation results showed a lower risk of cognitive impairment and psychomotor disability with EPO monotherapy. The pooled event rates of MDI <70 saw a reduction of 36% (95% CI 24%-54%) compared to the control group. There was a decrease of 37% (95% CI 24%-56%) of Psychomotor abnormal (PDI <70) in the EPO group.
EPO administration alone could improve the scores of mental and psychomotor in neonates with HIE. However, the level of evidence is low to moderate for the insufficient sample size, so large-scale, multicenter clinical trials are still needed.
既往的系统评价已显示促红细胞生成素（EPO）用于新生儿缺氧缺血性脑病（HIE）的安全性和有效性。迄今为止，关于EPO作为辅助治疗对亚低温有益的证据有限。尚未有关于无亚低温时EPO神经保护作用的简要讨论。为评估单独使用EPO治疗HIE的长期预后，我们开展了本研究，可为既往的荟萃分析提供补充。
检索了7个数据库（包括PubMed、EMBASE、Cochrane、中国知网、中国生物医学文献数据库、万方数据库和维普数据库）以及ClinicalTrials.gov，检索时间从建库至2020年3月1日。纳入标准为未进行亚低温治疗的EPO治疗随机对照试验（RCT）。结局指标采用贝利婴幼儿发育量表（BSID）进行测试，包括贝利智力发育指数评分（MDI）和贝利心理运动发育指数评分（PDI）。本荟萃分析旨在比较随访6个月以上后BSID评分低于70的风险比（RR）。
纳入11项RCT（1099例新生儿），排除死亡和失访病例后，最终对917例患者进行统计分析。在新生儿HIE患儿中，研究结果显示EPO单药治疗可降低认知障碍和精神运动障碍风险。与对照组相比，MDI<70的合并事件发生率降低了36%（95%CI 24%-54%）。EPO组精神运动异常（PDI<70）降低了37%（95%CI 24%-56%）。
单独使用EPO可提高HIE新生儿的智力和精神运动评分。然而，由于样本量不足，证据水平为低到中等，因此仍需要大规模、多中心的临床试验。
