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单唾液酸四己糖神经节苷脂治疗新生儿缺氧缺血性脑病的Meta分析
Monosialoteterahexosyl Ganglioside in the Treatment of Hypoxic ischemic Encephalopathy: A Meta analysis
  
DOI:
中文关键词:  单唾液酸四己糖神经节苷脂  新生儿缺氧缺血性脑病  随机对照试验  Meta分析
英文关键词:Monosialoteterahexosyl ganglioside  Hypoxic ischemic encephalopathy  Randomized controlled trials  Meta analysis
基金项目:武汉市卫生计生委2018年医学科研项目(编号:WX18C28),武汉药学会2017年第二届“步长杯”临床药学科学研究基金项目(编号:20170202)
作者单位
郑文霞 向竹枝 张倩睿 吴方建 长江航运总医院·武汉脑科医院药学部 武汉 430010 
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中文摘要:
      摘 要 目的:系统评价单唾液酸四己糖神经节苷脂(GM1)治疗新生儿缺氧缺血性脑病(HIE)的疗效及安全性。方法:计算机检索PubMed、Clinical Trials、Cochrane Library、Embase、WanFang Data、CNKI、VIP数据库,搜集GM1治疗HIE的随机对照试验(RCTs),检索时限均为建库至2018年8月31日。由两位研究者独立进行文献筛选、数据提取和偏倚风险评价后,采用RevMan 5.3软件进行Meta分析。 结果:共纳入14个RCTs,包括1 052名患儿。Meta分析结果显示:与常规治疗比较,加用GM1(单用)治疗HIE可提高有效率[RR=1.35,95%CI(1.21,1.51),P<0.01];与常规治疗+其他神经保护药比较,加用GM1(联用)治疗HIE可提高有效率[RR=1.20,95%CI(1.07,1.35),P<0.01];无论单用或联用GM1均可提高治疗7 d、10~14 d、28 d的新生儿行为神经评分(NBNA);与常规治疗或者常规治疗+其他神经保护药物的对照组相比,加用GM1可降低头颅CT检查异常发生率[RR=0.34,95%CI(0.18,0.61),P<0.01]和远期后遗症发生率[RR=0.25,95%CI(0.12,0.52),P<0.01]。结论:基于现有临床证据,GM1可能是HIE有希望的治疗选择,相对来说安全性良好。受纳入研究数量和质量的影响,研究结果有待进一步完善和充实以及更多高质量RCTs予以证实。
英文摘要:
      ABSTRACT Objective: To systematically review the efficacy and safty of monosialoteterahexosyl ganglioside (GM1) in the treatment of hypoxic ischemic encephalopathy (HIE). Methods:PubMed, Clinical Trials, Cochrane Library, Embase, WanFang Data, CNKI and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of GM1 in the treatment of HIE from inception to August 31th, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then Meta analysis was performed by RevMan 5.3 software. Results:A total of 14 RCTs involving 1 052 children with HIE were included. The results of Meta analysis showed that: the effective rate of HIE treatment was better than that of conventional treatment or conventional treatment combined with other neuroprotective drugs in the control group, whether alone (RR=1.35, 95%CI 1.21 to 1.51, P<0.01) or in combination with GM1 (RR=1.20, 95%CI 1.07 to 1.35, P<0.01). The neonatal behavioral neurological assessment (NBNA) (7d, 10 14d, 28d) was higher than that of the control group whether used alone or in combination. The incidence of abnormal head CT rate was lower than that of the control group (RR=0.34, 95%CI 0.18 to 0.61, P<0.01). The incidence of long term sequelae was lower than that of the control group (RR=0.25,95%CI 0.12 to 0.52, P<0.01). Conclusion:Based on the existing clinical evidence, GM1 may be a promising treatment option for HIE and is relatively safe. However, due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
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