选择性头部亚低温治疗新生儿缺氧缺血性脑病的疗效和安全性  

Efficacy and safety of selective brain hypothermia therapy on neonatal hypoxic-ischemic encephalopathy

作　　者：陈信[1] 彭万胜[1] 张阵[1] 赵茜 周艳 陈莉[1] 潘家华[2] Chen Xin;Peng Wansheng;Zhang Zhen;Zhao Qian;Zhou Yan;Chen Li;Pan Jiahua(Department of Pediatrics,the First Affiliated Hospital of Bengbu Medical College,Bengbu 233004,Anhui,China;Department of Pediatric,Anhui Provincial Hospital,the First Affiliated Hospital of University of Science and Technology of China,Hefei 230001,Anhui,China)

机构地区：[1]蚌埠医学院第一附属医院儿科,安徽蚌埠233004 [2]中国科学技术大学附属第一医院,安徽省立医院儿科,安徽合肥230001

出　　处：《中华危重病急救医学》2018年第11期1046-1050,共5页Chinese Critical Care Medicine

基　　金：安徽省自然科学基金(1608085QH188);安徽省高等学校自然科学研究项目(KJ20158082by).

摘　　要：目的探讨选择性头部亚低温(SBH)治疗中重度新生儿缺氧缺血性脑病(HIE)的疗效和安全性,以及SBH治疗对血清神经元特异性烯醇化酶(NSE)和中枢神经特异蛋白S100的影响。方法选择2015年1月至2017年6月蚌埠医学院第一附属医院新生儿重症加强治疗病房(NICU)收治的中重度HIE患儿42例,经患儿监护人同意后按随机数字表法分为SBH治疗组和常规治疗组。常规治疗组给予传统的“三对症”和“三支持”治疗,并辅以促进神经细胞生长的药物等。SBH治疗组在传统治疗的基础上,于出生6h内进行SBH治疗,使鼻咽部温度维持在33.0~34.5℃、直肠温度维持在34.5~35.0℃。收集两组患儿的性别、胎龄、出生体重、年龄、5min新生儿窒息评分(Apgar评分)、新生儿急性生理学评分围生期补充评分Ⅱ(SNAPPEⅡ)等一般临床资料。主要结局指标为患儿住院病死率、随访至15月龄严重伤残率,以及出生28d新生儿行为神经测定(NBNA)评分和15月龄贝利婴幼儿发展量表(BSID)评分(包括智力发育指数(MDI)评分和心理运动发育指数(PDI)评分];次要结局指标为患儿治疗前后血清NSE和S100蛋白水平。记录两组患儿不良事件的发生情况。结果42例HIE患儿中,排除严重先天性畸形和血小板计数(PLT)<50×10^9/L各1例,共入组40例;在随访过程中,SBH及常规治疗组分别有2例失访或结局不明,最终两组各有18例患儿纳入分析。两组患儿性别、胎龄、出生体重、年龄、5min Apgar评分和SNAPPEⅡ评分等基线资料比较差异均无统计学意义,说明两组基线资料均衡可比。SBH治疗组患儿15月龄严重伤残发生率显著低于常规治疗组[5.6%(1/18)比44.4%(8/18),P<0.05];住院期间常规治疗组死亡1例,SBH治疗组无一例患儿死亡。与常规治疗组相比,SBH治疗组患儿出生28d NBNA评分平均提高2.9分[95%可信区间(95%CI)=1.0~4.8],15月龄BSID评分明显改善,MDI评分平均提高11.8分(95%CI=4.3~Objective To evaluate the efficacy and safety of selective brain hypothermia (SBH)in the treatment of neonates with moderate or severe neonatal hypoxic-ischemic encephalopathy (HIE),and the effect of SBH treatment on serum levels of neuron-specific enolase (NSE)and central nervous specific protein S100.Methods A prospective randomized controlled trial was conducted.From January 2015 to June 2017,42 children with moderate to severe HIE in the neonatal intensive care unit (NICU)of the First Affiliated Hospital of Bengbu Medical College were enrolled,and they were randomly divided into SBH treatment group and routine treatment group after obtaining the consent of the guardian of the children.The children in routine treatment group were given the traditional symptomatic supportive treatment, supplemented by drugs to promote nerve cell growth.On the basis of traditional treatment,the children in the SBH treatment group were given SBH treatment within 6 hours after birth.The nasopharyngeal temperature was maintained at 33.0-34.5℃ and the rectal temperature was maintained at 34.5-35.0℃.The general clinical data of the two groups including gender,gestational age,birth weight,age,5-minute neonatal asphyxia score (Apgar score),score for neonatal acute physiology perinatal extension version Ⅱ(SNAPPE Ⅱ )were collected.The primary outcomes were hospitalized death,severe disability at 15 months of age,neonatal behavioral neurological assessment (NBNA)score at 28 days of age, and Bayley scales of infant development (BSID)score [including mental development index (MDI)score and psychomotor development index (PDI)score]at 15 months of age at follow-up.The secondary outcomes were serum levels of NSE and S100 protein.The occurrences of adverse events in the two groups were recorded.Results Among 42 HIE children, 1 child of severe congenital malformation and 1 child of platelet count (PLT)<50×10^9/L were excluded,and 40 children were enrolled in the study group.During the follow-up period,2 children of SBH treatment group a

关 键 词：亚低温治疗 新生儿缺氧缺血性脑病 中枢神经特异蛋白S100 神经元特异性烯醇化酶 

分 类 号：R722.1[医药卫生—儿科]