中国循证儿科杂志
中國循證兒科雜誌
중국순증인과잡지
CHINESE JOURNAL OF EVIDENCE-BASED PEDIATRICS
2009年
4期
340-348
,共9页
亚低温%新生儿%缺氧缺血%脑%Meta分析
亞低溫%新生兒%缺氧缺血%腦%Meta分析
아저온%신생인%결양결혈%뇌%Meta분석
Hypothermia%Neonate%Hypoxia-ischemia%Brain%Meta-analysis
目的 总结国内外亚低温治疗新生儿缺氧缺血性脑病(HIE)的研究结果,采用Meta分析方法评价亚低温治疗HIE的临床疗效,探讨亚低温治疗HIE的可行性.方法 制定原始文献的纳入标准、排除标准及检索策略,检索PubMed、EMBASE、Ovid、Springer、中国期刊全文数据库、万方数据库及维普中文科技期刊数据库等,获得亚低温治疗HIE的相关文献.使用Coehrane中心推荐的方法进行文献质量评价,采用RevMan 4.22软件对满足纳入标准的有关亚低温治疗HIE的RCT文献进行Meta分析.以病死率、严重神经系统发育障碍(脑瘫、发育迟缓、失明和听力损害)发生率和不良反应发生率作为观察指标,进行定性和定量综合评估.结果 共检索到846篇文献,符合纳入标准的9项RCT研究(16篇文献)进入Meta分析,纳入研究均未采用盲法,文献质量评价7项RCT研究为A级,2项为C级,漏斗图检验提示无发表偏倚.Meta分析结果显示,亚低温组和对照组比较:病死率显著降低(RR=0.73,95%CI:0.58～0.91);随访至18月龄时严重神经系统发育障碍发生率显著降低(RR=0.70,95%CI:0.53～0.92);脑瘫发生率显著降低(RR=0.72,95%CI:0.53～0.98);发育迟缓(RR=0.73,95%CI:0.53～0.99)、失明(RR=0.57,95%CI:0.30～1.08)和听力损害(RR=1.52,95%CI:0.71～3.25)发生率差异无统计学意义;不良反应发生率:窦性心动过缓(RR=6.35,95%CI:2.16～18.68)和PLT减少(RR=1.55,95%CI:1.14～2.11)发生率升高,需要治疗的心律失常、凝血功能异常导致的血栓或出血、脓毒症和惊厥发生率差异无统计学意义.结论 亚低温治疗可降低HIE患儿的病死率,改善神经系统发育障碍,且具有较好的安全性.
目的 總結國內外亞低溫治療新生兒缺氧缺血性腦病(HIE)的研究結果,採用Meta分析方法評價亞低溫治療HIE的臨床療效,探討亞低溫治療HIE的可行性.方法 製定原始文獻的納入標準、排除標準及檢索策略,檢索PubMed、EMBASE、Ovid、Springer、中國期刊全文數據庫、萬方數據庫及維普中文科技期刊數據庫等,穫得亞低溫治療HIE的相關文獻.使用Coehrane中心推薦的方法進行文獻質量評價,採用RevMan 4.22軟件對滿足納入標準的有關亞低溫治療HIE的RCT文獻進行Meta分析.以病死率、嚴重神經繫統髮育障礙(腦癱、髮育遲緩、失明和聽力損害)髮生率和不良反應髮生率作為觀察指標,進行定性和定量綜閤評估.結果 共檢索到846篇文獻,符閤納入標準的9項RCT研究(16篇文獻)進入Meta分析,納入研究均未採用盲法,文獻質量評價7項RCT研究為A級,2項為C級,漏鬥圖檢驗提示無髮錶偏倚.Meta分析結果顯示,亞低溫組和對照組比較:病死率顯著降低(RR=0.73,95%CI:0.58～0.91);隨訪至18月齡時嚴重神經繫統髮育障礙髮生率顯著降低(RR=0.70,95%CI:0.53～0.92);腦癱髮生率顯著降低(RR=0.72,95%CI:0.53～0.98);髮育遲緩(RR=0.73,95%CI:0.53～0.99)、失明(RR=0.57,95%CI:0.30～1.08)和聽力損害(RR=1.52,95%CI:0.71～3.25)髮生率差異無統計學意義;不良反應髮生率:竇性心動過緩(RR=6.35,95%CI:2.16～18.68)和PLT減少(RR=1.55,95%CI:1.14～2.11)髮生率升高,需要治療的心律失常、凝血功能異常導緻的血栓或齣血、膿毒癥和驚厥髮生率差異無統計學意義.結論 亞低溫治療可降低HIE患兒的病死率,改善神經繫統髮育障礙,且具有較好的安全性.
목적 총결국내외아저온치료신생인결양결혈성뇌병(HIE)적연구결과,채용Meta분석방법평개아저온치료HIE적림상료효,탐토아저온치료HIE적가행성.방법 제정원시문헌적납입표준、배제표준급검색책략,검색PubMed、EMBASE、Ovid、Springer、중국기간전문수거고、만방수거고급유보중문과기기간수거고등,획득아저온치료HIE적상관문헌.사용Coehrane중심추천적방법진행문헌질량평개,채용RevMan 4.22연건대만족납입표준적유관아저온치료HIE적RCT문헌진행Meta분석.이병사솔、엄중신경계통발육장애(뇌탄、발육지완、실명화은력손해)발생솔화불량반응발생솔작위관찰지표,진행정성화정량종합평고.결과 공검색도846편문헌,부합납입표준적9항RCT연구(16편문헌)진입Meta분석,납입연구균미채용맹법,문헌질량평개7항RCT연구위A급,2항위C급,루두도검험제시무발표편의.Meta분석결과현시,아저온조화대조조비교:병사솔현저강저(RR=0.73,95%CI:0.58～0.91);수방지18월령시엄중신경계통발육장애발생솔현저강저(RR=0.70,95%CI:0.53～0.92);뇌탄발생솔현저강저(RR=0.72,95%CI:0.53～0.98);발육지완(RR=0.73,95%CI:0.53～0.99)、실명(RR=0.57,95%CI:0.30～1.08)화은력손해(RR=1.52,95%CI:0.71～3.25)발생솔차이무통계학의의;불량반응발생솔:두성심동과완(RR=6.35,95%CI:2.16～18.68)화PLT감소(RR=1.55,95%CI:1.14～2.11)발생솔승고,수요치료적심률실상、응혈공능이상도치적혈전혹출혈、농독증화량궐발생솔차이무통계학의의.결론 아저온치료가강저HIE환인적병사솔,개선신경계통발육장애,차구유교호적안전성.
Objective To evaluate the efficacy of therapeutic hypothermia on mortality, long-term neuredevelopmental disability and clinical major side effects in eneephalopathie asphyxiated newborn infants. We summarized the data of hypoxic ischemic encephalopathy (HIE) newborns who were treated with mild hypothermia using meta-analysis method. Methods The standard search strategy of the Neonatal Review Group as outlined in the Cochrane Library ( Issue 2, 2007) was used. RCTs evaluating therapeutic hypothermia in newborns with hypoxic ischemic eneephalopathy were identified by searching the PubMed, EMBASE, Ovid, Springer and CNKI database with the terms "Infant or neonate and asphyxia or hypoxie-ischemic encephalopathy and hypothermia". No language restrictions were applied. RCTs comparing the usage of therapeutic hypothermia with standard care in eneephalopathic newborn infants with evidence of peripartum asphyxia and without recognizable major congenital anomalie s wereincluded. The primary outcome measure was death or long-term major neurodevelopmental disability. Other outcomes included adverse effects of cooling and other indicators of neurodevelopmental outcome. Two review authors independently selected, assessed the quality of the included studies and extracted data. Authors were contacted for further information. Meta-analysis was performed using relative risk and risk difference for dichotomous data with 95% confidence intervals. Results Nine trials involving 785 neonates were included in the analysis. Cooling techniques and the definition and severity of neuredevelopmental disability differed among studies. Overall, there was evidence of a significant effect of therapeutic hypothermia on the outcomes of mortality ( RR = 0.73, 95% CI: 0. 58 - 0.91 ) and neuredevelopmental disability at 18 to 22 months ( RR = 0. 70,95% CI : 0. 53 - 0. 92). Moreover, hypothermia significantly decreased the incidence of disabling cerebral palsy (RR =0. 72, 95% CI: 0. 53 -0.98).However, hypothermia had no effect on developmental delay ( BR = O. 73, 95% CI : 0.53 - 0.99), blindness ( RR = 0.57, 95% CI: 0.30 - 1.08) and hearing loss ( RR = 1.52, 95% CI: 0.71 - 3.25 ) in newborns with HIE. Adverse effects included benign sinus bradycardia ( RR =6.35, 95% CI: 2. 16 - 18.68 ) and thrombocytopenia ( RR = 1.55, 95% CI: I. 14 - 2. 11 ) without deleterious consequences. Conclusions In general, therapeutic hypothermia seemed to have a beneficial effect on the outcome of neonates with moderate to severe hypoxic ischemic encephalopathy. Despite the methodological differences between trials, wide confidence intervals, and the lack of follow-up data beyond the second year of life, the consistency of the results is encouraging. Further research is necessary to minimize the uncertainty regarding efficacy and safety of any specific technique of cooling for any specific population.
