中国循证儿科杂志
中國循證兒科雜誌
중국순증인과잡지
CHINESE JOURNAL OF EVIDENCE-BASED PEDIATRICS
2010年
2期
104-110
,共7页
重组人红细胞生成素%早产儿%神经系统%Meta分析
重組人紅細胞生成素%早產兒%神經繫統%Meta分析
중조인홍세포생성소%조산인%신경계통%Meta분석
Recombinant human erythropoietin%Preterm%Neural systerm%Meta analysis
目的 采用Meta分析方法 评价重组人红细胞生成素(rhEPO)对早产儿神经发育的保护作用.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、Cochrane图书馆、中国期刊全文数据库、万方数据库、维普中文科技期刊数据库及中国生物医学文献数据库等,获得rhEPO对早产儿神经发育保护的RCT或半随机对照试验(quasi-RCT)文献.使用Jadad量表对纳入文献进行质量评价,采用RevMan 5.0软件进行Meta分析.以智力发育指数(MDI)、神经运动发育指数(PDI)、新生儿行为神经评估(NBNA)评分、严重神经系统后遗症(脑瘫、失明和听力受损)发生率以及严重早产儿视网膜病(ROP,≥3级)、严重脑室内出血(IVH,≥3级)、坏死性小肠结肠炎(NEC)和支气管肺发育不良(BPD)的发生率等作为观察指标,进行综合评估.结果 共检索到118篇文献,符合纳入标准的2篇RCT和3篇quasi-RCT文献(n=233)进入Meta分析,其中英文文献2篇,中文文献3篇.文献质量评价A级1篇,B级1篇,C级3篇.各研究间的基线水平有一定差异,出生体重、孕周、rhEPO剂量和治疗持续时间不尽相同.Meta分析结果 显示,rhEPO治疗组MDI评分显著高于对照组(WMD=7.73,95%CI:3.45～12.01,P=0.000 4);rhEPO治疗组PDI评分显著高于对照组(WMD=3.81,95%CI:0.59～7.02,P=0.02);rhEPO治疗组NBNA评分显著高于对照组(WMD=1.95,95%CI:1.56～2.35,P＜0.000 01).两组MDI评分<70发生率(OR= 0.70,95%CI:0.31～1.61)、PDI评分<70发生率(OR=2.46,95%CI:0.94～6.45)、脑瘫(OR=1.08,95%CI:0.39～2.99)、失明(OR=0.34,95%CI:0.01～8.56)和听力受损(OR=1.04,95%CI:0.06～17.15)的发生率差异均无统计学意义.两组严重ROP(OR=1.30,95%CI:0.50～3.43)、严重IVH(OR=2.91,95%CI:0.64～13.23)、NEC(OR=0.57,95%CI:0.13～2.54)和BPD(OR=1.06,95%CI:0.50～2.26)发生率的差异均无统计学意义.结论 应用rhEPO治疗可能改善早产儿神经系统预后,可能对于早产儿神经系统发育有保护作用,且不增加严重ROP的发生率.
目的 採用Meta分析方法 評價重組人紅細胞生成素(rhEPO)對早產兒神經髮育的保護作用.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、Cochrane圖書館、中國期刊全文數據庫、萬方數據庫、維普中文科技期刊數據庫及中國生物醫學文獻數據庫等,穫得rhEPO對早產兒神經髮育保護的RCT或半隨機對照試驗(quasi-RCT)文獻.使用Jadad量錶對納入文獻進行質量評價,採用RevMan 5.0軟件進行Meta分析.以智力髮育指數(MDI)、神經運動髮育指數(PDI)、新生兒行為神經評估(NBNA)評分、嚴重神經繫統後遺癥(腦癱、失明和聽力受損)髮生率以及嚴重早產兒視網膜病(ROP,≥3級)、嚴重腦室內齣血(IVH,≥3級)、壞死性小腸結腸炎(NEC)和支氣管肺髮育不良(BPD)的髮生率等作為觀察指標,進行綜閤評估.結果 共檢索到118篇文獻,符閤納入標準的2篇RCT和3篇quasi-RCT文獻(n=233)進入Meta分析,其中英文文獻2篇,中文文獻3篇.文獻質量評價A級1篇,B級1篇,C級3篇.各研究間的基線水平有一定差異,齣生體重、孕週、rhEPO劑量和治療持續時間不儘相同.Meta分析結果 顯示,rhEPO治療組MDI評分顯著高于對照組(WMD=7.73,95%CI:3.45～12.01,P=0.000 4);rhEPO治療組PDI評分顯著高于對照組(WMD=3.81,95%CI:0.59～7.02,P=0.02);rhEPO治療組NBNA評分顯著高于對照組(WMD=1.95,95%CI:1.56～2.35,P＜0.000 01).兩組MDI評分<70髮生率(OR= 0.70,95%CI:0.31～1.61)、PDI評分<70髮生率(OR=2.46,95%CI:0.94～6.45)、腦癱(OR=1.08,95%CI:0.39～2.99)、失明(OR=0.34,95%CI:0.01～8.56)和聽力受損(OR=1.04,95%CI:0.06～17.15)的髮生率差異均無統計學意義.兩組嚴重ROP(OR=1.30,95%CI:0.50～3.43)、嚴重IVH(OR=2.91,95%CI:0.64～13.23)、NEC(OR=0.57,95%CI:0.13～2.54)和BPD(OR=1.06,95%CI:0.50～2.26)髮生率的差異均無統計學意義.結論 應用rhEPO治療可能改善早產兒神經繫統預後,可能對于早產兒神經繫統髮育有保護作用,且不增加嚴重ROP的髮生率.
목적 채용Meta분석방법 평개중조인홍세포생성소(rhEPO)대조산인신경발육적보호작용.방법 제정원시문헌적납입표준、배제표준급검색책략,검색PubMed、EMBASE、Cochrane도서관、중국기간전문수거고、만방수거고、유보중문과기기간수거고급중국생물의학문헌수거고등,획득rhEPO대조산인신경발육보호적RCT혹반수궤대조시험(quasi-RCT)문헌.사용Jadad량표대납입문헌진행질량평개,채용RevMan 5.0연건진행Meta분석.이지력발육지수(MDI)、신경운동발육지수(PDI)、신생인행위신경평고(NBNA)평분、엄중신경계통후유증(뇌탄、실명화은력수손)발생솔이급엄중조산인시망막병(ROP,≥3급)、엄중뇌실내출혈(IVH,≥3급)、배사성소장결장염(NEC)화지기관폐발육불량(BPD)적발생솔등작위관찰지표,진행종합평고.결과 공검색도118편문헌,부합납입표준적2편RCT화3편quasi-RCT문헌(n=233)진입Meta분석,기중영문문헌2편,중문문헌3편.문헌질량평개A급1편,B급1편,C급3편.각연구간적기선수평유일정차이,출생체중、잉주、rhEPO제량화치료지속시간불진상동.Meta분석결과 현시,rhEPO치료조MDI평분현저고우대조조(WMD=7.73,95%CI:3.45～12.01,P=0.000 4);rhEPO치료조PDI평분현저고우대조조(WMD=3.81,95%CI:0.59～7.02,P=0.02);rhEPO치료조NBNA평분현저고우대조조(WMD=1.95,95%CI:1.56～2.35,P＜0.000 01).량조MDI평분<70발생솔(OR= 0.70,95%CI:0.31～1.61)、PDI평분<70발생솔(OR=2.46,95%CI:0.94～6.45)、뇌탄(OR=1.08,95%CI:0.39～2.99)、실명(OR=0.34,95%CI:0.01～8.56)화은력수손(OR=1.04,95%CI:0.06～17.15)적발생솔차이균무통계학의의.량조엄중ROP(OR=1.30,95%CI:0.50～3.43)、엄중IVH(OR=2.91,95%CI:0.64～13.23)、NEC(OR=0.57,95%CI:0.13～2.54)화BPD(OR=1.06,95%CI:0.50～2.26)발생솔적차이균무통계학의의.결론 응용rhEPO치료가능개선조산인신경계통예후,가능대우조산인신경계통발육유보호작용,차불증가엄중ROP적발생솔.
Objective To assess the efficacy and safety of recombinant human erythropoietin (rhEPO) for improving neurodevelopment outcomes in preterm infants. Methods According to the requirements of Cochrane systematic review,a literature search was performed among PubMed,EMBASE, Cochrane library, CNKI, Wanfang data, VIP and CBM from the establishment of the database till 31 December 2009. Quality assessments of clinical trials were carried out. Randomized controlled trials(RCTs) or quasi-RCTs with rhEPO in preterm infants were enrolled and RevMan 5.0 software was used for meta-analysis. Data extraction, quality assessment, and meta-analysis for the results of homogeneous studies were done by two reviewers. The trials were analyzed using weighted mean difference (WMD) for continuous data and relative risk (RR) for dichotomous data, both kinds of data were expressed by 95%CI.For homogenous data(P≥0.10), fixed effect model was calculated.Results One hundred and eighteen literatures were reviewed. The studies including reviews(n=22),non-RCTs(n=35),foundational researches(n=40), anaemia studies(n=6), full-term infants RCTs(n=2), documents not meeting the major results of the meta analysis(n=8) were excluded. Two RCTs and 3 quasi-RCTs including 233 preterm infants(119 of treatment group and 114 of control group)were included in the analysis. The results of quality assessment were that 1 study was A, 1 was B, and 3 were C. There was evidence of a significant effect of therapeutic rhEPO on the outcomes of MDI scores (WMD=7.73,95%CI:3.45-12.01,P=0.000 4) , PDI scores (WMD=3.81,95%CI:0.59-7.02,P=0.02) at 18 to 22 months and NBNA scores (WMD=1.95,95%CI:1.56-2.35,P＜0.000 01) at 40 weeks of corrected gestational age. However, rhEPO had no effect on MDI<70(OR= 0.70,95%CI:0.31-1.61),PDI<70(OR=2.46,95%CI:0.94-6.45),cerebral palsy(OR=1.08,95%CI:0.39-2.99), blindness(OR=0.34,95%CI:0.01-8.56) and hearing loss(OR=1.04,95%CI:0.06-17.15). There were no differences between groups with respect to the percentage of preterm infants with severe ROP of stage Ⅲ or above(OR=1.30,95%CI:0.50-3.43),severe IVH of stage Ⅲ or above(OR=2.91,95%CI:0.64-13.23),NEC(OR=0.57,95%CI:0.13-2.54) and BPD(OR=1.06,95%CI:0.50-2.26).Conclusions The rhEPO treatment had beneficial effect on the neurodevelopment outcomes but did not produce severe ROP to preterm infants.
