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不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析

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不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析

硕士专业学位论文论文题目不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析研究生姓名沈勤指导教师姓名吕海涛专业名称儿科学研究方向小儿心血管论文提交日期2013年4月不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析中文摘要I不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析中文摘要第一部分静脉注射丙种球蛋白不同剂量及用法治疗川崎病疗效的Meta分析目的评价近20年静脉注射丙种球蛋白(intravenousimmunoglobulin,IVIG)不同剂量及用法治疗川崎病(Kawasakidisease,KD临床疗效的Meta分析。方法制定检索策略、原始文献纳入及排除标准,检索1993.3至2013.3,MEDLINE、EMBASE、PUBMED、Cochrane图书馆、万方数据库、重庆维普(VIP)数据库及中国期刊全文数据库(Chinanationalknowledgeinfrastructure,CNKI)。纳入初始静脉注射丙种球蛋白不同剂量及用法对川崎病患者冠状动脉损害(coronaryarterylesions,CALs)、丙种球蛋白无反应者、IVIG不良反应发生率、退热时间及治疗前后炎症指标如白细胞(Whitebloodcell,WBC)、血沉(Erythrocytesedimentationrate,ESR)、C反应蛋白(Creactiveprotein,CRP)的影响。并对纳入的相关文献进行质量评价。采用Stata11.0对数据进行统计分析。结果纳入40篇文献共包括7932例KD患者,研究中除了一篇为前瞻性研究外,余均为回顾性研究,提取数据资料后进行统计分析结果显示1)IVIG2g/kg.d1d与1g/(kg.d)2d比较,Meta分析结果示IVIG2g/kg.d1d的退热时间比IVIG1g/(kg.d)2d缩短加权平均差值weightedmeandifference,WMD0.54,95可信区间(confidenceinterval,CI)0.650.44,差异有统计学意义在急性期、亚急性期冠状动脉损害发生率方面两种用法无统计学差异优势比中文摘要不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析IIoddsratio,OR0.71,1.0795CI0.461.08,0.781.46。2)IVIG2g/kg.d1d与1g/(kg.d)1d比较,Meta分析结果示IVIG2g/kg.d1d较1g/(kg.d)1d能更好地缩短退热时间(WMD0.11,95CI0.160.06)及降低治疗前后炎症反应指标(WBC、ESR、CRP),差异有统计学意义在降低冠状动脉损害发生率(P0.996,OR1.12,95CI为0.413.04)及不良反应发生率P0.997,OR1.22,95CI为0.811.83方面两种用法无统计学差异。3)IVIG2g/kg.d1d与400mg/(kg.d)45d比较,Meta分析结果示IVIG2g/kg.d1d较400mg/(kg.d)45d能更好降低冠状动脉损害发生率(OR0.33,95CI0.270.41),缩短退热时间(WMD1.38,95CI1.451.32)及降低治疗前后炎症指标(WBC、ESR、CRP),差异有统计学意义。4)IVIG1g/kg.d1d与400mg/(kg.d)45d比较,Meta分析结果示IVIG1g/kg.d1d较400mg/(kg.d)45d能更好降低冠状动脉损害发生率(OR0.39,95CI0.250.60),缩短退热时间(WMD0.95,95CI1.010.89),及降低治疗前后炎症指标(WBC、ESR、CRP),差异有统计学意义在不良反应发生率方面(P0.786)两者无统计学差异。5)IVIG1g/kg.d2d与400mg/(kg.d)45d比较,Meta分析结果示IVIG1g/kg.d2d较400mg/(kg.d)45d更好降低冠状动脉损害发生率OR0.60,95CI0.440.81及缩短退热时间WMD1.25,95CI1.341.16,差异有统计学意义。结论1)IVIG2g/kg.d1d与IVIG1g/kg.d1d、IVIG1g/kg.d2d比较,三种用法在降低冠状动脉损害发生率上无明显差异2)IVIG2g/kg.d1d较IVIG400mg/(kg.d)45d、IVIG1g/kg.d1d、IVIG1g/kg.d2d更能有效缩短退热时间,降低炎症指标(ESR、CRP、WBC)3)IVIG400mg/(kg.d)45d疗法与IVIG2g/kg.d1d、IVIG1g/kg.d1d、IVIG1g/kg.d2d相比,冠状动脉损害发生率高。关键词川崎病静脉注射丙种球蛋白Meta分析不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析中文摘要III第二部分静脉注射丙种球蛋白联合糖皮质激素初始治疗川崎病疗效的Meta分析目的通过对近20年来静脉注射丙种球蛋白联合糖皮质激素与单用静脉注射丙种球蛋白两种方案治疗川崎病患儿疗效的Meta分析,以了解IVIG联合糖皮质激素对冠状动脉损害及IVIG无反应者发生率的影响。方法制定检索策略及原始文献纳入、排除标准,检索1993.32013.3MEDLINE、EMBASE、PUBMED、Cochrane图书馆、万方数据库、VIP及CNKI。纳入初始治疗IVIG联合糖皮质激素与单用IVIG对川崎病患儿冠状动脉损害、丙种球蛋白无反应者、不良反应发生率及退热时间的影响阿司匹林aspirin,ASA在两组中为基础用药)。对纳入相关文献进行质量评价。采用Stata11.0对数据进行统计分析。计数资料采用OR及95CI进行分析,计量资料采用WMD及95CI进行分析,并进行发表偏倚评估。结果8篇文献(共1727例KD患者)最终纳入分析。均为英文文献,其中4篇为随机对照试验(randomizedcontrolledtrial,RCT),4篇为回顾性对照研究。Meta分析结果显示(1)初始治疗IVIG联合糖皮质激素组与单用IVIG组在一月内及随访一月后冠状动脉损害发生率方面(P0.008、0.782,OR0.75、0.65,95CI0.511.09、0.351.19)无统计学差异。(2)初始治疗IVIG联合糖皮质激素组较单用IVIG组退热时间缩短OR1.07,95CI1.290.85,差异有统计学意义。(3)初始治疗IVIG联合糖皮质激素组较单用IVIG组IVIG无反应者的发生率降低(OR0.45,95CI0.310.66),差异有统计学意义。(4)初始治疗IVIG联合糖皮质激素组较单用IVIG组在不良反应发生率方面(P0.554)无统计学差异,甲基强的松龙30mg/kg单次静脉使用及强的松2mg/kg.d3d口服无严重不良反应发生。结论1)与单用IVIG治疗KD比较,联合激素组有同样降低冠状动脉损害的作用,且能更快缩短退热时间2)与单用IVIG治疗KD比较,联合激素组不良反应发生率未增加3)与单用IVIG治疗KD比较,联合激素组IVIG无反应者发生率明显降低。中文摘要不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析IV关键词川崎病糖皮质激素静脉注射丙种球蛋白Meta分析作者沈勤指导老师吕海涛不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析英文摘要VTreatmentofKawasakidiseasebydifferenttherapiesofintravenousimmunoglobulinaMataanalysisoftherapeuticeffectsAbstractPartIAMetaanalysisonefficacyofdifferentdosesandusageofintravenousimmunoglobulintreatmentinKawasakidiseaseObjectiveToassesstheefficacyofdifferentdosesandusageofintravenousimmunoglobulinintreatmentofKawasakidiseaseKD.MethodsWesearchedliteratureintheelectronicdatabasesincludingMedline,Pubmed,Wanfang,Chinanationalknowledgeinfrastructure,VIPandCochraneLibraryfromMarch1993toMarch2013.RandomizedclinicaltrialsRCTontheearlytreatmentofKDwithintravenousimmunoglobulinwereincludedandassessedforclinicalefficacy,StatisticalanalysiswasperformedbyusingState11.0software.DataswerecombinedformetaanalysisusingoddsratiosORfordichotomousdataorweightedmeandifferenceWMDforcontinuousdata.Randomeffectsstatisticalmodelorfixedeffectsmodelwasused.ResultsFortystudiesinvolved7932caseswereincluded.Theywereretrospectivestudiesexceptanarticleforprospectivestudy.1)ThemetaanalysisofthesestudiesrevealedthedurationoffeverwasshorteramongpatientswhoreceivedIVIG2g/kg.dinasingledoseforonedaycomparedwith1g/kg.dforcontinuoustwodays(WMD0.54,95CI0.650.44).However,therewasnosignificantreductionintheincidenceofcoronaryarterylesionsCALsintheacuteandsubacuteKD,OR0.71,1.0795CI0.461.08,0.781.46.2)ThemetaanalysisshowedasignificantreductionindurationoffeverandWBC,ESR,CRPdecreasedmorerapidlyamongpatientswhoreceivedIVIG2g/kginsingledoseforonedaycomparedwith1g/kg.dforoneday.However,therewasnosignificantdifferenceintheincidenceofCALs(P0.996,OR1.12,95CI0.413.04)andadverse英文摘要不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析VIreactionsofIVIGP0.997,OR1.22,95CI0.811.83.3)Themetaanalysisshowedasignificantreductionintheincidenceofcoronaryarterylesions(OR0.33,95CI0.270.41),aswellasthereductionindurationoffever(WMD1.38,95CI1.451.32)andWBC,ESR,CRPdecreasedmorerapidlyamongpatientswhoreceivedIVIG2g/kginsingledoseforonedaycomparedwith400mg/kg.dforfourorfivedays.4)Themetaanalysisof1g/kginasingledoseversus400mg/kgforfourorfivedaysshowedsignificantreductionintheincidenceofCALs(OR0.39,95CI0.250.60),aswellasthedecreaseofWBC,ESR,CRPandthedurationoffever(WMD0.95,95CI1.010.89).ThecomparisonshowednosignificantdifferenceofadversereactionsofIVIG.5)Themetaanalysisof1g/kgfortwodaysversus400mg/kgforfourorfivedaysshowedsignificantreductionintheincidenceofCALsOR0.60,95CI0.440.81,aswellasthereductionindurationoffeverWMD1.25,95CI1.341.16.Conclusion1TherewerenosignificantdifferenceinCALsoccurenceamongtheprimaryintravenousimmunoglobulintreatmentswith1g/kgfor2days,1g/kgand2g/kginasingleuseinKawasakidisease.2Theintravenousimmunoglobulintreatmentatthedoseof2g/kgforsingleusesignificantlyreducedthefeverduration,anddecreasedtheinflammatoryindicators,suchasESR,CRP,WBC.3)Theintravenousimmunoglobulintreatmentswith400mg/kgfor45dayshadahighestincidenceofcoronaryarterylesions.KeywordsKawasakidiseaseintravenousimmunoglobulinMetaanalysis不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析英文摘要VIIPartIIAmetaanalysisontheefficacyofintravenousimmunoglobulincombindedwithcorticosteroidforinitialtreatmentinKawasakidiseaseObjectiveToinvestigatetheefficacyofintravenousimmunoglobulincombindedwithcorticosteroidinKawasakiDiseasecomparedwithintravenousimmunoglobulinsingaltherapy.MethodsAllstudieswereobtainedbyasystematicsearchinPUBMED,MEDLINE,CochraneLibrary,EMBASE,WANFANG,CNKIandVIPdatabaseformMarch1993toMarch2013.Asetofinclusionandexclusioncriteriaselectedthestudiesforanalysis.DataswerecombinedformetaanalysisusingthepooledrelativeriskRRforCALs,retreatmentswithIVIGandadverseeventsandtheweightedmeandifference(WMD)fortheantifebriletime.Studiesthatsatisfiedthetestforhomogeneityweresubjectedtofurtheranalysisandwereinvestigatedqualityassessment.Hypothesetestingwasconductedtodeterminethestatisticalsignificanceofthecalculateddifferenceinthiscomparedtreatmentgroup.Stata11.0softwarewasusedtoperformthestatisticalanalysis.Results8studiesinvolved1727caseswereincluded4randomizedcontrolledtrialsand4comparativestudies.1TheincidenceofCALswasnotdifferentbetweenIVIGinadditiontocorticosteroidandIVIGgroupswith1monthor1monthposttreatmentP0.008、0.782,OR0.75、0.65,95CI0.511.09、0.351.19.2ThedurationoffeverwasshorterintheIVIGcombinedwithcorticosteroidgroupthaninthegroupofIVIGaloneOR1.07,95CI1.290.85.3MetaanalysisshowedasignificantreductionintheratesofretreatmentIVIG(OR0.45,95CI0.310.66)amongpatientswhoreceivedIVIGpluscorticosteroidtherapycomparedwithIVIGalone.4TheriskofadverseeventsdidnotincreasebetweenIVIGinadditiontocorticosteroidandIVIGgroups.Methylprednisoloneatadoseof30mg/kgonedayorprednisoneatadoseof2mg/kgthreedaysdidnothaveadverseevents.Conclusions1ComparedwithIVIGtreatmentKDalone,IVIGcombinedwithcorticosteroidgrouphadthesameeffectofdecreasetheincidenceofCALsandsignificantlyreducedthe英文摘要不同方案静脉注射丙种球蛋白治疗川崎病疗效的Meta分析VIIIfeverdurationafterinitiationoftherapy2ComparedwithIVIGtreatmentKDalone,IVIGcombinedwithcorticosteroidgroupdidnotincreasetherateofadverseevents.3TheadditionofcorticosteroidtoIVIGtherapycoulddecreasetheratesofretreatmentwithIVIG.KeywordsKawasakidiseasecorticosteroidintravenousimmunoglobulinmetaanalysisWrittenbyShenQinSupervisedbyLvHaitao

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