硫唑嘌呤治疗溃疡性结肠炎有效性及安全性的系统评价

【】　目的　采用循证医学的方法评价硫唑嘌呤（aiathioprine，AZA）治疗溃疡性结肠炎（ulcerativecolitis，UC）的有效性和安全性。　方法　计算机检索PubMed、Cochranelibrary、Embase、CNKI、维普和CBM数据库收集国内外关于AZA诊疗UC的随机对照试验（ramdomizedcontrolleltrial，RCT）。按Cochrane系统评价的方法评价纳入研究质量，并进行Meta分析。　结果　共纳入5个RCT，共262例UC患者。Meta分析结果显示，AZA治疗UC在缓解率方面与安慰剂比较，差异无统计学意义P=1.19，95%CI（0.94，1.49），P=0.14；在复发率方面，两者比较差异有统计学意义P=0.72，95%CI（0.54，0.95），P=0.02；全部不良反应方面和严重不良反应方面，两者比较差异无统计学意义，Meta分析结果分别为P=2.52，95%CI（0.82，7.74），P=0.11和P=4.03，95%CI（0.88，18.53），P=0.07。　结论　系统评价结果为AZA在疗效方面优于安慰剂，在不良反应发生率方面差异无统计学意义。但由于纳入的5个研究中没有高质量的RCT，且有1个可能产生高度偏倚，使得这一结论受到影响，有必要开展更多设计严谨，大样本、多中心的RCT。【Abstract】　Objective　Toassesstheefficacyandsafetyofazathio-prineinthetreatmentofulcerativecolitisthroughanevidence-basedmethod.　Methods　WesearchedtheliteraturefromdatabaseslikePubMed,Cochranelibrary,CNKI,VIP,andCBM,andevaluatedthequalityofstudiesaccordingtoCochranesystematicreview.Finally,Meta-analysiswasperformed.　Results　Fiverandomizedcontrolledtrials(RCT)wereincludedinthisstudywithatotalof262patients.Meta-analysisshowedthattherewasnosignificantdifferenceintherateofremissionbetweenazathio-prineandplacebointreatingulcerativecolitisP=1.19,95%CI(0.94,1.49),P=0.14.TherewassignificantdifferenceintherelapseratebetweenthetwotreatingmethodsP=0.72,95%CI(0.54,0.95),P=0.02.Inaddition,therewasnostatisticaldifferenceinalladverseeffectsP=2.52,95%CI(0.82,7.74),P=0.11andseriousadverseeffectsP=4.03,95%CI(0.88,18.53),P=0.07betweenthetwotreatingmethods.　Conclusion　Inthetreatmentofulcerativecolitis,azathio-prinehasasignificantadvantageinefficacythanplacebo,butthereisnosignificantdifferenceintherateofadverseeventsbetweenthetwogroups.However,noneofthe5RCTincludedinthisreviewhasahighqualityandoneofthemevenprobablyhasahighbias,whichhasabiginfluenceonourconclusion.Consequently,multi-centerlarge-scalerandomizedcontrolledtrialsofhigherqualityareneededtomakeconfirmation.