以痛泻要方为基本方治疗肠易激综合征随机对照试验的系统评价作者:苏国彬,刘文华,陈海滨,郭新峰【摘要】【目的】评价以痛泻要方为基本方治疗肝郁脾虚型肠易激综合征(IBS)的疗效。【方法】以“痛泻要方”、“肠易激综合征”、“随机对照试验”为关键词,在国内外中英文主要学术论文数据库查找,并进行相关参考文献的检索,用经过验证的中医药治疗性文献信息采集表对纳入的研究进行数据的采集与质量评价。以主要症状(腹痛、大便形状、大便频率等)和/或总体疗效评价以及生存质量为结局指标,将纳入文献分为腹泻型和不分亚型、中医辨证组和未配合中医辨证组等亚组,用ReviewManager42进行数据管理与Meta分析。用漏斗图分析发表性偏倚。【结果】46个随机对照试验符合纳入标准,共包括4155例患者。以痛泻要方为基本方治疗IBS的疗效优于西药或安慰剂,其差异有统计学意义[OR为530,95%CI(438,641)]。亚组分析中,治疗腹泻型IBS的OR值[OR为561,95%CI(433,725)]高于不分亚型组OR值[OR为495,95%CI(374,655)],但差异无统计学意义;痛泻要方为基本方配合中医辨证加减治疗腹泻型IBS的OR值[OR为650,95%CI(378,1120)]高于未配合中医辨证组OR值[OR为537,95%CI(401,719)],但差异无统计学意义。存在发表性偏倚。【结论】以痛泻要方为基本方治疗中医辨证为肝郁脾虚型的腹泻型肠易激综合征的效果优于西药或安慰剂,但尚未能证实配合中医辨证加减的疗效优于基本方,腹泻型疗效优于便秘型等其他类型;研究的总体质量偏低,受偏倚影响的机会较大;个别高质量研究的阴性结果值得进一步探讨。【关键词】肠易激综合征/中药疗法;痛泻要方/治疗应用;系统评价Abstract:ObjectiveToassesstheeffectivenessoftheChineseherbalformulaTongxieYaofang(TY)oritsmodifiedprescriptionsinthemanagementofirritablebowlsyndrome(IBS).MethodsAsystematicreviewwascarriedoutaccordingtotheCochranestandards.AcomputerizedliteraturesearchwascarriedoutinmainChineseandEnglishdatabasesincludingCNKI,CBMdisc,DatabaseofChineseDoctorateDissertation,DatabaseofexcellentChineseMasterDissertation,MEDLINEandCochraneLibrary.Studieswereretrievedwhentheywererandomizedcontrolledtrials(RCTs)whoseinterventionsforIBSpatientswereTYormodifiedprescriptionsofTYwithplacebosorconventionalmedicineascontrols.Outcomemeasurementincludedthealleviationofmainsymptomssuchasabdominalpain,diarrheafrequency,and(or)comprehensiveeffectivenessandqualityoflife(QOL).Metaanalysiswasperformedafterevaluatingthequalityofincludedstudies.SubgroupanalysiswasdonebetweensubgroupsofdiarrheapredominantIBSandsubtyperegardlessIBS,andwasalsodonebetweendiarrheapredominantIBStreatedwithTCMsyndromedifferentiationandthatwithoutTCMsyndromedifferentiation.Funnelplotanalysiswasusedtoanalyzethepublicationbias.ResultsFortysixstudiesmettheinclusioncriteria,and4155participantswereincludedinthemetaanalysis.TheresultsshowedthattheeffectivenessofTYormodifiedprescriptionsofTYwasbetterthanthatofconventionalmedicineorplacebos[OR=530,95%CI(438,641)].SubgroupanalysisshowedthattheORofTYormodifiedprescriptionsofTYinthediarrheapredominantgroups[OR=561,95%CI(433,725)]washigherthanthatofsubtyperegardlessgroups[OR=495,95%CI(374,655)],andORofTYormodifiedprescriptionsofTYinthestudiesofdiarrheapredominantIBStreatedbasedonTCMsyndromedifferentiation[OR=650,95%CI(378,1120)]washigherthanthatofthestudieswithoutTCMsyndromedifferentiation[OR=537,95%CI(401,719)],butthedifferencewasinsignificant.Funnelplotshowedcertainpublicationbias.ConclusionTheeffectivenessofTYormodifiedprescriptionsofTYforIBSpatientsisbetterthant...