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1、中文摘要目的:觀察補(bǔ)氣健脾湯治療功能性消化不良脾氣虛證的臨床療效,并從理論和臨床研究?jī)蓚€(gè)方面系統(tǒng)探討補(bǔ)氣健脾湯治療功能性消化不良脾氣虛證的機(jī)制。.方法:將符合納入標(biāo)準(zhǔn)的病人按照就診的先后順序,采用隨機(jī)法分為治療組和對(duì)照組。治療組36例給予補(bǔ)氣健脾湯水煎劑:對(duì)照組36例給予枸櫞酸莫沙必利分散片,5mg,3次/日。4周為1個(gè)療程。療程結(jié)束后將臨床癥狀根據(jù)《中藥新藥臨床研究指導(dǎo)原則》中的相關(guān)規(guī)定進(jìn)行評(píng)分,并做出療效評(píng)價(jià)。結(jié)果:1.治療組臨床治愈10例,顯效15例,有效8例,無(wú)效3例,總有效率91.67%。對(duì)照組治愈5例,顯效14例,有效9例,無(wú)效8例,總有效率77.78%。
2、治療組總有效率高于對(duì)照組,但經(jīng)Ridit檢驗(yàn),兩組無(wú)顯著性差異(歷O.05),表明兩組在臨床綜合療效改善方面作用相當(dāng)。2.在改善食少納呆,食后腹脹,脘悶,惡心嘔吐癥狀方面,兩組療效相當(dāng),無(wú)顯著性差異(P>O.05);在改善體倦乏力,大便異常,神疲懶言,口淡不渴,腹痛,排便,無(wú)力癥狀方面,治療組優(yōu)于西藥對(duì)照組(只0.05)。3.安全性評(píng)估:兩組患者用藥期間均未發(fā)現(xiàn)明顯不良反應(yīng),治療后經(jīng)復(fù)查三大常規(guī)及心電圖,肝腎功能,均未發(fā)現(xiàn)異常改變。結(jié)論:本次臨床試驗(yàn)研究結(jié)果表明,補(bǔ)氣健脾湯能緩解功能性消化不良脾氣虛證患者的臨床癥狀。且在服藥過(guò)程中,未發(fā)生不良反應(yīng)。臨床療效顯著,復(fù)發(fā)率
3、低,是一種安全有效的用藥方案?!P(guān)鍵詞:功能性消化不良;補(bǔ)氣健脾湯;脾氣虛證;臨床研究IIIIIIIIIIIIIIIUIY2115376CIinicaIStudyonBuqiJianpiDecoction’sTreatmentforFunctionaIDyspepsiaSyndromeWithSpIeenqiDefiCiencyAbstractObjective:ObservetheclinicaltherapeuticefficacyofBuqiJianpiDecoction’streatmentforfunctionaldyspepsiasyndromewiths
4、pleenqideficiency,andmakeasystematicstudyfromtwoaspectsoftheoryandclinicalresearchonthemechanismofBuqiJianpiDecoction’streatmentforfunctionaldyspepsiasyndromewithspleenqideficiency.Methods:Dividethepatientsmeetingtheinclusioncriteriaintotreatmentgroupandcontrastgrouprandomlyaccordingtot
5、heexaminingorder.36casesinthetreatmentgrouparegivenBuqiJianpiDecoction,while36casesinthecontrolgrouparegivenMosaprideCitrateDispersibleTablets,5mg,3timesperday.Onecourselastsforfourweeks.Attheendofthetreatmentcourse,gradetheclinicalsymptomsaccordingtotherelevantprovisionsinthe‘Guidingpr
6、incipleofclinicalresearchonnewdrugsoftraditionalChineseMedicine’,andmaketheevaluationofthetherapeuticefficacy.Results:I.Inthetreatmentgroup,10casesareclinicallycured,15casesshoweffect,8casesareeffective,and3casesareineffective.Thetotaleffectiverateis91.67%.Inthecontrastgroup,5casesarecu
7、red,14casesshoweffect,9casesareeffective,and8casesareineffective.Thetotaleffectiverateis77.78%.Thetotaleffectiverateinthetreatmentgroupishigherthanthatinthecontrastgroup,butaftertheRidittest。twogroupshavenosignificantdifference(P>0.05).It’ssuggestedthatthetwogroupshavecorrespon