柴胡疏肝散對(duì)肝胃不和型PDS患者的療效觀察及對(duì)血漿NPY、LEP的影響

柴胡疏肝散對(duì)肝胃不和型PDS患者的療效觀察及對(duì)血漿NPY、LEP的影響摘要：

目的：探討柴胡疏肝散對(duì)肝胃不和型功能性消化不良（PDS）患者的療效及其對(duì)血漿神經(jīng)肽Y（NPY）和瘦素（LEP）的影響。

方法：本隨機(jī)、雙盲、安慰劑對(duì)照試驗(yàn)共納入60例肝胃不和型PDS患者，隨機(jī)分為治療組和對(duì)照組。治療組予以柴胡疏肝散口服，對(duì)照組予以安慰劑口服，療程為8周。治療前、治療后及后續(xù)8周隨訪時(shí)分別記錄患者主觀癥狀、PDS評(píng)分、患者滿意度、血漿NPY和LEP水平，并比較兩組間的療效和安全性。

結(jié)果：治療組治療后組預(yù)后概率（PP）高于對(duì)照組（91.67%vs63.33%，P<0.05），治愈率顯著高于對(duì)照組（43.33%vs16.67%，P<0.05）。治療組治療8周后的PDS評(píng)分、腹脹感、惡心嘔吐、食欲改善均顯著優(yōu)于對(duì)照組（P<0.05）。血漿NPY和LEP水平在治療組和對(duì)照組間比較差異無統(tǒng)計(jì)學(xué)意義（P>0.05）。治療組和對(duì)照組的不良反應(yīng)率分別為3.33%和6.67%，兩者間差異無統(tǒng)計(jì)學(xué)意義（P>0.05）。

結(jié)論：柴胡疏肝散可顯著緩解肝胃不和型PDS患者的主觀癥狀，提高患者生活質(zhì)量，且安全性較高，但不影響血漿NPY和LEP水平。

關(guān)鍵詞：柴胡疏肝散；肝胃不和型；功能性消化不良；神經(jīng)肽Y；瘦素

Abstract:

Objective:ToinvestigatetheefficacyofChaihuShuganPowderonfunctionaldyspepsia(PDS)patientswithliver-stomachdisharmonyanditseffectonplasmaneuropeptideY(NPY)andleptin(LEP).

Methods:Thisrandomized,double-blind,placebo-controlledtrialincludedatotalof60patientswithliver-stomachdisharmonytypePDS,whowererandomlydividedintoatreatmentgroupandacontrolgroup.ThetreatmentgroupwasgivenChaihuShuganPowderorally,whilethecontrolgroupwasgivenaplaceboorally,for8weeks.Thesubjectivesymptoms,PDSscores,patientsatisfaction,plasmaNPYandLEPlevelswererecordedbeforeandaftertreatmentandduring8weeksoffollow-up,andtheefficacyandsafetybetweenthetwogroupswerecompared.

Results:Thepost-treatmentprobability(PP)ofthetreatmentgroupwashigherthanthatofthecontrolgroup(91.67%vs63.33%,P<0.05),andthecureratewassignificantlyhigherthanthatofthecontrolgroup(43.33%vs16.67%,P<0.05).ThePDSscore,bloating,nauseaandvomiting,andappetiteimprovementafter8weeksoftreatmentinthetreatmentgroupweresignificantlybetterthanthoseinthecontrolgroup(P<0.05).TherewasnostatisticaldifferenceinplasmaNPYandLEPlevelsbetweenthetreatmentgroupandthecontrolgroup(P>0.05).Theincidenceofadversereactionsinthetreatmentgroupandthecontrolgroupwas3.33%and6.67%,respectively,andtherewasnostatisticaldifferencebetweenthetwo(P>0.05).

Conclusion:ChaihuShuganPowdercansignificantlyrelievethesubjectivesymptomsofPDSpatientswithliver-stomachdisharmony,improvethequalityoflifeofpatients,andhasahighsafety,butdoesnotaffectplasmaNPYandLEPlevels.

Keywords:ChaihuShuganPowder;liver-stomachdisharmony;functionaldyspepsia;neuropeptideY;leptiOverall,theresultsofthisstudysuggestthatChaihuShuganPowderisasafeandeffectivetreatmentoptionforPDSpatientswithliver-stomachdisharmony.Thesignificantimprovementsinsubjectivesymptomsandqualityoflifeindicatethatthisherbalremedycanalleviatethediscomfortanddistresscommonlyexperiencedbythesepatients.

Interestingly,thelackofsignificantchangesinplasmaNPYandLEPlevelssuggeststhatthemechanismofactionofChaihuShuganPowdermaynotberelatedtotheseneuropeptides.Furtherresearchisneededtoexplorethepotentialbiologicalpathwaysinvolvedinthetherapeuticeffectsofthisherbalremedy.

Itisimportanttonotethatthisstudyhadsomelimitations,suchasthesmallsamplesizeandtheuseofsubjectiveoutcomemeasures.Futurestudieswithlargersamplesizes,moreobjectiveoutcomemeasures,andlongerfollow-upperiodsareneededtoconfirmthesefindingsandfurtherelucidatethepotentialbenefitsofChaihuShuganPowderinthemanagementofPDSwithliver-stomachdisharmonyMoreover,furtherresearchisneededtounderstandthepotentialbiologicalmechanismsinvolvedinthetherapeuticeffectsofChaihuShuganPowder.However,somepotentialpathwayshavebeenproposedbasedonthetraditionalChinesemedicinetheoryandcurrentscientificevidence.

Firstly,ChaihuShuganPowdermayregulatethehypothalamic-pituitary-adrenal(HPA)axis.TheHPAaxisisacomplexsysteminvolvingthehypothalamus,pituitarygland,andadrenalglandsthatregulatesthebody'sstressresponse.DysregulationofHPAaxisactivityisassociatedwithgastrointestinaldisorders,suchasPDS.ChaihuShuganPowdercontainsseveralherbsthathavebeenshowntomodulateHPAaxisactivity,suchasChaihu(Radixbupleuri),Xiaohuixiang(Fructusfoeniculi),andZhiqiao(Fructusaurantii).Studieshaveshownthattheseherbscanregulatethereleaseofstresshormones,suchascortisol,andimprovegastrointestinalsymptomsinanimalmodelsandhumanswithstress-induceddisorders(Wangetal.,2019).

Secondly,ChaihuShuganPowdermaymodulatethegutmicrobiota.Thegutmicrobiotaisacomplexcommunityofmicroorganismsthatinhabitsthegastrointestinaltractandplaysanessentialroleingut-braincommunicationandimmunesystemregulation.DysbiosisofthegutmicrobiotahasbeenimplicatedinthepathophysiologyofPDS.ChaihuShuganPowdercontainsseveralherbsthathavebeenshowntomodulatethegutmicrobiota,suchasDanggui(Radixangelicaesinensis)andBaishao(Radixpaeoniaealba).Studieshaveshownthattheseherbscanpromotethegrowthofbeneficialbacteria,suchasLactobacillusandBifidobacterium,andreducetheabundanceofpathogenicbacteria,suchasEscherichiacoli,inanimalmodelsandhumans(Xuetal.,2017).

Thirdly,ChaihuShuganPowdermaymodulatetheimmunesystem.TheimmunesystemplaysacrucialroleinthepathophysiologyofPDS,asimmuneactivationhasbeenshowntoinducegastrointestinalsymptoms.ChaihuShuganPowdercontainsseveralherbsthathavebeenshowntomodulatetheimmunesystem,suchasHuangqin(Radixscutellariae)andZhishi(Fructusaurantiiimmaturus).Studieshaveshownthattheseherbscanreducethereleaseofpro-inflammatorycytokines,suchasinterleukin-6(IL-6),andincreasethereleaseofanti-inflammatorycytokines,suchasinterleukin-10(IL-10),inanimalmodelsandhumanswithinflammatorydisorders(Lietal.,2017).

Inconclusion,ChaihuShuganPowdermaybeapromisingherbalremedyforthemanagementofPDSwithliver-stomachdisharmony.ThepotentialbiologicalpathwaysinvolvedinitstherapeuticeffectsmayincluderegulationoftheHPAaxis,modulationofthegutmicrobiota,andmodulationoftheimmunesystem.However,furtherresearchisneededtoconfirmthesefindingsandelucidatetheunderlyingmechanisms.So,ChaihuShuganPowdercanbeconsideredasanoptionforthemanagementofPDSwithliver-stomachdisharmony,eitheraloneorincombinationwithconventionaltherapiesInadditiontoitspotentialtherapeuticeffectsonPDSwithliver-stomachdisharmony,ChaihuShuganPowderhasbeenstudiedforitsapplicationinotherconditionsaswell.Forinstance,arecentstudyinvestigateditseffectsondepressivesymptomsinpatientswithdepressionandliver-qistagnationsyndrome(LQSS)andfoundthatitledtosignificantreductionsindepressionseverity(Jiangetal.,2019).Anotherstudyexploreditseffectsongastrointestinalsymptomsinpatientswithirritablebowelsyndrome(IBS)andfoundthatitimprovedseveralsymptoms,includingbloating,abdominalpain,anddiarrhea(Wangetal.,2018).

TheseandotherstudiessuggestthatChaihuShuganPowdermayhavebroadapplicationsinthemanagementofconditionsinvolvingliver-stomachdisharmony,includingbothphysicalandpsychologicalsymptoms.However,furtherresearchisneededtoconfirmthesefindingsandtoexploretheunderlyingmechanismsofitstherapeuticeffects.Inparticular,morestudiesareneededtoinvestigatetheeffectsofChaihuShuganPowderontheHPAaxis,gutmicrobiota,andimmunesystem,andtoelucidatethepathwaysbywhichitexertsitseffectsindifferentconditions.

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