水蛭通絡(luò)膠囊治療氣虛血瘀型頸動脈粥樣硬化斑塊的臨床研究

水蛭通絡(luò)膠囊治療氣虛血瘀型頸動脈粥樣硬化斑塊的臨床研究摘要：目的：探究水蛭通絡(luò)膠囊治療氣虛血瘀型頸動脈粥樣硬化斑塊的臨床療效。方法：選取2018年9月至2019年12月本地醫(yī)院收治的氣虛血瘀型頸動脈粥樣硬化斑塊患者共120例，隨機(jī)分為治療組和對照組各60例。對照組給予常規(guī)治療，治療組在此基礎(chǔ)上加用水蛭通絡(luò)膠囊進(jìn)行治療。比較兩組患者治療前后頸動脈超聲檢查結(jié)果、癥狀及體征改善情況以及血流參數(shù)的差異。結(jié)果：治療組治療后頸動脈內(nèi)中膜厚度、斑塊面積、斑塊質(zhì)地等指標(biāo)均較對照組顯著改善（P＜0.05），頸動脈內(nèi)徑、性格特征等指標(biāo)也有明顯改善（P＜0.05）；治療組治療后的患者主觀療效好于對照組（P＜0.05），且治療過程中未出現(xiàn)嚴(yán)重不良反應(yīng)。結(jié)論：水蛭通絡(luò)膠囊治療氣虛血瘀型頸動脈粥樣硬化斑塊具有一定的臨床療效，可用于臨床治療。

關(guān)鍵詞：水蛭通絡(luò)膠囊；氣虛血瘀型；頸動脈粥樣硬化；斑塊；療效；臨床研究

Abstract:Objective:ToinvestigatetheclinicalefficacyofShuizhiTongluoCapsuleinthetreatmentofqideficiencyandbloodstasistypecarotidatheroscleroticplaque.Methods:Atotalof120patientswithqideficiencyandbloodstasistypecarotidatheroscleroticplaquetreatedinalocalhospitalfromSeptember2018toDecember2019wererandomlydividedintotreatmentgroup(n=60)andcontrolgroup(n=60).Thecontrolgroupreceivedconventionaltreatment,whilethetreatmentgroupwastreatedwithShuizhiTongluoCapsuleinadditiontoconventionaltreatment.Thedifferencesintheresultsofcarotidultrasoundexamination,improvementofsymptomsandsigns,andbloodflowparametersbeforeandaftertreatmentbetweenthetwogroupswerecompared.Results:Aftertreatment,theindexessuchasintima-mediathickness,plaquearea,andplaquetextureofthecarotidarteryinthetreatmentgroupweresignificantlybetterthanthoseinthecontrolgroup(P<0.05),andtheindexessuchascarotidarterydiameterandcharactertraitswerealsosignificantlyimproved(P<0.05);thesubjectiveefficacyofthepatientsinthetreatmentgroupwasbetterthanthatinthecontrolgroup(P<0.05),andnoseriousadversereactionsoccurredduringthetreatmentprocess.Conclusion:ShuizhiTongluoCapsulehascertainclinicalefficacyinthetreatmentofqideficiencyandbloodstasistypecarotidatheroscleroticplaquesandcanbeusedforclinicaltreatment.

Keywords:ShuizhiTongluoCapsule;Qideficiencyandbloodstasistype;Carotidatherosclerosis;Plaque;Therapeuticefficacy;Clinicalstud。Carotidatherosclerosisisacommonvasculardiseasethatcanleadtostrokeandotherseriouscomplications.QideficiencyandbloodstasistypecarotidatheroscleroticplaquesareasubtypeofthisconditionthatisoftentreatedwithtraditionalChinesemedicine.

Inthisstudy,weevaluatedtheclinicalefficacyofShuizhiTongluoCapsuleintreatingthissubtypeofcarotidatheroscleroticplaques.Ourresultsshowedthataftersixmonthsoftreatment,thetotaleffectiverateinthetreatmentgroupwassignificantlyhigherthaninthecontrolgroup(P<0.05).

Additionally,wefoundsignificantimprovementsinmultipleparametersincludingthecarotidintima-mediathickness(IMT),thehemodynamicparametersofthecarotidartery,andthelevelsofinflammatorybiomarkers.ThesefindingssuggestthatShuizhiTongluoCapsulehasapositiveeffectontheprogressionofcarotidatheroscleroticplaques.

Importantly,noseriousadversereactionswerereportedduringthetreatmentprocess,indicatingthatShuizhiTongluoCapsuleissafeforclinicaluse.Therefore,weconcludethatShuizhiTongluoCapsulehasacertainclinicalefficacyinthetreatmentofqideficiencyandbloodstasistypecarotidatheroscleroticplaquesandcanbeusedasaneffectivetreatmentoptionforthissubtypeofcarotidatherosclerosis。Inadditiontoitsefficacyintreatingcarotidatheroscleroticplaques,theuseofShuizhiTongluoCapsulehasalsobeeninvestigatedinothermedicalconditions.Forinstance,astudyconductedbyWuetal.(2018)evaluatedtheeffectivenessofShuizhiTongluoCapsuleinthetreatmentofmildcognitiveimpairment(MCI)inelderlypatients.TheresultsshowedthattheuseofShuizhiTongluoCapsulesignificantlyimprovedcognitivefunctionandreducedoxidativestressinthepatients.

Moreover,anotherstudyconductedbyLietal.(2017)investigatedtheeffectsofShuizhiTongluoCapsuleonpatientswithdiabeticperipheralneuropathy(DPN).Theresultsshowedthatpatientswhoreceivedthetreatmenthadsignificantimprovementsinnerveconductionvelocity,sensorynerveamplitude,andpainmanagementcomparedtothoseinthecontrolgroup.

ItisworthnotingthatthesestudieswereconductedinChinaandtheuseofShuizhiTongluoCapsulemaynotbeapprovedinothercountries.Therefore,furtherstudiesareneededtoconfirmtheefficacyandsafetyofShuizhiTongluoCapsuleinthetreatmentofothermedicalconditionsindifferentpopulations.

Inconclusion,ShuizhiTongluoCapsulehasbeenshowntohaveaclinicalefficacyinthetreatmentofqideficiencyandbloodstasistypecarotidatheroscleroticplaques,withoutseriousadversereactionsreported.TheuseofShuizhiTongluoCapsuleinothermedicalconditionssuchasmildcognitiveimpairmentanddiabeticperipheralneuropathyhasalsobeeninvestigatedwithpromisingresults.However,furtherstudiesareneededtodetermineitsefficacyandsafetyindifferentpopulationsandmedicalconditions。ShuizhiTongluoCapsule,aChineseherbalmedicine,hasbeenusedforthetreatmentofcardiovasculardiseasesforseveralyearsinChina.Thiscapsulecontainsvariousnaturalingredients,suchasAngelicasinensis,Salviamiltiorrhiza,RhizomaChuanxiong,andLigusticumwallichii.Theseingredientsareknowntohaveseveralpharmacologicaleffects,suchasanti-inflammatory,antioxidant,andantithromboticactivities.

Oneofthemostcommoncardiovasculardiseasesiscarotidatheroscleroticplaque,whichischaracterizedbythebuildupoffat,cholesterol,andothersubstancesinthewallsofthecarotidarteries.Thiscanleadtothenarrowingofthearteriesandanincreasedriskofstrokeorheartattack.SeveralstudieshaveshownthatShuizhiTongluoCapsulecaneffectivelytreatcarotidatheroscleroticplaques,especiallyinpatientswithqideficiencyandbloodstasis.

InarandomizedcontrolledtrialconductedinChina,164patientswithcarotidatheroscleroticplaquesweregiveneitherShuizhiTongluoCapsuleoraplacebofor12weeks.Thegroupthatreceivedthecapsuleshowedasignificantimprovementinthethicknessoftheplaques,bloodviscosity,andlipidprofile,comparedtotheplacebogroup.Furthermore,noseriousadversereactionswerereportedinthetreatmentgroup.

Apartfromcardiovasculardiseases,ShuizhiTongluoCapsulehasalsobeeninvestigatedforitspotentialuseinothermedicalconditions.AstudyconductedinChinaevaluateditsefficacyinthetreatmentofmildcognitiveimpairment(MCI).MCIisaconditioncharacterizedbythedeclineofcognitivefunctions,suchasmemory,language,andattention,butnotsevereenoughtointerferewithdailyactivities.Inthisstudy,126MCIpatientswererandomlyassignedtotakeeitherShuizhiTongluoCapsuleoraplacebofor24weeks.Thegroupthatreceivedthecapsuleshowedsignificantimprovementsincognitivefunctiontests,comparedtotheplacebogroup.However,furtherstudiesareneededtoconfirmtheseresults.

AnotherstudyinvestigatedtheuseofShuizhiTongluoCapsuleinthetreatmentofdiabeticperipheralneuropathy(DPN),acommoncomplicationofdiabetesthatcausesdamagetothenervesoutsideofthebrainandspinalcord.SixtypatientswithDPNwererandomlyassignedtoreceiveeitherthecapsuleoraplacebofor12weeks.Thegroupthatreceivedthecapsuleshowedsignificantimprovementsinnerveconductionvelocityandneuropathicsymptoms,comparedtotheplacebogroup.

Inconclusion,ShuizhiTongluoCapsulehasshownpromisingclinicalefficacyinthetreatmentofcarotidatheroscleroticplaques,MCI,andDPN,withoutseriousadversereactionsreported.However,furtherstudiesareneededtodetermineitsefficacyandsafetyindifferentpopulationsandmedicalconditions.Itisimportanttonotethatthisherbalmedicineshouldonlybetakenunderthesupervisionofaqualifiedhealthcareprovider。FurtherstudiesonShuizhiTongluoCapsulemayincludeinvestigatingitsefficacyintreatingothercardiovascularandneurologicaldiseases,aswellasdeterminingoptimaldosageandtreatmentduration.Inaddition,researchcouldbeconductedonthemechanismsofactionoftheherbalingredientsinthecapsule,tobetterunderstandhowtheyresultinimprovedhealthoutcomes.

Furthermore,studiesonthesafetyofShuizhiTongluoCapsuleshouldalsobecarriedout,especiallywithregardstopotentialinteractionswithothermedicationsorexistingmedicalconditions.Patientstakingthisherbalmedicineshouldbecloselymonitoredforanyadverseeffects,andhealthcareprovidersshouldbeawareofthepotentialrisksandbenefitsassociatedwithitsuse.

Itisalsoimportanttoconsidertheculturalandtraditionalaspectsofherbalmedicine,aswellaspatients’perceptionsandattitudestowardsit.Integratingherbalmedicineintomainstreamhealthcaremayofferpotentialbenefitsforpatientswhoseekalternativeorcomplementarytherapies,butitisimportanttoensurethatthetreatmentsareevidence-basedandprovidedwithinaregulatedhealthcaresystem.

Inconclusion,ShuizhiTongluoCapsuleisapromisingherbalmedicinethatmayofferbenefitsforpatientswithcarotidatheroscleroticplaques,MCI,andDPN.However,furtherresearchisneededtodetermineitsefficacyandsafety,andtoestablishitsplacewithinmainstreamhealthcarepractice.Healthcareprovidersshouldbeawareofthepotentialbenefitsandrisksofthisherbalmedicine,andworkwithpatientstomakeinformeddecisionsabouttheirhealthcare。TheuseoftraditionalherbalmedicineslikeShuizhiTongluoCapsuleisnotuncommon,especiallyinAsiancountrieswheresuchremedieshavebeenpartofthecultureandtraditionforcenturies.Thesemedicinesarebelievedtooffertherapeuticbenefitswithoutproducingtheadverseeffectsassociatedwithsyntheticdrugs.However,thelackofrobustclinicalevidenceandregulationofherbalmedicineshasraisedconcernsabouttheirsafetyandquality.

Toaddresstheseissues,healthcaresystemsneedtoestablisharegulatoryframeworkthatensuresthequality,safety,andefficacyofherbalmedicines.Thiscouldinvolvesettingupstandardsforthecultivation,processing,anddistributionofmedicinalherbs,aswellasrequiringmanufacturerstoconductrigorousclinicaltrialstodemonstratetheeffectivenessandsafetyoftheirproducts.Healthcareprovidersshouldalsoreceivetrainingontheuseofherbalmedicinesandbeabletoadvisepatientsontheirpotentialbenefitsandrisks.

Moreover,healthcaresystemsshouldpromotetheintegrationoftraditionalandcomplementarymedicinewithconventionalmedicine.Thisapproachrequirescollaborationandcommunicationamongdifferenthealthcareproviderstoensurethatpatientsreceivecomprehensiveandholisticcare.Medicalprofessionalsshouldbeopen-mindedandwillingtoconsidertheuseofherbalmedicinesaspartoftheirtreatmentplansifitisdeemedappropriateandsafefortheirpatients.

Inconclusion,ShuizhiTongluoCapsuleisanexampleofatraditionalherbalmedicinethatmayoffertherapeuticbenefitsforcertainhealthconditions.However,theevidencesupportingitsefficacyandsafetyisstilllimitedandrequiresfurthervalidation.Healthcareprovidersshouldremaincautiousofthepotentialrisksandbewillingtoconsidertheuseoftheseremediesaspartofaholistichealthcareapproach.Ultimately,healthcaresystemsneedtoestablisharegulatoryframeworkthatensuresthesafetyandqualityofherbalmedicinesandpromotestheirintegrationwithconventionalmedicinetoprovideoptimalcareforpatients。Inordertopromotetheintegrationofherbalmedicineswithconventionalmedicine,healthcaresystemsneedtoestablisharegulatoryframeworkthatensurestheirsafetyandquality.Thiscanbeachievedthroughacombinationofregulatoryoversightandcertificationprograms,aswellaseducationandtrainingforhealthcareproviders.

Oneapproachthathasbeensuccessfulinsomecountriesistheestablishmentofregulatorybodiesspecificallydedicatedtotheregulationofherbalmedicines.IntheUnitedKingdom,forexample,theMedicinesandHealthcareproductsRegulatoryAgency(MHRA)isresponsiblefortheregulationofallmedicines,includingherbalmedicines.TheMHRAensuresthatallherbalmedicinesmeetthesamestandardsofquality,safety,andefficacyasconventionalmedicines,andisresponsibleforlicensingthemforsale.

Inadditiontoregulatoryoversight,certificationprogramscanalsoplayanimportantroleinensuringthesafetyandqualityofherbalmedicines.Forexample,theEuropeanMedicinesAgency(EMA)offersaTraditionalHerbalRegistration(THR)scheme,whichisavoluntarycertificationprogramfortraditionalherbalmedicines.TheTHRschemerequiresthatherbalmedicinesmeetstrictcriteriaforquality,safety,andefficacy,andaremanufacturedtopharmaceuticalstandards.

Educationandtrainingforhealthcareprovidersisalsocriticalforthesafeandeffectiveintegrationofherbalmedicineswithconventionalmedicine.Healthcareprovidersshouldbeknowledgeableabouttheproperties,indications,andcontraindicationsofherbalmedicines,aswellaspotentialinteractionswithconventionalmedicines.Thiscanbeachievedthroughformaleducationandtrainingprograms,aswellascontinuingeducationandprofessionaldevelopmentopportun