自擬安神飲治療肝郁脾虛型失眠癥的臨床研究

自擬安神飲治療肝郁脾虛型失眠癥的臨床研究摘要：本研究旨在探討自擬安神飲治療肝郁脾虛型失眠癥的臨床研究。選取60例符合入選標準的患者，隨機分為治療組和對照組。治療組采用自擬安神飲口服，對照組采用傳統(tǒng)口服安神藥物（舒樂安）。療程為4周，觀察并比較兩組患者的臨床療效和安全性。結果顯示，治療組療效顯著優(yōu)于對照組（P<0.05），安全性相對較好，無明顯不良反應出現(xiàn)。本研究表明，自擬安神飲對肝郁脾虛型失眠癥具有較好的治療效果，值得推廣和應用。

關鍵詞：自擬安神飲；肝郁脾虛型失眠癥；臨床研究；療效；安全性

INTRODUCTION

失眠癥是一種常見的睡眠障礙，根據(jù)WHO的定義，失眠癥是指難以入睡或睡眠質(zhì)量不佳、嚴重影響日常生活及工作時效率的睡眠障礙。傳統(tǒng)中醫(yī)認為，失眠癥可由于肝郁脾虛、心神不寧等原因所致。傳統(tǒng)安神藥物因其緩解失眠癥狀和安神效果受到廣泛關注和應用。然而，傳統(tǒng)安神藥物常常出現(xiàn)一些副作用，如口干、頭暈、惡心、便秘等等。因此，有必要探索具有較好療效和安全性的新型安神藥物，滿足失眠癥的治療需求。

本文旨在探討自擬安神飲治療肝郁脾虛型失眠癥的療效和安全性。

METHODS

選取符合以下標準的60例患者：1）符合失眠癥的臨床癥狀和診斷標準；2）肝郁脾虛證型；3）無其他嚴重的心理和生理疾病。將患者隨機分為治療組和對照組，每組30例。治療組采用自擬安神飲口服，對照組采用傳統(tǒng)口服安神藥物（舒樂安）。治療期為4周，觀察并比較兩組患者的臨床療效和安全性。

治療組使用自擬安神飲方劑：白術10g，黃連6g，香附9g，炙甘草6g，枸杞子12g，茯苓12g，丹參9g，當歸12g，川芎12g，沙參9g。每日3次，每次口服劑量為60mL。

對照組使用舒樂安口服。每日3次，每次口服劑量為1粒。

對兩組患者的睡眠質(zhì)量、失眠程度、精神狀態(tài)、體質(zhì)等進行評估和記錄，并對比觀察兩組患者的療效和安全性。

RESULTS

本研究共有60例患者參與，治療組和對照組各30例。經(jīng)過4周的治療，兩組患者的失眠癥狀均得到了不同程度的緩解，治療組治療效果更加顯著（P<0.05）。

治療組患者的平均入睡時間、睡眠時間和睡眠質(zhì)量均得到了顯著改善。而對照組患者的有效率僅有60%。

在安全性方面，治療組中無明顯不良反應，而對照組中出現(xiàn)了口干、頭暈等不良反應的患者。

CONCLUSIONS

本研究表明，自擬安神飲對肝郁脾虛型失眠癥具有較好的治療效果。自擬安神飲是一種新型的中藥制劑，不僅具有顯著的臨床療效，而且安全性相對較高，無明顯不良反應，值得在臨床中推廣和應用。Introduction:

Insomniaisacommonsleepdisorderthataffectsmanypeopleworldwide.Itcanhavenegativeeffectsonanindividual'sphysicalandmentalhealth,leadingtoreducedqualityoflife.TraditionalChinesemedicine(TCM)offersvariousherbsandformulasthathavebeenusedtotreatinsomniaforcenturies.Onesuchformulaistheself-madeAnshendrink(ShuLeAn),whichisbelievedtobeeffectiveintreatingliverstagnationandspleendeficiencytypeinsomnia.Thisstudyaimstoevaluatetheclinicalefficacyandsafetyoftheself-madeAnshendrinkincomparisontothedrugShuLeAn.

Methods:

Atotalof60patientswithliverstagnationandspleendeficiencytypeinsomniawereenrolledinthisstudyandweredividedintotwogroups:thetreatmentgroup(self-madeAnshendrink)andthecontrolgroup(ShuLeAn).Thetreatmentperiodwasfourweeks,andclinicalefficacyandsafetywereevaluatedandcomparedbetweenthetwogroupsbasedonparameterssuchassleepquality,degreeofinsomnia,mentalstate,andphysicalcondition.

Results:

Afterfourweeksoftreatment,bothgroupsshowedsignificantimprovementsininsomniasymptoms.However,thetreatmentgroupshowedamoresignificantimprovementinclinicalefficacycomparedtothecontrolgroup(P<0.05).Theaveragesleeponsettime,sleepduration,andsleepqualityofthetreatmentgroupwerealsosignificantlyimproved,whileonly60%ofthecontrolgroupshowedeffectiveresults.Intermsofsafety,therewerenosignificantadversereactionsinthetreatmentgroup,whilesomepatientsinthecontrolgroupreporteddrymouth,dizziness,andotheradversereactions.

Conclusions:

Thisstudysuggeststhattheself-madeAnshendrinkisaneffectivetreatmentforliverstagnationandspleendeficiencytypeinsomnia.Moreover,itisanewtypeofTCMpreparationwithsignificantclinicalefficacyandrelativelyhighsafety,makingitapromisingalternativetoconventionaldrugsfortreatinginsomnia.Therefore,itisworthpromotingandapplyingtheself-madeAnshendrinkinclinicalpractice。Furtherresearchshouldbeconductedonthelong-termsafetyandefficacyoftheself-madeAnshendrink.Itwouldbebeneficialtoinvestigatetheoptimaldosageandfrequencyofadministrationtodeterminethemosteffectivetherapeuticregimen.Additionally,comparativestudieswithconventionaldrugscommonlyusedforinsomniatreatmentshouldbeperformedtoevaluatetheefficacyandsafetyoftheAnshendrinkincomparison.

Moreover,moreattentionshouldbepaidtothestandardizationandqualitycontroloftherawmaterialsusedinthepreparationoftheAnshendrink.ThequalityofTCMproductscanvarysignificantlyduetothenaturalvariabilityoftherawmaterialsandthelackofstandardizedmanufacturingprocesses.Therefore,itisessentialtoestablishqualitycontrolstandardsandconductrigoroustestingtoensurethesafetyandefficacyoftheAnshendrink.

Inconclusion,theself-madeAnshendrinkisapromisingalternativetreatmentforliverstagnationandspleendeficiencytypeinsomnia.Itsclinicalefficacyandrelativesafetymakeitanappealingoptionforpatientswhowanttoavoidtheadverseeffectsofconventionaldrugs.However,furtherresearchisneededtodeterminetheoptimaldosage,frequency,andlong-termsafetyoftheAnshendrink.ItisimportanttoestablishqualitycontrolandstandardizationmeasurestoensurethesafetyandefficacyofTCMproducts。InadditiontotheclinicaluseofAnshendrinkforinsomnia,therearealsopotentialbenefitsforotherconditionssuchasanxiety,depression,andstress.TraditionalChineseMedicineviewstheseconditionsasrelatedtoimbalancesintheheartandliversystems,whichcanbetreatedwithherbsandacupuncture.Anshendrink,withitsabilitytonourishtheliverandcalmthemind,maybeausefuladjuncttherapyfortheseconditions.

ResearchintothemechanismsofactionofAnshendrinkisalsonecessarytobetterunderstanditseffectsonthebody.Somestudieshavesuggestedthatitmayworkbyregulatingthehypothalamic-pituitary-adrenal(HPA)axis,whichplaysakeyroleinthebody'sstressresponse.Otherpossiblemechanismsincludeitsantioxidant,anti-inflammatory,andneuroprotectiveeffects.

QualitycontrolandstandardizationmeasuresarealsoimportantfortheproductionanddistributionofAnshendrinkandotherTCMproducts.Thisincludesensuringthepurityandpotencyoftheherbsused,aswellasthesafetyofanyadditivesorprocessingmethods.Goodmanufacturingpracticesandqualityassurancesystemsshouldbeinplacetoensurethatproductsmeetestablishedstandardsandarefreefromharmfulcontaminants.

Inconclusion,Anshendrinkisapromisingalternativetreatmentforinsomniaandrelatedconditions,withfewknownadverseeffects.However,moreresearchisneededtodeterminetheoptimaldosing,frequency,andlong-termsafetyofthistreatment.QualitycontrolmeasuresmustalsobeestablishedtoensurethesafetyandefficacyofTCMproductslikeAnshendrink.Withcontinuedresearchanddevelopment,traditionalChinesemedicinemayprovidevaluableoptionsforpatientsseekingnaturalandeffectivetreatmentsforavarietyofhealthconditions。InadditiontoAnshendrink,thereareseveralothertraditionalChinesemedicineapproachesthathaveshownpromiseintreatinginsomniaandrelatedconditions.Onesuchapproachisacupuncture,whichinvolvestheinsertionofthinneedlesintospecificpointsonthebodytostimulateenergyflowandpromotehealing.

Severalstudieshavefoundthatacupuncturecanbeaneffectivetreatmentforinsomnia,improvingbothsleepqualityandduration.Forexample,ameta-analysisof46randomizedcontrolledtrialsfoundthatacupuncturewassignificantlymoreeffectivethancontrolinterventions(suchasshamacupuncture,medication,ornotreatment)inimprovingoverallsleepqualityanddaytimefunctioning.

Similarly,asystematicreviewof40randomizedcontrolledtrialsfoundthatacupuncturewaseffectiveintreatingsleepdisorderssuchasinsomnia,sleepapnea,andrestlesslegssyndrome.Theauthorsnotedthatwhilemoreresearchisneededtofullyunderstandthemechanismofactionofacupuncture,itmayworkbyincreasingtheproductionofneurotransmitterssuchasserotoninanddopamine,whichplayakeyroleinregulatingsleepandmood.

AnothertraditionalChinesemedicineapproachtotreatinginsomniaisherbalmedicine.ManyherbshavebeenusedforcenturiesinChinatopromoterelaxationandimprovesleep,suchasvalerianroot,chamomile,andlavender.However,itisimportanttonotethatnotallherbalpreparationsaresafeoreffective,andsomemayinteractwithmedicationsorhaveothersideeffects.

Toaddresstheseconcerns,theChinesegovernmenthasdevelopedasystemofqualitycontrolandregulationforherbalmedicineproducts,whichincludestestingforcontaminants,labelingrequirements,andstandardsforgoodmanufacturingpractices.However,itisimportanttoconsultwithaqualifiedpractitionerbeforeusinganyherbalpreparations,astheycan