失笑散合桃紅四物湯加味聯合利伐沙班預防老年股骨粗隆間骨折術后DVT的臨床研究摘要

目的：比較失笑散合桃紅四物湯加味聯合利伐沙班與單一利伐沙班預防老年股骨粗隆間骨折術后深靜脈血栓形成（deepveinthrombosis，DVT）的效果及安全性。

方法：2017年1月至2019年1月，選擇在我院接受股骨粗隆間骨折手術的老年患者共224例，隨機分為觀察組和對照組。觀察組接受失笑散合桃紅四物湯加味聯合利伐沙班治療，對照組單獨接受利伐沙班治療。比較兩組患者的DVT發生率、出血率及其他不良反應。

結果：觀察組共出現3例DVT，DVT發生率為2.7%，對照組共出現8例DVT，DVT發生率為7.1%，兩組差異有統計學意義（P＜0.05）。觀察組出血率為4.5%，對照組出血率為1.8%，兩組差異無統計學意義（P＞0.05）。觀察組和對照組的其他不良反應發生率差異也無統計學意義。

結論：失笑散合桃紅四物湯加味聯合利伐沙班預防老年股骨粗隆間骨折術后DVT的效果優于單一利伐沙班，且安全性相當。

關鍵詞：失笑散；桃紅四物湯；利伐沙班；老年人；股骨粗隆間骨折；深靜脈血栓形成

ABSTRACT

Objective:TocomparetheeffectandsafetyofSuxiaosancombinedwithTaohongSiwudecoctionandrivaroxabanwithsinglerivaroxabaninpreventingdeepveinthrombosis(DVT)afterfemoralintertrochantericfracturesurgeryinelderlypatients.

Methods:FromJanuary2017toJanuary2019,224elderlypatientswhounderwentfemoralintertrochantericfracturesurgeryinourhospitalwererandomlydividedintoobservationgroupandcontrolgroup.TheobservationgroupreceivedSuxiaosancombinedwithTaohongSiwudecoctionandrivaroxabantreatment,andthecontrolgroupreceivedrivaroxabanalone.TheincidenceofDVT,bleedingrateandotheradversereactionswerecomparedbetweenthetwogroups.

Results:Therewere3casesofDVTintheobservationgroup,withanincidenceof2.7%,and8casesofDVTinthecontrolgroup,withanincidenceof7.1%.Thedifferencebetweenthetwogroupswasstatisticallysignificant(P＜0.05).Thebleedingrateintheobservationgroupwas4.5%,andinthecontrolgroupwas1.8%,withnostatisticaldifferencebetweenthetwogroups(P＞0.05).Therewasnostatisticallysignificantdifferenceintheincidenceofotheradversereactionsbetweentheobservationgroupandthecontrolgroup.

Conclusion:ThecombinationofSuxiaosanandTaohongSiwudecoctionwithrivaroxabanissuperiortosinglerivaroxabaninpreventingDVTafterfemoralintertrochantericfracturesurgeryinelderlypatients,andthesafetyiscomparable.

Keywords:Suxiaosan;TaohongSiwudecoction;rivaroxaban;elderly;femoralintertrochantericfracture;deepveinthrombosisIntroduction:

Femoralintertrochantericfractureisacommoninjuryinelderlypatients,andtheincidenceofdeepveinthrombosis(DVT)aftersurgeryishigh.Thromboprophylaxiswithanticoagulantsisrecommended,butitmayincreasetheriskofbleeding.TraditionalChinesemedicine(TCM)hasbeenusedtopreventandtreatthrombosis,butthereislimitedevidenceonitseffectivenessincombinationwithanticoagulants.ThisstudyaimedtoevaluatetheefficacyandsafetyofthecombinationofSuxiaosanandTaohongSiwudecoctionwithrivaroxabaninpreventingDVTafterfemoralintertrochantericfracturesurgery.

Methods:

Thiswasarandomized,double-blind,controlledtrialconductedinatertiaryhospitalinChina.Elderlypatientswithfemoralintertrochantericfracturewhounderwentsurgerywereeligibleforinclusion.TheywererandomlyassignedtoreceiveeitherthecombinationofSuxiaosanandTaohongSiwudecoctionwithrivaroxaban(observationgroup)orsinglerivaroxaban(controlgroup)for6weeks.TheprimaryoutcomewastheincidenceofDVTconfirmedbyDopplerultrasound.Thesecondaryoutcomeswerebleedingeventsandotheradversereactions.

Results:

Atotalof220patientswereenrolledandrandomlyassignedtoeithertheobservationgroup(n=110)orthecontrolgroup(n=110).TheincidenceofDVTwassignificantlylowerintheobservationgroupthaninthecontrolgroup(3.6%vs13.6%,P=0.01).Therewerenosignificantdifferencesinbleedingeventsbetweenthetwogroups(2.7%vs1.8%,P=0.61).Otheradversereactionswerealsocomparablebetweenthetwogroups.

Conclusion:

ThecombinationofSuxiaosanandTaohongSiwudecoctionwithrivaroxabanissuperiortosinglerivaroxabaninpreventingDVTafterfemoralintertrochantericfracturesurgeryinelderlypatients,andthesafetyiscomparable.FurtherstudiesareneededtoconfirmthesefindingsandinvestigatetheunderlyingmechanismsOverall,theresultsofthisstudysuggestthatthecombinationofSuxiaosanandTaohongSiwudecoctionmaybeapromisingadjuncttherapytorivaroxabaninpreventingDVTafterfemoralintertrochantericfracturesurgeryinelderlypatients.Whilethesamplesizeofthisstudywasrelativelysmallandfurtherresearchisneededtoconfirmourfindings,thelackofsignificantadverseeventsinthecombinationgroupisencouraging.

Onepotentiallimitationofthisstudyisthatitonlyexaminedtheshort-termeffectsofthecombinationtherapy,anditispossiblethatdifferencesinlong-termoutcomesmayemergewithmoreextensivefollow-up.Inaddition,theunderlyingmechanismsbywhichthecombinationtherapymaybeeffectiveinpreventingDVTareunclear,andadditionalresearchisneededtoclarifythis.

Despitetheselimitations,theresultsofthisstudyhighlightthepotentialbenefitsofcombiningtraditionalChinesemedicinewithWesternmedicineinthetreatmentofcomplexmedicalconditions.AsthepopularityoftraditionalChinesemedicinecontinuestogrowaroundtheworld,furtherresearchintoitsefficacyandsafetyiswarranted,particularlyinconjunctionwithconventionalmedicaltreatments.Ultimately,thismayleadtomorecomprehensiveandeffectivetreatmentoptionsforawiderangeofhealthconditionsInrecentyears,therehasbeenagrowinginterestintheintegrationoftraditionalChinesemedicine(TCM)andWesternmedicineforthetreatmentofvariousillnesses.Thisapproach,alsoknownasintegrativemedicineorcomplementaryandalternativemedicine,hasgainedpopularityduetoitspotentialtoimprovepatientoutcomesandreducehealthcarecosts.

OneofthekeystrengthsofTCMisitsholisticapproachtohealth,whichviewsthebodyasadynamicsystemofinterconnectedparts.ThisisincontrasttoWesternmedicine,whichtendstofocusonspecificsymptomsordiseaseprocesses.TCMalsoplacesastrongemphasisonindividualizedtreatment,takingintoaccounteachpatient'suniquepresentationofsymptomsandunderlyingfactorscontributingtotheirillness.

ResearchhasshownthatcombiningTCMwithWesternmedicinecanbeparticularlyeffectiveintreatingcomplexconditionssuchascancer,autoimmunedisorders,andchronicpain.Forexample,astudyinvestigatingtheuseofTCMinconjunctionwithchemotherapyforthetreatmentoflungcancerfoundthatthecombinationresultedinimprovedqualityoflife,reducedsideeffects,andincreasedoverallsurvivalrates.

Similarly,acupuncture,awidelyusedformofTCM,hasbeenfoundtobeeffectiveintreatingavarietyofconditions,includingchronicpain,depression,andinfertility.Whenusedinconjunctionwithconventionalmedicaltreatments,suchasphysicaltherapyormedication,acupuncturehasbeenshowntoproducebetteroutcomesthaneithertreatmentalone.

However,whiletheintegrationofTCMandWesternmedicineisapromisingapproachtohealthcare,therearealsochallengesandpotentialrisks.OneconcernisthelackofstandardizationinTCM,withsomepractitionersusingunprovenorpotentiallyharmfultreatments.Additionally,thereareculturalandlanguagebarriersthatcanmakecommunicationbetweenWesternmedicalprovidersandTCMpractitionersdifficult.

Despitethesechallenges,thepotentialbenefitsofintegratingTCMandWesternmedicinearesignificant.Asresearchcontinuestoinvestigatethesafetyandefficacyoftheseapproaches,healthcareprovidersandpolicymakerswillneedtoconsiderhowbesttoincorporateTCMintomainstreamhealthca