精品医学文献翻译中英对照.docx
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精品医学文献翻译中英对照
医学文献翻译(中英对照)
Theclinicalandcost-effectivenessofPharmalgen®forthetreatmentofbeeandwaspvenomallergy
1TITLEOFPROJECT
TheclinicalandcosteffectivenessofPharmalgen®forthetreatmentofbeeandwaspvenomallergy
2TARTEAM
LiverpoolReviewsandImplementationGroup(LRiG),UniversityofLiverpool
Correspondenceto:
RumonaDickson,Ms
Director,LRiG
UniversityofLiverpool
Room2.12
WhelanBuilding
TheQuadrangle
BrownlowHill
Liverpool
L693GB
Tel:
+44(0)1517945682
Fax:
+44(0)1517945585
Email:
R.Dickson@liv.ac.uk
FordetailsofexpertisewithintheTARteam,seesection7.
3PLAINENGLISHSUMMARY
Allergicreactionstobeeandwaspvenommayoccurinvenom-sensitivepatientsimmediatelyfollowingasting,andcanvaryinseverity,withinitiallymildsymptomssometimesprogressingtocriticalconditionswithinseconds.Themostseveresystemicallergicreactions(generalisedreactions)areknownasanaphylaxis,areactioncharacterisedbyabnormallylowbloodpressure,faintingorcollapse,andinextremereactionsthesesymptomscancausedeath.
EachyearintheUKtherearebetweentwoandninedeathsfromanaphylaxiscausedbybeeandwaspvenom.Theimmediatetreatmentforsevereallergicreactionstobeeandwaspvenomconsistsofemergencytreatmentwithdrugstodecreasethepatient’sresponsetothevenomandsupportbreathing,ifrequired.
Toavoidfurtherreactions,theuseofsensitisationtobeeandwaspvenom,throughaprocessknownasvenomimmunotherapy(VIT),hasbeeninvestigated.Venomimmunotherapyconsistsofsubcutaneousinjectionsofincreasingamountsofvenomintopatientswithahistoryofanaphylaxistobeeandwaspvenom.Pharmalgen®hashadUKmarketingauthorisationforthediagnosisandtreatment(usingVIT)ofallergytobeevenom(usingPharmalgen®BeeVenom)andwaspvenom(usingPharmalgen®WaspVenom)sinceMarch1995,anditisusedbymorethan40centresacrosstheUK.ThisreviewaimstoassesswhetherusingPharmalgen®inVITisclinicallyusefulwhentreatingpeoplewithahistoryofseverereactiontobeeandwaspstings.ThereviewwillcomparepreventativetreatmentwithPharmalgen®toothertreatmentoptions,includinghighdoseantihistamines,adviceontheavoidanceofbeeandwaspstingsandadrenalineauto-injectorprescriptionandtraining.Ifsuitabledataareavailable,thereviewwillalsoconsiderthecosteffectivenessofusingPharmalgen®forVITandothersubgroupsincludingchildrenandpeopleathighriskoffuturestingsorsevereallergicreactionstofuturestings.
4DECISIONPROBLEM
4.1Clarificationofresearchquestionandscope
Pharmalgen®isusedforthediagnosisandtreatmentofimmunoglobinE(IgE)-mediatedallergytobeeandwaspvenom.TheaimofthisreportistoassesswhethertheuseofPharmalgen®isofclinicalvaluewhenprovidingVITtoindividualswithahistoryofseverereactiontobeeandwaspvenomandwhetherdoingsowouldbeconsideredcosteffectivecomparedwithalternativetreatmentoptionsavailableintheNHS.
4.2Background
BeesandwaspsformpartoftheorderHymenoptera(whichalsoincludesants),andwithinthisorderthespeciesthatcausethemostfrequentallergicreactionsaretheVespidae(wasps,yellowjacketsandhornets),andtheApinae(honeybees).1
Beeandwaspstingscontainallergenicproteins.Inwasps,thesearepredominantlyphospholipaseA1,2hyaluronidase2andantigen5,3andinbeesarephospholipaseA2andhyaluronidase.4Followinganinitialsting,atype1hypersensitivityreactionmayoccurinsomeindividualswhichproducestheIgEantibody.Thissensitisescellstotheallergen,andanysubsequentexposuretotheallergenmaycausetheallergentobindtotheIgEmolecules,whichresultsinanallergicreaction.
Theseallergenstypicallyproduceanintense,burningpainfollowedbyerythema(redness)andasmallareaofoedema(swelling)atthesiteofthesting.Thesymptomsproducedfollowingastingcanbeclassifiedintonon-allergicreactions,suchaslocalreactions,andallergicreactions,suchasextensivelocalreactions,anaphylacticsystemicreactionsanddelayedsystemicreactions.5-6Systemicallergicreactionsmayoccurinvenom-sensitivepatientsimmediatelyfollowingasting,7andcanvaryinseverity,withinitiallymildsymptomssometimesprogressingtocriticalconditionswithinseconds.1
Themostseveresystemicallergicreactionisknownasanaphylaxis.Anaphylacticreactionsareofrapidonset(typicallyupto15minutespoststing)andcanmanifestindifferentways.Initialsymptomsareusuallycutaneousfollowedbyhypotension,withlight-headedness,faintingorcollapse.Somepeopledeveloprespiratorysymptomsduetoanasthma-likeresponseorlaryngealoedema.Inseverereactions,hypotension,circulatorydisturbances,andbreathingdifficultycanprogresstofatalcardio-respiratoryarrest.
Anaphylaxisoccursmorecommonlyinmalesandinpeopleunder20yearsofageandcanbesevereandpotentiallyfatal.8
4.3Epidemiology
Itisestimatedthattheprevalenceofwaspandbeestingallergyisbetween0.4%and3.3%.9Theincidenceofsystemicreactionstowaspandbeevenomisnotreliablyknown,butestimatesrangefrom0.15-3.3%,10-11Systemicallergicreactionsarereportedbyupto3%ofadults,andalmost1%ofchildrenhaveamedicalhistoryofseverestingreactions.9,12Afteralargelocalreaction,5–15%ofpeoplewillgoontodevelopasystemicreactionwhennextstung.13Inpeoplewithamildsystemicreaction,theriskofsubsequentsystemicreactionsisthoughttobeabout18%.13HymenopteravenomareoneofthethreemaincausesoffatalanaphylaxisintheUSAandUK.14-15Insectstingsarethesecondmostfrequentcauseofanaphylaxisoutsideofmedicalsettings.16BetweentwoandninepeopleintheUKdieeachyearasaresultofanaphylaxisduetoreactionstowaspandbeestings.17Onceanindividualhasexperiencedananaphylacticreaction,theriskofhavingarecurrentepisodehasbeenestimatedtobebetween60%and79%.13
In2000,theregisteroffatalanaphylacticreactionsintheUKfrom1992onwardswasreportedbyPumphreytodeterminethefrequencyatwhichclassicmanifestationsoffatalanaphylaxisarepresent.18Ofthe56post-mortemscarriedout,19deathswererecordedasreactionstoHymenopteravenom(33.9%).Aretrospectivestudyin2004examinedalldeathsfromanaphylaxisintheUKbetween1992and2001,andestimated22.19%tobereactionstoHymenopteravenom(47/212).Thisfurtherbreaksdowninto29/212(13.68%)asreactionstowaspstings,and4/212(1.89%)asreactionstobeestings.Theremaining14/212wereunidentifiedHymenopterastings(6.62%).19
4.4Currentdiagnosticoptions
Currently,individualscanbetestedtodetermineiftheyareatriskofsystemicreactionstobeeandwaspvenom.Theprimarydiagnosticmethodforsystemicreactionstobeeand/orwaspstingsisvenomskintesting.
SkintestinginvolvesintradermalinjectionwiththefiveHymenopteravenomproteinextracts,withvenomconcentrationsintherangeof0.001to1.0μg/ml.Thisestablishestheminimumconcentrationgivingapositiveresult(areactionoccurringintheindividual).Asvenomtestsshowunexplainedvariabilityovertime,20andasnegativeskintestscanoccurfollowingrecentanaphylaxis,itisrecommendedthattestsberepeatedafter1to6months.21
Othermethodsofdiagnosisinpatientsfollowingananaphylacticreactionincluderadioallergosorbenttest(RAST),whichdetectsallergen-specificIgEantibodiesinserum.Thistestislesssensitivethanskintestingbutisusefulwhenskintestscannotbedone,forexampleinpatientswithskinconditions.22-23
4.5Currenttreatmentoptions
Preventativetreatmentsincludeeducationonhowtoavoidbeeandwaspvenom,andprescriptionofhighdoseantihistamines.Patientswithahistoryofmoderatelocalreactionsshouldbeprovidedwithanemergencykit,24containingaH1-blockingantihistamineandatopicalcorticosteroidforimmediateusefollowingasting.Patientswithahistoryofanaphylaxisshouldbeprovidedwithanemergencykitcontainingarapid-actingH1-blockingantihistamine,anoralcorticosteroidandanauto-injectorforselfadministration,containingepinephrine.
Injectedepinephrine(asympathomimeticdrugwhichactsonbothalphaandbetareceptors)isregardedastheemergencytreatmentofchoiceforcasesofacuteanaphylaxisasaresultofHymenopterastings.25Foradults,therecommendeddoseisbetween0.30mg/mland0.50mg/mlI.M,and0.01ml/kgI.M.forchildren.Individualswithahistoryofanaphylacticreactionsarerecommendedtocarryautoinjectorscontainingepinephrine(commonlyknownasEpiPen®,Adrenaclick®,Anapen®orTwinject®).Theseareintendedforimmediateself-administrationbyindividualswithahistoryofhypersensitivitytoHymenopterastingsandotherallergens.
PreventivemeasuresfollowingsuccessfultreatmentofasystemicallergicreactiontoHymenopteravenomconsistsofeitherallergenavoidanceorspecificallergenimmunotherapy,knownasVIT.Venomimmunotherapyisconsideredtobeasafeandeffectivetreatment.26Currently,VITcanbeusedwithseveralregimes,includingPharmalgen®(manufacturedbyALKAbello,andlicensedintheUK),Aquagen®andAlutardSQ®(bothmanufacturedbyALKAbelloandunlicensedintheUKbutlicensedinsomepartsofEurope),VENOMENHAL®(HALAllergy,Leiden,Netherlands,unlicensedintheUK),Alyostal®(Stallergenes,AntonyCedex,France,unlicensedintheUK),andVenomil®(Hollister-StierLaboratoriesLLC,unlicensedintheUK).Venomimmunotherapyisrecommendedtopreventfuturesystemicreactions.ItisrecommendedthatVITisconsidered‘whenpositivetestres