明晰报告中医药随机对照试验中中药的毒副作用

1、明晰报告中医药随机对照试验中中药的毒副作用【摘要】中药虽取诸天然，但亦可含对人体有害的物质，因此，近年来中药的毒副作用越来越受到关注。中药毒副作用可以分为不可预期类、使用不当类、中药“污染类、品种混乱类和中西药物互相作用类等。使用不当类包括处方不遵从中医药理论、过量使用、炮制及制剂方法不当和配伍不当等；中药“污染类包括重金属、农药残留及中药产品被化学药物成分“污染。中药的毒副作用，必须明晰报告。过高或过低估计中药的毒副作用，都会误导临床医生及患者。我们建议在中医药随机对照试验报告标准中，报告副作用时，应包括以下方面：研究药物毒副作用的背景资料、针对副作用的特异性结局评估指标；毒副作用的详细内容

2、及其诠释。【关键词】中医学中药临床研究随机对照试验循证医学1IntrdutinItisgenerallyaeptedthatallhealthinterventins,inludingtraditinalhineseediine(T),shuldbeassafeaspssibleprirtadptingtheinlinialpratie.Thereisanisneptinthatherbalaterials-inludingthseusedinT,knnashineseateriaedia()areharlessthuansbeausetheyefrnaturalsures1.Infat,Ta

3、yauseseriusadverseeffets(AEs)henadulteratedrusedinrretly.Althughtheptentialtxiityfspeifiinterventinshasattratedreattentinrldideastheusefherbalinterventinsinreases2,3,stresearhesnTntinuetfusalstexlusivelynestablishingeffiayandeffetiveness.urpreviusstudyreprtedthatnly30%frandizedntrlledtrials(RTs)fTre

4、prtedAEs,andstftheeretvaguenthistpifrreaderstapprpriatelydeterinethesafetyftheTinterventinsstudied.BetterreprtingnAEsinRTsfTistherefrerequired.TheDraftnslidatedStandardsfrReprtingTrialsfTraditinalhineseediine(NSRTfrT)erepublishedinhineseandEnglishin20224,5tsliitfeedbakfrexpertsindifferentspeialties.

5、Inthatdraft,neheklistiteaddressedthereprtingfsafetyfTinterventins.Upnfurthernsideratin,itbeaeapparentthatasingleheklistitetaddresstheissuefsafetyasntenugh.TheextensinftheNSRTstateentnreprtingfhar6hasaddressedhtillustratetheAEsinRTfesternpharaeutials.SineitisessentialttransparentlyillustratetheAEsfRT

6、sfrallinterventins,inludingthseusedinT,thisartileaistenhaneaarenessfsafetyissuesfrTinterventinsbyprtingiprvedreprtingby1)suarizingthetypesfAEsreprtedithT;2)exainingtheipatfAEsnRTsithT;and3)frulatingthereprtingstruture.TherrespndingrevisinsfthedraftNSRTfrTarealsreended.2TypesfAEsprdutsusedinTanrefert

7、aterialsfherbal,anialrineralrigin.Nrally,AEsassiatedithprdutsusedinTuldbedividedintfivetypesasflls.Firstly,presriptinsshuldbebasedntheTtreatentpriniples.Ifthesepriniplesarentbeyed,ptentiallyeffiaiusinterventinsayprdueAEs.Frexaple,Rhizaptidis(Huanglian)isveryldinnatureandbitterintaste.Usedprperly,ita

8、nlearheat,drydapness,drainfireandexpeltxiity.Usediprperly,itaydaagethespleenandstahresultinginnausea,viting,stahaheandlssfappetiteintheshrtter;verthelngter,iprperusageayresultinspleenqidefiieny.IftheTtheriesarestritlyflled,theseAEsuldbeavided.Thirdly,thepressingand/rpreparatinethdshuldbeseletedbased

9、nreduingtheptentialtxiityfherbsandfrulas,sineiprperpressingand/rpreparatinaninreasethepssibilityfAEs.Frexaple,RadixAniti(utu)shuldnlybeusedinitspressedfrandshuldbebiledseparatelyfratleast45inutesbefrebilingtgetheriththerpnentsinafrulatreduethepssibilityfanitepisning,hihayleadttxiityinpatients13.Furt

10、herre,failuretfllbasiTpriniplesduringthefrulatinfTfrulaayresultinAEsasitisellknnthatsesareinpatibleiththersandshuldntbebinedinfrulatins.Thestiprtantguidelinesaretheeighteeninpatibleherbsandthenineteenantagnistiherbs.Atthesaetie,anapprpriatebinatinfsanenhanetherapeutieffetsandredueharfulsideeffets.3T

11、heneedtniselyreprtAEsfRTithTdruginterventin4StruturefrreprtingAEsInrdertgivereadersaprehensiveunderstandingabutthesafetyfTinterventins,bakgrundinfratinnknnrsuspetedsideeffetsfeahnstituentinthestudyinterventin,asellasspeifiuteassessentnAEs,detailsfreprtedAEs,andtheinterpretatinftheAEsshuldbeinludedin

12、areprtfAEsinRTsfT.4.1BakgrundinfratinnAEsBefreaTinterventinentersintanRT,initialanalysisandreviefthesafetyftheinterventinisneessary.ThesafetybakgrundinfratinftheTdrugshuldbebrieflysuarized.Thedataayefrliteraturerevierprelinialpharalgy/txilgytesting.4.2SpeifiuteassessentuteeasuresspeifitsafetysurvEil

13、laneshuldbeaddressed,asellasdetailsregardingtherassessentsrelatedttreatenteffiay.Seletinratinale,nreteassessentethd,andreferenestandardsshuldalsbedefinedandexplained.IftheurrenefspeifiAEsistbeusedasneftheterinalevaluatinriteria,itsunderlyingratinaleshuldalsbedeterinedanddesribed.4.3DetailsfreprtedAE

14、sAllAEsdisveredintreatentandntrlgrups,regardlessfseverity,ustbetransparentlyreprted.ThedetailsshuldinludeleardefinitinfeahAE,tiefurrene,frequenyineahgrup,degreefseverity,andnuberfaseshithdrerreduedtheirdseduetAEs.IfnAEserereprted,authrsshulddelarethatnAEserereprted,insteadfntentiningAEsatallintheRTr

15、eprt.4.4InterpretatinAllAEsreprtedshuldbeinterpreted,intersfbthTtheryandnventinalediine,ifappliable,inludingadisussinftheptentialunderlyingausality.5ReendatinsfrrevisinfNSRTfrTTbetterrevealthesafetyissuesfinterventin,furtherdifiatinstthedraftfNSRTfrT,iththeadditinfthefllingdesriptivetextttheitenuber

16、sereindiatedandsuarizedinTable1.Table1ReendatinsfrrevisinfNSRTfrT6nlusinThesafetyfaninterventinisasiprtantasitseffiay.AEsareasignifiantaspetfdrugsafety.InrdertprvidealearprfilefthesafetyfTinterventin(s)inanRTreprt,reprtersshuld1)presentanddisussanyinfratinithregardtsafetybasednliteraturerevierprelinialstudies;2)niselydesribe