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Systematic review on safety of Xinyuan capsules

心元胶囊用药安全性系统评价



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SystematicreviewonsafetyofXinyuancapsules
WANGJidong1,2,XIEYanming1,LIAOXing1,CUIRuizhao3
(1.InstituteofBasicResearchinClinicalMedicine,ChinaAcademyofChineseMedicalSciences,Beijing100700,China;
2.WangjingHospital,ChinaAcademyofChineseMedicalSciences,Beijing100102,China;
3.XiyuanHospital,ChinaAcademyofChineseMedicalSciences,Beijing100091,China)
[Abstract] Tosystematicalyreviewtheadversedrugreactions/adverseevents(ADRs/AEs)ofXinyuancapsulesinclinicalapplica
tionAsystematicliteraturesearchwasperformedinthedatabasesoftheCochraneLibrary,Medline,EMBASE,theWebofScience,
Clinicaltrials,CNKI,VIP,WanFangDataandCBMTheliteraturewasscreenedanddatawasextractedaccordingtotheinclusion
andexclusioncriteriaBecauseofthesubstantialheterogeneityamongdiferentstudies,weassessedthemonlywithdescriptiveanalysis
bystudytype,diseasediagnosis,andADRs/AEsconditionsAlincludedstudieswereassessedbyusingtheinternationalyrecognized
reportqualityevaluationstandardormethodologicalqualityassessmenttoolsAtotalof42studiesinvolving3671patientswereinclud
edfinalyTwothouandfourhundredandthirtyminepatientsofthemtookXinyuancapsules,and1242patientsdidnottakeXinyuan
capsulesNoseriousADRsoccuredinalpatientsOnepatientdiedasAEduringtheresearchSixteenpatientsofthe2439patients
takingXinyuancapsules(aloneorincombination)hadADRs,including7patientswithpolytherapyofXinyuancapsulesand9pa
tientswithmonotherapyThemostcommonADRswereingastrointestinaltract,mainlyincludingthirst,nausea,vomitingandabdomi
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nalpain,etcTheADRsincluded10gastrointestinaltractADRs,3renalADRsand1ADRrespectiveinskinsystem,respiratorysys
temandcardiovascularsystemXinyuancapsuleswasgeneralysafeinclinicalapplicationThereportsonthestudyofXinyuancap
sulesweredispersedinvariousclinicalstudies,thestudyondrugsafetystilshouldbestrengthenedinthefutureFurthermechanism
studiesorclinicalobservationstudiesofthedrugsafetyshalbeconductedtobeterguideclinicalapplicationinthefuture
[Keywords] Xinyuancapsules;adversedrugreaction(ADR);systemicreview;safety
doi:10.4268/cjcmm20160928
  
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2)
¯,OP
3)
‚Ò ϖÒ
‚“
4) õïADR/AE
Šý%ë
5)
np
ADR/AE

%ëOP
ADRs AEs
‘}
OP
Ü\G
2007[44] 3 nC!SÍÐ 34 28/6 685±89 XYJN CT 56d ADR 0 - -
²G
2003[45] 3 SÍÐ 30 24/6 5690±582 XYJN  ƆÖ
,SÍÐ
,
28d  
t
RT,
¦
RT,
LF,RF,BL,ECG
0 - -
Š¶ˆ
2000[46] 3 =§ÞSêGt 58 38/20 695±78 XYJN  •‘E
¸oþ
28d  
t
RT,
¦
RT,
I
RT,LF,RF
 T1
µ^fß
¥`
;C4
µËÐ

D1Óò
- -
!wG
2010[4] 4 pSq 99 62/37 684±43 XYJN - 12w  t RT,¦ RT,
LF,RF,ECG,ADR
0 - -
žä
2009[47] 4 pSq 100 56/43 685±543 XYJN - 3m  t RT,¦ RT,
LF,RF,ECG,BL,
ADR
0 1 -
ºj>
2007[48] 4 S´XbªÉ 47 21/26  56±485 XYJN - 3m - 0 - -
“jê
2006[49] 4 pSq 73 61/12 742±82 XYJN - 2m LF,RF 0 - -
Æp
2003[50] 4 ‰Rt§ 71 61/10 6478±82 XYJN - 2m  tRT,¦RT,I
RT,LF,RF,BG
0 - -
èžX
2002[51] 4 pSq 42 35/7 þÆ642 XYJN - 56d tRT,LF,RF 0 - -
Ǚ
1998[52] 4 pSq 40 27/13 þÆ6375 XYJN - 28d - 0 - -
Š~
1995[1] 4  ×lSÍÐ59,
*! å ˜ Ê Ë


60 25/35 - XYJN - 28d  
t
RT,
¦
RT,
LF,RF,BL,BP,
HR,ECG,ADR
 3
µ
bun
­‰

1¡qBג
- -
!ýy
2001[53] 5 pSq 1 X 56   XYJN3
¨
tid,
·t
@/’“

¨
tid,
6S
Ð
10mg
tid
- 2d -  1
µ‰×‹q¯
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¥/õö
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q
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C®¯‰ŠmŸy´¡$
Fig2 Distributionofpublishingyearof42includedstudies
q
3 42
C®¯‰ŠS~’“‚¥¦¨qœ¡$OP
Fig3 DistributionofdiferentdiseasestreatedbyXinyuancap
sulesfrom42includedstudies
q
4 42
C®¯‰Šk˜œ
ADRs
৥¦ô©œ¡$OP
Fig4 DistributionofdiferentsystemsafectedbyADRsabout
42includedstudies
q
5 
¹ZÉGq
Fig5 Riskofbiasgraphof25RCTs
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S~’“¯,w!ô©56
q
6 
žÎfϖòo…†56á k˜
Fig6 QualityofnonRCTstudiesevaluatedbyTREND
Ÿ
2 
qµôO#Cªk˜
SUMARI
…†56
Table2 Qualityofcaseseriesandcasereportsassessedby
SUMARI
‰ŠÏc
yes no
5ná 
!wG
2010 3 5
«
 
žä
2009 3 5
«
 
ºj>
2007 5 3
ˆ‰
“jê
2006 3 5
«
 
Æp
2003 3 5
«
 
èžX
2002 3 5
«
 
Ǚ
1998 0 8
«
 
Š~
1995 2 6
«
 
!ýy
2001 0 8
«
 
  
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¥œ@ÆÓ
0,
¥`¯ÆÓ
1。
Ÿ
3 
¤ù‰Š?u
Table3 Summaryof42includedstudies
‰Š§m


XYJN

ADRs
µ= r¯
XYJN
qB= br
XYJN

ADRs
µ= br¯
XYJN
qB=
Îfϖòo
25 10 1551 12 1016
žÎfϖòo
5 1 234 0 226
MabÞϖ!òo
3 1 122 4 0
qµôO
8 3 531 0 0
Cªk{
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Ÿ
4 
¥/õöm©Èç
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ADRs
m©µ=
ADRs
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40min
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Ýr¯S~’“º˜þœ
ADRs,
žò%®,a¥
/õök˜#¹ºK}#û@1ëì
[54],
b„I
¥/õöm©

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[21]、
S´àŒµ—§
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Š~

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vÓ¬

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Šý
[J].
šKA
,1995,10(3):301
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S~’“Ï¥¦^›ºþœÒ¸G-œí
ª#3=‡¯
[J].
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