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Center for ADR Monitoring of Guangdong

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Title: Author: user Last modified by: thtfpc Created Date: 3/17/2004 1:38:51 PM Document presentation format: – PowerPoint PPT presentation

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Title: Center for ADR Monitoring of Guangdong


1
? ? ? ? ? ? ? ? ? ? ?? ? ? ? ? ? ?
  • ?????????????
  • Center for ADR Monitoring of Guangdong

2
? ? ? ? ? ? Adverse Drug Reaction,ADR
3
???? ?????????
  • ???????????
  • ??????(Adverse Drug Reaction,ADR)
    ???????????????????????????????????
  • ?????? (Adverse Drug Event,ADE)

4
?? ADR?????????
  • (?) ??? (Side effect)
  • ????????????????????????????????,?????,?????
    ????,???????????
  • ????????,?????????????
  • (?) ???? (Toxic effect)
  • ????????????????????????????????????????????
    ??,??????????????,???????????

5
  • (?) ???? (Residual effect)
  • (?) ???? (withdrawal reaction)
  • (?) ???? (Allergic reaction)
  • (?) ????? (Idiosyncratic reaction)
  • ????????????
  • (?) ???????????????????

6
?????????????
  • (?) ????
  • ????????????????,???????,????????????????????????
    ?????????
  • ?????????????????????,????????????(????????????)?

7
  • (?) ????
  • ?????????,????????????
  • ??,???????(?????)?
  • ???????????????
  • ???????(3?2)
  • ???????????????? ?(1?3)
  • ??????????????????????
  • ????????????????????
  • ????

8
  • ?????????(?????,?????)
  • ?????(????)
  • ???
  • ????????????????
    ?????????????
    ????????????????
  • ????
  • ???? ????????
    ???????????

9
  • (?) ????
  • ????????????????????,????????????
  • ??5??? 4.2
  • 6 10? 7.4
  • 1115? 24.2
  • 1620? 40.0
  • 21??? 45.0

10
???????????
  • ?????????
  • ?????
  • ????
  • ???????????????
  • ???????????????????????????????,???????????

11
???????????
  • ---?????

12
ADR????????
  • ???????????
  • ?????????????????????????????,??????????
    ???,????????????????????
  • ?????????????????,?????????????

13
ADR????????
  • ??????????
  • ?????(?????????)????,?????????????????????
    ??,??????????????????????????????????????????????
    ????,????????????????????????????????

14
ADR????????
  • ????
  • ??????????????????,??????????????????????????,???
    ?????????????,??????????

15
ADR????????
  • ??????-????
  • A?ADR????????????????,?????????????,??????????????
    ??????????,??????????????
  • ???????????
  • ???????????????????????????

16
?????????????
(??SFDA,ADR??????????) 1.?????????????????????????
??(?/?) 2.?????????????????????????
(?/?) 3.??????,??????????(?/?) 4.?????????????????
??? (?/?) 5.??????????????????????????????????????
(?/?)
17
?????ADR????
1 2 3 4 5
?? -
??? ? -
?? - ? ? ?
???? - - ? ? ?
????????????? ????????????? ????????????? ????????????? ????????????? ?????????????
??????????????? ??????????????? ??????????????? ??????????????? ??????????????? ???????????????
??????-???? ?????????????????
18
?1?,34?,?????????????????250mg,?????????100ml,??,
qd???8h?(?1??12h)??????????,??????,????????,??
?,???????????,?????????????????????,???????,4d
?,???????????????
??????????????????
19
?2??1?39???,???????????10mg qd,?????,???????,????
???,3??????,?????QT?????655µsec???,???10??,??????
????????,?????????????????? ?????????????????,??
??????????????????
????????????????????
20
??????
1.???????????????,??????,?????????QT??????????? 2
.?????????????,6???????10mg?????Cmax??2580mg/ml,?
??????cyp3A4? 3.?????????cyp3A4???,??????????,????
??????,??????????QT????,????????????????
21
? ? ? ? ? ?
--?????????????,?????????????
?????????
22
(No Transcript)
23
??(1)
  • ????????????

24
??(2)
  • ?????????
  • 1. ??????????????
  • (1) ??ADR????????????
  • (2)??????????????
  • (3)??????????????
  • (4)???????????????????

25
  • 2. ????????????????
  • (1)?????????????,?????
  • ???????????
  • (2)????????????
  • (3)????????

26
???????????
27
  • ??????????? ????????????????????????
  • WHO?????????????Pharmacovigilance
    ????Pharmacovigilance is concerned with the
    detection,assessment and prevention of adverse
    reactions to drugs.
  • WHO?????????????????????,???????????,?????,?????

28
ADR????
  • ??????(spontaneous reporting system SRS)
  • ?????(mandatory or compulsory monitoring)
  • ??????(intensive hospital monitoring)
  • ??????(intensive medicines monitoring)
  • ????(expedited reporting)
  • ??????????(pharmacoepidemiology)

29
??????????????
?? ?? ?? ??
???? ???? 1890 ??? ??
?????? ??? ???? 1950
???
gt585? 1900
?? ??? ?????
????? 1949


gt100? 1930 ?? ??? ??
??? ????? 1960


??(gt1??) 1922 ?? ????
????? ????? ??gt2082? 1970
1940 ?? ???? ??????
?????? ?1/3???
??
?? 1935 ?? ???? ??
??? ????? 1970


??9? 1937 ? ???
???? ???? 358???
(????)

107??? 1953 ??? ???? ????
?????? ??gt2000?

??500?
30
?? ?? ?? ?? ????
???? 1954 ? ???
???? ????? ??270?
???
????? ??110?
1956 ? ????
???? ??????? gt1000?,

??
?1 1956 ??? ??? ????
????? gt1?? 1961 ??

??5000? 1967 ?
??? ?? ?????
70???
??? 1960 ??? ??? ??
????? ??3500?
???
?? 1963
?? ???? ?? ?????
??gt7856? 1972
??
??5 1933 ?
???? ?? ????(?)
gt300? 1972
1968 ?
??? ????? ??????
gt2257? 1979 ??
16?
??2.2?? 18901980

??1.1??
31
?????????
??1994???????ADR?6.7,??ADR?0.32 (106000)
???????????????4-6?,??????(743460)???(529904)???(
150108)?????(101077)?
32
ADR?????2001?????????????????. 2001????????????
????1025?, ADR 958?,
???? 312?, ???? 240?, ???? 139?.
33
??????(ADR)?????
  • ??1906????????
  • ????????????,?????????,????????????????
    ???????
  • ??1938???????????
  • ?????????????,???????????

34
??????(ADR)?????
  • ??1954? ???1964? ???1965????1973?
    ???1965???ADR????,????ADR????????????????
    ?????????????
  • ??????????????????????????,??????????????(???
    ???)?

35
??ADR???????
  • ????????????80?????????????,???????????????
  • ?????????????,????????????????????????????????????
    ???????

36
  • 1989?,???????????????
  • 1998?3?,??WHO????????????
  • 1999?,????????????????????????????????,???????????
    ???
  • 1999?11?,??????? ????????????(??)

37
  • 2001?11?,???????????????????????????????????
  • 2001?12?1???????????????71???????????????????

38
  • 2003?8?18?,?????????? ??????????
  • 2003?11?,?5???????????,????????????????,??????????
    ???
  • 2004?3?4?,?????????????????????????

39
  • ?????ADR?????????,??????,?????ADR????,????????????
    ???????????,??ADR??????,???????????

40
??????????????
41
????????????
  • ????? ???????????????????????????????????????????
    ????????????????????????????????????,?????????????
    ??????????????????????????????????????????????????
    ?????

42
  • ???????????????,??????????????????????????????
    ??????????????????,???????????,???????????????????
    ??????

43
????????ADR?????
  • ??????????80?81?
  • ??????????80?
  • ??????????????65?

44
??ADR??????
  • ?ADR???????????
  • ADR??????????
  • ADR??????????,?????????
  • ??????????????????????
  • ?????????????????

45
???????????????
  • ??????????
  • ???????????
  • 2004?3?4???

46
(No Transcript)
47
  • ??? ??
  • ???????????????,????????????????,????????,???
    ?????????????????
  • ?????????????????????????????????????????????????
    ??????

48
  • ????????????????????????????,?????????????(??)???
    ???????????????????????,??????????????????????????
    ????????????

49
  • ???????????????????????????????????,????????????,
    (??)??????????????????
  • ???????????????????????

50
  • ??? ??
  • ??????????????????????????????,?????????
  • (?)????????????????????????????????,????????
    ???????????????????????????

51
  • (?)???????????????????????????????????
  • (?)???????????????,?????????????????????,????????
    ????

52
  • ????????????(??)???????????????????????????,??
    ???????
  • (?)????????????????????????????????????,?????
  • (?)????????????????????????????

53
  • (?)??????????????????????????????????????,????????
    ??????????????????????????????????????
  • (?)??????????????????????,?????????(??)???????????
    ??????,????????????

54
  • ?????????????????????????????,????????????????
    ???????

55
  • ????????????????????????????????,????????????
    ????????

56
??? ??
  • ?????????????????????,??????????
  • ??????????/????????????????????

57
  • ?????????????????????????(?)?????????????????????
    ?????????,???????????????????????????????,???????
    ??/?????,???????????????????????????????,????????
    ?????????????15????,??????????

58
  • ??????????????????????????????????????,?????????
    ??????????
  • ?????????????????,?????????/?????????????
    ????,?????????????????????????????????????,???????
    ????????????, ????????????????????????,???5??????
    ??

59
  • ??????????????????5??,?????????????????5??,?????
    ??????????????????,??????????????????????,????????
    ??????5??,?????????5??,?5????????
  • ????????????????????????,?????????????????
    ?????????????????????????

60
  • ????????????????????????????,?????????????????(??
    )???????????(?)????????????????????????(??)???????
    ??????????(?)??????,??????????????????????????????
    ???

61
  • ???????????????????????,?????????????????????????
    ???(??)??????????

62
??? ?????
  • ?????????????????????????????????????????????????
    ?????,?????????????????????????
  • ????????????????????????????????????????,????????
    ?????,?????????,??????????????????????,???????????
    ????????????

63
  • ?????????????,????????????????????????,??????????
    ????????????????????????,?????????????,??????
  • ?????????????,???????????????????????,???(??)??
    ???????????????

64
  • ????????????????????,??????????????????????
  • ????????????????????????????????????

65
??? ??
  • ?????????(??)????????????????????????????????????
    ????,???????,??????????????,?????????????????????
    ????????,????????????????

66
  • (?)????????????????
  • ????????
  • (?)?????????????
  • (?)?????????????
  • (?)????????????
  • (?)???????????
  • ??????????????,?(??)?????????????????
    ??????

67
??? ??
  • ????????????????
  • (?)?????? ??????????????????????????????????
    (?)??????????? ????????????????????????
    (?)???????? ?????????????????

68
  • (?)???????? ????????????????????
  • 1.????
  • 2.???????????
  • 3.?????????????????
  • ?????
  • 4.???????????
  • 5.????????????

69
  • ???????????????????????????????????????,?????????
    ????????????????

70
?????????????????
71
????
  • 1.??ADR??????
  • ??????(??)????????????
  • 2.??ADR?????
  • ????????????
  • ??????,???,?????????????

72
(?)????????????
73
(No Transcript)
74
2.??????????
  • (1)????
  • ??????????????????????????????????????????????
    ??
  • ?????????????????????,??????????????????? ?

75
  • (2)?????????
  • ??????????????????
  • ??????????????????????????

76
  • (3)??????
  • ???????????????
  • ?????????????????,???????????

77
  • (4)?????????(???)
  • ???????????????????????,???????????????????
  • ????????(??)???????????????????????????????????
    ????????????????????????????????????????????????
    ??????????????

78
  • (5)????????????
  • ?????????????
  • ??????????(??)??,????????????????????????(??)???
    ???(??????)??????????

79
(?)??????????
  • 1.?????????????????????(??????)
  • 2.???????????,?????????????,???????????????(??30
    )
  • 3.??????????????,???????????????????(???)
  • 4.????????????????

80
(?)???????(??)????????????
  • 1.??????????
  • 2.??(???)
  • 3.??(???????????)
  • 4.???
  • 5.???(?????????)
  • 6.???

81
(?)??????,????????????????
  • 1. ????,???????????????????????
  • 2.???????????????????(????????)
  • 3.????????,?????????(????)????????????
  • 4.????ADR???????

82
?????????ADR???????
  • ???????????????
  • ?????????

???????????? ?(?)???????
??????
ADR
??????
ADR????
83
?????????ADR?????????
  • ?????????(??)??????????????????????????
  • ??ADR?(?)???????????ADR??????,???????????
  • ???????????????????
  • ????????????????????

84
???????ADR??????
  • ??????,??????
  • ??????,??????
  • ??????,??????(??????,????,???,????)
  • ??????,?????????

85
  • ????????????
  • ????????????????????????????????????????????

86
??????????/???
87
???????????????
  • ??????/?????
  • ????????/?????
  • ??????/???????

????
88
????????/?????
??????????????????????? ???????
????
????
??????(????)--???? ???? ?????(15?)
? ??(??) ???????????(???)
3?
????????(??)
????
89
????
??????(??)ADR ? ?? ? ?????ADR????? ??????? ? ?????
???????
90
????
??????????? ? ???????????? ? ?????????? (????????U
MC)
91
????????
  • ????????
  • ???????????
  • ADR??(ADR???????????????????????????????? )
  • ?ADR????????(?????????????????????)
  • ??????????

92
??????????
  • ????,?????????????,????????????????????????????,
    ?2002001?
  • ?????????
  • ??(???????)???????????????
  • ??????????,??????????

93
???????????
  • ????
  • ????????????,??????????????(??)??????????
  • ??????
  • ???????????????????????????????????

94
  • ????
  • ???????????????,?????????????(?????????????????)?
    ????????(?????????),??????????????(??????????????
    ???,????????????????)?


95
????/????
  • ????/????
  • ?????????????????/?????????WHO???????????????,????
    ??????,???????????
  • ????,??????/?????????????,??????????? ??
    ??????,????,????????

96
????/?????
  • ??????/???????????????????????????????????
    ??????????????????????????

97
????/??????
  • ??????????????????/???????????????,???????
    ?????
  • ?????????????,????????????????????????????
    ??????????

98
  • ????/?????
  • ???????????/????????,??????????????

99
?ADR????????
  • ????????????,?????????
  • ??????(??????)
  • ??
  • ???????????????????
  • ???????????????

100
ADR???????
  • ??????????
  • ?????????????????,????????????ADR?????????

101
??????????
  • ??????????????

102
ADR ? ? ? ?
103
??????ADR????,??ADR???????,??ADR??????,??ADR
?????,??????????????,???????????????????????????
???????http//www.adr.gov.cn?????
http//www.gdadr.gov.cn ?????????,????ADR???,?
???
104
? ?
  • ???????????
  • ????????(????????)
  • ??????????(???????)
  • ?????????????
  • ???????????????

105
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(No Transcript)
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(No Transcript)
112
???????,??????? ????
???????753???12? ????????????????????
??510080 ??(020)37886559?37886558
??(020)37886559 ??http//www.gdadr.gov.cn
E-mailadr_at_gdda.gov.cn
113
? ? !
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