The document outlines principles of evidence-based medicine (EBM), emphasizing the importance of randomized controlled trials (RCTs) as the gold standard in clinical research. It discusses the methodologies used in EBM, including trial design and statistical analysis, while highlighting various types of studies like case reports and cohort studies. The content serves as a reference, indicating that the material is dated and may not be suitable for current educational use.

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2 F B B NB B F F B
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ver 4.0b
by T. Fukuoka
I Evidence based medicine (EBM) ________ 2
II EBM _______________________________ 2
III
_______________________________ 10
IV __________________ 11
IV ______________________________________________________ 11
V __________________________________ 14
VI ______________________________________________ 19
VII _________________________________________________ 19
VIII ____________________________________________ 20
IX ______________________________________________ 20
X _______________________________________________ 23
15年以上前の古い教材です。現在の学習教材
として使うのは不適です。ご注意ください。
あくまでも参考資料としてお使いください。

2. /EBM 1999/05/06 1:09
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I y s n Evidence based medicine (EBM)
Evidence based medicine (EBM)
EBM
II y c EBM z
EBM
randomized control trial: RCT
1) u i p
y y gb W
A) LKN EK . z
(post hoc, ergo propter hoc: after this, therefore because of this)
...
B) x y
.....
.....

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C) z v i
2) Randomized double-blind placebo-controlled clinical
trial
z i n z v z c gold standard u v
t W
A) v
randomize: To make random in arrangement, especially in order to control the
variables in an experiment.
B) v
blind: 2.a. Performed or made without the benefit of background information that
might prejudice the outcome or result: (exp) blind taste tests used in marketing
studies.
C) v xy W
placebo: 1.a. Medicine. A substance containing no medication and prescribed or
given to reinforce a patient's expectation to get well. b. An inactive substance or
preparation used as a control in an experiment or test to determine the
effectiveness of a medicinal drug.

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D) gt u x vo xz W
3) z z y
A) a g W
B) z a fk
1.
2.
3.
1.
2.
3.
4.
etc.
C) z vgt z x z
1.
2.
3.
4.
5.
6.
7.
4) xl yeo z p
A) u f nX x g
y i 9MF BM KC FKN FN F N L( ( ,
(a)

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(b)
1957
(c)
Am J Cardiol 1: 46-50, 1958
50 2 6
34 11 5
(d)
(e)
RCT
N Engl J Med 260: 1115-1118, 1959
radomized double-blind controlled trial
(f)
(g)

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(h)
radomized double-blind controlled trial
B) z z g
4 N MF 3MBBTB ;EB NF LM F B KC N FN F N L 1 F F
BLF B FK K L -
(a)
5 10
(b)
JAMA 180: 439, 1962
10
(c)
2500 ”gastric freezing machine”
(d) RCT
N Engl J Med 281: 16, 1969
30/68 44 GF 35/69 51
GF
(e)
gastric freezing
(f)
GF
2500 RCT
(g)
RCT

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C) y f nev g
z yr t z
4FP F F 2: B 7 K 1 F F LM F B KC M FK K M B 7KN --
(a)
(b) RCT
N Engl J Med 291: 1324-1326, 1974
212
(c)
(d) RCT =meta-analysis
JAMA 260: 1910-1916, 1988
14 9155
1/3
(e) RCT =meta-analysis
Circulation 86: 764-773, 1992
1970 1990
1970 4.32 4.51 1990 0.11
0.35 *
*: 1990 1/3
1970 1990 0.19 0.24
(f)
1980
(g)
RCT
RCT

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(h)
RCT
RCT
D) ez z
(a)
(b)
(c)
(d)
(e)
(f)
(nifedipine)
5) z
1.
” EB B EK KC F P FK ”
2.
RCT ” EB B EK KC
B P FK ”
3. MR
” EB B EK KC F FK ”
” EB B EK KC NB P FK ”
6) vi a z z
A) z
5B B 8 ;BR KKG KC F BM B F F B M B
6FLLF K : B
-- 1E L BM ((
(a) case report
case report
(b) case series study
case report

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RCT
(c) case control study
2
retrospective study
RCT
(d) cohort study
cohort study prospective study
case control study
(e) RCT
III-3)
B) y
level
Level 1 1 2
Level 2 1 2
Level 3
Level 4
Level 5
Level
Level 5

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1 2 X 2
III z g
1) vx yg
A) y patient)
B) ev i v(intervention
C) x outocome
D) z
2) i n y x m
A) MEDLINE exi
keyword keyword
B)
C) y r v y k
D) yv y b yeo
100
50 1 0.5 2
1 200 1

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E) y ev uat g ua z
y g
IV z
MEDLINE
keyword
1) y i
A) ua
B) z x z
C) zmgt z z y r
D) z uz x
a b
c d
Y=a/(a+b) =c/(c+d)
RR RR=Y/X
relative risk reduction: RRR RRR=1-RR or RRR=[(X Y)/X]
absolute risk reduction: ARR ARR=X Y
number needed to treat: NNT 1/ARR
20% 10 RR 1/2 RRR 50
ARR 10 NNT 10 4 2
RR 1/2 RRR 50 ARR 2 NNT 50
NNT 1

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3 /3
E) z z keyword
Clinical trial (publication type)
Randomized controlled trial (publication type)
2) y i
A) ua
B) z x z
C) zmgt z z y r
D) z z uz x
a b
c d
a/(a+c) d/(b+d)
positive predictive value: PPV a/(a+b)
negative predictive value: NPV d/(c+d)
(likelihood ratio of positive test: LR(+) / 1 or
a/(a+c)/b/(b+d)
(likelihood ratio of negative test: LR( ) (1 )/ or
c/(a+c)/d/(b+d)
LR ℃10 0.1
LR 5-10 0.1-0.2
LR 2-5 0.2-0.5
LR 2 ℃0.5
LR 1
E) z z keyword
Sensitivity and specificity --Explode
Diaginosis&(px)
3) y i
A) ua

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B) z x z
C) zmgt z z y r
D) z z uz x
5
stage
2
derivation sample validation sample
E) z z keyword
Cohort studies---Explode
Prognosis (text word)
4) y i
A) ua
B) z x z
C) zmgt z z y r
D) z z uz x
case-control study RCT
cohort study
a b
c d

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RCT prospective cohort study relative risk: RR
RR=a/(a+b)/c/(c+d)
RR 3.0 3
case-control study RR Odds ratio: OR
case-control study
case control
a/(a+b)
c/(c+d) 1 case 1 control 2 control
case-control study 2
OR=a/c/b/d=a*d/b*c
OR 3 case control 3
E) z z keyword
risk (text word)
Cohort studies---Explode
5) /
A) ua
B) z x z
C) zmgt z z y r
D) / uz x
2
E) z z keyword
meta-analysis (publication type)
review (publication type)
V n tz
gnev y g oi W y z

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g v k W MBC. 1 -,
z y sb y i
x
zX v m y vsb yr t z g W
z
1-1 10000
1-2
1-3 1000
500 500
1-4 1000
1-5 10
5 5
1-6 10
2-1 A B A
10 5 5 B 10
4 6
2-2 A B A
10 5 5 B 10
1 9
3-1 A B A
100 50 50 B 100
51 49
3-2 A B
A 100 50 50 B 100
10 90
4-1 A B A
1000 500 500 B 10
501 499
4-2 A B A
1000 500 500 B 1000
100 900
2) y y c z
A) x y
B) n y

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3) mz z vmz
A) y vsb
100
1
2 50 1
3 50 4
4 10
B) y sb
6
×

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C) y sb
D)
RCT
4) y z
y z y gn mz z
i
A)
X A E
A, B, C, D X A, B, C, E X
A, B, D, E X A, C, D, E X
4 A X
ref:

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B)
C)
)
mz zz
15
15
;83
;83

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VI y
EBM
RCT
RCT RCT
RCT
RCT
level 1 2
VII
1.
2. RCT
3. RCT RCT
4. 34 8
35 8 2 36 5 3
3
5.
1 10 1
2
3 RCT

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4 RCT
5 100
1
VIII
1) z
207 z vx gn zW x z u x W
y gn b i W
Moore, DS. The basic practice of statistics. W. H. Freeman and Company, 1995.
8000
Glantz SA. Primer of biostatistics. (4th ed.) McGraw Hill, 1997. 4500
Sackett, DL, et al; Clinical epidemiology. (2nd ed.) Little, Brown Company, 1991
7000
2) f y n z
x z z uz vgtz z t
yo f x n z
1994 EBM
EBM
R. K. Riegelman
1991
1996
× 1996
1997
T. 1993
J. R. 1995 ×
IX
1) v z
(clinical significancy)

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50
25
number
needed to treat (NNT)
2) z v EBM vgt
EBM level level 3
5
A) uz
1960 (phocomelia) 2
1959
1961
case series
Lentz 20
50 1961 11 15
11 20
11 26 11 28
phocomelia
1961 4 3 phocomelia
10 11 3 6
11 27
1961 10 phocomelia
2
10 8
1961 12 16 Lancet
1962 1 6 Lancet 1962
2 10 Lancet
350
13
7 4 7 2 phocomelia
1 4
300
phocomelia 2
40 phocomelia 75

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16000 phocomelia
1
7 phocomelia
phocomelia
B) Lenz
(Lenz ) 300
phocomelia
phocomelia phocomelia
90 2 92
22 186 208
112 188 300
Lenz
phocomelia 9
phocomelia
C) Lenz y i
Lenz
44
5 17
phocomelia
phecomelia
phocomelia
1 phecomelia
Lenz 10% phocomelia

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phocomelia
D) y i
Lenz
1961 11 28
1962 3 1962 4
1962 9 1962 2
phocomelia 1000 1963
219 1961
Lenz Lenz
z x n z u n vgt h d
gt W
x z x z z f v
z y y ht W u x i n y z
y t b a W
X
case control study, 10
case report, 9
case series study, 9
case-control study, 15
cohort study, 10
Evidence based medicine, 2
4 N MF 3MBBTB, 6
NNT, 23
phocomelia, 23

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randomized control trial, 2
, 2
, 20
, 19
, 9
, 15
, 17
, 13
, 18
, 9
, 4
, 18
, 20
. cohort
study
, 20
, 23
, 20
. case
series study
. case report
, 18
, 17
, 13
, 20
, 2
, 13
, 16
, 18
, 13
, 13
, 5
, 3
, 23
, 17
, 6
, 3
, 9
, 16
, 18
, 5, 18
, 3
.
, 13
.
z , 7
, 23
, 10
, 19
, 12