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서 론70%
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고창남1, 민인규, 박성욱
1, 정우상, 문상관, 박정미
1, 조기호, 김영석, 배형섭
1
원 저
Effectiveness of Bee Venom Acupuncture on Shoulder Pain after Stroke
Chang-nam Ko1, In-kyu Min, Sung-wook Park
1, Woo-sang Jung, Sang-kwan Moon,
Jung-mi Park1, Ki-ho Cho, Young-suk Kim, Hyung-sup Bae
1
Department of Cardiocascular & Neurologic Disease(Stroke center) College of Oriental medicine, Kyunghee University, Seoul, Korea
1Stroke Center, East-West Neo Medical Center
Objectives : Hemiplegic shoulder pain is one of the common sequelae of stroke. Although many different methods
of treatment are applied, none have yet been proved to be effective. In this study we assessed the effectiveness of
bee venom in patients with shoulder pain after stroke.
Methods : This study was a double blinded, randomized, placebo-controlled clinical trial. All subjects received
either 0.6 ml bee venom injection (venom:saline = 1:10000) or 0.6ml physiological saline solution (placebo) at three
acupoints. The effectiveness was assessed by visual analogue scale, pain rating score, Fugl-Meyer assessment and
passive external rotation.
Results : There were 24 patients in the venom group and 22 patients in the placebo group. The venom group
showed more effectiveness in VAS and PRS than the placebo group.
Conclusions : This study suggests that bee venom injection has significant analgesic effect on hemiplegic shoulder
pain. Further study based on multi-centers, larger population, and long term follow-up is needed to confirm this
suggestion.
: Bee venom acupuncture, stroke, shoulder pain
2006
(KHU-2006-073)
2006 12 20 2006 12 22
2007 1 16
, 1
2
(Tel: 02-958-9128, Fax: 02-958-9132,
E-mail: [email protected])
28 1 (2007 3 )J Korean Oriental Med 2007;28(1):11-24
28 1 (2007 3 )
12
.
,
, 5).
6)
7)
.
, ,
.
(LI15), (TE14), (GB21)
,
,
.
연구 대상 및 방법
1. 연구대상
1)
2006 7 1 2007 1
(1)
(2)
(2)
.
2)
(1)
(2)
(3)
(4)
(skin test)
(5) (VAS)
3 (6)
(6)
.
3)
, ,
.
2. 임상연구 증례기록지
(Case Form
Report, CRF) .
(Standard Operating Procedures,
SOP)
.
3. 실험 방법
1)
,
.
, 5
7
. , ,
,
(12)
8
13
.
,
, 2
.
.
2)
( :
=1:10000) .
, .
1ml 1:10000
0.1ml 20 , 8) 5mm
11mm Mueller
Grade 2 9-10)
.(Table 1)
2-3 1 , 1 3 2 6
,
. ,
, .
1cc ( 30 gauge)
0.4-0.8cm 0.2ml ,
.
-
, , ,
,
- , 1
.
1 1 , 3 ,
, ,
.
.
3)
(1)
, , ,
, ,
, ,
, , ,
, X ,
.
, , 11)
.
,
Grade Description
0 None or Local reactions only
1 systemic urticaria, pruritus, malaise
2 angioedema, chest tightness, nausea, vomiting, abdominal pain, dizziness
3 dispnoea, wheeze, stridor, dysphagia, hoarseness
4 hypotension, collapse, loss of consciousness, incontinence, cyanosis
(13)
28 1 (2007 3 )
14
12).
4
, ,
13).
Modified Ashworth sacle 2 14)
.(Table 2)
15). X-ray
. 199716)
>126mg/dl,
2 (2 hours)>200mg/dl
.
(2)
(Visual Analog
Scale, VAS) (Pain Rating Score,
PRS) . VAS
10cm
cm -1cm - 0-10
. PRS 1998
. (0-10) (0-5),
(0-5), (0-5)
0-150 17)
.
(painless passive ROM of shoulder
external rotation, PROM) Fugl-Meyer Motor
Assessment(FMMA) . PROM
45° , 90° ,
goniometer18)
.
,
. FMMA
0
, 1 ,
2
Grade Description
0 No increase in muscle tone
1slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the
end of the range of motion when the affrcted part(s) is moved in flexion or extension
1+Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throught the
remainder(less than half) of the ROM
2 more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
3 considerable increase in muscle tone, passive movement dificult
4 affected part(s) rigid in flexion or extention
(14)
8
15
(0-66) 19)
.
(3)
. Melittin,
Apamin -
Corticosteroid hormone
20) .
2 . ,
.
Muller grade .
4. 통계처리
SPSS(Stastical Program for Social
Science) 12.0 for Windows .
Mean±SD Number(%)
,
Mann Whitney U test , Chi-square
test ,
Wilcoxon Signed Ranks test . P
Value 0.05
.
결 과
46 .
1 2
2 1
VAS, Consent (n=46)
General Characteristics (n=46)
Patients randomized(n=46)
Venom(n=24) Placebo(n=22)
1st injection(n=24)2nd injection(n=24)3rd injection(n=23)4th injection(n=23)5th injection(n=23)6th injection(n=23)
1st injection(n=22)2nd injection(n=20)3rd injection(n=20)4th injection(n=20)5th injection(n=20)6th injection(n=20)
Assessment
Analysis
(15)
28 1 (2007 3 )
16
.
.(Figure
1)
1. 일반적 특징
64.33±9.88 67.50±9.60
. 12 (50%)
12 (50%) 9 (40.9%)
13 (59.1%) .
20 (83.3%), 4 (16.7%)
19 (86.4%) 3 (13.6%)
12 (50%)
12 (50%) 9 (40.9%)
13 (59.1%) .
5 (20.8%) 2 (9,8%) .
4 (16.7%),
12 (50%), 5 (20.8%),
2 (9.8%), 9 (40.9),
4 (18.2%) .
Venom(n=24) Placebo(n=22) P-Value
Age, Mean±SD, years 64.33±9.88 67.50±9.60 0.391*
Sex, n(%)
Male
Female
12(50)
12(50)
9(40.9)
13(59.1)
0.568+
Type of stroke, n(%)
Infarction
Hemorrhage
20(83.3)
4(16.7)
19(86.4)
3(13.6)
1.000+
First or Repeated stroke, n(%)
First
Repeated
19(79.2)
5(20.8)
20(90.9)
2(9.8)
0.418+
Side of Motor disorder
Right
Left
12(50)
12(50)
9(40.9)
13(59.1)
0.568+
Neglect 4(16.7) 2(9.8) 0.667+
Visual field deficits 12(50) 9(40.9) 0.568+
Hypertonia 5(20.8) 4(18.2) 1.000+
Cointervention 20(83.3) 19(86.4) 1.000+
Comorbidity(Diabetes mellitus) 7(29.2) 10(45.5) 0.361+
Time since onset of stroke
<6months
6months
23(95.8)
1(4.2)
20(90.9)
2(9.1)
0.600+
Time since onset of HSP
<6months
6months
24(100)
0(0)
21(95.5)
1(4.5)
0.468+
*Mann Whitney U test +Chi-square test
(16)
8
17
7 (29.2%) 10 (45.5%) .
20 (83.3%) 19 (86.
4%) .
.(Table 3)
12
. 1
45
. 12
9 (46.7%),
(40%), (31.1%), (31.1%),
(26.7%), (11.1%), (8.9%),
(6.7%), (4.4%)
.(Table 4)
X-ray
16 30 .
14
(93.3%) 4 (26.7%) .
14 (93.3%)
4 (26.7%) .(Table 5)
2. 주요평가척도의 변화
(VAS), (PRS),
(painless passive
ROM of shoulder external rotation, PROM)
Fugl-Meyer Motor Assessment(FMMA)
. ( ) VAS,
PRS, PROM, FMMA 2
. ( )
2 VAS, PRS
, FMMA PROM 2
.(Table 6)
Venom(n=23) Placebo(n=22)
43.5%
43.5%
34.8%
34.8%
34.8%
8.7%
8.7%
4.3%
0.0%
50.0%
36.4%
27.3%
18.2%
27.3%
13.6%
9.1%
4.5%
13.6%
Venom(n=15) Placebo(n=15)
Degenerative change 14(93.3%) 14(93.3%)
Subluxation 4(26.7%) 4(26.7%)
17
28 1 (2007 3 )
18
3. 보조평가척도의 변화
17 7 10
. 7 2
(PP2)
6 .
.
(Table 7)
2 8 (34.8%),
3 (13%), 2 (8.7%)
Venom(n=24) Placebo(n=22) P-Value
Visual Analogue
Scale
Baseline 7.17±1.90 7.09±1.60 0.911*
After 2weeks 4.74±1.66 5.95±1.67 0.022*
P-Value <0.000+ 0.002+
Pain Rating Score
Baseline 72.04±27.7 75.40±27.69 0.676*
After 2weeks 49.57±20.21 68.5±29.30 0.034*
P-Value <0.000+ 0.023+
Fugl-Meyer
Baseline 21.04±19.58 22.14±16.79 0.455*
After 2weeks 23.65±19.84 23.55±17.36 0.961*
P-Value <0.000+ 0.027+
Passive external
rotation
Baseline 40.83±24.88 42.06±27.28 0.938*
After 2weeks 33.48±23.95 36.75±24.30 0.722*
P-Value 0.005+ 0.026+
* Mann Whitney U test, +Wincoxon Signed Ranks test
Glucose(baseline) Glucose(2weeks later) P-Value
Venom, FBS mg/dL 118.42±58.75 113.57±53.15 0.172*
Venom, PP2 mg/dL 207.33±58.58 194.67±35.79 0.293*
*Wincoxon Signed Ranks test
The values are mean ± S.D
Venom(n=23) Placebo(n=20) P-Value
Pruritus 8(34.8%) 2(10%) 0.071*
Burning sensation 3(13%) 1(5%) 0.608*
Pain 2(8.7%) 3(15%) 0.665*
*Chi-square test
(18)
8
19
2 (10%), 1 (5%),
(15%) . ,
Mueller Grade 0
.(Table 8)
고 찰
,
,
.
- -
, 21)
.
22), NSAID
23),
24),
25-26),
27),
28), Botulinum
toxin29-30)
.
. 6)
7)
.
,
.
.
(Case Form Report, CRF)
.
(Standard Operating Procedures, SOP)
.
5 , 4 ,
1 10
. ,
.
,
. ,
. , ,
31).
.
1 1 , 3 ,
, ,
.
46 .
23 20
.
15). 1
45 ,
(19)
28 1 (2007 3 )
20
.
,
(57.8%) , , ,
, (53.3%)
, ,
, (33.3%) ,
. (40%)
.
.
.
,
.
(VAS) (PRS)
. VAS
,
, VAS
32) PRS
. 1 2
, 2 1
23 20
.
.
VAS PRS
, VAS PRS
.(p<0.05)
.(p<0.001)
.
(painless passive ROM
of shoulder external rotation, PROM) Fugl-Meyer
Motor Assessment(FMMA) .
33)
34). ,
. FMMA
, , 35)
.
23 20
. PROM, FMMA
. PROM,
FMMA
. ,
.
.
. Corticosteroid
hormone20)
.
2 . ,
.
17
7 2
6
.
.(P=0.071) 2
(20)
8
21
8 (34.8%), 3 (13%),
2 (8.7%)
2 (10%), 1 (5%), (15%)
. , Mueller Grade 0
.
, Mueller Grade 2
. ,
36)
.
, , ,
, , , , 20)
,
2-3
,
37),
38),
39),
40-41)
. 42)
, 43)
, 44)
,
.
.
PROM, FMMA
.
2
.
2
4
.
.
,
.
CRF
SOP ,
, , ,
,
.
결 론
2
, ,
,
.
1.
.
2. Fugl-Meyer Motor Assessment
.
(21)
28 1 (2007 3 )
22
3.
.
4. ,
.
5. (34%), (13%),
(8.7%)
. Mueller Grade 0
.
감사의 말씀
2006
.(KHU-2006-073)
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(24)