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11 70% 1) . , 2) . , , 3) , , , 4) . 고창남 1 , 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 Ko 1 , In-kyu Min, Sung-wook Park 1 , Woo-sang Jung, Sang-kwan Moon, Jung-mi Park 1 , 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 1 Stroke 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
Transcript
Page 1: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

11

서 론70%

1).

, 2).

, , 3), ,

, 4)

.

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

Page 2: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 3: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 4: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 5: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 6: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 7: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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

Page 8: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 9: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 10: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 11: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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)

Page 12: Effectiveness of Bee Venom Acupuncture on Shoulder Pain after

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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