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Update in COPD
Management
รศ. นพ. วชรา บญสวสด M.D., Ph.D. ประธานเครอขายคลนคโรคหดและปอดอดกนเรอรงแบบงาย
ภาควชาอายรศาสตร คณะแพทยศาสตร มหาวทยาลยขอนแกน
COPD
โรคปอดอดก นเร อรง
เปนโรคทผปวยท าตวเอง โทษใครไมได
หลอดลมตบไมดขนเมอใหยาขยายหลอดลม (Irreversible airway obstruction)
รกษาไมได
2
Old COPD Guidelines
3
หลอดลมอกเสบเรอรง (Chronic bronchitis)
ถงลมปอดโปงพอง (Emphysema)
โรคหด Asthma
Irreversible FEV1 Δ <15%
Reversible FEV1 Δ>15%
4
Evidence-based COPD Guidelines
5
Definition of COPD
6
COPD is a disease state characterized by
airflow limitation that is not fully reversible.
The airflow limitation is usually both
progressive and associated with an
abnormal inflammatory response of the lungs to noxious particles or gases.
การตรวจสมรรถภาพปอด (spirometry)
FEV1
Force Expiratory Volume in 1 second
FVC
Force Vital Capacity
airflow limitation that is not fully reversible.
Post Bronchodilator FEV1 /FVC < 70 %
8
Systemic effect of COPD
10 Barnes PJ. ERJ 2009:1165
COPD
Airflow obstruction
Death
Air trapping
exacerbation
Reduced activity
Exercise limitation
Deconditioning
infection
Traditional view of COPD progression
Age (year)
FE
V1 %
of
valu
e a
t a
ge 2
5 y
r
100
75
50
25
50 25 75
Death
Disability
Adapted from:Fletcher C,et al.Br Med J.1977;1:1645-1648
Nonsmokers 20-30 ml/year
COPD 60 mL/year
symptoms Stage II: Moderate 50% < FEV1 < 80% predicted
Stage III: Severe 30% < FEV1 < 50% predicted
Stage IV: Very Severe FEV1 < 30% predicted
Stage I: Mild FEV1 > 80% predicted
COPD
Airflow obstruction
Death
Air trapping
exacerbation
Reduced activity
Exercise limitation
Deconditioning
Systemic effect of COPD •Weight loss •Skeletal muscle dysfunction
infection
14
mMRC Dyspnea score
COPD
Airflow obstruction
Death
Air trapping
exacerbation
Reduced activity
Exercise limitation
Deconditioning
Systemic effect of COPD •Weight loss •Skeletal muscle dysfunction
infection
FEV1, PEFR
FRC, IC
6 Min walk CAT
Dyspnea score
Exacerbation
15
None of the existing medications for COPD have been
shown to modify the long-term decline in lung function that is the hallmark of this disease (Evidence A). Therefore, pharmacotherapy for COPD is used to decrease symptoms and/or complications.
Manage stable COPD 2001
Pharmacotherapy
Bronchodilators
1. Anticholinergics
2. B2 agonist
3. Theophylline
Corticosteroids
Oral
Inhaled
PDE4 PLAYS AN IMPORTANT ROLE IN
INFLAMMATION
P P P
P
PDE4 inhibition
PDE4
Adapted from Rabe KF. Expert Rev Resp Med 2010;4: 543–555.
19
European Respiratory Society’s study on Chronic Obstructive Pulmonary Disease (EUROSCOP)
Pauwels R. N Engl J Med 1999;340:1948-53.
Placebo
budesonide
Thorax 2005;60:992–997.
D D Sin,
Inhaled corticosteroids reduce all-cause mortality in COPD.
22
2.5
1.9
1.2
1.7
1.4 1.2
0
0.5
1
1.5
2
2.5
3
<1.25 1.25-1.54 >1.54
Ex
ac
erb
atio
ns
pe
r y
ea
r
FEV1
Placebo
Fluticasone
ISOLDE. BMJ2000;320:1297-1303
Management of Stable COPD
Pharmacotherapy: Glucocorticosteroids
The addition of regular treatment with inhaled glucocorticosteroids to bronchodilator treatment is
appropriate for symptomatic COPD patients with an FEV1 < 50% predicted (Stage III: Severe COPD and Stage IV: Very Severe COPD) and repeated exacerbations (Evidence A).
24
Short acting bronchodilator as needed
Regular bronchodilator treatment inhaled corticosteroids
Oxygen therapy
Regular bronchodilator treatment Consider inhaled corticosteroids
Regular bronchodilator treatment
FEV1>80%
FEV1 30-50%
FEV1 50-80%
FEV1 <30%
25
Short acting bronchodilator as needed
Regular bronchodilator treatment inhaled corticosteroids
Oxygen therapy
Regular bronchodilator treatment Consider inhaled corticosteroids
Regular bronchodilator treatment
FEV1>80%
FEV1 30-50%
FEV1 50-80%
FEV1 <30%
LABA ICS
LABA ICS
Oxygen therapy
Short-acting bronchodilator
prn
Short-acting bronchodilator
regular
Long-acting bronchodilator
Add ICS ( >1 exacerbation)
บทบาทของ
ICS/LABA
27
Rate of moderate and severe
exacerbations over three years
*p < 0.001 vs placebo; †p = 0.002 vs SALM; ‡p = 0.024 vs FP
Mean number of exacerbations/year
1.13
0.97* 0.93*
0.85*†‡
25% reduction
0
0.2
0.4
0.6
0.8
1
1.2
Placebo SALM FP SFC
Treatment
Calverley et al. NEJM 2007
SGRQ total score
–5
–4
–3
–2
–1
0
1
2
3
0 24 48 72 96 120 156
Adjusted mean change SGRQ total score (units)
Time (weeks)
Placebo
SALM *
FP †
*p = 0.057 vs placebo; †p < 0.001 vs placebo; ††p < 0.001 vs placebo, SALM and FP; vertical bars are standard errors
Number of
subjects
1149 1148 1155 1133
854 906 942 941
781 844 848 873
726 807 807 814
675 723 751 773
635 701 686 731
569 634 629 681
SFC ††
Calverley et al. NEJM 2007
C/08/185 August 2008
FEV1 (mL) 1350
1300
1250
1200
1150
1100
0 24 48 72 96 120 156 Time (weeks)
–39 mL/yr
–42 mL/yr
–55 mL/yr
–42 mL/yr
Control
SAL
FP
SFC
Error bars represent 5% and 95% confidence intervals
Rate of decline in lung function over
3 years
Celli et al. Am J Respir Crit Care Med 2008
• SFC significantly reduced the rate of decline in lung function compared with placebo
(39mL/year vs 55mL/year, difference 16mL/year p<0.001)
“…[Seretide] decreas[ed] the excess FEV1 decline attributable to COPD by
approximately half.”
“…halving the excess decline in FEV1 is likely to be clinically important…”
Definition of COPD: GOLD2006
COPD is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients.
Its pulmonary component is characterized by airflow limitation that is not fully reversible.
The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases.
31
เปาหมายของการรกษา
ปองกนหรอชะลอการด าเนนโรค
บรรเทาอาการ โดยเฉพาะอาการหอบเหนอย
ท าให exercise tolerance ดขน
ท าใหคณภาพชวตดขน
ปองกนและรกษาภาวะแทรกซอน
ปองกนและรกษาภาวะอาการก าเรบ
ลดอตราการเสยชวต
Current control
Prevent
Future risk
2009
Exacerbations
33
Patients with frequent exacerbations
Increased risk of
recurrent exacerbations
Increased
inflammation
Lower quality of life Increased mortality rate
Increased likelihood
of hospitalisation
Adapted from Wedzicha JA et al, 2007; Donaldson GC et al, 2006.
Faster disease
progression
GOLD 2011 revision
34
Current symptoms
Fu
ture
ris
ks
MRC 0-1
CAT<10
MRC 2+
CAT 10+
Association of disease severity
and exacerbations
35 Hurst JR(ECLIPSE), NEJM. 363; 1128::2010
36
GOLD 2011 revision
37
Current symptoms
Fu
ture
ris
ks
GOLD 1
GOLD 2
GOLD 3
GOLD 4
Exacerbations / y
0
2
1
>2
MRC 0-1
CAT<10
MRC 2+
CAT 10+
A
D C
B
GOLD 2011 revision
38
Current symptoms
Fu
ture
ris
ks
GOLD 1
GOLD 2
GOLD 3
GOLD 4
Exacerbations / y
0
2
1
>2
MRC 0-1
CAT<10
MRC 2+
CAT 10+
A
D C
B SABA
or
SAMA
LABA
or
LAMA
ICS/LABA
or
LAMA
ICS/LABA
or
LAMA
39
Study design Run-in Randomisation
–0.5 0 1 2 3 Months 6 9 12
Clinic visits 1–8
Treatment
(Budesonide/Formoterol Turbuhaler ) 320/9 ug bid
1 2 3 4 5 6 7 8
Terbutaline as reliever for all patients
ORAL
PRED
+FORM
Symbicort Turbuhaler 160/4.5 g delivers the same amount of budesonide
and formoterol as the corresponding Turbuhaler monoproducts
(Budesonide Turbuhaler®) 320 g bid
(Formoterol Turbuhaler®) 9 g bid
Placebo
40
80
84
88
92
96
100
104
-0.5 1 3 5 7 9 11
Mean F
EV
1, %
of
baseline
Months since randomization
Placebo
Budesonide
Formoterol
Bud/For
***
***
41
Budesonide/formoterol improves morning PEF
1 3 5 7 9 11
Time since randomisation (months)
–22
–17
–12
–7
–2
3
8
Change in morning
PEF (L/min)
from baseline
Budesonide/Formoterol
Budesonide
Formoterol
Placebo ***
***
p<0.001 Symbicort
vs budesonide
***p<0.001 vs placebo
p=0.007 Symbicort
vs formoterol
0 2 4 6 8 10 12
42
Time to first exacerbation
43
*
1.4
1.6
1.9 1.8
*p<0.05 vs placebo
p=0.015 Symbicort vs formoterol
Budesonide/formoterol reduces severe
exacerbations Mean no. of severe
exacerbations/
patient/year
0
0.2
0.4
0.6
0.8
1.0
1.2
1.4
1.6
1.8
2.0
Symbicort Budesonide Formoterol Placebo
44
-3
-2
-1
0
1
2
3
4
5
-0.5 0 6 12
Mean c
hange in s
core
Month since randomization
ชอแผนภม
4 Placebo
2 Budesonide
3 Formoterol
1 Bud/For
1
3
2
4
Run-in
* **
***
45
การศกษานสรปวา
การรกษาผปวยใหเตมทตงแตแรกเรมรกษาดวย prednisolone และยาขยายหลอดลม จะท าใหผปวยรสก
ดข นมากอยางรวดเรว
การให Budesonide/formoterol จะรกษาสมรรถภาพปอดทดข นจากการรกษาเตมทดวย prednisolone ลด
อตราการเกดการก าเรบของโรค และเพมคณภาพชวต ดกวาการให Budesonide หรอ formoterolเดยวๆ
46
COPD
Airflow obstruction
Death
Air trapping
exacerbation
Reduced activity
Exercise limitation
Deconditioning
Systemic effect of COPD •Weight loss •Skeletal muscle dysfunction
infection
Bronchodilator
ICS
47
Easy COPD Treatment
Airway obstruction
48
•Prednisolone
•ICS
•LABA
ท าปจจบนใหด เพออนาคตทสดใส
COPD
โรคปอดอดก นเร อรง
เปนโรคทปองกนได แตเราไมไดปองกนใหผปวย (preventable disease)
หลอดลมตบดขนได เมอใหยาขยายหลอดลม แตไมเปนปกต (incomplete reversible airway
obstruction)
รกษาได (treatable disease)
49
เกณฑการใหคะแนน ภาวะหายใจล าบาก (Modified Medical Research Council Dyspnea Score; mMRC)
50
51
www.catestonline.org