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- Assessment of arterial blood gas: followed by Weinberger et al. (2013).

- Assessment of arterial blood gas: followed by Weinberger et al. (2013).

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10

difference was statistical when p < 0.05. Calculate the Pearson

correlation. Management and analysis of the data by the SPSS 20.0

program.

2.2.6. Ethics in the research

This research was carried out in accordance with the principles

of ethics in medicine.

DIAGRAM OF STUDY

185 COPD patients

Clinical examination, lung function

mesuament and chest HRCT

66 ones with severe emphysema



33 ones in group 1



Characteristics

of clinical

examination,

lung function

mesuament and

chest HRCT



Purpose

1



33 ones in group 2



23 ones at 1 months after valve placement

33 ones at 3 months after valve placement

16 ones at 6 months after valve placement



23 ones after 3 months



Changes of clinical examination, lung

function mesuament and chest HRCT

Complications, adverse events



Changes of clinical

examination, lung function



Purpose 2



PURPOSE



1



11

Chapter 3: RESULTS

3.1. Characteristics of clinical symptoms, chest CT-scan images

and respiratory function disorders of the studied patients

3.1.1. Characteristics of clinical symptoms of the studied patients

All patients were male, with average age of 65.80 ± 6.96 years

old.

Duration of disease was 7.61 ± 4.72 years.

Patients smoked much, with the pack-year index of 26.71 ±

11.81.

Low BMI (18.26 ± 2.46 kg/m2) with the rate of underweight of

66.60%. SMWD was short (302.82 ± 59.33 meters).

High CAT was 19.38 ± 3.26 and average mMRC score was

2.38 ± 0.84.

3.1.2. Characteristics of chest computer tomography images

Severe emphysema concentrated mainly in lower lobes

(78.79%).

80.30% had only panacinar emphysema and 9.09% of patients

had panacinar emphysema plus paraseptal emphysema.

Mean of emphysema score was 2.76 ± 0.48. The rates of

emphysema with degree 3 and 4 on chest CT-scan images were

45.45% and 51.52%.

3.1.3. Characteristics of respiratory function disorders

VC and FVC decreased significantly. FEV 1 decreased

severely (35.02 ± 13.22 %predicted).

RV (252 ± 72.81 %predicted) and Raw (9.28 ± 4.14

cmH2O/l/s) corresponded with severe increase. TLC increased

moderately (140.67 ± 26.17 %predicted).

PaO2 reduced (76.36 ± 12.13), with the lowest of 39 mmHg.



12

The proportion of patients having decreased O2 in blood was

65.15%.9.09% of patients had respiratory failure.

3.1.4. The correlation between emphysema severity on chest CTscan image and respiratory function parameters

Emphysema score had a moderate negative correlation with

VC and MVV (p < 0.01) and FEV1 (p < 0.05).

Table 3.13. The correlation between emphysema severity and

plethymosgraphy parameters

Correlation

r

p

RV

Emphysema score

0.537

0.001

TLC

Emphysema score

0.479

0.001

Raw

Emphysema score

0.105

0.440

Emphysema score had a relatively strong positive correlation

with RV (r = 0.537, p < 0.01) and TLC (r = 0.479, p < 0.01).

3.2. Results of one-way valve placement

3.2.1. Characteristics of clinical and para-clinical symptoms of 2

groups of patients before valve procedure

The average age of patients in group 1 was 65.70 years old,

with high CAT, mMRC and short 6-MWD. There was no difference

between 2 groups in most parameters.

Patients in group 1 had highly increased RV, TLC, Raw and

emphysema score, while VC, FVC, FEV1, MVV and PaO2 decreased.

Most parameters in 2 groups had no difference.

3.2.2. Quantity, size and location of valve

The rate of valve with the size 5.5 mm used was 75.00%. 31

patients (94.94%) were treated with only one valve. The proportion

of valve located in the right lung was 88.88%, in which in the right

lower lobe (55.55%).

3.2.3. Changes of clinical characteristics of patients after therapy



13

Table 3.18. Changes of clinical characteristics of patients after 3

months

Parameters



Group 1

Group 2

Before

After 3 months

Before

After 3 months

therapy (1)

(2)

treatment (3)

(4)

(n=33)

(n=33)

(n=23)

(n=23)



BMI (kg/m2)

- ± SD

18.61 ± 2.44

18.58 ± 2.55

17.61 ± 2.70

17.58 ± 2.70

p

p2,1 > 0.05; p2,4 > 0.05; p3,1 > 0.05; p4,3 > 0.05

- Changes

-0.03 ± 0.38

-0.03 ± 0.10

CAT (points):

- ± SD

20.12 ± 3.42

17.79 ± 3.39

18.78 ± 3.10

17.65 ± 3.71

p

p2,1 < 0.01; p2,4 > 0.05; p3,1 > 0.05; p4,3 < 0.01

- Changes

-2.33 ± 1.27

-1.13 ± 1.36

p

< 0.05

-Reduced ≥ 2 (n) (%)

25 (75.76)

11 (47.82)

p

< 0.05

6-MWD (meters):

- ± SD

302.0 ± 59.53 333.48 ± 62.69 307.39 ± 67.89 326.74 ± 88.72

p

p2,1 < 0.01; p2,4 > 0,05; p3,1 > 0.05; p4,3 < 0.05

- Changes

31.48 ± 26.30

19.35 ± 36.03

p

> 0.05

- Increased ≥26 m(n) (%)

16 (48.48)

5 (21.74)

p

< 0.05

mMRC (poits):

- ± SD

2.52 ± 0.80

2.03 ± 1.05

2.26 ± 0.92

2.09 ± 0.79

p

p2,1 < 0.01; p2,4 > 0.05; p3,1 > 0.05; p4,3 < 0.01

- Changes

- 0.48 ± 0.57

- 0.17 ± 0.49

p

< 0.05



Patients in group 1 witnessed the significant increase of 6MWD (p < 0.01), with statistical decrease of CAT, mMRC (p < 0.01).

In comparison with group 2, group 1 had the significant improvement

of 6-MWD, CAT and mMRC (p < 0.05).

With 1 valve, patients had a clear improvement of CAT,

mMRC and 6-MWD in comparison with before treatment (p < 0.01).

3.2.4. Changes of emphysema on chest CT-scan image



14

Table 3.20. Changes of emphysema score and severity after being

inserted 1 valve in comparison with before treatment

Characteristics

of emphysema



Before

therapy

(n = 23) (1)



After 1

month

(n = 23)(2)



After3

months

(n = 23)(3)



Emphysema

score ( ± SD)



2.59 ± 0.49



2.42 ± 0.52



2.36 ± 0.52



Degree 2



1 (4.35%)



2 (8.70%)



4 (17.39%)



Degree 3



16 (69.57%)



15 (65.22%)



15 (65.22%)



Degree 4



6 (26.08%)



6 (26.08%)



4 (17.39%)



p

p2,1 < 0.01

p3,1 < 0.01

p3,2 > 0.05



Patients in group 1 had mainly emphysema with degree 3

(69.57%). After valve placement, the emphysema score decreased at

both times follow-up statistically (p < 0.01). The decrease of

emphysema score was seen clearly at 3 months later.

3.2.5. Changes of spirometry and plethymosgraphy parameters of

patients after valve therapy

After 3 months, FVC and FEV1 rose. Especially, 3 patients

(9.09%) in group 1 increased FEV1 > 10% predicted. FVC improved

clearly in comparison with group 2 and before treatment (p < 0.05).

Table 3.23. Changes of plethymosgraphy parameters after 3

months

Group 1

Group 2

Before therapy After 3 months

Before

After 3 months

(1)

(2)

treatment (3)

(4)

(n=33)

(n=33)

(n=23)

(n=23)

RV (%predicted):

- ± SD

250.27 ± 73.88 215.00 ± 60.70 251.43 ± 64.93 275.9 ± 88.56

p

p2,1 < 0.01; p2,4 < 0.01; p3,1 > 0.05; p4,3 > 0.05

- Changes

-35.27 ± 62.00

23.65 ± 60.72

p

< 0.01

TLC (%predicted):

- ± SD

138.12 ± 24.01 126.15 ± 22.25 144.70 ± 24.84 154.39 ± 35.47

Parameters



15

p

p2,1 < 0.05; p2,4 < 0.01; p3,1 > 0.05; p4,3 > 0.05

- Changes

-11.97 ± 27.43

9.70 ± 24.45

p

< 0.05

Raw(cmH2O/l/s)

- ± SD

9.04 ± 4.31

10.07 ± 4.50

9.72 ± 4.41

11.13 ± 4.77

p

p2,1 > 0.05; p2,4 > 0.05; p3,1 > 0.05; p4,3 > 0.05

- Changes

1.03 ± 3.97

1.41 ± 5.44

p

> 0.05



After 3 months, RV and TLC of patients in group 1 reduced (p

< 0.05), with RV more than TLC. To compare with group 2, the

decrease of RV and TLC was more statistical (p < 0.05).

3.2.5.2. Changes of respiratory function parameters of patients

placed 1 valve

After locating 1 valve, patients witnessed the improvement of

FVC, FEV1 and MVV, while VC decreased. However, the difference

was not statistical (p > 0.05).

After locating 1 valve, patients decreased RV and TLC, in

which RV went down significantly after 3 months (p < 0.05).

In group of patient with 1 valve, the number of patients with

increased FEV1 1 month after procedure was higher than 3 months

later. 8.7% of patients increased FEV1 > 10% 3 months later.

After placement of 1 valve, the highest proportion of patients

with decreased RV was met 1 month after procedure (65.22%). The

proportion of patients with decreased RV > 20% was the highest at

everytime of follow-up.

After placement of 1 valve, the rate of patients with decreased

TLC was 73.97% after 1 month and 56.52% after 3 months. The

proportion of patients with decreased RV > 20% was high (30.43%).

3.2.5.3. Changes of respiratory function parameters after 6 months

Table 3.30. Changes of spirometry and plethymosgraphy

parameters at 6 months later in comparison with before treatment



16

Parameters

( ± SD)

VC (%predicted)



Before therapy

(n = 16)

75.11 ± 16.62



After 6 months

(n = 16)

71.43 ± 21.59



p

p > 0.05



FVC (%predicted)



63.63 ± 16.09



67.75 ± 21.68



p > 0.05



FEV1 (%predicted)



37.88 ± 15.30



36.5 ± 12.81



p > 0.05



RV (%predicted)



244.19 ± 63.16



197.37 ± 56.55



p < 0.01



TLC (%predicted)



137.75 ± 19.20



117.25 ± 18.60



p = 0.01



Raw (cmH2O/l/s)



8.49 ± 4.41



11.53 ± 5.21



p < 0.01



RV and TLC decreased clearly in comparison with those

before treatment (p ≤ 0.01).

3.2.6. Changes of arterial bood gas parameters after valve

placement

3.2.6.1. Changes of arterial bood gas parameters after 3 months

After 3 months, PaO2 of patients in group 1 increased (p <

0.01) and in group 2 decreased. This difference was statistical (p <

0.01).

After 3 months, the proportion of patients in group 1, having

improvement of PaO2, was significant higher in comparison with

group 2 (68.75% and 40.91%).

3.2.6.2. Changes of arterial bood gas parameters in patients with 1

valve

After insertion of 1 valve, PaO2 increased and PaCO2 decreased

in both times of follow-up, with the clearest improvement after 3

months, with PaO2 increasing statistically (p < 0.05).

3.2.6.3. Changes of arterial bood gas parameters after 6 months in

comparison with before treatment

At 6 months after the therapy, PaO 2 went up and PaCO 2 went

down not very clearly (p > 0.05). SaO 2 changed insignificantly and

stayed in normal limitation.



17

3.2.7. Complications after vale therapy

Table 3.36. Early complications after vale therapy

Complications

n

%

COPD exacerbations

3

9.09

Pneumothorax

1

3.03

Respiratory failure

0

0

Valve imigration

0

0

Total

4

12.12

The proportion of COPD exacerbations was 9.09% (3/33

patients). Pneumothorax was seen in 1 patient after 1 week (3.03%).

Table 3.37. Later complications after vale therapy

Complications

n

%

Hemoptysis

2

6.06

Blocked valve by mucus

3

9.09

Covered valve by granulation

2

6.06

Valve imigration

0

0

Valve removement

0

0

Total

7

21.21

Blocked valve by mucus was seen of 9.09%. Hemoptysis was

witnessed in 2 patients (6.06%) and granulation nearby the location

of valve was seen 6.06%.

Chapter 4: DISCUSSIONS

4.1. Characteristics of clinical symptoms, chest computer

tomography images and respiratory function disorders of the

studied patients

4.1.1. Characteristics of clinical symptoms of the studied patients

4.1.1.1. Characteristics of age and gender

Characteristics of age, gender was suitable with results of other

studies in Vietnam and in over the world. However, the proportion of

female in the studies in Europe and in the USA is ussually higher.

This could be related to the rate of higher smoking female.

4.1.1.2. Duration of disease



18

To compare with other previous studies by Pham Kim Lien

(2012)… patients in this study had a different duration of disease.

This related to the method to choose studied patients.

4.1.1.3. Risk factors

Characteristics of risk factors were similar to results of

previous studies, with most COPD patients having prehistory of

smoking and high pack-year index.

4.1.1.4. Characteristics of clinical symptoms

Characteristics of BMI index was likely the results of COPD

studies in Vietnam, including by Pham Kim Lien (2012)…In studies

in the world, BMI usually higher than that in Vietnam. This

difference could be caused by the socioeconomic conditions as well

as healthy care services and affected much to the results of new

methods of treatment.

Results of characteristics of dyspnea, mMRC points were

suitble with selection criteria of previous studies for LVR. Results of

CAT index, 6-MWD showed that severe COPD patients decreased

physical activities and quality of life: Sciurba F.C. et al (2010)…

The number of COPD exacerbations per year was high, similar

to some studies by Pham Kim Lien (2012)…, but more than in the

studies by Burgel P-R. et al (2010)... This has shown the level of

awareness as well as the quality of medical care in every area.

4.1.1.5. Classification of COPD group

The characteristics of COPD group showed that the

hospitalizied patients usually are severe, need to be treated

completely and controll carefully after leaving the hospital.

4.1.2. Characteristics of emphysema on CT-scan images

4.1.2.1. Locations of severe emphysema

The characteristics of emphysema location were also suitable

with the emphysema types of selected patients, with most patients

having panacinar emphysema (80.3%). This result was similar to that

in the study by Pham Kim Lien (2011).



19

4.1.2.2. Classification of emphysema types

The characteristics of emphysema types was similar to Pham

Kim Lien (2011), but different from Benjamin M.S. et al. (2014).

This difference might be caused by selection patients, preparing for

LVR, with mix or severe emphysema.

4.1.2.3. Severity of emphysema

In comparison with previous studies, the rate of severe

emphysema patients in this study was higher, such as Pham Kim Lien

(2011), Makita H. et al. (2007),...This difference could relate to

selection criteria, being severe emphysema patients.

4.1.3. Characteristics of respiratory function disorders

4.1.3.1. Changes of VC, FVC and FEV1

The results of this study were similar to that in previous ones,

for examples: Nguyen Huy Luc (2010), Ju J. et al (2014)...

4.1.3.2. Classification of obstructive airway severity

The characteristics of obstructive airway severity were suitable

with selection criteria in this study, with mainly obstructive severity

of stage III or IV.

4.1.3.3. Changes of RV and TLC

RV increases much and TLC stayed in moderate increase. This

characteristic is a basis for indications of LVR.

4.1.3.4. Changes of Raw

63.60% of patients increased Raw. This was similar to that in

the studies by Mahut B. et al (2012)... It showed that Raw of small

airways accounts more than 50% of total Raw in COPD patients.

4.1.3.5. Changes of arterial blood gas parameters

The characteristics of arterial blood gas were also suitable with

selection criteria, similar to other studies about valve placement by

Sciubar F.C. et al (2010)... This meant that arterial PaO 2 is always

low in severe COPD patients, needed oxygen therapy in treatment.

4.1.4. Correlations between emphysema severity on chest CTscan images and respiratory function parameters



20

Emphysema severity had a moderate negative correlation with

VC, MVV and FEV1 and a relatively strong positive correlation with

RV and TLC. This result has an important mean in clinical practice.

In the medical facilities without plethymosgraphy, it could be based

on the result of CT-scan image to speculate the values of RV and

TLC in COPD patients.

4.2. Results of one-way valve placement in LVR treatment

4.2.1. Clinical and para-clinical characteristics of valve placement and

control group

4.2.1.1. Characteristics of age and gender

In comparison with other previous studies about valve

placement in the world, patients in this study had similar

chracteristics of age but different of gender.

4.2.1.2. Clinical characteristics

Clinical characteristics of patients in group 1 showed that the

status of nutrition was low with bad control of disease and COPD had

affected much daily life. To compare with other studies by Sciubar

F.C. et al. (2010),... patients had similar 6-MWD, demonstrating poor

exertion. This is a target of the LVR methods. Besides, BMI was

significant lower, demonstrating lower status of nutrition, leading to

affecting of the efficacy of valve placement later.

4.2.1.3. Para-clinical characteristics

Para-clinical characteristics were suitable with the selection

criteria for BLVR. This character was similar to that in the previous

studies in the world by Sciubar F.C. et al. (2010),... All patients

decreased VC, FVC and FEV 1, combined with severe increased RV,

TLC and Raw. These patients had indications of LVR.

4.2.2. Results of one-way valve placement

4.2.2.1. Quantity, size and location of bronchial valve

Characteristics of quantity, size and location of bronchial valve

were diffrent from those in previous studies in the world, such as:

Herth F.J.F. et al. (2012),... Patients were placed fewer vales, with



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