แนวทางเวชปฏิบัติการรักษาวัณโรคในผู้ใหญ่ พ.ศ. 2555 (ฉบับปรับปรุงเพิ่มเติมพ.ศ

. . 2556 0

. . 2556 1

. . 2556

. . 2556

5

10

15

ISBN

1

5,000 20

. . 2556 2

5

10

15

20

. . 2556 3

77 5

. . 2463

2

10

15 . .2536 19

. . 2553 22 80 22 22

20

25

. . 2556 4

. . 2556

o

o 5

o (

)

10

o

o

15

o ,

o

20

o

o . . 2556

o (

)

o 25

. .

2556

. . 2556 5

(ABBREVIATION) .................................................................................................................................... 7 (STRENGTH OF RECOMMENDATION AND QUALITY ... 9

OF EVIDENCE) .................................................................................................................................................. (STRENGTH OF RECOMMENDATION) ............................................................................... 9 5 (QUALITY OF EVIDENCE) .................................................................................................. 9

.................................................................................................................................................................... 11 1

2 .............................................................................................................................................. 14 2.1 ....................................................................................................................................... 15 10

2.1.1 ...................................................................................................................... 15 2.1.2 .................................................................................................................. 16 2.1.3 ................................................................................................... 17 2.1.4 tuberculin skin test, Interferon gamma-released assays (IGRA)

2.2 ..................................................................................................................................... 20 15 2.2.1 .................................................................................................... 20 2.2.2 ......................................................................................................................................... 21 2.2.3 ................................................................................................................... 23 2.2.4 (Treatment after interruption) .................................................................................................................. 30 20

2.2.5 (ORGANIZATION OF TUBERCULOSIS TREATMENT UNIT, TB CLINIC) ( 4 4.5)

3 ....................................................................................................................................... 33 3.1 ............................................................................................................................................. 34 3.2 ................................................................................................................................................ 36 25

4 (FIRST-LINE ANTI-TUBERCULOSIS DRUGS, FLD) ............................. 40 4.1 ............................................................................................................ 41 4.2 .................................................................................................. 42 4.3 ....................................................................... 44

. . 2556 6

4.4 ............................................................. 49 5 ............................................................................................... 52

5.1 / .................................................................................................. 53 5.2 ......................................................................................................................... 56 5.3 .......................................................................................................................... 57 5 5.4 ......................................................................................................................... 58

............................................................................................................................................................. 60 1 ................................................................................................ 61

1.1 .......................................................................................... 62 1.2 ................................................................................................................. 66 10

2 RAPID MOLECULAR TESTING ................................... 68 3 ................................................................... 72

3.1 ...................................................................................................................................... 72 3.2 .......................................................................... 73 3.3 .......................................................................................................................................... 77 15

20

. . 2556 7

(Abbreviation)

AFB Acid-fast bacilli AIDS Acquired immunodeficiency syndrome ART Antiretroviral therapy 5 Cs D-cycloserine CSF Cerebrospinal fluid CXR Chest X-ray DOT Directly observed treatment DST Drug susceptibility testing 10 DR-TB Drug-resistant tuberculosis E, EMB Ethambutol Eto Ethionamide EPTB Extrapulmonary tuberculosis FDC Fixed-dose combination 15 FLDST First-line drug susceptibility test H, INH Isoniazid HIV Human immunodeficiency virus INF Interferon IGRA interferon-gamma release assay 20 Ix investigation Km Kanamycin Lfx Levofloxacin MDR-TB Multi-drug-resistant tuberculosis NNRTIs Non-nucleoside reverse transcriptase inhibitors 25 NRTIs Nucleoside reverse transcriptase inhibitors NTM Non-tuberculous mycobacterium NTP National tuberculosis control programme PAS P-aminosalicylic acid

. . 2556 8

PIs Protease inhibitors PMN Polymorphonuclear cell PTB Pulmonary tuberculosis Rapid DST Rapid drug susceptibility test R, RMP Rifampicin 5 SLDST Second-line drug susceptibility test S, SM Streptomycin SSC Standard short-course (2HRZE/4HR) TAD Treatment after default TAF Treatment after failure 10 TB Tuberculosis TB/HIV HIV-related TB TST Tuberculin skin test WHO World Health Organization XDR-TB Extensively drug-resistant tuberculosis 15 Z, PZA Pyrazinamide

20

. . 2556 9

(Strength of Recommendation and Quality of Evidence)

(Strength of Recommendation) ++ 5

(Cost-effective)

+

10

+/-

- 15

- - trongly against)

(Quality of Evidence) 20

I

1) (systematic review) (randomize-controlled clinical trials)

. . 2556 10

2) (well-designed, randomize-controlled, clinical trial) 1

II

1) (systematic review) (non-randomized, controlled, clinical trials) 5

2) (well-designed, non-randomized, controlled clinical trial)

3) (cohort) (case control analytic studies)

/ 10

4) (multiple time series)

. .2480

III

1) (descriptive studies) 15

2) (fair-designed, controlled clinical trial)

IV

1) (consensus) 20

2) 2

V

(Anecdotal report)

. . 2556 11

(incidence)

10 5

. . 2552 30

(new case) (relapse) 9.4

1.7

9 22

10

.2558

15

. . 2556 12

1

Genus Mycobacterium M. tuberculosis

complex M. tuberculosis ( ), M. africanum ( ), M. bovis (5

/ ), M. canetti M. microti ( ),

M. pinnipedii, M. caprae M. mungi 3 species DNA sequence

M. tuberculosis (M. TB)

10

airborne-transmitted infectious disease

(TB infection)

30

(tuberculin skin test; TST) interferon gamma (15

) interferon-gamma release assay (IGRA)

(latent TB infection; LTBI)

10 LTBI

(reactivated TB) ) (primary 20

TB) 4-6

. . 2556 13

(Standard short-course; SSC) 2

o 2 5

(++, I)

o 2

SSC (+, II)

o

2 SSC 10

(++, II)

o

(++, II)

(+, IV)

o 15

5 (++, II)

1. , .

2.

2548-2552 - . . 2554 20

3. Tuberculosis ; Epidemiology and Control . World Health Organization , 2002.

4. WHO report 2011 .Global tuberculosis control: Geneva, World Health organization

(WHO/HTM/TB/2011.16).

. . 2556 14

2

2.1

5

2.1.1

rales stethoscope 10

(post-tussive rales)

o 2

15

o 2.1 ( )

2.1.2 reticulonodular cavity

20

. . 2556 15

o

(++, I)

o

2.2 ( )

2.1.3 5 2.1.3.1

,

o

(true sputum) 2 ( ) 10

(++, II)

o ( )

1 (++, II)

3 (+, III)

o 2 (spot sputum) 15

(collected sputum) (++, II)

o /

2 (++, IV)

o

( ) 20

- (3% saline via nebulization)

(

. . 2556 16

)

(+/-, IV)

- /

(biopsy) (+/-, III) 5

2.1.3.2

(Gold standard)

(Non-tuberculous Mycobacterium; NTM)

10

o

( )

(++, II)

- 15

- 2

(default), (relapse) ( 1

)

- (treatment failure) ( 2.2.3

) 20

-

. . 2556 17

o NTM

, bronchiectasis (++, II)

o

(+, IV) 5

2.1.3.3

(nucleic acid amplification test; NAAT) PCR, real-time PCR,

(rapid molecular test) ,

NTM,

2.1.4 tuberculin skin test, Interferon gamma-released assays (IGRA) 10

15

. . 2556 18

2.1

patchy infiltrates + cavitary lesion

fibroreticular infiltrates with/without calcification 5

. . 2556 19

2.2

patchy infiltrates + cavitary lesion

fibroreticular infiltrates with/without calcification 5

2.2

2.2.1

o (++, I) 10

o > 60 ,

, , ,

, (++, II)

. . 2556 20

o nephrotic

syndrome, , ,

Aminoglycosides (++, II)

o (+, III)

o 5

( ) (++, II)

2.2.2 ( . . 2552) Category 1 4

3 10

1: New patient regimen ( 1 )

2HRZE / 4HR

1

o 2.1.3.2 15

o ( 1 1.1.3 )

o ( , 6 , , )

(delay treatment response) 20 (continuation phase) SSC 9-12

(++, II)

2: Re-treatment regimen with first-line drugs ( )

. . 2556 21

2HRZES5 / 1HRZE / 5HRE

default relapse ( 1)

2

o (++, II)

o treatment failure 5

( 1)

o TA ( 1.1 1.1.3 )

3: MDR regimen ( )

> 6Km5LfxEtoCs (+PAS )/ > 12 LfxEtoCs (+PAS ) 10

treatment failure

3

o (++, II)

o

(+, III) 15

o (DOT) (+, III)

o (++, II)

1 4

20

. . 2556 22

o ( )

Kanamycin 5 (++, II)

Kanamycin 3

(+, IV)

. 5 5

.

Streptomycin

6 4

(++, I)

o 18 2 (++, I) 10

o (

) 3 (

) (+, III)

2 3

( 2.1) 15

2.1

Treatment after failure (TAF)

Relapse or treatment after default (TAD)

. . 2556 23

Empirical MDR-TB regimen: > 6Km5LfxEtoCs (+PAS) / > 12 LfxEtoCs (+PAS)

Retreatment regimen: 2HRZES/1HRZE/5HRE

DST

( )

2.2.3 (2 ) (

) 5

1)

2)

(++, II)

1: New patient regimen ( 2.2) 10

. . 2556 24

2.2

1) 2.1.3.2

2) ( 2 ) 5

o 2

HR

PTB (SS+) 5

10

. . 2556 25

PTB (SS neg.)

o 2

5

- HR (

HRZE 1 )

3

- 10

2

1.

2.

3. (drug-to-drug / drug-to-food interaction)

15

4.

(immuno-compromised host)

5.

6. NTM

7. 20

8.

. . 2556 26

3) 3 ( 2 )

o 3

HR ( HRZE HR )

2 5

o 3

( )

10

rapid

molecular testing ( 2)

- HR ( HRZE HR)

- 15

4) 5 ( )

o 5 ( )

( )

- HR

(20

)

. . 2556 27

-

o 5 ( )

5

treatment failure* 3: MDR regimen (

)

(*

treatment failure ) 10

5) MDR-TB

treatment failure MDR-TB (

)

6)

15

2: Re-treatment regimen with first-line drugs ( 2.3)

. . 2556 28

2.3

(Re-treatment regimen with first-line drugs)

1) 5

2) ( 3 )

o 3

HRE 10

5

. . 2556 29

o 3

( )

rapid

molecular testing ( 2) 5

- HRE (

5 )

- HRE 10

5

-

3) 5 ( )

o 5 ( )

15

- HRE (

)

-

o 5 ( ) 20

. . 2556 30

treatment failure* MDR-TB

(* 5

treatment failure )

4) MDR-TB

treatment failure MDR-TB (

)

2.2.4 (Treatment after interruption) 10 ( 4

4.5)

( 2.3)

2.3 15

1.

2.

3.

treatment after interruption (+, III)

o 20

o

DOT

. . 2556 31

o

2.3

2.2.5 (Organization of tuberculosis treatment unit, TB Clinic) 5

2.2.5.1

-

10

2.2.5.2

. . 2556 32

( 1-2

5-7 )

2.2.5.3

(daily package) 5

(FDC) Bioavailability

2.2.5.4

2.2.5.5 10

2.2.5.6

(DOT)

15

2.2.5.7

2.2.5.8

20

)

. . 2556 33

1. American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America: Treatment of Tuberculosis Am J Respir Crit Care Med 2003; 67:603 662.

2. Centers for Disease Control and Prevention. Treatment of Tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR 2003;52(No. RR-11):177. 5

3. Drug Information Handbook with International Trade names index 2008-2009. 17th edition. American Pharmacist Association. Senior Editor: Charles F Lacy, Lora L Armstrong, Morton P Goldman, Loonard L Lance.

4. The Sanford Guide to Antimicrobial Therapy 2009. 39th edition. Editors: David N Gilbert, Robert C Moollering Jr, George M Eliopoulos, Henry F(Chip) Chambers, Michael S Saag. 10

5. World Health Organization 2003. Treatment of Tuberculosis: Guidelines for National Programmes. 3rd Edition. WHO, Geneva, 2003. WHO/CDS/TB/2003.313

6. World Health Organization 2010. Treatment of tuberculosis: Guidelines. 4th edition. WHO/HTM/TB/2009.420

7. WHO Model Formulary 2008.Available at http://www.who.int/selection_medicines/list/WMF 2008.pdf 15

. . 2556 34

3

primary reactivated TB

5

3.1

3.1

( )

5 -44

30 -50

32

20 - 28

10

Documents

แนวทางเวชปฏิบัติการรักษาวัณโรคในผู้ใหญ่ พ.ศ. 2555 (ฉบับปรับปรุงเพิ่มเติมพ.ศ