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Essentials of Diagnosis

• The cardinal symptoms of tuberculosis (TB) are fatigue, weight loss, fever, and night sweats.

• The most commonly infected populations include the homeless, institutionalized patients, and HIV-positive patients.

• In most cases, a TB skin test (PPD) is positive.

• To establish presence of infection, an acid-fast bacilli (AFB) smear demonstrates the acid-fast bacillus.

• In primary pulmonary TB, an infiltrate in the lower lobes of the lung is usually seen on chest x-ray. In contrast, apical lung infiltrates are commonly seen in the reactivation of pulmonary TB.

General Considerations

Mycobacterium tuberculosis is still an important pathogen. Approximately one-third of the world’s population is infected with M tuberculosis, according to World Health Organization estimates, resulting in 2.9 million annual deaths. In the United States, tuberculosis is on the rise, after several decades of steady decline.

The disease develops in a subset of those who are infected. In most patients, the reason disease develops is unclear unless they are immunosuppressed by either HIV infection or other immunocompromising diseases. HIV has played a major role in the resurgence of tuberculosis in the United States and in the emergence of multidrug-resistant disease. Prompt diagnosis and treatment of active disease is important in all patients to prevent severe disease and infection of the surrounding population. In those infected with the tuberculosis bacillus, the prevention of active tuberculosis disease is also important.

A. Epidemiology. In the United States, tuberculosis had been on the decline until 1985, when the number of cases began to increase. This increase was undoubtedly a result of the HIV epidemic. Cases continued to increase until 1995, when the 22,813 new cases documented in the United States constituted a 6.4% drop from 1994. This drop resulted from a decreased incidence in the U.S.-born population. The overall incidence of tuberculosis in the United States is quite low, but case rates are high among specific groups such as HIV-infected patients, the homeless, recent immigrants from countries that have a high prevalence of tuberculosis, intravenous drug users, inner-city dwellers, and minorities.

In the late 1980s, tuberculosis caused by organisms resistant to antimicrobial agents increased sharply, especially in New York City, where, in 1991, one-third of all cases were resistant to at least one agent. The rates of resistance in the United States began to decrease in 1995. Of cases reported, the isoniazid (INH) resistance rate was 7.6%, and the INH-rifampin resistance rate was 1.4%. The decrease in resistance rates was most likely caused by the introduction of directly observed therapy and intensive case management.

One lesson learned from the resurgence of tuberculosis and multidrug-resistant tuberculosis is the importance of tuberculosis control strategies and the importance of making sure patients adhere to the medication regimens. The Centers for Disease Control recommends that all tuberculosis patients be observed taking their medications by health care providers (“directly observed therapy,” [DOT]). The decrease in U.S. case rates has been attributed to the institution of DOT. Other factors thought to have decreased the case and resistance rates are improved laboratory methods for identifying tuberculosis, broader use of drug-susceptibility testing, expanded use of preventive therapy in high-risk groups, decreased transmission of tuberculosis in congregative settings, improved follow-up of persons with TB, and increased federal resources for state and local TB control efforts.

M tuberculosis is transmitted in the air. The bacillus is packaged in a droplet nucleus and coughed out into the surrounding air by one person and inhaled by another. Patients with bronchopulmonary TB with a productive cough are particularly infectious. Other factors that increase the infectivity of a person are the extent of cavitary disease of the lung, presence of AFB on the sputum smear, unprotected coughing, and crowding in a household. Generally, patients with extrapulmonary TB are not infectious.

B. Microbiology. M tuberculosis is an AFB that is curved or straight and nonmotile. It is slow growing, taking = 18 h for one replication. Typically, it may take 2-6 weeks to grow a significant colony. The bacillus is non-pigment producing, which can be used to differentiate it from some other atypical mycobacteria.

C. Pathogenesis. A person is infected with M tuberculosis by inhaling bacilli in droplet nuclei. The particles must be retained in the lung. Thus the inhaled particles, which are < 5 um in size, travel to the alveolus during inspiration and are retained in the lung. Larger particles are filtered out before they reach the alveoli. In the alveolus, the bacillus activates the immune system. The first line of defense is the alveolar macrophage. These macrophages engulf the bacilli. Some macrophages are capable of killing the bacillus, whereas others cannot. The bacilli multiply within the cells. The factors controlling the macrophages’ ability to kill M tuberculosis are not all known and may be genetic. At any rate, T cells are then attracted to these macrophages and recognize the M tuberculosis protein presented by the macrophage. The T cell lyses the infected macrophage. Memory T cells then develop which are thought to contribute to the delayed hypersensitivity reaction relied on by the purified protein derivative (PPD) skin test. These memory T cells also enable patients previously infected with TB to resist reinfection. Other factors that influence the progression of infection to disease include the intensity of exposure, interval since infection, age, and other coexisting or comorbid diseases. Extrapulmonary disease develops when the bacillus is not contained in the lungs and travels to other organs by way of the bloodstream.

Infection by M tuberculosis is reflected by a positive skin test reaction, although, in some immunocompromised patients, a PPD test result may be negative even though these patients are infected. Those who are immunosuppressed have an increased chance of developing illness, which may be caused by an ineffective cell-mediated response (Box 1). Cell-mediated immunity is thought to be the mechanism by which a contained TB infection is kept quiescent. Patients who are HIV positive (who have ineffective cell-mediated immunity) and are infected with TB have a 7% chance per year of developing active tuberculosis.

Active tuberculosis disease is defined as tissue involvement by the M tuberculosis bacillus that progresses to produce clinical symptoms and signs. On average, illness develops in 3-5% of infected patients. Of the other 95-97% of infected patients, 5% develop active tuberculosis in their lifetime. M tuberculosis infection can cause several clinical syndromes.

Tuberculosis: Clinical Syndromes

Table 1. Factors causing a false-negative PPD test.1

Technical errors

• Improper administration

• Inaccurate reading

• Loss of potency of antigen

Patient-related factors

• Age

• Nutritional status

• Medications — corticosteroids, immunosuppressives, anti-neoplastic agents

• Severe tuberculosis

• Coexisting diseases such as renal failure

• HIV infection

• Viral illness or vaccination

• Lymphoreticular malignancies

• Sarcoidosis

• Solid tumors

• Lepromatous leprosy

• Sjogren’s syndrome

• Ataxia telangiectasia

• Uremia

• Primary biliary cirrhosis

• Systemic lupus erythematosus

• Severe systemic disease of any etiology

 Table 2. Treatment options per risk of antimicrobial resistance.1,2

Risk Group

First Option

Second Option

Third Option

U.S. born & not living in an area of increased resistance (<4%) & no risk factors for MDR TB

• 1st 2 mo, INH + RIF + PZA

• Followed by 16 weeks of INH + RIF daily or 2× per week

• INH + RIF + PZA+ SM or ETB daily for 2 weeks

• Then 2×/week for 6 weeks by DOT

• Then INH + RIF 2x/week for 16 weeks by DOT

• INH + RIF + PZA + ETB or SM for 6 mo 3×/week by DOT

Recent immigrant from Latin America or Asia or living in an area of increased resistance or previous treatment without RIF

• INH + RIF + PZA + ETB or SM for 2 mo

• If INH + RIF sensitive, then DC PZA + ETB or SM after 2 mo of four-drug treatment

• Then INH + RIF daily or 2×/ week for 4 mo

• DOT preferred unless com- pliance is quite certain

Proven, high-risk, or known exposure to MDR TB

Injectable drug (amikacin or capreomycin or kanamycin) + fluoroquinolone (cipro or oflox) + ETB + PZA + INH + RIF + cycloserine or ethionamide or aminosalicylic acid

Daily treatment recommended, not intermittent

HIV+ or AIDS, pulmonary or extrapulmonary

Same as row 2 above: stop protease inhibitor

If INH or RIF can’t be used, treatment should be for 18 and 12 mo after cultures are negative

Maintenance treatment is not required

Table 3. Side effects of anti-TB drugs.1

Anti-TB Drug

Major Side Effects

Major Drug Interactions

Ethambutol

• Optic neuritis

None noted in the PDR

Isoniazid

Hepatitis

• Peripheral neuropathy (prevent by coadministering pyridoxime)

• Inhibits some cytochrome P-450 enzymes

• Warfarin (potentiation)

• Benzodiazepines (potentiation)

• Theophylline (potentiation)

Pyrazinamide

• Arthralgia

• Hyperuricemia

None noted by the PDR

Rifampin

• Elevated liver function tests

• Flu-like syndrome

• Discoloration of secretions which stain

• Induces cytochrome P-450 system

• Inhibits effects of oral contraceptives, quinidine, corticosteroids, warfarin, methadone, digoxin, and oral hypoglycemics

Streptomycin

• Ototoxicity

• Potentiates the action of neuromuscular blocking agents

Table 4. Preventive therapy for tuberculosis infection.1

Tuberculin Reaction Classification

Persons Recommended for Preventive Therapy =5 mm is positive if high risk

• Known or suspected HIV infection including injection drug users

• Close contacts of active cases

• Chest radiograph suggests previous inactive tuberculosis =10 mm is positive if intermediate risk

• HIV-negative injection drug users

• Immunosuppressive illness or therapy (diabetic, renal failure, hematologic malignancy, rapid weight loss illness, prolonged prednisone use >15 mg/d)

• Immigrants from high-prevalence countries

• Residents of long-term care or correctional facilities

• Locally identified high-prevalence groups (migrant workers, homeless, high-risk racial or ethnic groups)

• Children =4 years old

=15 mm is positive if no known risk

New converters on serial testing

• =10 mm increase if <35 years old

• =15 mm increase if =35 years old

PPD negative but high risk

• Anergic HIV-infected persons

• High-risk contacts of active cases

All persons regardless of age

All persons regardless of age

All persons regardless of age

Only if <35 years old

Only if <35 years old

Only if <35 years old

Only if <35 years old

All persons

All persons

All persons

Treat until repeat PPD is negative 12 weeks later

Table 5. Prophylaxis for drug-resistant M tuberculosis.1,2

Prophylaxis Therapy

Resistance

First Option

Other Options

INH-Resistant Organisms

• RIF, 600 mg/d orally for 6-12 months

• Children (<4 years), RIF + INH for 9 mo

• ETB + RIF daily × 6-12 mo

• PZA + RIF daily × 2 mo; then INH + RIF daily until sensitivities are known (if index case is INH resistant, DC INH & continue RIF × 9 mo)

INH + RIF-Resistant Organisms

• PZA (25-30 mg/kg/d orally) + ETB (15-25 mg/kg/d orally) for 6 mo (if HIV positive, treat for 12 mo)

• PZA + ciprofloxacin (750 mg orally twice a day) or ofloxacin (400 mg orally twice a day) for 6-12 mo

BOX 1. Mycobacterium tuberculosis

Children

Adults

More Common

• Lymphatic

• Other extrapulmonary sites

• Pulmonary

Less Common

• Pulmonary

• Extrapulmonary

BOX 2. Mycobacterium TB in AIDS Patients

(CD4 < 100)

Children

Adults

More Common

• Disseminated

• Pulmonary

• Pulmonary

• Disseminated

Less Common

• Other extrapulmonary sites

• Other extrapulmonary sites

BOX 3. Treatment of Mycobacterium TB.

Children

Adults

First-Line Drugs

Isoniazid

• Daily dose 10-15 mg/kg/d (300 mg/d max)

• 2× weekly dose 20-40 mg/kg/dose (900 mg/dose max)

Rifampin

• Daily dose and 2× weekly 10-20 mg/kg/d (600 mg/d per dose max)

Pyrazinamide

• Daily dose 15-30 mg/kg/d

• 2× weekly 50-70 mg/kg/dose

• Max dose 2 g

Streptomycin

• Daily dose 20-40 mg/kg/d IM (max dose 1 g)

• 2× weekly dose 25-30 mg/kg/dose IM

Ethambutol

• Daily dose 15-25 mg/kg/d

• 2× weekly dose 50 mg/kg/dose

• Max dose 2.5 g

Ethambutol (bacteriostatic)

• Daily dose 25 mg/kg/d for 2 mo, then 15 mg/kg/d

• 2× weekly dose 50 mg/kg/dose

Isoniazid (bactericidal)

• Daily dose 5-10 mg/kg/d (300 mg/d max)

• 2× weekly dose 15 mg/kg (900 mg max)

Pyrazinamide (bactericidal)

• Daily dose 25 mg/kg/d (2.5 g/d max)

• 2× weekly dose 50-70 mg/kg/dose

Rifampin (bactericidal)

• Daily and 2× weekly dose 10 mg/kg/d (600 mg/d max)

Streptomycin

• 15 mg/kg IM daily for initial 2 mo

• Rest of Rx if needed 1.0 g IM 2-3×/week (25-30 mg/kg/dose)

Second-Line Drugs

Ethionamide

• 10-20 mg/kg/d (max dose 1 g)

Kanamycin

• Daily dose 15 mg/kg/d IM

• 2× weekly dose 15-25 mg/kg/dose IM or IV

• Max dose 1 g

Cycloserine

• Daily dose 10-20 mg/kg/d (max dose 1 g)

Amikacin (bactericidal)

• 7.5-10 mg/kg IV or IM daily

Capreomycin sulfate

• 1 g/d (15 mg/kg/d) IM

Ciprofloxacin

• 750 mg orally or IV twice a day

Clofazimine

• 50 mg/d + 300 mg 1×/mo supervised or 100 mg/d orally

Cycloserine (bacteriostatic)

• 750-1000 mg/d (15 mg/kg/d) in 2-4 doses/d orally

Ethionamide (bacteriostatic)

• 500-1000 mg/d (10-15 mg/kg/d) orally in 1-3 doses/d

Ofloxacin

• 400 mg orally or IV twice a day

• Para-aminosalicylic acid (bacteriostatic)

• 4-6 g orally twice a day (200 mg/kg/d)

Rifabutin

• 300 mg/d orally

Special Considerations

• Other drugs used in children but rarely are listed in second line under adults; optimal doses for children have not been established.

Ethambutol is not recommended in children < 13 years of age

• In patients older than 60 years, the daily dose of streptomycin should be only 10 mg/kg/d (max dose of 750 mg)

BOX 4. Control of Mycobacterium TB

Prophylactic Measures

• Preventative therapy for PPD-positive patients and known household contacts

• See Table 5 for preventative therapy

Isolation Precautions

• Negative pressure room for patient with pulmonary TB until AFB sputum smear quantifications are significantly decreased

• Masks for health care workers are of unproven efficacy

 

 

 

 

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