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Interventions for Tuberculosis Control and Elimination 2002

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mendation by WHO states that no principal changes in BCG vaccine policy<br />

are warranted unless children present with symptomatic HIV infection, 721<br />

a statement that has not been challenged. 722,723<br />

Management of adverse reactions due to BCG vaccination<br />

Children with lymphadenitis due to BCG were r<strong>and</strong>omly allocated to receive<br />

either isoniazid or no treatment. 724 There was no difference in the duration<br />

of lymphadenitis between the two groups, nor did isoniazid prevent<br />

the occurrence of suppuration. Similarly, children with abscess <strong>for</strong>mation<br />

were r<strong>and</strong>omly assigned to receive either isoniazid or erythromycin (serving<br />

as placebo). 725 The response in each treatment group was the same.<br />

In another study, comparing excision, excision plus isoniazid, <strong>and</strong> isoniazid<br />

alone compared to a control group without intervention, no significant differences<br />

were observed between the various interventions, <strong>and</strong> in particular,<br />

isoniazid offered no advantage. 726 Non-suppurative lymphadenitis is a<br />

normal reaction, <strong>and</strong> is best left without antibiotic treatment. 690,727<br />

Patients with suppurative lymphadenitis following BCG vaccination<br />

were r<strong>and</strong>omly assigned to treatment with simple needle aspiration, introducing<br />

the needle subcutaneously two to three centimeters distant from the<br />

node, versus no treatment. 728 Regression was significantly faster in the<br />

treated than in the non-treated group, <strong>and</strong> spontaneous drainage was less<br />

frequent.<br />

For osteoarticular mycobacteriosis due to BCG, combination therapy<br />

is indicated, but results were not always favorable (both in terms of sequelae<br />

<strong>and</strong> relapses) in a case series from Sweden. 729<br />

A st<strong>and</strong>ard course of treatment (as <strong>for</strong> clinically manifest tuberculosis)<br />

is also indicated in disseminated mycobacteriosis due to BCG. As this<br />

is a rare complication, however, treatment regimens have not been amenable<br />

to <strong>for</strong>mal study. In treatment, it should be kept in mind that BCG is, like<br />

its parent organism, M. bovis, naturally resistant to pyrazinamide.<br />

Efficacy <strong>and</strong> effectiveness of BCG vaccination<br />

Efficacy is the extent to which an intervention produces a beneficial result<br />

under ideal conditions. The best setting to address efficacy is thus prospectively,<br />

in a controlled clinical trial. In contrast, effectiveness takes the various<br />

constraints that are found in the field into account in the actual routine<br />

delivery of the intervention. 730 Effectiveness is often ascertained<br />

104

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